cyrilzakka/clinical-trials huggingface dataset:
Weight Bearing Exercises With and Without Jaffrey's Core Stability Exercise Training in Children With Down Syndrome.

Down syndrome also known as trisomy 21, is a genetic disorder caused by the presence of all or part of a third copy of chromosome 21. It is usually associated with physical growth delays, mild to moderate intellectual disability, and characteristic facial features. There is no cure for Down syndrome. Education and proper care have been shown to improve quality of life. Some children with Down syndrome are educated in typical school classes, while others require more specialized education. Those with Down syndrome nearly always have physical and intellectual disabilities. They also typically have poor immune function and generally reach developmental milestones at a later age. They have an increased risk of a number of other health problems, including congenital heart defect, epilepsy, leukemia, thyroid diseases, and mental disorders. This study will determine effects of weight bearing exercises with and without Jaffery's core stability exercise training on dynamic balance and trunk muscles strength in children with Down syndrome. Randomized controlled study will be conducted in which data will be collected from children with down syndrome with calculated sample size of 18 which will randomly assigned into group A and group B. Group A would receive weight bearing exercises (I.e.

standing on preferred foot, standing with close eyes, walking forward on a line using normal stride and heel to toe gait, stepping over response speed stick on balance beam ).Group B would receive weight bearing exercises along with the jaffrey's core stability exercises (I.e.

contracting muscles, sitting on Swiss ball, Bridging, Squatting side lying bridge etc.).Frequency will be 5 sessions per week, of 1 hour and duration is of 5 months. Balance and trunk muscle strength will be pre assessed using pediatric balance scale and trunk control measurement scale respectively. The improvement will be measured with same tools. Data will be analyzed through SPSS 25.


Eligibility Criteria:
Inclusion Criteria:

* Children with medical diagnosis of DS
* Age ranging from 4 to 10 year
* Both male and female genders
* Children who was able to stand and walk.

Exclusion Criteria:

* Any orthopedic limitation to exercise such as hip, knee, foot or spinal deformity.
* Children with planned orthopedic surgery in 6 months.
* Children with significantly impaired cognition.
* Children with hearing impairment
Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa

Anorexia nervosa is an eating disorder whose symptomatology induces a modification of the intestinal microbiota. To date, studies have shown variable profiles without linking them to metabolic and neuropsychological energy phenotyping. This intestinal dysbiosis could be involved in the maintenance of the disorders. Bidirectional communication channels exist between the microbiota, the intestine and the brain. Anomalies in these pathways could explain the impact of the microbiota on the pathophysiology of anorexia nervosa. Therapeutic interventions would then be possible to restore the microbiota in anorexia nervosa and influence the treatment of this disease. This study aims to explore the hypothesis of disruption of the microbiota-intestinal-brain axis transversely and measuring the intestinal microbiota, urinary metabolome, biological factors nutritional, immunological and physiological plasma plasma of the intestine, and finally, the psychological dimensions characteristic of anorexia nervosa.


Eligibility Criteria:
Inclusion criteria common to all four groups

* Patient affiliated or entitled to a social security scheme
* Patient who received informed information about the study
* Patient does not object to participating in the study

Inclusion criteria specific to mental anorexia

* BMI between 13 and 17.5 kg/m2
* Diagnostic and Statistical Manual of Mental Disorders IV restrictive anorexia nervosa diagnostic criteria
* Evolution of the troubles since less than 1 year.
* with feeling of hunger: "hunger" = total score on the 24-hour hunger scale \> 15 and presence of the three prandial peaks (score = 3)
* having lost the feeling of hunger: "not hungry" = total score on the 24-hour hunger scale ≤ 5 and absence of the three prandial peaks (score ≤ 2)

Inclusion criteria specific to constitutionally thin patients

* BMI between 13 and 17.5 kg/m2
* Stable weight for at least 3 months
* No eating disorder
* No markers of undernutrition

Inclusion criteria specific to normal weight subjects

* 20 kg/m2 ≤ BMI ≤ 25 kg/m2
* Stable weight for at least 3 months
* No eating disorder
* No markers of undernutrition

Non-inclusion criteria for all subjects :

* Antibiotic treatment during the 2 months preceding the sampling.
* History of immune system/autoimmune disease: Immune deficiency, Crohn's disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, psoriasis, Behçet's disease, celiac disease, type I diabetes.
* History of metabolic pathology: intestinal malabsorptive disease
* Medical or surgical history deemed by the investigator to be incompatible with this study.
* Severe progressive condition other
* Pregnant woman
* Majors under guardianship or subjects deprived of their liberty by judicial or administrative decision
* Ongoing psychotropic treatment
* Progressive diarrhea (Bristol Type V and VI)
7T MRS in Parkinson's Disease

This study is looking for healthy controls and patients with Parkinson's (PD) to perform an MR scan.

