cyrilzakka/clinical-trials huggingface dataset:
Pamidronate Administration in Breast Cancer Patients With Bone Metastases

The study objective is to evaluate the differences, in terms of first occurrence of a skeletal event, in patients with breast cancer and symptomatic bone metastases, when pamidronate is administered during 2 years, or when it is administered during 6 months, followed by a six month rest period, and again a 6 month treatment period.

Background: Pamidronate (PMT) is effective in reducing skeletal related events (SRE) in breast cancer (BC) patients with bone metastasis (BM). Its best way of administration and optimum treatment duration are still to be determined.

Objective: evaluate the efficacy of continuous administration (arm A) vs. alternate administration (arm B) of PMT to delay time to first SRE in BC pt presenting with symptomatic BM.

Methods: patients aged \>18, Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2, adequate renal function, and BC symptomatic BM were eligible. BM was defined as presence of 3 or more hot spots (HS) in skeletal scintigraphy (SS), or any number of HS in SS if osteolytic, osteoblastic or mixed bone lesions determined by radiography, or 2 or less HS in SS if magnetic resonance or CT scan confirmation of BM. Symptomatic BM was defined as pain associated to SS HS, or SRE (pathological fractures or spine cord compression or radiation bone treatment or tumour induced hypercalcemia), or treatment with analgesia due to bone pain. Patients were allowed up to 1 previous chemotherapy and 2 previous hormone therapy lines for metastatic disease. Antineoplastic therapy could be changed at any time during the study. Eligible patients were stratified (isolated bone metastasis or associated to node or skin lesions vs. bone metastasis associated to visceral disease) and randomized to receive 2 hour-iv. PMT 90 mg every 3-4 weeks for 18 months (arm A) or iv. PMT 90 mg every 3-4 weeks for 6 months, followed by a 6 months rest, and a new 6 months on-treatment period (arm B). Quality of Life (QoL) was measured with short form (SF)-36 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Up to two previous or current hormone therapy treatments for metastatic breast cancer are allowed.
* Normal or borderline renal function (serum creatinine \< 1.5 x upper normal limit \[UNL\]).
* Normal calcium levels in serum, or slightly non-symptomatic high levels (\< 1.25 x UNL).
* Performance status 0, I or II in World Health Organization (WHO) scale.

Exclusion Criteria:

* Treatment with bisphosphonates in the 30 previous days, or any time if the indication was treatment of metastatic bone lesions.
* Treatment with bisphosphonates is only allowed if the indication is hypercalcaemia.
* Metastases in central nervous system (CNS).
* Hypersensitivity to bisphosphonates or other components of the formula.
* Pregnant or lactating women.
* Previous or current treatment with a second chemotherapy line or a third hormone therapy line for metastatic disease.
Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal Aflibercept Injection

This is a one month pre post intervention study. Subjects with diabetic macular edema were given intravitreal anti VEGF (Aflibercept) injection. Central retinal thickness, macular electrophysiology, and visual acuity were observed one week and one month after injection was given to the eye to describe early anatomical, physiological, and clinical changes. We hypothesized that changes to these outcomes can be found and documented.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 y.o.
* Diagnosed with Type 1 or 2 Diabetes Mellitus
* Have either one of mild non-proliferative diabetic retinopathy (NPDR), moderate NPDR, severe NPDR, or Proliferative Diabetic Retinopathy with clinically significant macular edema according to Early Treatment for Diabetic Retinopathy Study (ETDRS) criteria
* Best corrected visual acuity between one meter finger counting to 6/12 (ETDRS chart)
* Minimum Central Macular Thickness by Optical Coherence Tomography examination of 250 um
* Willing to participate and sign the informed consent.

Exclusion Criteria:

* Ongoing pregnancy or planning to be pregnant for the next 6 months.
* Media opacity (e.g. corneal scar, corneal edema, cataract, vitreous hemorrhage) which make macular OCT not possible
* History of intraocular surgery in the last 6 months
* Vitreoretinal surface disorders e.g. epiretinal membrane, vitreoretinal traction
* History of panretinal laser photocoagulation in the last 6 months
* Presence of iris neovascularization
* History of eye trauma
* HbA1c level \> 10,0 %
* Any other contraindication(s) for intravitreal anti VEGF injection.
Operative Time During the Use of the Synthetic Glue IFABONDTM in Laparoscopic Sacrocolpopexy

Laparoscopic sacrocolpopexy has now become the gold standard technique for correction of anterior and apical prolapse. In order to provide an alternative to stapling system and sutures involving vaginal erosion and shrinkage phenomena, there is a technique to fix material meshes by the use of a liquid, tissue, synthetic adhesive and sterile. The investigator hypothesizes that the use of IFABOND ™ adhesive in laparoscopic sacrocolpopexy significantly reduces the time of surgery compared to the classic suture technique. The prospective, randomized, multicenter study therefore aims to compare the time of surgery when using the IFABOND™ synthetic adhesive and the technique by sutures to fix material meshes in laparoscopic sacrocolpopexy.


