cyrilzakka/clinical-trials huggingface dataset:
A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic kidney disease;
* anemia;
* not on dialysis therapy;
* not receiving epoetin.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of another investigational drug within 4 weeks before screening, or during the study period.
Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)

The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.


Eligibility Criteria:
Inclusion Criteria:

* Willing to use COC for at least 6 cycles.
* 18 - 35 years of age at screening.
* Body Mass Index (BMI) of \>/= 17 and \</= 35.
* Good physical and mental health.
* Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle.
* Willing to give informed consent.

Exclusion Criteria:

* Contraindications for contraceptive steroids (general).
* Additional contraindications (renal, hepatic or adrenal insufficiency).
* Breastfeeding.
* Present use (or use within 2 months prior to start of the trial medication) of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex

steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing Hypericum perforatum (St. John's Wort).

* Administration of any other investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
* Abnormal cervical smear at screening, or documentation of an abnormal smear performed within 6 months before screening.
* Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Raman Spectroscopy Diagnosis of Kidney Diseases

This research plan, from January 2021 to December 2024, aims to collect serum and morning urine from patients diagnosed with IgA nephropathy, idiopathic membranous nephropathy, diabetic nephropathy, and focal segmental glomerulosclerosis the Nephrology Department of Qianfoshan Hospital in Shandong Province, through renal biopsy. These samples will be scanned using a Raman spect to obtain Raman spectral data. The scattering peaks in the Raman spectra will be analyzed using Origin software for Gaussian curve fitting. The position of the peaks will used to query relevant literature to identify the corresponding chemical bonds and confirm the presence of compounds.

The intensity and area of the chemical substance peaks in the Raman will be calculated and used to plot calibration curves, thereby establishing a quantitative analysis equation. This equation will be used to accurately calculate the concentration of each analyte in serum and urine samples. Based on the average concentration data for each patient group, multivariate analysis methods, such as principal component analysis (PCA) and Mahalanis distance discriminant model, will be used to classify and predict the disease types.

The preliminary data for this study comes from the Nephrology Department ofianfoshan Hospital, where different types of glomerular diseases have been pathologically classified using tools such as light microscopy, electron microscopy, and immunoforescence microscopy. By combining Raman spectroscopy technology and statistical analysis, this study aims to establish a non-invasive and efficient diagnostic tool to assist in the of kidney diseases and predict treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. Patients diagnosed with IgA nephropathy, idiopathic membranous nephrop, diabetic nephropathy, or focal segmental glomerulosclerosis confirmed by renal biopsy;
3. Patients who have not received hormone and/or immunosup therapy before the renal biopsy;

Exclusion Criteria:

1. Presence of factors causing secondary membranous nephropathy: such as autoimmune diseases (systemic lupus erythematosus),/infections (viral hepatitis), drugs or toxins, etc.;
2. Severe infection: clinical manifestations such as fever, cough and sputum, throat, abdominal pain, diarrhea, boils and other skin and soft tissue infections, with white blood cell count in blood routine exceeding the normal range (10×09/L);
3. Severe cardiovascular disease: including chronic heart failure of grade 3 or above and various arrhythmias;
4. Infect diseases: active phase of various types of hepatitis, AIDS, syphilis, etc.;
5. Evidence of tumor: already diagnosed with a certain tumor or manifestations, tumor markers, etc. indicating the possibility of a tumor;
6. Patients with incomplete data or missed diagnosis.
Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia

There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia. The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia. This monocentric retrospective comparative study included all consecutive bloodstream infection episodes among acute myeloid leukemia patients with febrile neutropenia for 3 years (2017-2019). Episodes were classified regarding the length of antibiotic treatment, considered as short course if the treatment lasted ≤7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was ≤10 days and ≤14 days, respectively. The primary outcome was the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.


Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia
* chemo-induced febrile neutropenia
* Bloodstream infection

Exclusion Criteria:

* lack of data
* endovascular infections
* surgical treatment required
* central nervous system infections
* antibiotic treatment \< 4 days
* death before the end of antibiotic treatment
* unappropriated antibiotic treatment at 48h
* relapses of bloodstream infection episodes already included
* hematopoietic stem cell transplant
Repair of Oronasal Fistula Using Interpositional Buccal Pad of Fat as a Free Graft in a Cleft Palate Patient

18 cleft palate patients had residual oronasal fistula included in this study divided randomly to two groups group I (control group): the fistula was repaired using two layers (oral and nasal layers) group II (study group): The fistula was repaired using two layers (oral and nasal layers ) with interpositional free buccal pad of fat graft between two layers

18 cleft palate patients had residual oronasal fistula included in this study devided randomly to two groups group I (control group):the fistula was repaired using two layers nasal layer:closed by turn-in flaps, taken from around the margins of the fistula by making incision around margins of distance slightly larger than half of diameter of fistula bilaterally, then closed by inverted interrupted suture Vicry l 4/0.

oral layer:(Bardach two-flap palatoplasty) was used and raised on opposite sides of the cleft palate and brought together in the midline to create a continuous palate

group II (study group): The fistula was repaired using two layers (oral and nasal layers ) as group I with buccal pad of fat free graft was taken through veastibular incision at zygomatic buttress then blunt dissection to get buccal fat which was released from its pedicle and inserted between oral and nasal layers.

Eligibility Criteria:
Inclusion Criteria:

* cleft palate patients with oro-nasal fistula fistula in hard palate

Exclusion Criteria:

* syndromatic patients
Long-term Lifestyle Change and Testosterone Replacement

Older hypogonadal obese veterans previously participated in a 6 month lifestyle change (diet-induced weight loss and exercise) study with or without testosterone replacement therapy before being followed for the following year at the clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy. This study will determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults.

Background: There are studies on long-term testosterone replacement in older adults with hypogonadism showing benefits on body composition, sexual function and mood but not on testosterone replacement therapy in combination with lifestyle change (diet-induced weight loss and exercise) in the specific population of older adults with both obesity and hypogonadism.

Purpose: To determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults .

Design: Overweight/obese older veteran patients with obesity and hypogonadism who are being followed at the endocrine clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy will be recruited for testing of physical, metabolic, cognitive/mood, quality of life, and body composition testing.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese (BMI = or \> 27 kg/m2)
* Older (65-85 yr)
* Male veteran patients being seen at the PI's endocrine clinic and receiving standard of care consisting of diet and regular exercise counseling
* Diagnosed with hypogonadism on current or previous testosterone replacement at the PI's endocrine clinic
* Willing to provide informed consent

Exclusion Criteria:

* Failure to provide informed consent
* Unstable cardiopulmonary disease (e.g. recent MI, unstable angina, stroke) or unstable disease (Class III or IV congestive heart failure).
Single Human Embryo Transfer in Assisted Reproduction Programs

Embryo selection based on the use of morphometric parameters should increase the implantation success rate.

One of the most important issues of "Assisted Reproduction Technologies (ART)" is the possibility of multiple pregnancies which carries a significant risk for maternal-fetal health. These risks can be reduced by restricting the number of embryos transferred.

To do this, it is essential to improve current techniques of embryo selection by developing new tools that would allow the selection of the embryos with higher implantation potential. In previous works (Molina et al 2011) the investigators have demonstrated greater efficacy for the embryo classification systems based on the use of the morphometric variables. The investigators have also developed a profile of embryo implantation using these morphometric variables. In this project the investigators intend to validate the clinical validity of this new embryo classification system by conducting a prospective study of single embryo transfer (SET) in young women at risk of multiple pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* Personal and family history without interest, not toxic habits.
* Less than 35 years at the time of IVF-ICSI cycle
* Sterility of unknown origin or tubal obstruction.

