cyrilzakka/clinical-trials huggingface dataset:
Personalized Dietary Advice After Discharge From Hospital in Geriatrics: Factors Associated With Improved Nutritional Status and Autonomy

The purpose of this study is to identify the factors associated with the effectiveness of home dietary management in these elderly people returning home (personal home or independent residence) after hospitalization in acute geriatrics.

Patient recruitment will be carried out in the 6 participating hospital centres.

All patients willing to participate, will benefit from an Inclusion Visit (J0): Conducted in hospital in acute geriatric services before discharge from hospital. Verification of inclusion criteria, collection of patient consent by investigator, assignment of patient identification number, declaration of inclusion, and collection by investigator of inclusion data (age, sex, weight, height, appetite, dietary intake scale, risk factors for undernutrition by HAS, albumin, CRP, exit treatment, ADL, IADL and GIR, technical aids for walking, presence of professional and non-professional home workers).

Home visit J7 (30 min to 1 hour): initial dietary assessment, will be carried out between 24 hours and 7 days after discharge from hospital. During this visit, the dietician will perform several measurements (MNA-SF, weight, height, appetite assessment, ingest/24h Consumption of NOCs if prescribed in hospital, Quality of Life, ADL, IADL, acceptance of visit, follow-up of dietary advice and intercurrent medical events).

Home visit J30, J60 (30 min to 1h): Made by the dietician, during these visits will be carried out various measurements and questionnaires: Appetite assessment, weight, ingesta/24h, consumption of NOCs, acceptance of the visit, follow up on dietary advice, compendiums of intercurrent medical events.

Home visit J90 = Final visit. This visit is identical to the initial assessment (J7). Patients who are undernourished or at risk of undernutrition will receive an additional J15 home visit (15 days after discharge from hospital). This visit will be identical to visits J30, J60.

Eligibility Criteria:
Inclusion Criteria:

* Unscheduled hospitalization of at least 4 days in acute geriatrics,
* Direct return to home or independent residence after hospitalization,
* To be domiciled in the Hauts-de-Seine department,
* Good understanding of the French language,
* Beneficiary of a social security scheme,
* Having read the briefing note and having consented to participate in the study by signing a written consent,

Exclusion Criteria:

* Severe cognitive impairment according to DMS-IV criteria,
* Inflammatory syndrome (CRP \> 30 mg/l)
* Evolving cancer;
* Chronic respiratory failure,
* Stage IV heart failure
* long-term corticosteroids (\> 10 mg/d prednisolone or equivalent),
* Enteral and parenteral nutrition at home,
* Chronic end-stage pathology;
* Inability to walk without human help
* Major person subject to a legal protection measure (guardianship, guardianship and safeguarding of justice)
Subcutaneous Progesterone Supplementation in Patients With Endometriosis

The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day; Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction in patients with grade I-II endometriosis and / or endometrioma \<4 cm subjected to time intercourses or COS/IUI cycles.

Patients with grade I-II endometriosis and / or endometrioma \<4 cm subjected to time intercourses or COS/IUI cycles will be subjected to subcutaneous or vaginal progesterone for their luteal phase supplementation in time intercourses or IUI cycles.

The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day; Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic or ultrasonographic diagnosis of endometriosis grade I-II and / or endometrioma \<4 cm;
* Menstrual VAS score\> 5 cm before the last menstrual period with progesterone treatment
* Infertility for at least 1 year
* Body Mass Index 19 to 30 kg / m2
* Basal FSH serum \<15 IU / ml
* Normal levels of serum prolactin
* Normal uterine cavity and fallopian patency

Exclusion Criteria:

* Previous ovarian surgery
* Endocrine disorders (eg polycystic ovary syndrome, thyroid disease, hyperprolactinemia, hypogonadotropic hypogonadism)
* Reduced ovarian reserve (basal levels of FSH\> 15 IU / mL)
* Acute or chronic infectious state
* Chronic drug intake, alcohol, or drugs that affect cognitive functions, alertness and / or mood
* Psychiatric disorders
* Kidney or liver diseases
* Male factor infertility
Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba

Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. The objective is to evaluate the effect of topical pimecrolimus in the treatment of treatment of PA

Background and Rationale:

Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and adolescents of darker phototypes. PA usually manifests as erythematous lesions followed by smooth scales with residual characteristic pruritic or non-pruritic ill-defined hypopigmented patches, that typically occur on the upper part of the body, especially the face. A history of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic individuals as well. It is thought to represent nonspecific dermatitis with residual post-inflammatory hypopigmentation. Sun exposure is a triggering and accentuating factor.