1. The neurochemical profile of the SN of patients with PD as measured by high field MRS will differ from that of healthy controls, in that glutathione will be lower due to oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis markers myo-inositol and glutamine will be higher due to inflammation (glial activation) and N-acetylaspartate and glutamate will be lower due to neuronal loss/damage.
2. There will be a relationship between neurochemical changes and disease severity.


Eligibility Criteria:
Inclusion Criteria:

Parkinson's disease Group

* Parkinson's disease (clinical diagnostic criteria)
* Age 45-75 years inclusive
* Able to safely undergo MRI scanning
* Absence of diabetes and smoking
* Capable of giving informed consent

Healthy Control Group

* Age 45-75 years inclusive
* Able to safely undergo MRI scanning
* Absence of diabetes and smoking
* Capable of giving informed consent

Exclusion Criteria:

Parkinson's disease Group

* Dementia (clinically determined by PI Dr. Tuite)
* Diagnosis of atypical parkinsonism
* Inability to safely undergo MRI scanning
* Inability to give informed consent
* Unstable medical conditions
* Present smoker
* Diabetic (on oral or injectable medications for diabetes)
* Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan
* Does not meet age criteria

Healthy Control Group

* Has a 1st degree relative with PD
* Dementia (clinically determined by PI Dr. Tuite)
* Inability to safely undergo MRI scanning
* Inability to give informed consent
* Unstable medical conditions
* Present smoker
* Diabetic (on oral or injectable medications for diabetes)
* Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan
* Does not meet age criteria
Fosrenol Post-marketing Surveillance for Hemodialysis in Japan

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia

Exclusion Criteria:

* Patients who are contraindicated based on the product label
Retrospective Clinical and Functional Evaluation of Patients Undergoing Knee Replacement With Small Implants

Retrospective evaluation of:

Functional results Clinical results Survivorship of knee replacement performed with small implants, isolated or combined

Retrospective evaluation of partial knee replacements (medial UNI, lateral UNI, patellofemoral replacement, combined UNI+ patellofemoral replacement, combined medial and lateral UNI) performed in the Joint Replacement Department of the IRCCS Istituto Ortopedico Galeazzi.

evaluation includes: clinical examination, functional results, survivorship at 1, 2, 5 , 10 and 15 years.

Eligibility Criteria:
inclusion criteria:

* patients receiving medial UNI or lateral UNI or patellofemoral replacement or combined UNI+ patellofemoral replacement or combined medial and lateral UNI
* age \> 18 years

exclusion criteria

* patients receiving total knee replacement
* patients having revision or a knee replacement
A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults

To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in healthy Chinese participants 18 to 55 years of age, approximately 60 participants will be randomised in a 4:1 ratio to either AZD7442 or placebo, administered by intramuscular (IM) injection or intravenous (IV) infusion, and approximately 479 days in duration for each participant.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 to 55 years of age
2. Healthy by medical history, physical examination, and baseline safety laboratory tests
3. Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
4. Contraceptive within 365 days post dosing

Exclusion Criteria:

1. Medical condition:

   * Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component.
   * Acute illness including fever on the day prior to or day of dosing.
   * Any other significant disease increase the risk to participant study.
2. Laboratory related:

   * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> upper limit of normal (ULN), or alkaline phosphatase (ALP) or TBL (total bilirubin) \> 1.5 × ULN
   * Serum creatinine \> ULN
   * Haemoglobin \< lower limit normal (LLN)
   * Platelet count \< LLN
   * White blood cell or neutrophil count outside normal reference ranges
   * Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.
Controlled Pilot Study to Assess Soft Tissue Reaction at the Crestal Part of a Dental Implant With ESTA Surface

This study will investigate the effect on the soft tissue that is in contact with a dental implant with a modified surface of the neck (the part of the implant that is above the bone and in contact with the soft gum tissue).

This is a prospective, controlled, randomised clinical pilot study with parallel groups and blinded subject.

