cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers

The main objective of this study is to document the effectiveness of a honey-based medical device (Hyalumel) in the management of pressure ulcers. The effectiveness of the medical device will be judged according to the evolution of the surface of the wound at the end of 12 weeks of treatment.

The secondary objectives of this study are to compare the following items between the two arms of the study:

A. The evolution of skin microbiota in the wound B. The evolution of the surface and the depth of the wound during follow-up C. The healing process D. Patient and caretaker acceptability

Eligibility Criteria:
Inclusion Criteria:

* Information provided on the implementation of the study, its objectives, constraints and patient rights
* The patient, or his/her legal guardian, must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 weeks of follow-up
* Presence of one or more pressure ulcers at stages 2, 3 or 4 according to the European Pressure Ulcer Advisory Panel - National Pressure Ulcer Advisory Panel (EPUAP-NPUAP) classification
* Wound whose surface is between 1 cm\^2 and 15 cm\^2
* Wound present for more than 6 weeks
* Patient whose wound requires a modern dressing (that is to say, a bandage that is neither tulle nor gauze) without bactericidal agents or antibiotics
* No antibiotics for at least 7 days prior to inclusion (after inclusion, the patient can be treated with antibiotics if necessary, regardless of the indications)

Exclusion Criteria:

* Patient participating in or having participated in another interventional study in the previous 3 months or currently in a patient exclusion period determined by a previous study.
* Patient under judicial protection
* Failure to correctly inform the patient or his/her legal representative
* Patient (or his/her legal guardian) refusal to sign the consent
* The patient is pregnant, parturient, or breastfeeding
* Contraindications (or incompatible combination therapy) for a necessary treatment in this study
* Patient with an allergy to honey or propolis
* The patient's general condition suggests study exclusion before twelve weeks of follow-up
* Antibiotics received within 7 days prior to inclusion
* Active neoplastic lesion treated with radiation or chemotherapy
* Immunosuppressive therapy or other treatment which, in the judgment of the investigator, may interfere with the healing process
* Surgery planned within twelve weeks of inclusion
* Stage 1 wound according to the EPUAP-NPUAP classification
* Amputation wound
* Wound related to a surgical treatment or for which an act of revascularization is envisaged within twelve weeks of inclusion
* Malignant wound
Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.


Eligibility Criteria:
Inclusion Criteria:

* age \> 1 year
* \>90% of total calories via G-tube for \> 6 months
* G-tube diameter ≥ 14 French
* moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score \> 2
* anticipated stable GI-related medications for the duration of the study.

Exclusion Criteria:

* cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant
* untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease)
* Nissen fundoplication
* use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases
* allergy or intolerance to any component of the study diet
* inability to tolerate bolus gastric feeds.
Relaxation, Depressive Symptoms, Quality of Life in People Living With HIV: a Pilot Study

Progressive muscle relaxation (PMR) and autogenic training (AT) are effective relaxation techniques to reduce depressive symptoms. However, no studies on their effectiveness have been conducted among people living with HIV and depressive symptoms. The primary aim of this pilot study was to assess the feasibility and acceptability of PMR and AT interventions among people living with HIV who have depressive symptoms. A secondary aim was to assess the potential effectiveness of these interventions on depressive symptoms and quality of life.

This study was a three-arm pilot randomized control trial with mixed methods. Participants were randomized to PMR, AT, or control group (CG), with four assessments (baseline, one-, three-, and six-month). The PMR and AT interventions consisted of six one-hour sessions of individual training over 12 weeks and home practice. Recruitment, attrition, and completion rates were calculated. Depressive symptoms and quality of life were assessed at all times. Participants' perceptions of the interventions were collected in semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* HIV diagnosis of at least two years
* Depressive symptoms between 5 and 14 in the PHQ-9 scale
* Untreated with antidepressants or psychotherapy
* Able to speak and understand French

Exclusion Criteria:

* Started antiretroviral treatment within the last 6 months
* Start or already receiving Interferon
Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685

This is an early phase study to assess the safety and tolerability of ONO-4685 in patients with psoriasis. In addition, the study will assess how the drug is distributed and eliminated by the body (pharmacokinetics) and how the drug affects the body (pharmacodynamics). This will be done by measuring the amount of drug in the blood and measuring other markers in the body that might have been affected by ONO-4685. The study will also look at preliminary information on whether ONO-4685 might be effective in treating psoriasis.

