cyrilzakka/clinical-trials huggingface dataset:
Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization

The goalf of the study is to have a basis about QOL for colo-stoma and ileo-stoma for patients which are hospitalized at home. The QOL measurement is done with a questionnaire of several items made by stomatherapist and also using EQ5D QOL form.

After reviewing of the data, our goal is to create or improve some solutions to improve their QOL during their home hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Colo-stomy or Ileo-stomy patient
* Patient hospitalized at home by Fondation Sante Service (Fr)
* 18 YO or more
* Non-opposition to the study

Exclusion Criteria:

* Patient not able to read or properly understand the Information Consent Form and not able to complete the questionnaire for any reason.
Quality-of-Life-and-Cognitive-Oriented Rehabilitation Through the NeuronUP in Alzheimer's Disease

Introduction: New technologies are a support in the rehabilitation of users. The therapeutic approach to cognitive rehabilitation encompasses a variety of techniques, among which traditional occupational therapy stands out. This modality includes a series of interventions such as cognitive stimulation through the use of cards, functional activities, psychomotor exercises, the application of sensory stimuli and the incorporation of music therapy. An additional alternative is to integrate a cognitive stimulation program such as NeuronUP, which is a computerized tool. This integration can increase adherence to treatment and contribute to preserving or improving the individual's cognitive functioning and improving quality of life.

Objective: The objective established for this study was to verify whether the combination of occupational therapy with the NeuronUP computer program improves or maintains the cognitive status and quality of life of users with Alzheimer's disease. In addition, to determine whether the use of this program leads to greater adherence to treatment by patients.

Material and methods: This is a randomized clinical trial. Participants' cognitive status will be assessed using the MEC (Mini Cognitive Examination) tool, cognitive skills using the LOTCA (Loewenstein Occupational Therapy Cognitive Assessment), and perceived quality of life using the Whoqol-Bref questionnaire. At the end of treatment, the CSQ-8, a tool designed to determine the degree of user satisfaction, will be administered.


Eligibility Criteria:
Inclusion Criteria:

* Adult men or women, aged 65 years or olde.
* Not present severe cognitive impairment, measured through the Mini Cognitive Examination test (MEC\>22 points).
* To reside permanently in the Nursing Home.
* Attend Occupational Therapy sessions regularly.
* Have adequate manual dexterity to be able to use a Tablet.
* Agree to participate voluntarily in the study.

Exclusion Criteria:

* Having severe cognitive impairment, as measured by the Mini Cognitive Examination (MEC\<22 points).
* Having comorbid diagnoses such as stroke, brain tumours or heart disease, among others.
* Not attending Occupational Therapy sessions regularly.
* Poor adherence to the treatments offered at the centre.
* Not agreeing to participate voluntarily in the study.
Suture of the Ovary After Enucleation of Ovarian Endometrioma

Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity.

According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate).

To date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation.

In this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.


Eligibility Criteria:
Inclusion Criteria:

* Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;
* Normal AFC at the enrollment (baseline).

Exclusion Criteria:

* Any other disease;
* Bilateral endometriomas;
* Deep infiltrating endometriosis;
* No previous pelvic surgery (even not gynecological);
* Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);
Efficacy and Safety Study of Drugs for Treatment of Visceral Leishmaniasis in Brazil

This study is aimed to compare the efficacy and safety of medications currently used in Brazil for treatment of visceral leishmaniasis. The investigators will compare the effects of meglumine antimoniate, two formulations of amphotericin B: deoxycholate and liposomal, and a combination of meglumine plus the liposomal amphotericin B formulation. The study is designed to demonstrate the difference in efficacy measured as cure rate at six months after treatment and the safety profile based on the adverse event rate observed with each intervention.

Visceral leishmaniasis is a relevant public health problem in Brazil with approximately 3500 cases registered every year. Eight percent lethality rate has been observed during the past decade in spite of free of charge availability of antileishmanial drugs supplied by the public health system.

The present study was designed as a phase IV, multicentric, open label, active controlled clinical trial targeted to visceral leishmaniasis adult and pediatric cases.

The current drugs approved for visceral leishmaniasis treatment in Brazil will be compared in four treatment groups: meglumine antimoniate, amphotericin B deoxycholate, liposomal amphotericin B and a combination of single dose of liposomal amphotericin B plus meglumine antimoniate. Meglumine antimoniate treated patients will constitute the active control group.

Drugs will be compared based on the cure rate observed after six months follow-up.

The study arm submitted to treatment with Amphotericin B deoxycholate was suspended in September 2012.