The design has been chosen to obtain data to base a sample size calculation for future studies on by comparing the degree of mucosal inflammation of the mucosa in conjunction with the modified surface of the top of the test implant and the machined surface on the top of the control implant.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have voluntarily signed the informed consent form before any study related action
* Males and females must be at least 18 years of age and not more than 80 years old.
* Partially edentulous in posterior (position 3-7) maxilla or mandible with implants planned for single crowns in an area with a healed extraction socket.
* Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann Soft Tissue Level implant of 4.1mm diameter without augmentation (at least 1mm bone buccally and lingually/palatal)

Exclusion Criteria:

* Oral surgery contraindicated according to the judgement of the investigator (should be explained in the CRF)
* Local inflammation, including untreated periodontitis
* Patients with inadequate oral hygiene or unmotivated for adequate home care. Full mouth plaque index \> 25% at time of surgery
* Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
* Major systemic diseases
* Medical conditions requiring prolonged use of steroids
* Current pregnancy or breastfeeding women
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene
* Use of any investigational drug or device within the 90 day period immediately prior to implant surgery on study day 0
* Alcoholism or chronically drug abuse
* Smokers; more than 10 cigarettes per day
* Immuno-compromised patients
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.

Secondary Exclusion Criteria:

* GBR procedures at or adjacent to the planned study site
* Lack of primary stability of the dental implant at site of interest (e.g., rotational movement of the implant at a minimum of 15 Ncm torque at connection of the healing abutment, or tactile mobility)
A Real-World Study of COVID-19 Infection in Patients With Malignant Lymphomas Participating in Clinical Trials

This study focuses on the population of malignant lymphoma patients who are also in clinical research. Through a real world cross-sectional survey of infection and death risk during the COVID-19 pandemic in Guangzhou from December 2022 to January 2023, this study aims to clarify the risk, level and mortality of lymphoma patients infected with COVID-19 during their clinical research, and provide necessary research data for Chinese lymphoma patients during the COVID-19 pandemic,


Eligibility Criteria:
Inclusion Criteria:

(1) the diagnosis of lymphoma was confirmed by pathology according to World Health Organization (WHO)-criteria; (2) diagnosed with COVID-19 based on a positive polymerase chain reaction (PCR) test result for SARS-CoV-2 from oropharyngeal swabs, or on a positive detection of covid-19 antigen from nasopharyngeal swabs and typical clinical history; (3) participated in registered clinical trials and received anti-lymphoma treatment within four weeks before COVID-19 infection; (4) complete data on clinico-pathological characteristics, treatment approaches and follow-up were available.

Exclusion Criteria:

* Patients who could not provide detailed information about COVID-19 infection.
Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression

The purpose of this research study is to study closed-loop transcranial alternating current stimulation (tACS) to determine its effects on symptoms of depression in people with major depressive disorder.

The purpose of this clinical trial is to investigate the preliminary efficacy of closed-loop tACS for the treatment of major depressive disorder (MDD) in an open-label pilot study. We will recruit up to 35 participants with unipolar, non-psychotic MDD. Participation will include seven visits, two of them remotely (with an in-person option as needed), and one electronic survey.

Potential participants fill-in an electronic pre-screening form. If potentially eligible, a remote screening visit is performed. If eligible, participants attend five consecutive, daily stimulation sessions. Clinical assessments will be performed at baseline (Day 1 of stimulation, D1), Day five of stimulation (D5), and at their follow-up visit (14 days after the completion of stimulation, FU2) using the Hamilton Depression Rating Scale (HDRS-17).

For a subset of patients, electroencephalography (EEG) is collected at D1 prior to stimulation and after stimulation and again at FU2.

For a subset of patients, self-scoring surveys will be sent bi-weekly until 12 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70 years
* Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of MDD; unipolar, non-psychotic
* Hamilton Rating Depression Rating Scale (HRDS-17) score \>8
* Low suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) triage form (no intent or plan)
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)

Exclusion Criteria:

* DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months.
* DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months.
* Lifetime history of bipolar disorder, psychotic disorder, schizophrenia, autism
* Current use of benzodiazepines \> 20mg diazepam/d equivalent
* Antidepressant dose change within the last 2 weeks
* Initiated new antidepressant within the last 4 weeks
Urinary Tract Infection in Patients With Chronic Kidney Disease

This study aims to investigate the etiology and associated risk factors for UTI in Egyptian chronic kidney disease patients. In addition, to identify the isolated micro-organisms and their sensitivity patterns for better anticipation of treatment regimen.