Eligibility Criteria:
Inclusion Criteria:

* Woman aged 18 years or more
* Stage III or IV medial and/or anterior genital prolapse on the Pelvic Organ Prolapse Quantification (POP-Q) classification (hysterocele and/or cystocele) requiring surgical correction
* Patient requesting surgery for the trouble caused by the prolapse

Exclusion Criteria:

* Prolapse of POP-Q stage \<III or without functional impact
* Unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc.
* Impaired lower-limb range of motion preventing positioning for surgery
* Pregnancy or intended pregnancy during study period
* Evolutive or latent infection or signs of tissue necrosis on clinical examination
* Non-controlled diabetes (glycated haemoglobin \>8%)
* Treatment impacting immune response (immunomodulators), ongoing or within previous month
* History of pelvic region radiation therapy, at any time
* History of pelvic cancer
* Non-controlled evolutive spinal pathology
* Known hypersensitivity to one of the implant components (polypropylene)
* Cyanoacrylate hypersensitivity
* Formaldehyde hypersensitivity
* Inability to understand information provided
* No national health insurance cover; prisoner, or ward of court
A Comparison of Methods to Detect Polyps During Colonoscopy

Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer deaths in western countries. Colonoscopy is a preferred colorectal screening modality since it has both diagnostic and therapeutic capability. Detection and removal of polyps at colonoscopy decreases the incidence and mortality from colorectal cancer.

Typical practice is to insert the colonoscope rapidly until it reaches the cecum (a pouch-like portion of the intestines, where the large bowel and the small bowel meet). The physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities within the large bowel. The purpose of this study is to compare this standard practice to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patients able to provide an informed consent
* Patients undergoing colonoscopy

Exclusion Criteria:

* Pregnant women
* Patients with Familial Adenomatous Polyposis Syndromes (FAP)
* Patients with Hereditary Non-polyposis Colon Cancer Syndrome (HNPCC)
* Patients who have undergone previous surgical resection of the colon
* Patients who have been diagnosed with inflammatory bowel disease
Research on the Role of Probiotics in Human Intestinal Health

Evaluate the efectiveness and safety of Bifidobacterium bifidum BBi32 as a food supplement compared to a placebo in improving intestinal andimmune functions in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to attend 3 follow-up visits during the intervention period
2. Agree to provide blood, urine, and stool samples twice during the intervention period
3. Good eyesight, able to read and write, and capable of wearing glasses if needed
4. Good hearing and able to fully comprehend all instructions during the intervention

Exclusion Criteria:

1. Presence of digestive diseases, particularly gastrointestinal disorders (e.g., celiac disease, ulcerative colitis, Crohn's disease)
2. History of serious neurological conditions (e.g., epilepsy, stroke, severe head trauma, meningitis within the last 10 years, brain surgery, brain tumor, or prolonged coma-not including general anesthesia)
3. History of or currently receiving treatment for mental health disorders such as alcohol/drug/substance abuse, schizophrenia, psychosis, or bipolar disorder
4. Currently taking medication for depression or low mood
5. Presence of internal organ failure (e.g., heart, liver, or kidney failure)
6. History of radiation therapy or chemotherapy treatments
7. Underwent general anesthesia within the past three years or are scheduled for general anesthesia within the next 3 months during the trial period
8. History of hepatitis (B or C), HIV, or syphilis
The Erlangen Fitness and Prevention Study (EFOPS).

The study determines the long-term effect of exercise on osteoporotic fracture risk. Since actually no controlled supervised exercise study exceeds the time frame of 4 years, knowledge concerning the long-term effect of exercise on fractures and fracture-risk factors is scarce. Within the Erlanger Fitness and Osteoporosis Study (EFOPS, an ongoing controlled exercise study with currently 16 years of supervised exercise with 45-50 osteopenic, early-postmenopausal women in exercise and sedentary control group each, the investigators therefore focus on overall-fractures, Bone Mineral Density and falls.


Eligibility Criteria:
Inclusion Criteria:

* participants of the EFOPS-study,
* 12 years of exercise training according to the EFOPS-protocol (exercise).

