cyrilzakka/clinical-trials huggingface dataset:
A Safety and Efficacy Study of Abiraterone Acetate in Participants With Prostate Cancer Who Have Failed Hormone Therapy

The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[MTD\]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).

This is an open-label (all people know the identity of the intervention) study to evaluate the safety, tolerability, and recommended dose of abiraterone acetate taken orally (by mouth), once daily in participants with HRPC. The study will consist of a dose escalation stage (Phase 1) that will be conducted to determine the MTD of abiraterone and an activity evaluation stage (Phase 2) to evaluate the activity of abiraterone in participants with HRPC. Escalated doses of abiraterone (starting at 250 milligram \[mg\] up to a maximum of 2000 mg) will be given for 28-day treatment periods to determine the MTD. Participants will be given MTD of abiraterone for up to 12 cycles (28 day each) in Phase 2 of the study. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically (pertaining to the disease status of body tissues or cells) documented adenocarcinoma of the prostate, clinically refractory (not responding to treatment) or resistant to hormone therapy, as documented by progression following at least one hormonal therapy
* Prostate specific antigen (PSA) evidence for progressive prostate cancer
* Participants who were withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the study require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA documented after the post-withdrawal nadir(value) greater than or equal to 4 weeks from treatment withdrawal if treated with flutamide and greater than or equal to 6 weeks if treated with bicalutamide or nilutamide
* Eastern Cooperative Oncology Group (ECOG) performance status score equal to 0 or 1
* Life expectancy of greater than or equal to12 week

Exclusion Criteria:

* Participants with central nervous system (the brain and spinal cord) disease and/or brain metastases
* No currently active second malignancy (cancer or other progressively enlarging and spreading tumor) other than non-melanoma skin cancer
* Myocardial infarction within the 6 months prior to start of study
* No active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy during protocol treatment
* Major surgery or significant traumatic injury within 4 weeks of start of study
Pre and Post-gastrostomy Evaluation of GER in Children Using 24-hour pH Monitoring

The aim of this study was to evaluate 24-hour pH monitoring results before and after gastrostomy in neurological impaired (NI) children who underwent gastrostomy or Nissen fundoplication (NF) concurrently with gastrostomy.

Gastrointestinal (GI) problems causing malnutrition may develop quite frequently in patients with neuromotor developmental delay. Diagnosis of GERD in patients with neurological impairment (NI) might be more difficult due to the absence of characteristic features in many cases. One of the best methods for the diagnosis of GER is the 24-hour esophageal pH monitoring.Even though there are some statements in the literature advocating that gastroesophageal reflux may develop in the late period in patients undergoing only gastrostomy, there are also reports supporting that gastrostomy does not contribute to the development of reflux.Regardless of whether the patient received anti-reflux surgery or not, the long-term follow-up is necessary in patients feeding with gastrostomy.The aim of this study is to compare the results of pre- and postoperative 24-hour pH monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of neurological damage Must be able to apply gastrostomy or Nissen fundoplication concurrently with gastrostomy.

exclusion Criteria: to use anti-reflux medications long period of time gastroesophageal reflux disease
The EPOCH Study (Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients With Hypertension)

In a prospective single centre placebo-controlled trial over ten weeks, 24 CKD II-III patients (eGFR 30-89 ml/min per 1.73 m2) with DM II will be randomized to enalapril 20mg per day after a two week run-in phase. Thereafter, patients will either receive eplerenone 25mg (n=12) or a placebo (n=12) for eight weeks. Eplerenone will be increased to 50mg under close monitoring of serum potassium levels. Employing a novel mass-spectrometry ( MS)-based method, quantification of up to 10 different Ang metabolites (Ang I, Ang II, Ang 1-7, Ang 1-9, Ang 2-10, Ang 1-5, Ang 2-7, Ang 3-7, Ang 3-8 and Ang 2-8) will be performed simultaneously out of blood sera (after run-in phase and after 10 weeks).