Chronic kidney disease (CKD) patients are at higher risk of urinary tract infections (UTI), as CKD is a state of chronic inflammation, metabolic disturbance and impaired immunocompetence. Moreover, patient with CKD are usually of advanced age and suffer from other comorbidities such as diabetes, hypertension, obesity, and cardiovascular diseases, which also add to their risk of infection.

UTI comprises heterogeneous conditions ranging from mild cystitis, easily treated with oral antibiotics, to life-threatening sepsis and multiple organ failure.

There is scarce information about risk factors of recurrence of UTI and infection with multidrug-resistant organisms in the Egyptian population.

Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant females aged ≥ 18 years old
2. Patients with CKD stages (G1 to G4)
3. Patients diagnosed with UTI due to urine culture

Exclusion Criteria:

1. Non-CKD patients
2. pregnant females
3. CKD patients on immunosuppressant agents
4. ESRD patients on hemodialysis
5. Patients with structural abnormalities which make them liable to frequent UTI
A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)

This is a Phase 1, pharmacokinetic and pharmacodynamic study of intravenous and subcutaneous administered golimumab in patients with rheumatoid arthritis.

A Phase 1, randomized (study drug route of administration assigned by chance), open label (both physician and patient know that golimumab has been assigned), study of golimumab in patients with rheumatoid arthritis (RA). The purpose of this study is to compare the pharmacokinetic (how the body effects the drug) and pharmacodynamic (how the drug effects the body) effects of golimumab administered through a vein in the arm or by injection under the skin. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. The study will also assess the clinical effects of golimumab on RA. The study is planned for approximately 45 patients, which are randomized at a 2:1 ratio to receive golimumab SC or IV. Male or female patients who have been diagnosed with RA for at least 3 months and who are 18 years of age or older may be able to participate. Subcutaneous (SC) injections of 100 mg golimumab every 4 weeks through Week 20 or intravenous (IV) administrations of 2 mg/kg golimumab on Days 1 and 85.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of RA for at least 3 months prior to screening
* Have no history of latent or active tuberculosis (TB) and test negative for TB

Exclusion Criteria:

* Have inflammatory diseases other than RA
* Have been treated with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than methotrexate (MTX), sulfasalazine, or hydroxychloroquine during the 4 weeks prior to the first administration of study agent
* Have received intramuscular (IM), IV, or intra-articular corticosteroids within 4 weeks of study agent administration
* Have a known hypersensitivity to human Ig proteins
* Have received infliximab, golimumab, adalimumab or abatacept within 3 months, or etanercept or anakinra within 1 month prior to the first administration of study agent
* Have received alefacept, efalizumab, natalizumab, rituximab, or any B-cell-depleting agent
* Have been treated with any other biologics or investigational drugs, within 5 half-lives of that drug prior to the first administration of study agent
* Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis, prior to screening
* Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
* Have had a serious infection (eg, hepatitis, pneumonia, pyelonephritis, or sepsis)
Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

This is a single center, observational study of posaconazole PK sampling in lung transplant recipients. The patients enrolled will have up to 6 (3ml) pk samples (a total of 18 ml) and one 10ml blood sample for a total collection of 28ml of blood obtained over the entire study. In addition, the investigators will collect medical record information and any excess BAL samples available during the study (tests done as part of the patient's clinical care and the samples would have been discarded once diagnosis was made).

PK blood samples will be obtained around a clinical dosing of posaconazole

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older receiving posaconazole post transplant as part of their care received a lung transplant

Exclusion Criteria:

* must meet inclusion criteria
Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion

This study will focus on patients undergoing total hip arthroplasty and Loma Linda University Medical Center \& East Campus. These patients will be randomized to receive a low dose lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. These groups will be compared to one another statistically to determine which group shows the safest and most satisfying pain control.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female undergoing a total hip arthroplasty Subject is American Society of Anesthesiologists physical status 1, 2, or 3 Subject has voluntarily signed and dated the informed consent document approved by the IRB Be English speaking

Exclusion Criteria:

* Age \> 80 years old or younger than 18 years old Congestive heart failure Hepatic insufficiency Neurological disorders Psychiatric disorders Steroid treatment No history of atrial fibrillation Chronic pain disorder with opioid treatment