cyrilzakka/clinical-trials huggingface dataset:
The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection

The goal of this observational study is to test whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome . The main questions it aims to answer are:

* whether the dynamic changes of CD4+T lymphocytes can predict infections in patients with primary nephrotic syndrome
* effect of different immunosuppressive therapy on the number and function of T lymphocyte subsets in patients with primary nephrotic syndrome

Participants will be divided into infection group and non-infection group according to whether they are infected


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 14 years and\<75 years.
2. It meets the diagnostic criteria of primary nephrotic syndrome, i.e. a. A large amount of proteinuria (24h urine protein quantity \> 3.5g/d); b. Hypoalbuminemia (liver function: albumin\<30g/L); c. Edema; d. The blood lipid is elevated. Among them, item a and b are necessary conditions for diagnosis.
3. Nephrocentesis pathology indicates the pathological type of nephrotic syndrome (minimal change glomerulonephritis, membranous nephropathy, focal segmental glomerulonephritis, membranous proliferative glomerulonephritis, mesangial proliferative glomerulonephritis).
4. Glucocorticoids or corticosteroids combined with immunosuppressants should be used clinically.

Exclusion Criteria:

1. Secondary nephrotic syndrome, such as secondary to systemic lupus erythematosus, hepatitis B, hepatitis C, tumor, organic solvent , heavy metal poisoning, etc.
2. Patients with tumor and chronic infectious diseases, such as HIV infection, cardiac insufficiency, acute hepatitis, transaminase increase more than twice the normal value, deep vein thrombosis.
3. The subjects were pregnant and lactating women.
4. Patients with serious primary diseases such as heart, brain, liver and hematopoietic system.
5. Those who can not cooperate, such as the mentally ill.
6. It is known that it is allergic to or has contraindications to any component in glucocorticoid, FK506, MMF and CTX.
7. Serum creatinine (SCR) \> 265.2 μ mol/L（3mg/dl）。
Disability and Health Outcomes in COPD

To test a conceptual model of how disability develops in chronic obstructive pulmonary disease (COPD).

BACKGROUND:

Background. COPD is a common chronic health condition. Because current medical treatments have minimal impact on disease progression, a strategy to prevent COPD-related disability would have important clinical and public health benefits.

DESIGN NARRATIVE:

The study will test a specific conceptual model of how disability develops in COPD. The aims are: (1) To evaluate the impact of respiratory impairment, especially pulmonary function impairment, on the risk of functional limitation in COPD. Using a control group, to elucidate the prevalence of respiratory impairment, functional limitation, and disability that is directly attributable to COPD. (2) In adults with COPD, to delineate the longitudinal effect of functional limitation on the risk of incident disability. The investigators hypothesize that development of functional limitation, and not pulmonary function impairment, is the major determinant of disability. (3) To determine the prospective impact of disability on the risk of future adverse health outcomes. The investigators will assemble a prospective cohort of 1200 randomly sampled adults with COPD who are members of a large regional health maintenance organization. A matched control group of 300 subjects will be recruited. Subjects will undergo a detailed physical assessment that measures respiratory impairment (e.g., pulmonary function) and functional limitation (e.g., lower extremity function, muscle strength, exercise performance, and cognitive function). Structured telephone interviews will ascertain disability outcomes at baseline and 18-month prospective follow-up. The investigators will also study the modulating effects of specific risk factors and protective factors on the progression from functional limitation to COPD-related disability, including psychological factors, environmental exposures, and health care process factors.

Eligibility Criteria:
Inclusion:

1. COPD diagnosis and
2. Medication use for cases

Exclusion:

1. Withdrew from Kaiser Plan prior to baseline contact
"Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."

A prospective interventional trial for 9 months will be carried out on 300 type-2 diabetes mellitus volunteer patients who are above 18-year-old and participants will be selected through consecutive sampling and will be evaluated on the basis of glycemic index and history of patients. Selected parameters will be measured at baseline and after the 12 weeks of therapy. Statistical analysis will be carried out by SPSS, ANOVA, and t-test.

From this experimental design, we are expecting improvement in the management of glycemic index, reduction in systolic and diastolic blood pressure, and reduction in weight GLP-1 naive patients.

Patients will be recruited from all the 12 centers included in the trial across Pakistan and data will be electronically transferred to the main center. All GLP-1 naive patients fulfilling the inclusion criteria will be recruited after informed written consent and started on Semaglutide injection 0.25mg for 2 weeks and will be escalated to 0.5 mg for the next 10 weeks. Socio-Demographic Data and health vitals including height, weight, BMI, baseline HbA1c, FBS and RBS will be recorded in preset Performa. All those who agree to participate will be given structured education on diet and exercise and those willing to comply will be recruited. A research assistant will be recruited and trained to teach the injection technique and discuss the adverse effects of Semaglutide to the participants. Patients taking DPP-4 inhibitors will be switched to GLP-1 analogue and only a single drug change in the form of adding Semaglutide will be done at the time. Semaglutide injection technique will be explained to the patient and one injection at a time will be provided to the patient to ensure compliance and avoid bias in the study. Patients will be asked to revisit after 4 weeks with the used injection device. After completion of 3 months of treatment vitals including height, weight, BMI, baseline HbA1c, FBS and RBS will be recorded in preset Performa.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female Type 2 Diabetic patients with age ≥18 years.
* Patients with HbA1c ≥ 7.5 % - ≤ 10.0%
* Patients with BMI ≥ 30