Eligibility Criteria:
Inclusion Criteria:

* CKD II to III and diabetes mellitus type 2
* CKD will be defined according to estimated glomerular filtration rate (eGFR) with the MDRD formula
* eGFR between 30 and 89 ml/min
* albumin excretion rates \> 300 mg/24 hours (UACR \> 300 mg/gram) or \> 200 mg/g if already receiving any RAS blockade Patients should be hypertonic stage I or II according to the European guidelines (Chobanian et al. JAMA 2003)

Exclusion Criteria:

* Age \< 18 years
* UACR \> 3500mg/g
* severe hypertension
* pregnancy
* unwilling or inability to sign the informed consent
* coronary heart disease
* systolic blood pressure \< 130 mmHg
* additional RAS interfering drugs (ACEis, ARBs, direct renin inhibitors)
* 25-hydroxy vitamin D levels below 16.6±8.3 pg/ml
* 1,25-dihydroxy vitamin D 33.1±15.5 pg/ml

Intolerance to eplerenon or an excipient of it:

tablettcore: Lactose-Monohydrat Mikrokristalline Cellulose (E 460) Croscarmellose-sodium (E 468) Hypromellose (E 464) Sodiumdodecylsulfat Talkum (E 553b) Magnesiumstearat (E 470b)

filmcoat

Opadry, yellow:

Hypromellose (E 464) Titandioxid (E 171) Macrogol 400 Polysorbat 80 (E 433) Yellow ironoxide (E 172) Red ironoxide (E 172)

* Patients with Serumpotassium \> 5,0 mmol/l at start of the treatment
* Patients with severe renal insufficiency (eGFR \<30ml/min./1.73 m2)
* Patients with severe liver insufficiency (Child-Pugh class C)
* Patients taking potassium saving diuretics, potassium supplements or strong CYP3A4-inhibitors (z. B. Itraconazol, Ketoconazol, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin und Nefazodon)
Utility of the Evaluation of Blood Flow of the Remnant Esophagus in Esophagectomy With Pedicled Jejunum Reconstruction

Pedicled jejunal flap can be utilized with various tips for esophageal reconstruction in patients with a history of gastrectomy, or those who have undergone synchronous esophagogastrectomy, although the rate of anastomosis leakage is high with this technique. Therefore, in the current study, we considered the utility of the evaluation of blood flow of the remnant esophagus with indocyanine green in setting the anastomosis site. We included 50 patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020. From June 2019, the blood flow of not only the pedicled jejunum, but also the remnant esophagus were evaluated in order to set the anastomosis site of the latter because the color was not definitive criteria for judging in surgery on the remnant esophagus. Usually, the second and third jejunal vessels are transected, and if the jejunal flap cannot reach to the anastomosis point, we actively transect the marginal vessels in order to stretch the jejunal flap. Microvascular anastomosis between the jejunal branches (the second) and the internal thoracic vessels is usually made, and the anastomosis site is set at the part of the esophagus that is well-dyed with indocyanine green. A total of 39 patients underwent the procedure prior to June 2019 ( Group A), and 11 patients underwent the procedure as of June 2019 (Group B). No significant difference was found in the patients' background, type of preoperative therapy, and presence or absence of ligation of marginal vessels and two-stage operation between the two groups. Group A had 16 cases of anastomosis leakage, while Group B only has one (P \< 0.05). There were no cases of significant pedicled jejunum graft necrosis. Our findings demonstrate that the evaluation of the blood flow of the remnant esophagus during setting of the anastomosis site may decrease the rate of anastomosis.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent radical esophagectomy with pedicled jejunal flap between April 2012 and June 2020

Exclusion Criteria:

* patients who did not complete the esophagectomy
Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care

The aim of this study is to eliminate the malodorous of chronic wound and increase the chance of the healing of recalcitrant wounds by using the repairing gel (supraz gel) which has the approved components in wound healing and platelet-rich plasma-fibrin glue.

The current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) along with the use of the repairing gel which has the approved components on wound healing in patients with chronic wounds and to eliminate the malodorous of chronic wound. This randomized controlled trial is performed on patients with chronic wounds. Patients will be treated with repairing gel (supraz gel) plus PRP-FG dressing (intervention group) or only Supraz gel (intervention group) or only PRP-FG dressing (intervention group) every 48 hours for 8 weeks versus standard of care of treatment (control group: irrigation of wound by normal saline 0.9%).

Eligibility Criteria:
Inclusion Criteria:

* Having a single wound on the body that has been at least 3 months old and has not been repaired by wound irrigation with normal saline and changing the dressing
* Having a body mass index of 18-35
* Sign the informed consent by the patient

Exclusion Criteria:

* Having concurrent diseases that may cause problems in wound healing, such as cancers, vasculitis, kidney and liver failure, and heart failure
* Taking certain drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents
The Health and Social Consequences of Depression Among the Elderly