The study will be split into three parts. Part A will assess a single dose of ONO-4685 in small groups of patients, each group planned to receive a higher dose than the last group. In Part B and C, patients will receive multiple doses of ONO-4685 over a period of 4 weeks.


Eligibility Criteria:
Inclusion Criteria

* Subjects must be willing and able to participate in the study
* A diagnosis of plaque-type psoriasis for ≥6 months.
* Plaque-type psoriasis involving ≥3% of body surface area (BSA) (Parts B and C).
* Willing to provide skin biopsies (Parts B and C).
* Subjects in good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests.
* Subjects willing to comply with the contraception and sperm and ova donation requirements of the protocol.

Exclusion Criteria

* Subjects with any clinically significant abnormality in screening tests.
* Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the psoriasis, or other skin condition (eg eczema).
* Presence or history of alcohol or drugs abuse.
* Heavy smokers (more than 20 cigarettes or use more than ½ ounce (12.5 grams) of tobacco each day).
* Subjects have had any 'live' vaccines (excluding COVID-19 vaccine) during the 3 months before the first dose of study medicine.
* Subjects have had a first COVID-19 vaccine within 6 weeks or second and booster COVID-19 vaccinations within 2 weeks before the first dose of study medicine.
* Subjects have had any clinically significant disease or infection, including tuberculosis.
* Presence or history of malignancy (cancer) including lymphoproliferative disorders.
* Subject is pregnant, lactating, or breastfeeding.
* Subjects have received treatment with biologics in the last 3 months, immunosuppressant medicine or prescription medicine for psoriasis within 4 weeks before admission to the ward; have used phototherapy from 2 weeks before admission to the ward; have used highly potent or potent topical steroids within 2 weeks before admission to the ward.
* Subjects have used topical corticosteroids or Vitamin D analogues within 7 days before admission to the ward (Parts B and C).
Effect of Oral Galactose on Focal Segmental Glomerulosclerosis (FSGS) Permeability Factor

This study is a proof-of-concept clinical study designed to test the hypothesis that oral administration of galactose can lower the level of a circulating factor that increases glomerular permeability to albumin in patients with resistant FSGS.

Patients with resistant FSGS have persistent proteinuria and a high risk of progression to end stage kidney disease (ESKD). A circulating factor that increases glomerular permeability to albumin (Palb) has been detected in over 50% of these patients. While the molecular identity of the factor has not been fully established, in vitro studies and limited clinical experience suggest that galactose can reduce the level of the FSGS permeability factor.

This study is a pilot study to determine if oral administration of galactose can lower the circulating level of the FSGS permeability factor.

Two groups of patients with biopsy proven primary FSGS who are resistant to steroids and one other immunosuppressive agents will be studied:

l. FSGS, pre-ESKD 2. FSGS, with ESKD on renal replacement therapy

The only eligibility factor is presence of the FSGS permeability factor.

Five patients will be included in each group.

The experimental intervention is administration of galactose, orally, 0.2 g/kg body weight/dose twice daily. the duration of treatment will be 28 days,.

Patients will be seen on days 0, 14, and 28 of treatment. They will be seen at week 8, 16 and 24 after discontinuation of the galactose.

Physical examination and routine laboratory tests (SMAC, CBC, urine protein:creatinine ratio in an early morning sample) will be done at each visit. The FSGS permeability factor will be assayed at days 0 and 28 of treatment and 6 months after discontinuation of the galactose. The permeability factor will be tested in the laboratory of Virginia Savin MD (Medical college of Wisconsin) using previously described methods.

All other treatments will be unchanged during the 28 day oral galactose Treatment Period.

The study will be analyzed based on the number of patients in whom the FSGS permeability factor is lowered to normal levels.

Eligibility Criteria:
Inclusion Criteria:

* Primary FSGS
* Resistance to steroids and another immunosuppressive medication

Exclusion Criteria:

* Secondary FSGS
Kinematical Evaluation of Lumbar Rotation in Chronic Low Back Pain

Low back pain (LBP) is considered one of the most common musculoskeletal disorders in modern society, resulting in substantial costs to society. Factors associated with the development of low back pain include poor posture, strenuous work with the body, inadequate non ergonomic work and traumas.

Rotation movement pattern of the lumbar spine in different positions is essential aspect in understanding the LBP Pathophysiology. Rotation coupled with forward bending (flexion) is a dominant factor which could increase the risk LBP and disc prolapse. There is also a decline in range of motion (ROM) of rotation in forward bending (flexion) compared to neutral position during sitting and standing.

