cyrilzakka/clinical-trials huggingface dataset:
Retrospective Study to Describe the Real-world Treatment Patterns and Associated Clinical Outcomes in Patients With Metastatic Castration-resistant Prostates Cancer

This is a multi-country, multi-centre, retrospective, non-interventional cohort study planned to include patients diagnosed with mCRPC between 01 January 2016 and 31 December 2018, who have received at least 1 line of treatment (LOT) in the mCRPC setting, and have 12 months of follow-up data available.

This is a multi-country, multi-centre, retrospective, non-interventional cohort study planned to include patients diagnosed with mCRPC between 01 January 2016 and 31 December 2018, who have received at least 1 line of treatment (LOT) in the mCRPC setting, and have 12 months of follow-up data available.To describe the real-world treatment patterns in patients with mCRPC

The data will be collected retrospectively between the date of diagnosis of mCRPC (index date) and the end of follow-up, i.e., until death, the last medical record entry, or the date of data extraction, whichever is the earliest. The data on different types of treatment received by the patients, sociodemographic and clinico-pathological characteristics, and healthcare utilization will be extracted from the medical records of patients (alive or deceased) into a centrally designed electronic data capture system. For the exploratory end point on real-world treatment patterns in patients with mCSPC, data on different types of treatment received by the patients, sociodemographic and clinico-pathological characteristics will be retrospectively extracted from the medical records of patients (alive or deceased) into a centrally designed electronic data capture system.

Eligibility Criteria:
Inclusion Criteria:

* Male patients ≥18 years of age OR legal age of being an adult in the country as per local regulations 2. Patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver is granted) willing and able to provide written informed consent according to the local regulations 3. Patients with a diagnosis of metastatic (stage IV) mCRPC, confirmed by either biopsy of a metastatic tumour site or by history of biopsy-proven localized disease and evidence of metastatic disease on imaging studies (which is clearly noted in hospital/clinical records) and progression on ADT alone between 01 January 2016 and 31 December 2018 4. Availability of medical records at the participating site reflecting at least one LOT received in the mCRPC setting and 12 months of follow-up from the index date (unless the patient died or was lost to follow-up within the first 12 months after diagnosis)

Exclusion Criteria:

-1. Patients with a concomitant cancer at the time of diagnosis of mCRPC or those who are treated with any anti-cancer therapy indicated for other cancers within 6 months of diagnosis of mCRPC, except for non-metastatic non-melanoma skin cancers or in situ or benign neoplasms.

2. Patients unable to give an informed consent (unless a waiver is granted)
Sex Differences in Early Brain Development; Brain Development in Turner Syndrome

Relative risk for many psychiatric disorders differs dramatically in males and females. Early-onset disorders, such as autism, occur more often in males; other conditions, such as schizophrenia, occur at similar rates in males and females, but the sexes differ in expression. It has been hypothesized that the prevalence and expression of these disorders is related to sex differences in brain development. X-chromosome effects and early exposure to gonadal hormones are strong candidates for a causal role. The aims of the research are (1) to characterize sex differences in brain development from birth to age 2; (2) to test whether brain development is altered in infants with Turner syndrome, a well-defined genetic disorder resulting from the partial or complete loss of one of the sex chromosomes. To address aim 1, high resolution MRI, including diffusion tensor imaging (DTI), will be used to characterize sex differences in brain development from birth to age 2 in a longitudinal cohort of 250 children. To address aim 2, high resolution MRI, including DTI, will be used to compare brain development in 70 infants with Turner syndrome (X monosomy) to matched controls from aim 1. The investigators hypothesize that sex differences in gray and white matter development and in white matter maturation as assessed by DTI will be present during the first 2 years of life and that children with TS will exhibit abnormal gray and white matter development in the neonatal period.


Eligibility Criteria:
Inclusion Criteria:

* For controls a child must have a normal ultrasound at the 18 week prenatal visit and the absence of major medical or psychiatric conditions in the mother.
* Children with Turner Syndrome must have diagnosis confirmed by genetic testing.