Eligibility Criteria:
Inclusion Criteria:

* patients with visceral leishmaniasis characterized by fever plus hepatomegaly or splenomegaly with at least one positive result in the following laboratory tests:
* direct observation of leishmania amastigotes in bone marrow smear
* leishmania in vitro culture from bone marrow aspirates
* leishmania kDNA amplification by PCR in bone marrow or peripheral blood samples
* rK39 immunochromatographic rapid test performed on serum sample

Exclusion Criteria:

* pregnancy
* HIV infection
* chronic diseases such as diabetes mellitus,kidney, liver or cardiac diseases, schistosomiasis, malaria or tuberculosis
* immune disorders or use of drugs which interferes with the immune response
* treatment with drugs with increased risk for toxicity associated with the study drugs
* exposure to antileishmanial drugs during the past six months
* I.V. drug users
* episodes of visceral leishmaniasis relapse
* hypersensibility to the study drugs
* difficulties for accomplishing the follow-up schedule
* any of the following clinical signs of laboratory abnormalities: hepatic encephalopathy, generalized edema, toxemic individuals, severe malnutrition, jaundice, abnormal serum creatinine, bilirubin, INR \> 2,0, platelet count \< 20000/mm3
Clinical Investigation of a New Version of MAIA Microperimeter on Healthy Subjects and Patients With Retinal Pathology

The purpose of this pre-market, monocentric cross-sectional study is to evaluate the clinical usefulness of a new version of the MAIA device (MAIA) through an agreement with the established version of the MAIA microperimeter (MAIA 2013 EDITION). Moreover, the study aims to evaluate MAIA test-retest repeatability in comparison with MAIA 2013 EDITION and to evaluate MAIA safety and adverse events. These purposes will be achieved by collecting data of healthy subjects and patients with retinal pathology. All participants will undergo repeated microperimetric examinations with both devices during one single visit.


Eligibility Criteria:
Healthy Subjects

Inclusion Criteria:

* Age: 18-90 years old;
* BCVA ≥ 0.8 Decimal;
* Equivalent spherical refraction between -12D and +6D; astigmatism within 2D;
* IOP ≤ 21 mmHg;
* Clinically normal appearance of the optic nerve head (examined with Spectralis OCT);
* Clinically normal appearance of the macula (examined with Spectralis OCT);
* No ocular pathologies, trauma, surgeries;
* Absence of pathologies that can affect visual field;
* No use of drugs inferfering with the correct execution of perimetry;

Exclusion Criteria:

* Glaucoma or glaucoma suspect diagnosis;
* IOP ≥ 22 mmHg;
* Presence or history of disc hemorrhage;
* Presence of amblyopia;
* Nystagmus or poor fixation;
* Previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment;
* Any active infection of anterior or posterior segments;
* Subjects with significant ocular media opacities;
* Evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease;
* Use of any drug that can interfere with the correct execution of microperimetry or that would produce visual field loss;
* Unable to tolerate ophthalmic imaging;
* Claustrophobia;
* Inability to provide informed consent.

Patients with retinal pathology

Inclusion Criteria:

* Age: 18-90 years old;
* BCVA ≥ 0.1 Decimal;
* Equivalent spherical refraction between -12D and +6D; astigmatism within 2D;
* Diagnosis of any type of retinal disease by investigator based on fundoscopy and Spectralis OCT for which microperimetry is indicated;

Exclusion Criteria:

* Any ocular surgery, with the exception of uncomplicated cataract surgery performed at least 6 months before enrollment;
* Subjects unable to tolerate ophthalmic imaging;
* Nystagmus;
* Subjects with significant ocular media opacities;
* Use of any drug that can interfere with the correct execution of microperimetry or that would produce visual field loss;
* Claustrophobia;
* Inability to provide informed consent;
* Vulnerable subjects according to the investigator's judgement.
Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts

To evaluate whether salicylic acid was superior to cryotherapy for plantar warts

Patients with plantar warts were randomized equally to receive salicylic acid or cryotherapy. Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart. Thirty percent of salicylic acid is applied once daily by the patient (or parent) for a maximum of 12 weeks. The primary outcomes were the cure rates at 12 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HPV1-induced plantar warts.
* Total number of warts is ≤5.
* Aged 12 years or older.