In addition,lumbar rotation movement patterns differ in population with LBP compared to asymptomatic individuals. Healthy individuals exhibit rotation accompanied by consistent coupled movement patterns of lateral bending in the opposite direction at thr upper levels, and by lateral bending in tge same direction at the lower levels . while Chronic LBP patients exhibit non consistent patterns altered from those of the normal population.

According to the investigators, Kinematic measures of velocity and acceleration of lumbar rotation in neutral position and full flexion in sitting and standing did not studied yet. Evaluating these parameters, in addition to ROM and plains evaluation in the LBP population, compared to healthy population will contribute a lot in understanding this issue.

Eligibility Criteria:
Inclusion Criteria:

* non specific chronic LBP (three months or more)
* Insured by Clalit Health Care Services
* Signed informed consent

Exclusion Criteria:

* History of spinal /pelvic surgery.
* Trauma or fracture of spine /pelvis.
* Inflammatory diseases of spine.
* radiation to lower extremities .
* Neurological disease.
* malignancy disease. structural deformity of vertebral structures(scoliosis, kyphosis).
Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement

Poor nutritional status and malnutrition are prevalent for patients undergoing treatment for head and neck cancer. Inadequate dietary intake is multi factorial, with patients experiencing dysphagia and or anorexia caused by various cancer treatments. Current standard practice utilizes Gastrostomy Tube placement to manage adverse nutritional effects related to Head and Neck cancer treatment.

The purpose of this study is to assess the quality of life and educational intervention outcomes of Head and Neck Cancer patients who have a gastrostomy tube placed per standard of care.

A high incident of Gastrostomy tube replacement occurs related to clogged, dislodged, and/or pulled out tubes. In addition, patients not eating or drinking after Gastrostomy tube placement, compounded by complications related to radiation treatment, results in decreased swallowing function. Inadequate swallow function, especially when combined with inadequate use of Gastrostomy tube, due to non-functional tube or insufficient patient knowledge in use of tube, results in poor nutritional status and excessive weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Head and Neck cancer diagnosis
* Esophageal cancer diagnosis
* Receiving chemotherapy and/or radiation therapy
* Gastrostomy Tube placed within the last 30days or scheduled to have a gastrostomy tube placed within the next 30 days

Exclusion Criteria:

* Not eligible for chemotherapy and/or radiation therapy
* Unwilling or unable to sign informed consent
* Any cognitive or mental deficits that would prevent patient from completing questionnaires or understanding educational interventions
* Current pre-existing Gastrostomy tube complications if a current Gastrostomy tube is in place prior to informed consent (i.e., skin breakdown, tube breakdown, other tube complications).
* No Gastrostomy tube placement
* Non-English Speaking
French Renal Epidemiology and Information Network (REIN) Registry

The Renal Epidemiology and Information Network (REIN) Registry was created in 2002 (after study pilot in 2001) to contribute to the development and evaluation of health strategies aiming at improving prevention and management of end-stage renal disease, and promoting clinical and epidemiological research in this field. It relies on a network of nephrologists, epidemiologists, patients and public health representatives, coordinated regionally and nationally.

The REIN registry is intended to include all end stage renal disease patients on renal replacement therapy (RRT) - either dialysis or transplantation - living in Lorraine area.

New (incident) patients are reported from the first day of RRT. Patients with a diagnosis of acute renal failure are excluded, i.e. those who recover all or some renal function within 45 days or are considered as such by experts when they die before 45 days. Patients with pre-emptive grafts and those living with a functioning graft are identified from the transplant database.

A set of basic items, including fixed and annually updateable items, was defined for all dialysis patients. Five types of events are reported to the registry on occurrence from the first day of any treatment: (1) renal transplantation, (2) changes in dialysis setting, (3) changes in type of dialysis, (4) transient recovery of renal function and (5) death.

The participation rate of centres in Lorraine is 100%. A clinical research assistant visits every dialysis centre to verify the completeness of patient and event registration, by comparing reports to the registry with centre administration files.

The REIN guide defines all items to be recorded, includes coding instructions, and serves as a standard for all participating regions.

REIN consists of a partnership network and professionals whose Biomedicine Agency is the institutional support. The National level consists of a national coordination, a steering group and a scientific board. Regional level includes a Regional Steering Group led by nephrologist and epidemiological coordinators and an epidemiological unit.

