cyrilzakka/clinical-trials huggingface dataset:
Pain and Magnesium

In breast cancer patients undergoing a mastectomy, the aim of this study is to evaluate if the magnesium administered for 6 weeks starting two weeks before the surgery induces a decrease of pain intensity one month post-mastectomy compared to the placebo group.

This is a randomized, placebo-controlled double-blind clinical trial conducted in the Oncology Hospital, Clermont-Ferrand, France, in 100 patients suffering from breast cancer and undergoing a total mastectomy.

This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale. Cognition, anxiety, depression, sleep and quality of life are also assessed.

Eligibility Criteria:
Inclusion Criteria:

* - Age ≥ 18 years,
* Patient with breast cancer who has a scheduled total mastectomy with or without treatment two weeks after inclusion with or without preoperative chemotherapy,
* Patient free from any new treatment or diet at the time of the inclusion,
* Cooperation and understanding sufficient to comply with the requirements of the study,
* Patients affiliated to the French Social Security,
* Patients with free and informed consent has been obtained

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Patient with magnesemia \>1,05 mmol/l
* Patient with severe renal insufficiency with creatinine clearance \<30 ml min,
* Patient with an addiction to alcohol, as determined by the investigator,
* Diabetes (type I and II),
* Medical and surgical history incompatible with the study,
* Patient receiving treatment with Quinidine, L-Dopa,
* Childbearing age, no use of effective contraceptive method, pregnancy or lactation
* Patient exclusion period, or the total allowable compensation exceeded
* Patients undergoing a measure of legal protection (guardianship, supervision ...)
A Comparison of 4% Articaine Versus 0.5%Bupivacaine for Ambulatory Surgery Under Supraclavicular Block

Effect of 2%Articaine versus 5%bupivacaine in pt undergoing short duration surgery in upper limb

The investigator aim to compare Articaine 2% versus bupivacaine 0.5% in patient undergoing upper limb procedure under ultrasound guided supraclavicular block as regard onset and duration of sensory and motor block

Eligibility Criteria:
Inclusion Criteria:

* upper limb surgery
* ganglion removal
* k wiring
* Carapal tunnel

Exclusion Criteria:

* Coagulopathy.
* infection at site of injection.
* patient refusal.
* hypersensitivity.
A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del

This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F).


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects with confirmed diagnosis of CF.
* Homozygous for F508del (F/F).
* Subjects who weigh ≥8 kg without shoes and wearing light clothing at the Screening Visit.

Key Exclusion Criteria:

* Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject.
* Solid organ or hematological transplantation.
* History of any illness or comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study.

Other protocol defined Inclusion/Exclusion criteria may apply.
Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.

OBJECTIVES:

* To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer.
* To determine the optimal dose level of this treatment regimen to be used in future studies.

OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume \< 450 cc vs high small bowel volume ≥ 450 cc).

Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of prostate cancer meeting 1 of the following criteria:

  * Stage T3b/T4 disease or radiological or pathological pelvic nodal metastases
  * Localized disease (stage pT2-T4) with \> 30% estimated risk of pelvic nodal metastases
  * High-risk (Gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease according to the National Collaborative Cancer Network (NCCN)
  * Has undergone prostatectomy AND has stage T2-T3a, N0 disease with extensive high-risk disease (Gleason score ≥ 8) or seminal vesicle or lymph node involvement
* Candidate for radical radiotherapy

PATIENT CHARACTERISTICS:

* No inflammatory bowel disease or other small bowel disease

PRIOR CONCURRENT THERAPY:

* No prior pelvic radiotherapy or surgery (excluding prostatectomy)
Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease

Extracorporeal photopheresis (ECP) is a cellular therapy indicated in the treatment of chronic GVHD (cGVHD). In this study protocol, patients suffering from inaugural cGVHD will be treated with the association of ECP and corticosteroid treatment. Treatment will start by an induction stage with 2 sessions of ECP per week until the 10th week followed by a maintenance stage including one session every other week until the 22th week. The objective of this study is to highlight the immunological mechanism of extracorporeal photopheresis treatment. Indeed, ECP is based on an immunomodulatory immunological effect and despite several hypotheses highlighted by different teams; clear mechanisms still need to be defined. This French multicenter study realize an immunological follow-up before and during treatment to elucidate the impact of ECP on immune system of responder patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years who had a first allo-CSH for hematological pathology
* Body weight ≥ 40 kg.
* Confirmed diagnosis of inaugural cGVHD requiring systemic treatment.
* Any source of hematopoietic stem cells is allowed.
* All conditioning treatments are allowed.
* Patient validated by the local investigator as eligible for treatment with ECP according to the criteria of the investigating centers
* Patient treated according to the study plan with a ECP in 2 steps
* Patient having signed informed consent.
* Prophylaxis of GVH maintained during the onset of cGVHD is accepted.
* Effective contraception for men and women of childbearing age.