PA is a common reason for dermatologic consultation due to its chronic course, frequent relapses and cosmetic appearance. Spontaneous healing occurs in several months to few years, therefore impacting the quality of life. Emollients and mild-potency topical steroids are the mainstay of treatment, with a potential risk of skin atrophy and hypopigmentation.

Pimecrolimus is a topical calcineurin inhibitor that prevents T-cell activation, approved for the treatment of atopic dermatitis, and proved efficacious for seborrheic dermatitis, without having the potential adverse effects of topical corticosteroids. Tacrolimus 0.1% ointment, another calcineurin inhibitor is an effective and safe treatment for PA, a similar efficacy of calcitriol and tacrolimus was shown after 9 weeks of treatment. An exploratory study evaluated the efficacy of pimecrolimus cream in the treatment of PA. To the best of our knowledge there is no randomized placebo-controlled trial in the literature proving the efficacy of pimecrolimus in PA.

Objective: To evaluate the effect of topical pimecrolimus in the treatment of treatment of PA

Hypothesis: Pimecrolimus is an efficacious, well-tolerated and safe treatment for pityriasis alba.

Trial design: A randomized placebo-controlled double blinded trial establishing the superiority of topical pimecrolimus 1% over placebo.

Eligibility Criteria:
Inclusion Criteria:

* Pityriasis alba Patients confirmed by a board certified dermatologist
* Age over 2 years
* Written informed consent signed by the patients or the legal guardians of patients younger than 18 years in the native language (Arabic)

Exclusion Criteria:

* Other concomitant dermatosis (except atopic dermatitis)
* Use of topical steroids, or topical agents other than emollients and sunscreen, in the last 4 weeks
* Known allergy to pimecrolimus
* Pregnant and nursing women
Adipose-derived Stem Cells (ADSCs) for Moderate to Severe Chronic Kidney Disease

1. To assess the safety of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease
2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease


Eligibility Criteria:
Inclusion Criteria:

A patient is eligible for the study if all of the followings apply:

1. Aged 20-80 years (inclusive)
2. With chronic kidney disease (CKD)stage 3B to 4 (eGFR 15 to 44 mL/min/1.73m2 (inclusive)) Note : eGFR = estimated glomerular filtration rate
3. Having provided informed consent

Exclusion Criteria:

Any patient meeting any of the exclusion criteria will be excluded from study participation.

1. Ascertained hypersensitivity to any component used in the study Note: including gentamicin, DMSO, Agglutex (heperin)
2. With inadequate hematologic function with: absolute neutrophil count (ANC) \<1,500/μL OR platelets \< 100,000/μL OR Hemoglobin \< 8 g/dL
3. With inadequate hepatic function with: serum bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (AKP) \> 2.5 x the institutional upper limit of normal (ULN)
4. With hemoglobin A1c (HbA1c) \> 8.0%
5. With serious prior or ongoing medical conditions (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the patient
6. Pregnant or lactating women or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period
7. With body mass index (BMI) greater or equal to 36 kg/m2
8. With known history of human immunodeficiency virus (HIV) infection or any type of hepatitis
9. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
10. With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
11. Having participated other investigational study within 4 weeks of entering this study
12. Known or suspected abuse of alcohol or narcotics
13. With known history of cancer within past 5 years
14. With any autoimmune disease
15. With cystic kidney disease or requiring kidney dialysis
16. With precancerous condition or with cancer within past 5 years before Screening visit
Surveillance for Nosocomial Infections in Pediatric Cancer Patients

The Oncoped 2006 study implements a multicenter prospective surveillance module for nosocomial infections in pediatric cancer patients.

Type of study:

Prospective multicenter surveillance study referring to file data collected routinely during the management of infectious and thrombotic complications in high risk pediatric cancer patients.

Primary aims of the Oncoped 2006 Study

1. To describe the epidemiology of selected nosocomial infections in pediatric cancer patients as well on the unit level as in a reference database of cumulative data from a prospective multicenter surveillance perspective.
2. To allow the participating institution

