cyrilzakka/clinical-trials huggingface dataset:
Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis

The objective of this study is to assess whether supplementation with curcumin could modulate the intestinal microbiota, reducing levels of inflammatory markers of oxidative stress, uremic toxins and inflammasome, in patients with chronic kidney disease in peritoneal dialysis.

Curcumin is a chemical compound of the curcuminoids class found in the root of Curcuma (Curcuma longa), and due to its potential antioxidant and anti-inflammatory, has been suggested as a nutritional strategy to reduce oxidative stress and inflammation present in several chronic diseases. Although it is a promising therapy, there are no studies evaluating the effects of curcumin in patients with chronic kidney disease (CKD) in peritoneal dialysis (PD). The aim of this study is to evaluate the effect of curcumin supplementation on inflammatory markers and oxidative stress in patients with CKD in PD. Methods: This is a longitudinal randomized clinical double-blind crossover study, with a washout period and placebo-controlled, where patients will be randomized into two groups: Turmeric and Placebo. After the 12-week supplementation period, a washout (12 weeks) will be performed for subsequent crossover of the patients. Mononuclear cells will be extracted from whole blood and the expression of m ribonucleic acid from transcription factors (Nrf2 and NF-kB), antioxidant enzymes (NQO1, HO-1), as well as NLRP3 inflammasome will be analyzed by real-time Polymerase Chain Reaction and protein expression by western blotting. Inflammatory cytokine levels will be assessed by ELISA, also, plasma levels of TBARS, routine laboratory parameters, as well as food intake and nutritional status.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic Kidney Disease
* Peritoneal dialysis patients for more than 6 months
* Aged from 18 to 60 years
* Must be able to swallow tablets

Exclusion Criteria:

* Patients pregnant
* Smokers
* Using antibiotics in the last 3 months
* Using antioxidant supplements in the last 3 months
* Usual intake of turmeric
* Usual intake Autoimmune
* Clinical diagnosis of infectious diseases
* Clinical diagnosis of Cancer
* Clinical diagnosis of AIDS
Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery

This is a Randomized controlled trial evaluating the effects of the use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery

The trial will randomize 60 patients into an experimental group with HemaClear or Active comparator group with Pneumatic Tourniquet.

The outcomes are: effectiveness of the tourniquet, bleeding escapes, infection, deep vein thrombosis, pain at the tourniquet site, neurologic problems related to the tourniquet


Eligibility Criteria:
Inclusion Criteria:

* Ankle and foot surgery

Exclusion Criteria:

* Infection
* Tumors
* Open fracture
* Burns
* Varicose veins
* Isquemia
Postoperative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgery

The aim of our study is to reduce postoperative pain by performing external oblique intercostal block in L/S cholecystectomy surgeries. Our main goal is to provide well managed post-operative analgesia.

The patients will be divided into two groups and general anesthesia will be applied to all of them. There will be no regional anesthetic technique to be performed, on the other hand, external oblique intercostal nerve block will be applied to patients in the other group before the patients are extubated. Study randomization is done with computer-generated randomization codes (computer-generated) by a physician who will not participate in patient follow-up. Interfascial plane block (external oblique intercostal block) will be given to the anesthesiologist in a sealed envelope by an independent assistant staff outside the study, the patient will not know which block is applied. The anesthetist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study.

For the standardization, the block procedure will be performed by an experienced anesthesiologist who has performed at least 20 previous successful and uncomplicated procedures.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 35 kg/m²
* Patients with ASA scores I and II

Exclusion Criteria:

* Patients who do not want to be included in the study
* Psychiatric and neurological disease with blurred consciousness
* Patients with ASA \> 3
* BMI \> 35 kg/m²
* Abnormality in coagulation parameters
* History of allergy to local anesthetic drugs
* Infection at the injection site
Diabetes Smoking Cessation Incentives Study

The purpose of this study is to evaluate the feasibility of contingency management on improving smoking cessation among individuals with type 2 diabetes.

Type 2 diabetes (T2DM) and cigarette smoking are major causes of morbidity and mortality in US, and research indicates there is a complex relationship between these two risk factors. Smoking cessation is recommended as a standard treatment of diabetes by the American Diabetes Association; however, patients with T2DM and their providers are often inundated with other challenging lifestyle changes and disease management. Due to the complex relationship between diabetes and smoking and the large number of competing lifestyle changes recommended at diagnosis, smokers with T2DM may benefit from a contingency management (CM) program that incentivizes cessation. Providing patients tangible rewards to reinforce positive behaviors such as smoking abstinence has been proven effective in substance abuse programs, smoking cessation among pregnant women unwilling or unable to quit, and other population subgroups. In this CRUK2 study the investigators aim to test and further explore the potential effectiveness of financial incentives contingent upon proof of quitting smoking. The investigators will gather diabetes-related contextual factors associated with participation in the program and smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* earn a score \> 4 on REALM indicating \> 6th grade English literacy level
* willing to quit smoking 7 days from their first visit
* have an expired CO level \>8 ppm suggestive of current smoking at baseline
* currently smoking \> 5 cigarettes per day
* willing and able to attend 6 study visits