Exclusion Criteria:

* For controls - major medical or psychiatric conditions in the mother and major medical problems or congenital conditions in the child.
* For Turner children - The study is open to all TS karyotypes except those with Y chromosome material.
* For both groups children with conditions that preclude participating in an MRI scan ( i.e. metal in the body)
Enhancing Consent for Alzheimer's Research

The purpose of this study is to evaluate the efficacy of an enhanced consent procedure for patients with mild-to-moderate Alzheimer disease, and to identify factors and patient characteristics that predict the degree to which enhanced consent is more beneficial than routine consent procedures.

Alzheimer disease can impair the capacity of patients to give informed consent for research participation. Studies of informed consent involving other patient populations suggest better understanding of consent-relevant information may be achieved through modifications in the consent delivery process, including incorporation of multimedia learning tools into the consent discussion.

In the present study, participants with Alzheimer disease and age-comparable healthy participants will be randomly assigned to review a hypothetical research protocol via routine or enhanced consent procedures. Participants will also complete standard cognitive and other rating scales so that we can characterize the sample, as well as evaluate the degree to which specific characteristics may be associated with need for enhanced consent procedures. Advances in the methods to optimize the informed consent process should enable future research participants to make more fully informed decisions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild to moderate possible or probable AD or demographically comparable healthy comparison subjects
* Fluency in English
* 50 yrs and older
* Informed written consent (or written assent with consent from legally authorized representative)

Exclusion Criteria:

* Diagnosis of Lewy Body Dementia or Mild Cognitive Impairment
* MMSE less than 15
* Physical or medical conditions that preclude participants from completing tasks
* Healthy comparison volunteers if they have a known neurologic or psychiatric condition that could impair neurocognitive functioning
Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer

This pilot clinical trial studies how well intravital microscopy works in evaluating patients with primary peritoneal, fallopian tube, or stage IA-IV ovarian cancer. Intravital microscopic evaluation of tumor blood vessels, blood flow, immune cell interactions, and drug uptake may be eventually visualized and may lead to valuable prognostic information.

PRIMARY OBJECTIVES:

I. To determine the feasibility of performing intravital microscopy on accessible human ovarian, primary peritoneal and fallopian tube cancers during their standard course of treatment (i.e., surgical debulking).

SECONDARY OBJECTIVES:

I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein as a marker of tumor vessel permeability.

OUTLINE:

Patients receive fluorescein sodium injection intravenously (IV). Patients also undergo observation of primary and metastatic tumors via microscopy over 15-20 minutes during the course of standard of care surgery.

After completion of study, patients are followed up for 30 days, at 1-3 weeks, and then up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Suspicion of gynecological malignancy that requires a standard of care surgical resection in the operating room;
* Have measurable lesion in the pelvis or abdomen, at a minimum of 0.5 cm in diameter on standard of care pre operative imaging studies (CT, MRI or PET scan),
* Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* Serum Creatinine \<= 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL/min for participant with creatinine levels \> 1.5 X institutional ULN (using Cockcroft-Gault Equation), GFR can also be used in place of creatinine or CrCl.

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Any known allergy or prior reaction to fluorescein
* Nursing female subjects
* Liver dysfunction; normal liver function defined as total bilirubin within normal institutional limits and aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
* Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography (EKG), chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure

The aim of the present prospective study was to evaluate dynamic changes in both pulmonary artery pressure and ductus arteriosus during the first 72 hours after birth.

Healthy newborn infants born in Alexandria University Children's Hospital were studied. Dynamic changes during the first 72 hours after birth were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age: 37-42 weeks.
* Birthweight: 2500-4000 g.

Exclusion Criteria:

* Neonates more than 6 hours of age at time of enrollment.
* Perinatal asphyxia or hypoxia (1 min Apgar scoring\<7 points)
* Cardiac structural abnormalities detected by echocardiography except patent foramen ovale and patent ductus arteriosus
* Other clinically detected congenital malformations such as cleft lip and palate, omphalocele, meningocele, etc.
* Maternal history of gestational hypertension, gestational diabetes, hyperthyroidism, hypothyroidism, and autoimmune disease
Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers

Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 20 and \<= 35 years
* Weight: Body Mass Index \>= 18.5 and \< 25
* Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
* Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent

Exclusion Criteria:

* History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
* History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin etc.) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
* History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
* History of bleeding tendency
* History of alcohol or drug abuse
* Participation to another trial with an investigational drug within 4 months prior to the trial
* Whole blood donation more than 400 ml within 3 months prior to the trial
* Whole blood donation more than 100 ml within 1 month prior to the trial
* Donation of constituent of blood of more than 400 ml within 1 month prior to the trial
* Any medication which might influence the results of the trial within 10 days prior to the trial
* Excessive physical activities within 7 days prior to the trial
* Alcohol drinking within 3 days prior to the trial
* History of orthostatic hypotension, fainting spells or blackouts
* Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
Dynamic Oscillatory Stretch Technique Versus Static Stretching In Reduced Hamstring Flexibility

This study compared the effects of dynamic oscillatory stretch technique (DOS) and static stretching (SS) technique in order to improve hamstring extensibility in healthy individuals with asymptomatic hamstring tightness. Half of study participants received DOS whereas other half received static stretching technique.

This was a single blind randomized control trial conducted at District Head Quarter teaching hospital Sargodha, Sargodha institute of health sciences Sargodha, Sadiq hospital Sargodha (march 2018-June 2018). Sample size of 83 individuals was calculated through Open Epi tool version 3 with 95 % confidence interval (CI), and power 80%. 83 individuals were screened out on the basis of inclusion and exclusion criteria. Individuals of this selected population were randomly allocated as 42 individuals in Dynamic Oscillatory Stretch(DOS) group and 41 individuals in Static Stretching(SS) group by sealed envelope method.

After the application of hot pack treatment of 7-10 minutes to both groups dynamic oscillatory stretch technique (30 repetitions each of 2 seconds stretch duration in one session) was applied to DOS group and SS stretching (2 repetitions each of 30 seconds in one session) was applied to SS group.

Assessment was done at baseline, immediate post-intervention levels (immediately) and post-intervention level after 1 hour. At baseline and immediately post-intervention level there was no dropout but after 1 hour post-intervention level there were two dropouts from DOS group and 1 dropout from SS group. 40 individuals were analyzed in each DOS and SS group. Data analysis was done through Statistical Package of Social Sciences(SPSS) version 20. Normality of different variables was assessed. Shapiro-Wilk test provided the basis for normality distribution of data.

Eligibility Criteria:
Inclusion Criteria:

* Males and females with age limit 20 to 40 years,
* Active knee extension/90-90 test positive for Screening (With AKE range less than 160 degrees),
* No known history of hip joint or knee joint disease,
* No history of recent hamstring strain.

Exclusion Criteria:

* History of sub-acute and chronic back pain of lumber region and SI joint in past 6 months,
* Neurological pathology,
* Patients with some kind of particularly specific pathology (e.g. infection, tumor, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder).
Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants

The aim of this study is to evaluate the influence of superstructure material on crestal bone resorption and esthetic outcome of dental implants in patients with single missing tooth in the aesthetic zone.

The transfer of occlusal forces to the implant bone interface greatly influence the long term prognosis of implants and crestal bone resorption. Accordingly this study will investigate the influence of metal ceramic crowns and monolithic zirconia crowns on crestal bone resorption under loading. Also these crown materials greatly influence the final aesthetic outcome of the definitive restoration, which will be evaluated using the pink and white aesthetic scoring systems.

Eligibility Criteria:
Inclusion Criteria:

1. Patients above 18 years old.
2. Patients able to read and sign the informed consent document. 3. Medically free patients or with controlled systemic disease.

4. Patients with good bone quality and quantity evaluated using C.B.C.T. 5. Patients willing to return for follow-up examinations and evaluation. 6. Patients having single missing recently extracted premolar tooth.

Exclusion Criteria:

1. Young patients in growth stage.
2. Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
3. Pregnant women to avoid any complication that may occur in dental office.
4. Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
5. Psychiatric problems or unrealistic expectations.
6. Multiple adjacent missing teeth.
7. Patients with bad oral hygiene
Ilomedin Treatment for Patients Having Undergone Primary Percutaneous Coronary Intervention (PCI)

Acute myocardial infarct patients with STEMI (ST-elevation on ECG) whom undergo a primary percutaneous cardiac intervention will following the standard treatment , received low dose of Ilomedin and to low dose of standard treatment for another 24 hours.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Undergoing primary PCI due to STEMI (TIMI flow I -III before PCI and symptom duration \< 12 hours)

6) Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study data is used.