Mental illnesses often go undiagnosed or untreated in low-income settings. Mental health care may be especially important for the elderly - events in the lives of the elderly, like illnesses or deaths of peers, may put these individuals at high risk of mental illness. The study will constitute a randomized controlled trial aimed at reducing depression among elderly women over a 12-week period. Through two interventions, the investigators will aim to improve women elder's outlook on life and relationships through cognitive behavioral therapy (CBT) and facilitated group activities. There will be a total of four treatment arms: one for CBT during home visits, one for facilitated group activities, one for both, and a control group receiving neither the CBT nor facilitated group activities. All activities will be delivered by lay government community volunteers. Randomization for group activities will be at the village level, and randomization for CBT will be at the individual-level within each village. Investigators will track outcomes of the elderly at two points in time: immediately after the 12-week intervention and 6 months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* At least 55 years of age
* Women

Exclusion Criteria:

* Those with hearing, speech or mental impairment
Reducing Cognitive Impairment in Glioma with Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training

The TRUE-GRIT study will assess the feasibility of a study protocol investigating the efficacy of a combination therapy consisting of cognitive strategy training (CST) and repetitive transcranial magnetic stimulation (rTMS) to reduce cognitive impairment in adult glioma patients. This study is part of the GRIP-project, a project aimed at investigating interventions for improving quality of life in brain tumor patients.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Histological diagnosis of diffuse glioma (WHO grade 2,3, or 4)
* Subjective cognitive impairment, defined as CFQ-score ≥ 44
* Being able to give informed consent and undergo treatment and measurements based on researchers insight
* Stable disease, i.e. no oncological treatment for ≤ 2 months prior to inclusion; no radiological progression on the most recent MRI, not older than 6 months, and no clinical progression at inclusion
* Stable dosage (for at least 8 weeks) of anti-epileptic medication

Exclusion Criteria:

* Current pregnancy or have given birth less than three months ago
* Current other treatment for cognitive complaints
* Karnofsky performance score \<70
* A tumor located in the parietal cortex
* TMS exclusion: implanted medical devices (e.g. pacemaker, deep brain stimulator, cochlear implants, medical infusion device, etc.); metal in the body; sleep deprivation
* MRI exclusion: extreme claustrophobia or metallic objects in or on the body
Assessing the Fertility Status of Men With Spinal Muscular Atrophy (SMA)

This study will aim to assess the fertility status of men with Spinal Muscular Atrophy (SMA) not on disease-modifying therapies.

Participants will:

1. Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives.
2. Over the 3-month initial study baseline period participants will provide two separate ejaculates for semen analysis and a single determination of sperm quality using DNA fragmentation testing using home collection and subsequent shipment to a central laboratory.
3. Over the initial study baseline period of 3 months study participants will obtain a blood test to determine male reproductive hormone levels.

During the 24-month study duration, participants will be requested to undergo a yearly semen analysis and complete online relevant questionnaires.

Study participants will:

1. Complete online questionnaires that will assess SMA diagnosis and disease burden, medical and surgical history, medication usage, and fertility status and perspectives.
2. Over the 3-month initial study baseline period participants will provide two separate ejaculates for semen analysis and a single determination of sperm quality using DNA fragmentation testing using home collection and subsequent shipment to a central laboratory.
3. Over the initial study baseline period of 3 months study participants will obtain a blood test to determine male reproductive hormone levels.

During the 24-month study duration, participants will be requested to undergo a yearly semen analysis and complete online relevant questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form (or assent)
* Male and age greater than 18 years and less than 50 years of age with a confirmed diagnosis of SMA at the time of signing the Informed Consent Form (or assent)
* Currently not on a disease-modifying agent or therapy for SMA
* Adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate in the study.

Exclusion Criteria:

Men with a prior history of chemotherapy, radiation therapy, prostate or testicular cancer, undescended testicles and use of anabolic steroids or testosterone usage will be excluded
Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage

The investigators intend to determine if using Optison echocardiography contrast increases sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo contrast.

Accurate determination of the presence or absence of left atrial appendage (LAA) thrombus has a large impact on the clinical course of patients with atrial fibrillation or ischemic stroke and has large financial implications as well. Misdiagnosing the presence of LAA thrombus can lead to unnecessarily cancelled procedures (cardioversion and atrial fibrillation ablation) and potentially hazardous, unnecessary changes in clinical care (such as prolonged Coumadin anticoagulation). Missing LAA thrombus can result in continuation of cardioversion or atrial fibrillation ablation procedures at a time when there is higher risk of subsequent embolic stroke.

Several of the patients with atrial fibrillation require transesophageal echocardiography (TEE) performed prior to cardioversion or atrial fibrillation ablation procedures. There is opportunity to enroll most of these patients in our proposed study. There has been essentially no work published about the use of echo contrast materials in TEE (other than agitated saline), particularly the use of Optison. Thus, the investigators will be exploring a new field in echocardiography and echo contrast.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Cognitively sound and able to provide informed consent
* Indicated for TEE as a standard clinical procedure for evaluation of cardiac health status.