Exclusion Criteria:

* Patients are currently participating in another trial for the treatment of plantar warts.
* Patients had received two or more consecutive sessions of cryotherapy, with an interval of no more than 4 weeks (The history of salicylic acid treatment was not considered as criteria for exclusion because high concentration salicylic acid is not commercially available in Chinese mainland).
* Patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months.
* Patients have impaired healing eg due to diabetes, vitamin A deficiency, hyperthyroidism and hypothyroidism.
* Patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases).
* Patients are pregnant or ready for pregnancies or breast-feeding.
* Patients have cold intolerance (such as cold urticaria, cryoglobulinaemia, cold agglutinin syndrome or Raynaud's syndrome).
* Patients have local pain intolerance.
* Patients have local hypoesthesia.
* Patients are unable to tolerate salicylic acid or cryotherapy.
Effects of Saline on Circulation in Children

Pulmonary hypertensive crisis is a life-threatening condition, in which the blood pressure in the pulmonary artery, vein, and capillaries. Infusion of hypertonic saline solutions expand the circulating volume, thus allowing more blood to flow and reducing pressure in the artery, vein, and capillaries. Furthermore, infusion of hypertonic saline has been shown to reduce both systemic and pulmonary vascular resistances in adults. If the pulmonary vascular resistance decreases more or to the same degree as the systemic resistance, infusion of hypertonic saline may prove beneficial in the treatment of pulmonary hypertensive crisis. The primary objective of this study is to investigate how a clinically relevant dose of hypertonic saline affects the systemic and pulmonary circulations in children undergoing cardiac catheterization during general anesthesia. This study hypothesizes that an infusion of hypertonic saline over 10 minutes will reduce the pulmonary vascular resistance more than the systemic vascular resistance.


Eligibility Criteria:
Inclusion Criteria:

* Children who have had a heart transplant and are scheduled for elective endomyocardial biopsies during general anaesthesia
* Age \> 2 years

Exclusion Criteria:

* Plasma Na \< 130 mmol/l or \>150 mmol/l
* Refusal of consent
* An estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
* Children with heart failure (right and/or left), i.e clinical suspicion by either a cardiologist or an anesthesiologist of inability to tolerate a fluid bolus of 3 ml/kg 7.2% NaCl corresponding to an expansion of the circulatory volume by approximately 9% (see the section on safety), which is the equivalent of infusion approximately 20 ml/kg 0.9% NaCl over 10 minutes.
Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval

The effects of two different sedation protocols during transvaginal oocyte retrieval will be investigated on propofol consumption as a rescue sedative and on IVF success. One group will receive dexmedetomidine and fentanyl while the other will receive midazolam and remifentanil.

Women will be consecutively allocated into one of the following two groups using a 1:1 ratio in order to avoid any potential source of bias.

Group DEX: women will receive dexmedetomidine (solution 4 γ/ml) continuously infused at a dose of 1 γ/kg/ and fentanyl 100γ iv. Dexmedetomidine infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of procedure. At that time point, both total volume (ml) and dose (γ) of dexmedetomidine administered will be recorded.

Group MZM: women will receive remifentanil (solution 50γ/ml) continuously infused at a dose of 0.2 γ/kg/min και midazolam 1 mg iv. Remifentanil infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure. At that time point, both total volume (ml) and dose (γ) of remifentanil administered will be recorded.

In both groups, in case of non-co-operation of the woman (e.g. kinetic response), propofol will be given as a bolus rescue dose as follows: the 1st rescue dose will be 1mg/kg while all the next doses will be 0.5 mg/kg. At the end of the procedure, the number of rescue doses and the total rescue dose (mg) of propofol given will be recorded.

Intraoperative monitoring will include ECG, noninvasive blood pressure, SpO2, EtCO2 and depth of sedation using BIS values and ΟΑSS scale. Also, adverse effects such as hypotension, bradycardia, nausea \& vomiting, rigidity, airway obstruction, and need for bag-mask ventilation will be recorded. The use of vasoactive drugs will also be reported.

At the end of the procedure, the time and quality of recovery will be assessed using ΟΑSS scale (max score=5), while postoperatively the Post Anesthesia Discharge Scoring System, as well as woman's and gynecologist's (physician) overall satisfaction related to the sedation techniques used, will be recorded.

Regarding the IVF outcome, the following parameters will be recorded: number of oocytes retrieved, the percentage of mature oocytes, embryo quality, percentage of positive pregnancy test, percentage of clinical pregnancy, the percentage of live birth.