Exclusion Criteria:

* cGVHD ≥ 2nd line of treatment
* Exclusive pulmonary cGVHD
* cGVHD before J100
* cGVHD occurring after Donor Lymphocyte Injection (DLI)
* Overlaps syndrome aGVHD-cGVHD
* Late aGVHD
* Relapsed patient or progressive disease
* Non-controlled infection
* Second Allograft
* Leukopenia \<0.5G / l at screening
Supplementary Intake of Vitamin D During 12 Weeks Strength Training in Younger and Older People

The aim is to investigate the importance of vitamin D levels to achieve the effect of strength training. If we can show that vitamin D has an effect of training, the ultimate goal is to find out why and how vitamin D affects muscle.

This would potentially have important implications for public health. Since a large number of populations, including elderly, are shown to have too little vitamin D and also has low muscle strength, it will be essential that these people added vitamin D in relation to training and rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Men 20-30 or 60-75 years old

Exclusion Criteria:

* smokers Knee problems On medication affecting protein synthesis High exposure to sun light (ex. ski holiday) during the trial
Hemostatic Matrix in Endoscopic Sinus Surgery

Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving hemostasis in patients undergoing endoscopic sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years or older.
* Patients undergoing elective primary or re-do endoscopic sinus surgery for chronic sinusitis with bleeding surface requiring an adjunct to achieve hemostasis.
* Patients must be willing and capable of cooperating to the extent and degree required by the protocol and sign the IRB approved Informed Consent Form prior to any participation in the study.

Exclusion Criteria:

* Patients with bleeding diathesis, pathologic coagulopathy, systemic disorders, inflammatory conditions (other than chronic sinusitis or nasal polyposis) or autoimmune, immunodeficiency diseases or any other disorder that may interfere with hemostasis.
* Patients with severe (brisk or forceful) bleeding site(s).
* Patients undergoing urgent or emergency endoscopic sinus surgery.
* Patients with bronchial asthma who have aspirin intolerance.
* Patients with diffuse polyposis that would require chronic oral steroids or patients on chemotherapeutic agents that might delay healing (short term pulse steroid therapy and topical steroids are acceptable).
* Patients who have used anticoagulant, antiplatelet or nonsteroidal anti-inflammatory analgesic (NSAID) within 7 days prior to surgery.
* Patients who are morbidly obese (Body Mass Index \> 35).
* Patients with acute local infection at the operative side.
* Patients who are current alcohol and/or drug abusers.
* Patients with neoplasm, craniofacial abnormalities (e.g. cleft palate), or sleep apnea using nasal CPAP, or patients that may require a Lothrop procedure.
* Female patients who are pregnant or nursing.
* Patients who have uncontrolled diabetes mellitus (blood glucose levels \>400 mg/dl) as determined by the Investigator based on medical history.
* Patients who have participated in another investigational drug or device research within 30 days of enrollment.
* Patients with known antibodies to bovine thrombin preparations, sensitivities or religious prohibitions to porcine gelatin or bovine components.
Functional Dyspepsia Microbiome Study

Recurrent abdominal pain has long been acknowledged to be the most common chronic pain entities in children. The purpose of this study is to describe the microbiome in children with FD and to explore relationships between the microbiome and postprandial distress syndrome, anxiety scores, and mucosal biomarkers or anxiety. The specific goals of this study are to: 1) Determine the frequencies and relative proportions for specific bacteria or bacteria phyla in children with FD in both duodenal mucosal specimens and stool samples. 2) Determine if the frequencies or proportions of specific bacteria or bacteria phyla differ between children with and without PDS. 3) Determine bi-variate correlations between bacteria/phyla frequency, bacteria/phyla proportions, anxiety scores, and mucosal biomarkers, respectively.

The purpose of the current study is to describe the microbiome in children with FD and to explore relationships between the microbiome and postprandial distress syndrome, anxiety scores, and mucosal biomarkers or anxiety.