Exclusion Criteria:

* Contraindicated for Optison administration
* Known right-to-left or bi-directional cardiac shunts
* Hypersensitivity to perflutren, blood, blood products or albumen
* Women who are pregnant
* Removal of Left Atrial Appendage
* Not able to provide informed consent
Kettlebell Swings & Low Back Pressure Pain Threshold

The purpose of this study is to determine whether a high intensity kettlebell workout, utilizing a Tabata protocol format, can decrease objective measures of pain pressure threshold in subjects without low back pain. The results of the study could have implications for the use of high intensity kettlebell workouts in the rehabilitation of patients with low back pain.

The kettlebell swing is a full body, posterior-chain focused, ballistic exercise shown to register large recruitment of the gluteal muscles, which are frequently weak in a patients suffering from low back pain. The Tabata protocol is a high-intensity training protocol in which subjects perform 20 seconds of all out effort (i.e. as many swings as possible), followed by 10 seconds of rest, repeated for a total of eight rounds. The rapid contraction-relaxation cycles utilized in the kettlebell swing are theorized to aid in the pumping out of muscle metabolites in the low back musculature, thus providing potential relief of chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Those subjects between the ages of 18 and 45
* No current low back pain or pre-existing injuries that may be currently affecting them
* No positive response on the Health History questionnaire and PAR-Q.

Exclusion Criteria:

* Current low back pain
* Pre-existing injuries currently affecting the subject
* Positive response on the Health History Questionnaire or PAR-Q
* We will also be excluding minors and prisoners from this study.
Epidemiological Profile of Children With Early Caries.

The objective of the study is to determine the different profiles of patients with early caries consulting at the Lille CHU and to analyse the characteristics associated with the severity of the pathology. The data will be collected using a simple clinical examination of the child and a survey of the parent using a questionnaire. The typology of patients with early caries will be analysed according to the predefined variables collected using the questionnaire via a main component analysis in order to study the links between these variables. At the same time, a hierarchical classification analysis will be carried out to study the existence of homogeneous sub-groups of individuals in regard to the early caries. These sub-groups will be described


Eligibility Criteria:
Inclusion Criteria:

* be a child under the age of 6,
* having been diagnosed with early caries
* be accompanied by at least one parent (the mother or father).
* be affiliated to a social security

Exclusion Criteria:

* be a child over the age of 6
Health Behaviour Change in Brazilians

Chronic diseases are the leading health problem in Brazil and Canada. Such diseases share common risk factors in common, such as physical inactivity, poor diet, and smoking. This context requires a comprehensive approach to change these behavioural risk factors, aiming at the promotion of healthy lifestyles and the prevention of diseases. Although Brazil and Canada have significant differences, particularly in terms of socioeconomic factors, some similarities in the health domain allow both countries to mutually benefit from an exchange of knowledge. For instance, the newest version of Canada's dietary guidelines has incorporated several aspects presented in the pioneering evidence-based dietary guidelines for the Brazilian population, launched in 2014. Similarly, Brazil can greatly benefit if the country follows the Canadian lead in prioritizing investment in physical activity initiatives. The present project aims to verify the effectiveness of a Canadian program to change health behaviours, specifically physical inactivity, poor diet, and smoking, adapted for Brazilians. The project consists of a 12-week randomized controlled trial, based on education and behaviour change techniques focusing on physical activity, healthy eating habits, and smoking cessation. Pre-, post, and 3-month follow-up health and fitness assessments will evaluate respectively the initial condition of the participants, eventual changes and if the changes persist.


Eligibility Criteria:
Inclusion Criteria:

Brazilians who speak Brazilian Portuguese fluently, and present at least one of the following risk factors:

* physical inactivity (\<150 min of MVPA per week)
* unhealthy diet (consumption of fewer than five fruits/vegetables per day)
* smoking (any amount of personal tobacco use)

Exclusion Criteria:

* unstable clinical conditions
* inability to participate fully in the program due to mental or physical limitations
* concurrently participation in other studies of intensive health behaviour modification
Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer

To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women.
* Biopsy confirmation of primary breast cancer.
* Oestrogen receptor positive tumour.
* Fit for surgery within one month.
* Written informed consent to participate in the study

Exclusion Criteria:

* Previous treatment with any anti-hormonal therapy for breast cancer.
* Previous radiotherapy to the primary tumour.
* Previous chemotherapy for the primary tumour.