Exclusion Criteria:

* unable to demonstrate use of or unwilling to use the remote CO monitor and phone app
Bicycle Training on Ventilatory Functions in Duchenne Muscular Dystrophy

The purpose of the study is to investigate the effect of bicycle ergometry training on ventilatory functions in boys with Duchenne muscular dystrophy.

Duchenne muscular dystrophy (DMD) is a common genetic X chromosome-linked recessive muscular dystrophy. It causes deterioration in mobility, progressive deformities in musculoskeletal system, upper limb impairment, and impaired airway clearance. Deterioration in respiratory muscles is the major cause of mortality and morbidity in DMD in their second to the third decade as a secondary complication in respiratory and cardiovascular systems. Cycling exercise is an easy functional treatment that considered as an aerobic exercise used to improve ventilatory functions, strength of respiratory muscles and therefore prevents respiratory diseases. Several studies support the benefit of bicycle ergometry training on ventilatory functions in different diseases while, there is no research conducted its effect on Duchenne muscular dystrophy. Hence, there is need to study the effect of bicycle ergometry training on ventilatory functions in Duchenne muscular dystrophy.

Thirty boys with Duchenne muscular dystrophy aged from 8-10 years will be recruited from Abu El-Rish Pediatric Hospital. They will be divided randomly into control group (15 boys) and study group (15 boys). Control group will be participated in designed physical therapy program. Study group will be trained on the bicycle ergometer in addition to the same designed physical therapy program participated in control group.

Eligibility Criteria:
Inclusion Criteria:

1. Boys ages will be ranged from 8 to 10 years old.
2. Confirmed diagnosis as Duchenne muscular dystrophy.
3. Lower limb functional levels ranged from Grades 1 through 3 acc. to Vignos scale for lower extremities.
4. Still ambulant and able to sit independently for at least 1 hour.

Exclusion Criteria:

1. Ccongenital or acquired skeletal deformities or cardiopulmonary dysfunction.
2. Previous orthopaedic surgery in lower limbs.
3. Behavioral problems causing inability to cooperate during the study.
Identification of Heart Failure Patients by Seismocardiography

The aim of the current study is to develop and validate an algorithm based on seismocardiography recordings to detect heart failure. Echocardiography will be used as the golden standard for defining patients with heart failure.

Seismocardiography is inspired from methods for the analysis of seismic activity and can be used to describe the heart's movements using a specially developed sensor placed on the patient's chest. The project aims to describe the motion of the heart using automated computer analysis of the seismocardiography signal for development of a simple method for the analysis of myocardial performance.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years or older
* Clinically suspected heart failure, and referred to an outpatient clinic
* Be able and willing to comply with the clinical investigational plan
* Have signed the informed consent form

Exclusion Criteria:

* Known HF
* Known atrial fibrillation
* Acute coronary syndrome
* Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD)
* Implanted electronic equipment in the area above and around the heart
* Significant operation scars, abnormal body shape, fragile or compromised skin in the seismocardiographic recording area (fourth left Inter Costal space and xiphoid process)
* Pregnancy

Extension study:

Inclusion criteria

1. Male or female, aged 18 years or older
2. Newly diagnosed HFREF
3. Be able and willing to comply with the clinical investigational plan
4. Have signed the informed consent form

Exclusion criteria

1. Known atrial fibrillation
2. Acute coronary syndrome
3. Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD)
4. Implanted electronic equipment in the area above and around the heart
5. Significant operation scars, abnormal body shape, fragile or compromised skin in the seismocardiographic recording area (fourth left Inter Costal space and xiphoid process)
6. Pregnancy
Impact of Milk on Erosion/Abrasion of Enamel and Dentin - an in Situ Study

This in situ study aims to investigate

* the protective potential of milk and fluoridated milk on erosive wear of enamel
* the protective potential of milk and fluoridated milk on erosive wear of dentin
* to compare to protective potential of milk and fluoridated milk with products containing casein phosphopeptide-amorphous calcium phosphate
* to compare the protective potential of milk and fluoridated milk with a fluoridated toothpaste or stannous-chloride containing fluoride solution (SnCl2/AmF/NaF)

Dental erosion is defined as the pathogenic, chronic, chemical removal of dental hard tissues due to the frequent contact to extrinsic or intrinsic acids. The dissolution process is determined by the pH, the chelating properties, mineral content and kind of acid, but in the same time modified by various biological (e.g. saliva, pellicle) and behavioural factors.