SPECIFIC AIMS

1. To determine the frequencies and relative proportions for specific bacteria or bacteria phyla in children with FD in both duodenal mucosal specimens and stool samples.
2. To determine if the frequencies or proportions of specific bacteria or bacteria phyla differ between children with and without PDS.
3. To determine bi-variate correlations between bacteria/phyla frequency, bacteria/ phyla proportion, anxiety scores, and mucosal biomarkers, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FD as determined by the GI physician in accordance with Rome III criteria
* Age 8-17 years inclusive
* Scheduled for upper endoscopy as part of routine care after failing to respond to acid suppression therapy

Exclusion Criteria:

* Use of oral antibiotic or probiotic within 8 weeks prior to enrollment
* Use of systemic steroid or immunomodulating drug within 8 weeks of enrollment
Data Collection of OCT and OCTA-based Ocular Measurements

Data Collection of OCT and OCTA-based Ocular Measurements

The purpose of this study is to collect measurements of anatomical structures of the posterior pole of the eye based on OCT scans in subjects without clinical signs of pathology.

Eligibility Criteria:
Inclusion Criteria:

* No glaucoma
* No retinal pathology
* No systemic disorders impacting the eye
* No ocular surgery or medical treatment of ocular condition

Exclusion Criteria:

* High IOP
* Poor vision
* Clinical findings consistent with pathology
* Unable to complete the study
Screening of Obstructive Sleep Apnea Syndrome in Patients With Resistant Systemic Arterial Hypertension: Pilot Study

This study evaluates the utility and reliability of Somnocheck micro Weinmann for obstructive sleep apnea syndrome (OSAS) screening in patients affected by resistant systemic arterial hypertension. Results are compared with a modified portable sleep apnea testing (type III portable monitoring: Somnocheck 2 Weinmann).

OSAS is a syndrome characterized by the partial or total collapse of the high airways which determines snore, airflow limitation, hypopnea and apnea.These events cause desaturations, daytime sleepiness and an increased risk of cardio and cerebral vascular diseases.

OSAS's prevalence is estimated between 64-83% among patients affected by resistant arterial hypertension; therefore OSAS's screening is mandatory during the clinical work-up of these patients.

This study is a randomized, interventional, spontaneous, exploratory, cross-over and monocentric trial, which assesses the utility and reliability of the reduced cardio-respiratory monitoring (type IV portable monitoring: Somnocheck micro Weinmann) to estimate the prevalence of OSAS among patients affected by resistant systemic arterial hypertension. The results are compared with a complete cardio-respiratory monitoring (type III portable monitoring: Somnocheck 2 Weinmann).

Eligibility Criteria:
Inclusion Criteria:

* Resistant Arterial Hypertension
* Patients must sign the informed consent

Exclusion Criteria: ,

* atrial fibrillation with haemodynamic instability
* congestive hearth failure,
* BMI\>45 kg/m2,
* respiratory failure
* renal or liver failure,
* stroke,
* implantable cardioverter-defibrillator (ICD),
* pacemaker (PM),
* previous diagnosis of OSAS,
* pregnancy,
* breastfeeding,
* patients must not be already enrolled in other clinical trial.
Movement Analysis in Musculoskeletal Oncology: a Pilot Study

Noninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques


Eligibility Criteria:
Inclusion Criteria:

* Age \> 6 years
* Diagnosis of primary and secondary tumors of the musculoskeletal system
* Patients who will need to undergo surgery for bone resection or wide excision of soft tissue lesion, and/or radiation or drug treatments
* Availability of follow-up data (for at least 6 months)
* Written informed consent

Exclusion Criteria:

- Inability to perform pre-post treatment assessment
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation

Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL) is a drug that may stabilize or improve kidney function for patients with chronic kidney disease (CKD) that has been caused by immunosuppressants. EVL is used for standard of care treatment to prevent transplant liver rejection in combination with other immunosuppressants, such as tacrolimus. The overall aim of this study is to examine a combination of two different immunosuppressants and EVL to determine if patients may have stabilized and/or improved kidney function without liver rejection. This study will look at how safe it is to slowly withdraw one anti-rejection medication while continuing to take the other medicine, and whether this can be done without liver rejection occurrence.


Eligibility Criteria:
Inclusion Criteria:

* Adult LT candidates ≥ 18 years of age
* Listed for or recent (within 1 month) recipient of deceased or living donor liver transplantation

Exclusion Criteria:

* Combined or previous organ transplantation
* Human immunodeficiency virus (HIV) infection
* Inability to provide informed consent or comply with the protocol.
Evaluation Study of the Effects of Sulphurous Water in the Treatment of Knee Osteoarthritis.

The objectives are to evaluate the effects of immersion bath with sulphurous water in pain, joint mobility and quality of life in patients with knee osteoarthritis. Patients will undergo three weekly baths in sulphurous water and not sulphurous, twenty minutes each, for ten weeks.