Exclusion Criteria:

* Repeat nonvoluntary abortions
* Endometriosis
* Polycystic ovary syndrome (criteria Rotterdam 2004)
* Severe male factor (REM \<1 million sperm / ml)
Extracts of Amla, Walnut Leaf, Red Yeast Rice and Olive in Cardiovascular Prevention

The aim of this study is to evaluate whether the use of a commercially available standardized combination preparation (Cholesfytol NG®), containing extracts of amla, walnut leaf, red yeast rice and olive, in individuals with hypercholesterolemia

1. Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
2. Leads to a clinically relevant reduction of blood pressure on the short term,
3. Leads to a change in oxidative stress biomarkers.

Participants will be stratified by sex before randomization to one of the two treatments for 8 weeks:

* Cholesfytol NG: 500 mg Amla dry extract, 50 mg Walnut leaf dry extract, 33.6 mg Red yeast rice powder (equivalent to 1.45 mg monacolins), 25 mg Olive dry extract (equivalent to 5 mg of hydroxytyrosol) per day
* Placebo All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, not to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured.


Eligibility Criteria:
Inclusion Criteria:

* LDL ≥ 130 mg/dL

Exclusion Criteria:

* \<18 jaar
* \>76 jaar
* Smoking
* Use of nutritional supplements or (chronic) medication\*
* Triglycerides \> 400 mg/dL
* \> 14 alcoholic consumptions/week
* Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)
* Acute infection
* Current pregnancy or pregnancy wish during the study period
* Breast feeding
* When nutritional supplements were used regularly, participation is allowed after a 10-day wash out period. Use of medication will be individually assessed and is permitted if it does not interfere with the used treatments and the patient is stable on the medication. Use of lipid lowering medication of food supplements is only permitted after a wash out period of at least 6 weeks.
Sleep Characteristics in Post-COVID-19 Patients

After acute infection, patients with coronavirus disease 2019 (COVID-19) often suffer from persisting symptoms for more than 3 months (post COVID-19). Sleep disorders (31%) have already been assessed by questionnaires and interviews in post-COVID-19, but have not yet been proven by polysomnography (PSG), the gold standard for sleep testing. This study aimed to measure sleep characteristics in post-COVID-19 patients.

Hypothesis: We hypothesize that post-COVID-19 patients have a significantly higher apnea-hypopnea index (AHI) during sleep compared to healthy controls.

15 post-COVID-19 patients and 15 healthy controls will perform a baseline assessment on day 1 including a 1-minute sit-to-stand test (STST), post-COVID functional scale (PCFS), Ordinal Scale for Clinical Improvement (OSCI), history of COVID-19, social anamnesis, Pittsburgh Sleep Questionnaire and subjective limitations of sleep.

On day 4, after an initialization phase for WHOOP strap (a digital fitness and health coach), all patients performed a single night sleep assessment in a sleep lab via Polysomnography and WHOOP.

Eligibility Criteria:
Inclusion Criteria:

Post-COVID-19 Group:

* Patients after SARS-CoV-2 infection with signs of Post-COVID-19
* ≥18 years
* written informed consent

Healthy controls:

* No history of SARS-CoV-2 infection
* ≥18 years
* written informed consent

Exclusion Criteria:

Post-COVID-19 Group:

* Diagnosis of a breathing-related sleep disorder before SARS-CoV-2 infection
* BMI \>25kg/m2

Healthy controls:

* Diagnosis of a breathing-related sleep disorder
* BMI \>25kg/m2
Effect of Preclinical Training in Periodontal Instrumentation on Undergraduate Students&#39; Anxiety, Clinical Performance and Satisfaction

The purpose of this study was to evaluate the effect of periodontal instrumentation preclinical training using a teaching typodont-phantom head model on undergraduate students; anxiety levels, clinical performance, and educational satisfaction.

Sixty fourth-year undergraduate dental students will be randomly divided into two groups. Both groups will receive one hour of theoretical periodontal training.

Group 1 will receive only theoretical training, while Group 2 will complete this training as well as pre-clinical practical training with a typodont-phantom head with synthetic calculus. Before performing supragingival instrumentation on their first patient, students in both groups will be administered a state anxiety test. After the procedures, participants will complete a Visual Analog Scale (VAS) to assess training satisfaction. Students\&amp;#39; clinical performance will be evaluated using the scaling procedure score sheet.