The anticariogenic properties of milk are widely investigated, but information of the effects of milk or milk components on the development of erosion are limited. It is suggested that the demineralisation process is reduced by the presence of calcium and phosphate, but also that casein proteins affect the demineralisation by adsorbing to the hydroxyapatite surface and inhibiting its dissolution. Initial studies suggest that milk is able to increase rehardening of acid-softened enamel, but information about the effects of milk on dentin erosion are not available yet. Particularly, the effect of fluoridated milk on dental erosion was not investigated yet.

In contrast, recent studies analysed the effects of products containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) on erosion, as it is suggested that CPP-ACP promotes a supersaturated state and increased remineralisation of demineralised dental hard tissue. However, in situ studies on the effect of CPP-ACP on erosion are limited to one study, which compared microhardness of enamel after treatment with CPP-ACP and CPP-ACP and 900 ppm fluoride, but failed to use appropriate controls in form of other products containing calcium and phosphate or fluoride. In summary, the effects of milk, in particular fluoridated milk, and products containing milk proteins, such as casein phosphopeptide-amorphous calcium phosphate, on erosive wear were not analysed in an in-situ-model so far.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* non-treated caries lesions
* orthodontic treatment which does not allow to wear an intraoral device
* hyposalivation
* allergy against milk or milk proteins
Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

The primary purpose of this study is to test the effects of a targeted, computerized cognitive training program on verbal memory in older women who have undergone chemotherapy treatment for early-stage breast cancer. As measured by neuropsychological assessment, this treatment will result in improved verbal memory. Secondarily, processing speed and naming abilities are expected to improve. Enhanced self-perception of cognitive ability is also expected.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 65-90
* Chemotherapy treatment for early-stage (I, IIa, IIb, IIIa) breast cancer
* Post-menopausal
* High school education or greater
* Geographically available for followup assessment
* Native English speaker
* Normal or corrected to near-normal hearing and vision

Exclusion Criteria:

* Psychiatric history including past or current psychotic spectrum disorders (schizophrenia, bipolar disorder, major depressive disorder, dementia, schizoaffective disorder)
* Brain injury (e.g., stroke, heart attack, aneurysm, tumor, concussion, head trauma)
* Brain disease
* History of brain irradiation or surgery
* Current or past disease/disorder of the central nervous system or medical condition affecting cognitive functioning (e.g., chronic migraine, epilepsy or history of seizures, encephalitis, meningitis, multiple sclerosis, thyroid condition, Parkinson's, Alzheimer's, Huntington's disease)
* Active diagnosis of autoimmune or inflammatory disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, insulin-dependent diabetes, Crohn's disease, uncontrolled allergic reaction or asthma)
* History of other cancer, except for basal cell carcinoma
* Development of a second primary malignancy during the study
* Drug or alcohol abuse (i.e., more than 7 drinks per week)
* Chronic use of oral steroid medication
* Former (prior to early-stage breast cancer) intrathecal therapy, radiation therapy, chemotherapy, or any neoadjuvant chemotherapy
* Acquired or developmental speech, language, or learning disorders (e.g., aphasia, dyslexia, dysgraphia, auditory processing disorder, autism, developmental delay)
* Hormone replacement therapy, excluding vaginal estrogen
Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

Primary Objective:

To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma.

Secondary Objective:

To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

The total study duration for each participant was between approximately 29 and maximum of 30 weeks, consisting of a screening period of 5 weeks and optional up to 7 additional days, a treatment period of 12 weeks, and a post-treatment period of 12 weeks.

Participants who completed the treatment period could be eligible to participate in an open-label extension study.

Eligibility Criteria:
Inclusion criteria:

* Male and female adults with a physician diagnosis of persistent asthma for ≥12 months.
* Existing treatment with medium to high dose inhaled corticosteroids in combination with a long-acting beta agonist for at least 3 months with a stable dose ≥1 month prior to Visit 1 (Screening Visit).
* Treatment with a third asthma controller for at least 3 months with a stable dose \>=1 month prior to Visit 1 was allowed.
* Pre-bronchodilator forced expiratory volume (FEV1) 55 to 85% of predicted normal.