   * to compare its own results with other centers and with the reference database (median and 75. percentile).
   * to reduce the incidence density of nosocomial infections and the incidence rate of catheter-associated infections in pediatric cancer patients.
3. To promote patient's safety by means of quality assurance and a reduction of nosocomial infections.
4. To describe objective outcome variables related to the documented NI events (mortality, duration of hospitalization, need for intensive care, need for surgical interventions)
5. To intensify the practical collaboration of the health care team with infection control personnel and infectious disease specialists in this clinical context.
6. To describe the distribution of bacterial pathogens of blood stream infections and to determine the sensitivity (minimal inhibitory concentration) of bacterial pathogens detected in blood cultures to first and second line antimicrobial agents in this high risk population with a standardized method (central reference laboratory).
7. To detect bacterial isolates with emerging types of antimicrobial resistance.
8. To describe the therapeutic use of antibacterial and antifungal agents in pediatric cancer patients related to nosocomial infections.
9. To describe the incidence and incidence density of invasive Aspergillosis in pediatric cancer patients.
10. To describe the clinical impact of common and emerging viral respiratory pathogens (RSV, Influenza, hMPV, hCoV, hBoV) in pediatric cancer patients with nosocomial lower respiratory tract infection (central reference laboratory for emerging viral pathogens).
11. What is the incidence and incidence rate (per 1000 catheter utilization days) of thrombotic events in pediatric cancer patients and in patients with hemophilia, who have a CVAD in use?
12. How many of the children with an event do have congenital risk factors (thrombophilia)?
13. What are the objective outcome parameters in this population considering antithrombotic treatment (at the discretion of the attending physicians)?

Eligibility Criteria:
Inclusion Criteria:

* pediatric cancer patients receiving inpatient treatment with chemotherapy, -
* radiotherapy or stem cell transplantation

Exclusion Criteria:

* no informed consent
* no inpatient treatment
Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study

This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be randomized into one of 4 possible treatments. The purpose is to individually examine the efficacy of each treatment, and determine if one treatment method is more effective than another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.


Eligibility Criteria:
Inclusion Criteria:

* pain over the lateral epicondyle (via palpation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for less than six-months duration prior to enrollment
* conservative treatment of tennis elbow is recommended as standard of care treatment
* over the age of 18 and under the age of 65
* ability to give informed consent

Exclusion Criteria:

* treatment by a health care profession (MD, physicians assistnat, therapist, or nurse practitioner) within the previous 6 months for tennis elbow
* congenital deformities, tendon ruptures, or fractures of the elbow within the previous 12 months
* immobility casts or splints within the last 6 months for tennis elbow
* co-existing elbow diagnosis (i.e. osteoarthritis or instability)
* pregnant women, women trying to get pregnant, or breastfeeding women
* under the age of 18 or over the age of 65
The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III

This study aimed to evaluate the concurrent validity information of the 24-, 30-, and 36-month Indonesian ASQ-3 with the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III) in Indonesian children. Children living in Tanah Tinggi subdistrict, Central Jakarta, were recruited conveniently from November to December 2019. Children within the 24-, 30-, or 36-month age group were assessed for Indonesian ASQ-3 concurrently with BSID-III as the reference standard according to their age groups. Screening test accuracy was measured in sensitivity, specificity, and predictive values for both overall dan specific domains.


Eligibility Criteria:
Inclusion Criteria:

* Parents with children aged 23 - 38 months
* Parents who finished at least elementary school

Exclusion Criteria:

* Parents with communication difficulties
* Parents who could not speak Indonesian language
Different Phenotypes of Bronchiectasis

Bronchiectasis is defined as abnormal chronic dilatation of one or more bronchi. Patients have a structural abnormality of the bronchial wall that predisposes them to bacterial infection likely due to impaired mucus clearance. A vicious cycle of chest infections and chronic lung inflammation can lead to further damage of the bronchial wall and spread of disease to normal areas of bystander lung.

A search for an underlying cause, which may be amenable to a targeted intervention to prevent ongoing damage, is essential but often fruitless, and the focus of therapy rapidly turns to empiric treatments to prevent infective exacerbations and retard disease progression. The British Thoracic Society Bronchiectasis management guidelines provide an in-depth summary of the available literature and are an excellent tool for guiding treatment decision making. However, they do not provide guidance on which patients are most likely to benefit from specific interventions.Disease severity in bronchiectasis is hard to define. Radiological severity grading scores exist; however, there is often a disconnect between radiological severity, symptom burden and disease progressionIn 2014, competing bronchiectasis severity scores were published (FACED and the Bronchiectasis Severity Index (BSI).

In each of these, a combination of patient demographics, symptom scores, comorbidities, and clinical, radiological and microbiological parameters were used to construct scoring systems.

In case of the BSI, it predicted future mortality, and in the case of FACED, extended to prediction of future exacerbation frequency, hospitalisation and quality of life.These severity scores have utility in identifying an individual's risk of disease progression to a predefined outcome and aid in sub classifying this heterogeneous group of patients in a manner that may pave the way to future mechanistic studies, which explain how these different disease phenotypes arise and inform the development of targeted therapeutics.