Eligibility Criteria:
Inclusion Criteria:

* All patients with end stage renal disease on renal replacement therapy

Exclusion Criteria:

* Patients with acute renal failure ( i.e. those who recover all or some renal function within 45 days or are considered as such by experts when they die before 45 days)
* Patient's refusal
Biomechanical and Electrophysiological Effects of Duloxetine in the Treatment of Women With Urinary Stress Incontinence

Biomechanical and electrophysiological effects of duloxetine in the treatment of women with urinary stress incontinence


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of only stress urinary incontinence
* Have no pelvic organ prolapse protruding more than 1 cm beyond the hymen

Exclusion Criteria:

* At visit 1, have a positive urine culture or a history of four or more urinary tract infections in the preceding year.
* Have had more than one continence surgery.
* Have a current or past urogenital cancer.
Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

Previous studies suggest that chronic idiopathic thrombocytopenic purpura is associated with Helicobacter pylori infection. The objective is to study the effect of Helicobacter pylori eradication on platelet count.

Children with chronic idiopathic thrombocytopenic purpura who have Helicobacter pylori infection are enrolled. Helicobacter pylori infection is diagnosed by urea breath test. Patients who have Helicobacter pylori infection will be randomized into 2 groups: control and treatment groups. The treatment group will receive 2 antibiotics and proton-pump inhibitors for 14 days for eradication of infection. Repeated urea breath test at week 6-8 after treatment. Blood tests for platelet count will be performed every month for 6 months in both groups. Platelet count at 6 months in both group will be compared.Blood for platelet antibody will be performed at 3 and 6 months. Control group will receive treatment for Helicobacter pylori at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Children who was diagnosed as chronic ITP, defined by platelets below 100,000/uL for more than 6 months without identified causes.
* 13C-urea breath test (UBT) was performed for diagnosis of Helicobacter pylori infection.

Exclusion Criteria:

* Patients who had a previous treatment for H. pylori infection.

  * Patients require prednisolone more than 0.5 mg/kg/day
A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis

AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met, suggesting that its anti-tumor effect mainly inhibits the activation of key downstream oncogenic pathways by inhibiting expression of c-met, tumor angiogenesis and tumor cell migration.


Eligibility Criteria:
Inclusion Criteria:

* 1.Understood and signed an informed consent form. 2.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

  3.Histologically confirmed advanced non-small cell lung cancer with at least one bone metastatic lesion with bone destruction.

  4.Has received at least two systematic treatment regimens that failed or were unable to tolerate treatment.

  5.EGFR, ALK gene mutations are negative. 6.Adequate laboratory indicators. 7.No pregnant or breastfeeding women, and a negative pregnancy test.

Exclusion Criteria:

* 1.Small cell lung cancer. 2. Diagnosed and/or treated additional malignancy within 5 years with the exception of cured cervical carcinoma in situ and non-melanoma skin cancer.

  3. Has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment.

  4. Has received systemic radionuclide therapy or semi-extracorporeal radiation for bone metastases.

  5. Has known to be allergic to the study drug or any of its excipients. 6. Has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by CT or MRI examination before the first dose.

  7. Has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by Oxaliplatin.

  8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.

  9. Has spinal cord compression or mandibular osteonecrosis. 10.Has multiple factors that affect oral medications. 11.Has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.

  12.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

  13. Has severe acute comorbidities before the first dose. 14. Has participated in other clinical trials within 4 weeks before the first dose.

  15.According to the investigators' judgment.
Central Temperature Monitoring by Zero-heath-flux a Non-invasive Technic Compared to Two Invasive Technic During Surgery

Core temperature monitoring is mandatory during major surgery. The accurate techniques currently used are invasive, such as artery catheter and oesophagal probe. A new non-invasive cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure core temperature. This prospective study compare the accuracy of Zero-Heath-Flux to oesophagal temperature (30 patients) and to artery catheter (20 patients) in adult patients during surgery.

Every patients undergoing heavy surgery had their central temperature monitoring, through an arterial catheter if the surgery required it (30 patients in this arm), otherwise the investigators used an oesophagus tube (20 patients). We also monitored every 50 patients with a non-invasive method 3M spot on (Zero-heath-flux technic) in order to measure its fiability and validity during the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo general anaesthesia for gut surgery lasting more than 2 hours
* Patients with core temperature monitored with oesophagal probe only (30 patients) or with oesophagal probe and PICCO device (20 patients)
* Patients without opposition to this study after informations given

Exclusion Criteria:

* Patients with frontal cutaneous decay wich avoid using 3M Spot-on
* Patients whom oesophagal probe was prohibited (oesophagal varices, oesophagal surgery)
* Pregnant women or breast-feeding, women who may become pregnant unless adequate contraceptive measures