The expected results are: reduction of pain, improved range of motion of the lower limbs with consequent increase in muscle mass improvement in postural balance, which will come due to the reduction of pain and improvement movements of the lower limbs; greater independence in performing the activities of daily living, better quality of life.

The baths were performed in individual tubs, properly disinfected, supplied with thermal water and sulphurous thermal sulphurous not at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects drank two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water. Treatment consisted of 30 individual treatment sessions, three times a week, lasting twenty minutes each session, for ten weeks. The experiment was performed at the Therms Antonio Carlos, institution belonging to the Municipality of Poços de Caldas, Minas Gerais, Brazil.

Eligibility Criteria:
Inclusion Criteria:

We selected individuals of both genders, diagnosed with Osteoarthritis of the knee according to the classification criteria of the American College of Rheumatology (ACR) only grades I to III chronic pain at some knees, for a minimum period of three months.

Exclusion Criteria:

* Patients with fibromyalgia;
* Individuals with respiratory diseases;
* Rheumatic diseases autoimmune inflammatory;
* Patients with uncontrolled thyroidopathies;
* Patients with injuries or amputations of lower limbs;
* Patients with psychiatric disorders or cognitive;
* Patients with a history of osteoporotic fracture;
* Patients with malignant
* Patients with infectious processes;
* Patients pregnant;
* Individuals who failed to enter the baths due to physical limitations;
* Were also excluded those who were engaged in other forms of treatment or using painkillers and anti-inflammatory drugs for other diseases. Note: were not excluded participants who were diagnosed with osteoarthritis in the spine, herniated, or degenerative disc protrusions.
Consuming Grass Finished Lamb Improves Blood Plasma ω-3 Fatty Acid Response Among Healthy Consumers.

This study will investigate the impact of consuming grass-finished lamb meat on blood omega-3 PUFAs and cardiovascular risk factors compared to concentrate-finished lamb meat. Healthy volunteers will consume three portions of lamb meat/week from a grass-finished meat treatment or a concentrate-finished meat treatment for four weeks. Blood samples will be taken at weeks zero and four. The primary outcome is to assess difference in change in omega-3 PUFA concentration in plasma and platelets between treatment groups. The secondary outcome is to assess between groups differences in change in cardiovascular disease risk factors including blood pressure, BMI and lipids among healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers aged between 18-64 years old.

Exclusion Criteria:

* Participants with a BMI of \<18.5 km/m² and greater than \>35 km/m².
* Participants who take prescribed medication, including statins to reduce LDL cholesterol, and any form of dietary supplements (excluding vitamin D).
* People who smoke.
* Participants who consume more than two portions of fish per month.
Use of Binaural Beats for Colonoscopy

Investigators verify the effectiveness of "binaural beats" to reduce pain during colonoscopy .

Colonoscopy is a disturbing and painful procedure, so whenever possible it is performed in sedation. Although the use of sedative drugs is effective in relieving anxiety and pain such drugs can cause significant side-effects.

This study examines the effect of Binaural Beats stimulation on pain perception during colonscopy.

Binaural Beats is a simple technique, described for the first time since by Gerald Oster , that include the presentation of two acoustic stimuli with similar frequencies through the two channels of stereo headphones. The interference of their waves which occurs at the level of the central nervous system, produces a composite signal with a frequency resulting from the difference of the two original frequencies. For example if you give an acoustic stimulus of 100 Hz to an ear and simultaneously administering another acoustic stimulation of 104 Hz to the opposite ,ear the person who listens to these stimuli will perceive a "Binaural Beat" of 4 Hz caused by the difference between the two frequencies.

These Binaural Beats are of interest because they have been thought to cause hemispheric synchronization and influence the EEG frequency like light stimulation .

Binaural Beats have already been used in humans undergoing outpatient surgery in urogynecological and have been shown to help increase patient comfort by reducing the state of anxiety and pain without interfering negatively with postoperative functional recovery . In this study the investigators evaluate the use of Binaural Beat in outpatients to undergo colonoscopy to reduce pain .

A total of 100 patients divided into two groups, 50 treatment and 50 control will be considered.

Both patient groups will be invited to wear headphones regardless of whether they have been randomized to Binaural Beats with white noise or white noise only to ensure blindness of participation The headphones will be worn ten minutes before and throughout the procedure. Pain will be measured by VAS scale and satisfaction by Likert scale after the procedure in both groups. Blood pressure and heart rate will be monitored before, during, and after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for outpatient colonoscopy
* Valid consent expression to the study participation
* Good collaboration in activities provided by the study

Exclusion Criteria:

* Insufficient degree of collaboration
* Abnormal hearing
* Denial of informed consent to participate in the study
* Previous colon resection surgery