Eligibility Criteria:
Inclusion Criteria:

patient diagnosed as bronchiectasis according to clinical picture and high- resolution computed tomography scan of the chest.

can perform pulmonary function test.

Exclusion Criteria:

No
Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

Patients with rectal cancer who are candidates for pre-operative radiation therapy may be enrolled in the Phase I, single center study. Patients will have a full blood count, biochemistry, urinalysis, and ECG for safety evaluation. Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45 Gy) over five weeks. The starting dose of oral topotecan is 0.25 mg/m2 to be concomitantly administered with radiation (45 Gy) x 5 days every week unless the radiation is interrupted for Holidays/Weekends or toxicity requiring treatment delays occurs. A total of 25 doses are planned.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed rectal cancer.
* Candidates for preoperative radiotherapy.
* Primary tumor at least 3cm and clinical stage of T2, T3, or T4 and any N according to the Astler-Coller modification of the Dukes staging system.
* Eastern Cooperative Oncology Group (ECOG) performance status less than 2.
* Diagnosis of rectal cancer should be no more than 90 days from start of therapy.
* Evaluation at the H. Lee Moffitt Cancer Center.
* Recovery from prior surgery and life expectancy at least 3 months.

Exclusion Criteria:

* A primary tumor totally excised.
* Recurrent rectal cancer that failed initial treatment.
* Exposure to topotecan, infection, immunodeficiencies, conditions of the gastrointestinal (GI) tract which would affect absorption, medication that maintains motility/gastric emptying.
* Any concomitant malignancy within the last five years.
* Severe medical problems unrelated to the malignancy which would limit compliance with the study.
* Patients of child bearing potential.
* Not practicing adequate contraception.
* Patients who are pregnant or lactating.
* Use of an investigational drug within 30 days or 5 half-lives of the first dose.
Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults

To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients


Eligibility Criteria:
Inclusion criteria:

* CD4 cell count greater than or equal to 200 cells/mm3.
* HIV-1 RNA \>2000 copies/mL.
* Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine.
* Normal resting 12-lead electrocardiogram.

Exclusion criteria:

* Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion.
* Chronic diarrhea (\>3 loose stools/day).
* An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.
* Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.
* Any acute laboratory abnormality.
* Positive for HCV antibody or HepBsAG.
* Active infections requiring therapy in the previous 4 weeks.
Magnetic Sentinel Lymph Node Mapping in Gastric Cancer

This phase I finds out the possible benefits and/or side effects of using magnetic tracer FerroTrace and the fluorescent dye indocyanine green to identify the lymph nodes that cancer is most likely to have spread to in patients with gastric cancer that are undergoing gastrectomy. Using FerroTrace in combination with the indocyanine green dye may help researchers better detect the disease.

PRIMARY OBJECTIVE:

I. To assess safety by assessing short term toxicity associated with the gastric injection of the novel magnetic tracer.

SECONDARY OBJECTIVES:

I. To determine the feasibility of sentinel lymph node (SLN) imaging and mapping using novel magnetic nanoparticles (iron conjugated polymers in saline suspension \[FerroTrace\]) for gastric cancer, and to determine whether pre-operative injection, intra-operative injection, or both are feasible.

II. To test the validity of this procedure by correlating sentinel lymph nodes (SLN) to predict pathologic Lymph node (LN)-positive status i.e., will a negative SLN accurately predict the negativity of the other LNs? III. To determine the diagnostic value of additional hematoxylin and eosin (H\&E) sections and immunohistochemistry to assess sentinel lymph nodes compared to routine assessment with one H\&E stain alone.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I (PREOPERATIVE INJECTION): Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive indocyanine green (ICG) peritumorally.

COHORT II (INTRAOPERATIVE INJECTION): Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing to provide informed consent
* Biopsy proven gastric cancer, undergoing curative-intent gastrectomy
* No distant metastases
* Pathologic diagnosis of gastric adenocarcinoma
* Pre-treatment endoscopic measurement of less than or equal to 4 cm in diameter of the gastric cancer

Exclusion Criteria:

* Contraindications to surgery +/- adjuvant therapy
* Allergy or intolerance to iron oxide compounds
* Allergy or intolerance to iodides
* Iron overload disorder
* Pregnant or lactating women\*

  * Use of contraception is required for females during the study. Male patients who are sexually active with a female of childbearing potential are allowed for study enrollment and will not require use of contraception