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Exclusion Criteria:

2) Not able to give informed consent 3) Women with childbearing potential 4) On-going concomitant treatment with K-vitamin antagonists (one bolus dose pre-PCI allowed) 5) Known congenital or acquired coagulopathy and/or thrombocytopathy s 8) Participation in a clinical study and/or another investigational device within the past four weeks prior to Day 1 9) Major surgery or trauma within the past 6 weeks prior to Day 1 10) A blood coagulation disorder (i.e. international normalized ratio \[INR\] \> 2.0, platelet count \< 100,000/mm3, or hematocrit \< 30%) 11) Renal insufficiency (creatinine \> 140 mmol/l) 12) Major procedure related bleeding (TIMI major criteria); GI or urinary tract bleeding prior to inclusion in the trial 13) Known active hepatitis B and/or hepatitis C or HIV 14) Known or suspected hypersensitivity to components of the investigational medicinal product

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Compensatory Kinematic Movements in Various Directions After Stroke

This is cross-sectional study. By comparing kinematic analysis between stroke and healthy subjects in various directions, this investigation analyzes the compensatory kinematic movement for reaching task in stroke survivors

After Institutional Review Board approval, It recruits 2 groups. one group is elderly and another group is stroke survivors. the stroke group that meets the criteria. Another group is age matching of the stroke and not having an orthopedic or neurological disease. Participants of all the groups are assessed for kinematic by motion capture During reaching arm(affected side; stroke group, non-dominant side; healthy group) in 3 directions(medial_45, forward_90 and lateral_135 degrees). Retroreflective markers are placed on 11 anatomical place (3th metacarpal joint, both acromion, elbow lateral and medial epicondyle, lateral and medial styloid process, xyphoid process, sternum, C7, T4). Participants reach to a bell as quickly as possible in three directions. The subject reach to a bell 5 times in each direction and assess clinical evaluation such as Fugl Meyer Assessment, Postural Assessment Scale, Modified Ashworth Scale, shoulder-elbow range of motion and Trunk Instability scale.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria used in the randomized controlled trials were as follows:

Stroke

* Subject consisted of the physician's confirmation of chronic hemiplegia
* onset ≥ 6 months
* Mini-mental state examination≥25
* Biceps ≤2, Triceps≤2
* Ability to Sit on a chair alone
* FMA upper extremity score ≥ 21 points, FMA upper extremity ≤ 66 points

Healthy

* Age of matching the stroke group
* Absence of neurological disease and orthopedic disease

Exclusion Criteria:

Stroke

* Biceps\>2, Triceps\>2
* Flaccid
* Neglect syndrome
* Have neurological disease and orthopedic disease
* Lack of coordination
Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

An alpha linolenic acid (ALA) rich diet in the Lyon Diet Heart Study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994).

Since then, there has been a growing interest in ALA, ω-3 fatty acid family precursor, as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of longer chain ω-3 fatty acids, DHA and EPA, derived from fish.

We therefore concluded it important to test wether vegetable source ω-3 also had antiarrhythmic effects, as shown in animals by Leaf and McLennan, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Diet Heart Study.

Objective: To determine the effect of an ALA rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia.

Design: Randomized parallel design efficacy study.

Setting: Three university hospital centers in the Bordeaux region, France.

Patients: 98 patients randomized immediately after successful atrial fibrillation electrical cardioversion.

Intervention: A canola margarine and oil, versus a conventional diet (control), with a one year follow-up.

Main outcome measure: Length of time to first recurrence of atrial fibrillation.

Significance: If ALA is antiarrhythmic, this action may explain its cardioprotective effect in clinical trials and cohort studies.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in one of the three centers in the Bordeaux region
* clinical diagnosis of atrial fibrillation
* who subsequently underwent successful electrical cardioversion

Exclusion Criteria:

* unable to receive electrical cardioversion
* already enrolled in another trial
* unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements
* clinically significant cardiac disease, advanced heart failure, cardiac cachexia
* thyroid disease, treated or untreated,
* clinically significant hepatic or renal disease
* history of malignant disease
* alcohol abuse
* taking ALA rich foods or recording intakes of ALA \>2g/d on the control diet or reporting using \<1g/d on the ALA diet was considered a major deviation from the protocol