Eligibility Criteria:
Inclusion Criteria:

* To be a fourth year student of the Faculty of Dentistry
* To successfully complete pre-clinical theoretical and practical training
* To perform periodontal treatment for the first time in the undergraduate clinic

Exclusion Criteria:

* Not being a fourth year student of the Faculty of Dentistry
* Lack of attendance to pre-clinical theoretical training
* Failure to demonstrate competence in pre-clinical theoretical education
* Having previously performed periodontal treatment in undergraduate clinic
Phase I/II Study of JR-441 in Patients With Mucopolysaccharidosis Type IIIA

A Phase I/ II, open-label, randomized, 2-arm study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of MPS IIIA patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronological age of ≥1 year and ≤18 years.
* Confirmed diagnosis of MPS IIIA.
* Body weight ≥ 10 kg.

Exclusion Criteria:

* Prior experience to gene therapy or HSCT with successful engraftment.
* Past use of another investigational drug or product in last 4 months or 5 half-lives (whichever is longer) before signing ICF.
* Current participation in a clinical trial or past participation (within 30 days of enrolment into this study) in a study involving invasive procedures.
* Past use of Genistein or Kineret (anakinra) within 4 months before signing ICF.
* Serious drug allergy or hypersensitivity.
* Contraindication for lumbar puncture or MRI.
* History of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following lumbar puncture.

The above information is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.
Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation

Background: During the first half of the 20th century, scalp irradiation was a standard treatment for induction of epilation in children suffering from Tinea Capitis. These children are now more than 50 years old and the aim was to investigate the possible association between their childhood low dose irradiation exposure and development of carotid atherosclerotic disease in adulthood.

Methods: The study included 145 individuals treated by irradiation in their childhood, and 150 matched control subjects with no history of irradiation. B-mode ultrasound imaging and US Doppler were used to measure carotid and femoral stenosis and Intima-Media Thickness (IMT). Blood samples were taken for lipid profile and homocysteine evaluation.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* childhood scalp irradiation or mach controls
* writen informed consent

Exclusion Criteria:

* inability to give written informed consent
XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer

This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in participants with HER2-negative metastatic breast cancer. Participants will be followed for approximately 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* HER2-negative metastatic breast cancer
* Participants initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; participants who started treatment with Xeloda and docetaxel no more than 3 months before enrollment in this study are also eligible

Exclusion Criteria:

* Contraindications to Xeloda treatment according to the Summary of Product Characteristics
Ocular Discomfort Assessment After Intravitreal Injections

In this study, ocular discomfort following intravitreal injection in naïve patients will be studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular discomfort.

In naive patients, the two first intravitreal injections will be studied. Within the first injection, no wetting agent will be delivered. Within 72hours after this first intravitreal injections, patients will be contacted by phone by a nurse to complete questionnaires on quality of life and on ocular pain and eye discomfort.

After the second injection, a treatment with wetting agent will be prescribed. With 72hours after the second injection, quality of life, ocular discomfort as well as acceptability and tolerance of the eye drops will also be assessed by a phone questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with social healthcare
* Patient understanding French language
* Patient requiring anti-VEGF treatment by intravitreal injection

Exclusion Criteria:

* Patient treated by Ozurdex® before
* Patient with known and treated ocular dryness
* Non naive patient for intravitreal injection
* Hypersensitivity to Carmellose
* Patient who received wetting agent within the 3 last months
* History of povidone-iodine allergy
* Pregnant or breastfeeding mother
Cognitive Correlates of Substance Abuse, Part 2 - 16

Part II: Examine cognitive performance of stimulant abusers (methamphetamine and cocaine) during recovery by assessing their cognitive function at monthly intervals.

Part II: Examine cognitive performance of stimulant abusers (methamphetamine and cocaine) during recovery by assessing their cognitive function at monthly intervals.

Eligibility Criteria:
Please contact site for information

Inclusion Criteria:

M/F. Meet DSM-IV criteria for stimulant dependence. Agree to conditions of the study and sign informed consent.