Exclusion Criteria:

* medication and diseases affecting bone metabolism,
* inflammable diseases,
* cardiovascular diseases,
* start of relevant physical exercise programs beside the EFOPS protocol.
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Subject's parent has provided informed consent and subject has provided assent
* Children Age 2 to less than 18 years
* Diagnosed with chronic kidney disease
* Diagnosed with secondary hyperparathyroidism receiving hemodialysis,
* Weighing at least 7 kg
* Laboratory results within specified range.

Exclusion Criteria:

* Currently receiving treatment in another investigation device or drug study
* Subject has received cinacalcet therapy within 30 days
* History of prolongation QT interval
* Subject is taking any medications that are on the QT prolongation medication list
* Electrocardiograph (ECG) measurements within specified range.
Interrupters of VAscular daMAge in Malignant Hypertension

The pathophysiology of malignant hypertension is poorly understood. The objective of this translational research project is to evaluate the relationship between activation of vasoactive systems (renin-angiotensin and endothelin systems), angiogenic signal deficiency (VEGF and sFlt-1) and the occurrence of malignant hypertension episodes in humans.

The pathophysiology of malignant hypertension is poorly understood. The current dogma is based on an overwhelming renin-angiotensin-aldosterone system activation, leading to arterial hypertension that overcomes target organ auto-regulatory mechanisms and leads to subacute microvascular lesions. However, some patients present with normal or lowered renin in the acute phase of malignant hypertension, suggesting other pathophysiological pathways. Malignant hypertension was reported following anti-VEGF treatment, suggesting that this pathway may be involved. Recent unpublished animal data highlight 1/ the possibility of severe deregulation of the VEGF (vascular endothelial growth factor) system in malignant hypertension 2/ the possibility of compensation of the vasculotoxic effects of VEGF deficiency by inflammasome components. These systems have never been studied together in human hypertension.

Investigators will analyze the angiogenic, vasoactive and VEGF systems through blood and urine sampling. These samples will be collected at the time of malignant hypertension diagnosis and repeated one month later in 30 patients. The same tests will be performed in 15 patients with severe non-malignant hypertension, constituting the control group.

Eligibility Criteria:
Inclusion Criteria:

Patients group :

* Patients included in the HAMA cohort
* Who is willing to take part in the IVAMA project

Control group :

* Grade 2 or 3 hypertension with office blood pressure measurement (above 160 and/or 100 mmHg for systolic and diastolic)
* Persistence of blood pressure above 160 / 100 mmHg on the average of 3 "attended" blood pressure measurements

Exclusion criteria:

Patients group :

* Age \< 18 years old
* Patients with chronic renal failure of stage 3 or higher.
* Patients with any type of diabetes
* Patient in per partum
* Patients who cannot freely give their consent, or patients who refuse to participate
* Chronic dialysis patient

Control group:

* Evidence of subacute involvement of one of the following target organs: brain, kidney, eye, heart, thrombotic microangiopathy. Target organ impairment is defined in the inclusion criteria for the "Patients" group.
* Presence of known chronic kidney insufficiency of grade 3 or higher
* Chronic dialysis patient
* Diabetes of any type
* Patients who cannot freely give their consent, or patients who refuse to participate
Positive Pressure at Induction of Anesthesia in Children

SCENARIO: Hypoxemia is one of the most common adverse events during the induction of general anesthesia and may culminate with more serious complications such as cardiac arrest and death. Pediatric patients, due to their anatomical and physiological characteristics, are more likely to develop hemoglobin desaturation levels. Some preventive strategies are used during this period to reduce the chances of occurrence of adverse event. Continuous Positive Airway Pressure (CPAP) may be useful during anesthetic induction in delaying the drop in oxygen levels in the blood by increasing this body gas reserves. OBJECTIVES: To assess the effectiveness of CPAP during anesthetic induction in increasing apnea time until hemoglobin saturation falls to 95% in children undergoing general anesthesia for elective surgery. METHODS: Phase III, parallel, randomized clinical trial to be developed at the Teaching Hospital of the Federal University of Pernambuco. Patients (72) are divided into two groups (36 in each) in which all patients will spontaneously ventilate: group C will receive CPAP and group A will use the open system. Children of pre-school age with physical status I or II, according to the American Anesthesia Society, candidates for elective surgery under general anesthesia will be included. Patients with pre-existing parenchymal lung disease, cyanotic children or patients with oxyhemoglobin saturation \<95% prior to anesthetic induction and recent history (\<4 weeks) or active upper respiratory tract infection will be excluded. The descriptive statistical analysis will be carried out through measures of central tendency and dispersion for quantitative variables and via distribution of frequencies for qualitative variables. ETHICAL ASPECTS: This work will respect human rights, principles of bioethics, the resolution 466/2012 of the National Health Council and the statement from Helsinki. Submission and approval by the research ethics committee is required prior to data collection. KEYWORDS: Continuous Positive Airway Pressure, Hypoxia, General Anesthesia