Exclusion criteria:

* Participants \<18 years or \>65 years.
* Fractional exhaled nitric oxide (FeNO) \<26 parts per billion (ppb) at Visit 1 (Screening Visit).
* Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis, eosinophilic granulomatosis with polyangiitis \[Churg-Strauss Syndrome\]) which could impair lung function.
* A participant who experienced an asthma exacerbation that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids at any time from 1 month prior to Visit 1.
* A participant who had experienced an upper or lower respiratory tract infection within the 4 weeks prior to Visit 1.
* Evidence of lung disease(s) other than asthma.
* Previous smoker (smoking history \>10 pack-years) or current smoker (within 6 months prior to Visit 1).
* Comorbid disease that might interfere with the evaluation of investigational medicinal product or conduct of study procedures (e.g., bronchoscopy).
* Anti-immunoglobulin E (IgE) therapy (omalizumab) or any other biologic therapy within 6 months of Visit 1.
* Exposure to another investigative study medication within a time period prior to Visit 1 that is less than 5 half-lives of the study medication.
* Treatment with systemic (oral or injectable) corticosteroids within 28 days of Visit 1.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Acceptance of Uterus Transplantation

Transplantation of an uterus

Uterus transplantation will be performed from live donors to patients with absolute uterine factor infertility. Organ procurement from the donor will be performed by laparotomy. Transplantation will also be performed by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* age below 40 years
* absolute uterine factor infertility
* BMI \< 30

Exclusion Criteria:

* systemic disease
* psychiatric disease
The Natural History of Mucolipidosis Type IV

The purpose of this study is to define the natural history of Mucolipidosis Type IV and identify potential clinical outcome measures.

Mucolipidosis type IV (MLIV) is an autosomal recessive disorder typically characterized by severe psychomotor delay evident by the end of the first year of life and slowly progressive visual impairment during the first decade as a result of a combination of corneal clouding and retinal degeneration. By the end of the first decade of life, and always by their early teens, individuals with typical MLIV develop severe visual impairment as a result of retinal degeneration. MLIV is an under-diagnosed and unique lysosomal disorder in that it often is mistaken either for cerebral palsy or for a retinal dystrophy of unknown cause. In addition, it is caused by a defect in a cation channel rather than by a lysosomal hydrolase. This study represents the only prospective clinical study in this patient population. Now that an animal model has been created and novel therapies will likely be tested, it is particularly important to define the natural history of this disorder and identify potential clinical outcome measures.

Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* Have a definitive diagnosis of MLIV based at least on a compatible history and significantly elevated blood gastrin levels
* Be able to travel to the Baylor Institute of Metabolic Disease in Dallas and spend 2-3 working days on site
* Be able to tolerate a general exam and neurological exam
* Be able to tolerate a modest amount of blood drawing, provide a urine specimen, and have a skin biopsy(if not previously done)
* Be able to tolerate the performance of necessary neuroimaging studies to include EEG and Head MRI
* Be able to tolerate a neuropsychological testing and rehabilitation evaluation

Exclusion Criteria:

-
Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients

Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Male patients
* Severe Hemophilia A (FVIII:C \<1%)
* No previous treatment with FVIII concentrates or other blood products containing FVIII

Exclusion Criteria:

* Diagnosis with a coagulation disorder other than Hemophilia A
* Severe liver or kidney disease
* Concomitant treatment with any systemic immunosuppressive drug
CD123-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies

Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD123-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignancies.

AML bears heterogeneous cells that can consequently offset killing by single-CAR-based therapy, which results in disease relapse. Leukemic stem cells (LSCs) associated with CD123 expression comprise a rare population that also plays an important role in disease progression and relapse for myeloid malignancies. CD33 is widely expressed in AML, high risk myelodysplastic syndromes (MDS) and myeloproliferative neoplasms. Targeting both CD33 and CD123 surface antigens together may offer two distinct benefits. First, targeting both bulk disease and leukemic stem cells together allows for a more comprehensive ablation of the disease. Second, dual targeting of myeloid malignancies by both CD33 and CLL1 directed therapy overcomes the pitfalls of single-antigen therapy by preventing relapse due to antigen loss. While loss of a single antigen under antigen-specific selection pressure is possible, loss of two antigens simultaneously is much less likely.

CD123-CD33 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CLL1 and CD33. cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape and leukemic stem cells.

Eligibility Criteria:
Inclusion Criteria:

1. Prior HSCT relapse beyond 6 months without active GVHD; systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
2. De novo AML
3. Transformed AML
4. MDS with excess blasts (RAEB-2)
5. MDS that is not a candidate for induction chemotherapy.
6. Myeloproliferative neoplasms with blastic transformation
7. Patients have exhausted standard therapeutic options

Exclusion Criteria:

1. Prior solid organ transplantation
2. Potentially curative therapy including hematopoietic cell transplant
3. Prior treatment with CD123xCD3 or CLL1x3 bispecific agents, T cells expressing CD123 CAR or CLL1 CAR, or toxin-conjugated to CD123 or CLL1 antibodies.