Eligibility Criteria:
Inclusion Criteria:

* female patients between 25 and 45 years old that do not meet any of the exclusion criteria

Exclusion Criteria:

* patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class \>2, severe hypotension or bradycardia, presence of atrioventricular block, cerebrovascular disease or hepatic dysfunction
Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease

The study is a Phase II clinical trial. Patients will receive intensity modulated total body irradiation (TBI) at a dose of 3 Gy with standard fludarabine/ i.v. cyclophosphamide conditioning prior to human leukocyte antigen (HLA)-haploidentical hematopoietic stem cell transplant (HSCT).

The primary objective of the study is to determine the engraftment at Day +60 following HLA-haploidentical hematopoietic stem cell transplant protocol using immunosuppressive agents and low-dose total body irradiation (TBI) for conditioning and post-transplant cyclophosphamide in patients with sickle cell disease.


Eligibility Criteria:
Patient Eligibility:

1. Patients with sickle cell disease are eligible if they have any of the following complications:

   1.1 Stroke or central nervous system event lasting longer than 24 hours 1.2 Frequent vaso-occlusive pain episodes, defined as ≥ 3 per year requiring emergency room, acute care center, hospital admissions, or home bedrest leading to absence from work or school. 1.3 Recurrent episodes of priapism, defined as ≥ 2 per year requiring emergency room visits 1.4 Acute chest syndrome with recurrent hospitalizations, defined as ≥ 2 lifetime events 1.5 Red-cell alloimmunization (≥ 2 antibodies) during long-term transfusion therapy 1.6 Bilateral proliferative retinopathy with major visual impairment in at least one eye 1.7 Osteonecrosis of 2 or more joints 1.8 Sickle cell nephropathy, defined by a GFR \< 90mL/min/1.73m2 or the presence of macroalbuminuria (urine albumin \> 300 mg/g creatinine) 1.9 Pulmonary hypertension, defined by a mean pulmonary arterypressure \>25mmHg
2. Age 16-60 years
3. Karnofsky performance status of 60 or higher (Appendix A)
4. Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40%
5. Adequate pulmonary function, defined as diffusion lung capacity of carbon monoxide ≥ 50% predicted (after adjustment for hemoglobin concentration)
6. Estimated GFR ≥ 50mL/min/1.73m2 as calculated by the modified MDRD equation
7. ALT ≤ 3x upper limit of normal
8. HIV-negative
9. Patient is not pregnant
10. Patient is able and willing to sign informed consent
11. Patient does not have a fully HLA-matched sibling donor
12. Patient has an HLA-haploidentical relative

Donor Eligibility Relatives (parents, offspring, siblings, aunts/uncles, cousins) will be tested by molecular typing of HLA class I (A, B, and C) and class II (DRB1) at low resolution. Only those that are an HLA-haploidentical match (≥ 4/8) will be considered as a potential donor. NOTE: If during testing, a fully HLA-matched sibling donor is found and is willing to donate his/her stem cells, the potential subject will not be eligible for this protocol.

Donor consent will be obtained as per standard protocol of the bone marrow transplant unit.
Maitland Mobilization and Scapular Stabilization Shoulder Dysfunction

Sixty patients from both genders suffering from shoulder disability post unilateral NDS (modified radical, selective) will participate in this study. Their ages will be ranged from 30 to 50 years. They will be selected randomly from Damanhur Oncology center, El-Behira, Egypt. They will be randomly distributed into three equal groups (each group 20 patients).

Design of the study:

In this study the patients were randomly assigned into three equal groups (twenty patients for each group).

Group (A) :

This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique and scapular stabilization exercises in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.

Group (B):

This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received Maitland mobilization Technique in addition to the traditional physical therapy program which included (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.

Group (C) :

This group included twenty patients suffering from shoulder disability following NDS (modified radical, selective). They received scapular stabilization exercises in addition to the traditional physical therapy program which include (ROM exercises, stretching exercises and strengthening exercises for shoulder muscles) 3 sessions per week, for 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients' age will be ranged between 30-50 years.
* Both genders will participate in this study.
* All patients suffering from shoulder pain and disability following unilateral modified radical NDS or selective NDS.
* All patients will begin the treatment program from 1 to 3 months after NDS.
* All patients will have limited ROM of shoulder flexion, abduction, external rotation.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* Subjects with rotator cuff tears or other •shoulder ligament injuries.
* Adhesive capsulitis secondary to Diabetes mellitus or fractures.
* Recurrent shoulder dislocation.
* Recent fracture or surgery to the shoulder.
* Reflex sympathetic dystrophy.
* Neurological disorder.
* Epilepsy or any psychological disorders.
* The presence of residual local-regional cancer or distant metastases to other regions.