Eligibility Criteria:
Inclusion Criteria:

* Pre-school children, ASA physical status I or II, Children undergoing general anesthesia for elective surgery

Exclusion Criteria:

* Pre-existing parenchymal lung disease, Children cyanotic or with oxyhemoglobin saturation less than 95% before anesthetic induction, Recent history (\<4 weeks) or current upper respiratory tract infection
Genetics and Cardiovascular Reactivity in Young Twins

To evaluate the effects of genetic variants in all of the nine adrenergic receptor subtype genes, alone or in combination, on cardiovascular reactivity and other quantitative cardiovascular traits in a population of 1048 healthy young twins.

BACKGROUND:

Several studies have shown that cardiovascular reactivity (CVR) to acute laboratory stress is a stable and heritable trait and predictive of future blood pressure (BP) levels and essential hypertension (EH). The sympathetic nervous system (SNS) has a major role in BP regulation and adrenergic receptor subtypes mediate BP responses to acute challenges. As such, our hypothesis is that individual differences in CVR are partly determined by variation in genes encoding for adrenergic receptors mediating the sympathoadrenal response to stress. There is increasing evidence that this cardiovascular response is regulated by multiple adrenoceptor subtypes with structural homology. To date, nine homologous adrenergic receptor subtypes have been described. Only one study has found a gene-gene interaction upon CV disease incorporating two adrenergic receptor subtypes. Genetic variants in all the nine adrenergic receptor subtypes have never before been investigated in a single study as this study will do.

DESIGN NARRATIVE:

The study will evaluate the effects of genetic variants in all of the nine adrenergic receptor subtype genes, alone or in combination, on CVR and other quantitative cardiovascular traits in a population of 1048 healthy youth. Subjects are black and white twins that have already been comprehensively phenotyped as part of the Georgia Cardiovascular Twin Study (HL56622). Racial differences in adrenoceptor gene effects will receive special attention, because such differences may offer a partial explanation for the higher prevalence of essential hypertension (EH) in blacks. Primary measures are systolic BP at rest and in response to two behavioral stressors. Secondary measures are diastolic BP, cardiac output and total peripheral resistance (TPR) at rest and in response to the stressors, left ventricular mass (LVM), endothelium dependent arterial dilation to reactive hyperemia (EDAD), arterial stiffness and 24-hour ambulatory BP. This data set will be expanded through collection of buccal cell DNA from the parents of the twins, enabling performance of TDTs (transmission disequilibrium tests) and haplotype reconstruction and analyses. This candidate gene study in a large group of black and white twins including TDT and haplotype analyses provides an innovative approach to help identify individuals at particular risk for the development of EH and improve options for primary prevention as well as individualized therapy of EH (pharmacogenetics).

Eligibility Criteria:
No eligibility criteria
Clobazam in Patients With Lennox-Gastaut Syndrome

The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly assigned to either a low, medium or high dose, or placebo. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, patients will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

LGS poses a significant treatment challenge. No single antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Even with combination therapy, many LGS patients show resistance to treatment. Adjunctive therapy with newer anticonvulsant medications has demonstrated efficacy for some patients, although polytherapy and high medication doses are often associated with unfavorable adverse event profiles.

More effective and better-tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam may provide an improved safety profile compared to other AEDs currently approved for the treatment of LGS and may have less hypotonia and drooling effects than other benzodiazepines.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have been \<11 years of age at the onset of LGS.
* Patient must have LGS.
* Patient must be on at least 1 AED.
* Parent or caregiver must be able to keep an accurate seizure diary.

Exclusion Criteria:

* Etiology of patient's seizures is a progressive neurologic disease. Patients with tuberous sclerosis will not be excluded from study participation, unless there is a progressive tumor.
* Patient has had an episode of status epilepticus within 12 weeks of baseline.
* Patient has had an anoxic episode requiring resuscitation within 6 months of screening.
* Patient has a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines.
* Patient is taking more than 3 concurrent AEDs.
* Patient has been on the ketogenic diet for less than 30 days prior to screening or suffers from frequent stooling.
* If the patient has a Vagal Nerve Stimulator (VNS), the settings have not been stable for at least 30 days prior to screening.
* Patient has taken corticotropins in the 6 months prior to screening.
* Patient is currently taking long-term systemic steroids (excluding inhaled mediation for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for idiopathic nephrotic syndrome or asthma.
* If the patient is taking felbamate, has been taking it for less than 1 year prior to screening.

Other protocol-defined inclusion and exclusion criteria may apply.