Exclusion Criteria:

* Patients with Type 1 Diabetes Mellitus
* Patients with Gestational Diabetes Mellitus.
* Patients with Chronic Renal Failure with eGFR of ≤ 30ml/min
* Patient already on another GLP 1 analogue
* The patient stopped any GLP1 analogue treatment less than 3 months back.
* Patients with history of chronic pancreatitis or pancreatic cancer.
Bone Regeneration Using Bone Marrow Stromal Cells

Deficient or inappropriate healing of bone impacts clinical decision-making and treatment options in orthopedics, oral and maxillofacial surgery, plastic surgery and periodontics. While a number of auto- and allografting techniques have been used to regenerate craniofacial defects caused by infective, neoplastic or trauma-induced bone loss, each method has significant limitations. Our research group in the Craniofacial and Skeletal Diseases Branch of NIDCR has developed methods to culture and expand cell populations derived from mouse bone marrow stroma. We believe that an important next step is to apply the information gained in animal studies to treat osseous defects in humans. We propose to examine the potential of cultured human bone marrow stromal cells to serve as an abundant source of osteoblastic progenitor cells. These cells will ultimately be used to graft craniofacial osseous defects. In the course of this study we will: (1) develop methods for the propagation and enrichment of osteoblastic progenitor cells from bone marrow stroma; (2) test various vehicles for the transfer of bone marrow stromal cells to osseous defects in recipient animals; (3) determine optimal culturing and transplantation conditions for the eventual transplantation of bone marrow stromal cells into human recipients. These studies will define the parameters of bone marrow stromal cell transplantation and will generate models for future therapeutic strategies.

Deficient or inappropriate healing of bone impacts clinical decision-making and treatment options in orthopedics, oral and maxillofacial surgery, plastic surgery and periodontics. While a number of auto- and allografting techniques have been used to regenerate craniofacial defects caused by infective, neoplastic or trauma-induced bone loss, each method has significant limitations. Our research group in the Craniofacial and Skeletal Diseases Branch of NIDCR has developed methods to culture and expand cell populations derived from mouse bone marrow stroma. We believe that an important next step is to apply the information gained in animal studies to treat osseous defects in humans. We propose to examine the potential of cultured human bone marrow stromal cells to serve as an abundant source of osteoblastic progenitor cells. These cells will ultimately be used to graft craniofacial osseous defects. In the course of this study we will: (1) develop methods for the propagation and enrichment of osteoblastic progenitor cells from bone marrow stroma; (2) test various vehicles for the transfer of bone marrow stromal cells to osseous defects in recipient animals; (3) determine optimal culturing and transplantation conditions for the eventual transplantation of bone marrow stromal cells into human recipients. These studies will define the parameters of bone marrow stromal cell transplantation and will generate models for future therapeutic strategies.

Eligibility Criteria:
* INCLUSION CRITERIA:

Males and females 18 years and older.

EXCLUSION CRITERIA:

Subjects may not have metabolic bone diseases, pregnancy or taking drugs affecting skeletal metabolism.
Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation

Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. In the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. Evaluation of the effect of silica-calcium phosphate nanocomposite (SCPC) graft material versus demineralized freeze dried bone allograft (DFBA) in horizontal alveolar ridge augmentation before implant insertion will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm.
* Augmented area length in the mesial-distal direction of less than 20 mm.
* Adequate physically healthy condition.

Exclusion Criteria:

* A systemic disease that would contraindicate oral surgical treatment.
* Treated patients who had undergone therapy involving radiation
* Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure.
* Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.
Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ

This study aims to evaluate the in situ antibacterial activity of a mouthwash containing essential oils with and without alcohol on undisturbed de novo plaque-like biofilm (PL-biofilm) up to 7 h after its application.

An appliance was designed to hold six glass disks on the buccal sides of the lower teeth, allowing PL-biofilm growth. Twenty healthy volunteers will the appliance for 48 h and then performed a mouthwash with essential oils. Disks will be removed after 30 s and at 1, 3, 5, and 7 h later. After a washout period, the same procedure will be repeated with a sterile water mouthwash and a mouthwash with essential oils without alcohol. After PL-biofilm vital staining, samples will be analyzed using a confocal laser scanning microscope analysing their bacterial viability and thickness.


Eligibility Criteria:
Inclusion Criteria:

Systemically healthy adults.

* Minimum of 24 permanent teeth.
* No gingivitis (Community Periodontal Index score = 0).
* No periodontitis (Community Periodontal Index score = 0).
* Absence of untreated caries.

Exclusion Criteria:

* Smoker or former smoker.
* Presence of dental prostheses.
* Presence of orthodontic devices.
* Antibiotic treatment or routine use of oral antiseptics in the previous 3 months.
* Presence of any systemic disease that could alter the production or composition of saliva.
COVID Screening Strategies in Homeless Shelters

Residents in homeless shelters will be randomized to 4 different COVID-19 screening strategies with the primary outcome being COVID-19 detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18
* Able to provide oral consent
* Able to perform a self-collected swab if in the relevant intervention arm

Exclusion Criteria:

-
The Effect of Sevelamer Carbonate on Serum Trimethylamine-n-Oxide (TMAO) Level in Patients With Chronic Kidney Disease (CKD) Stage 3b-4

The aim of this study is to investigate effects of sevelamer carbonate on reducing TMAO in stage 3b-4 CKD (pre-dialysis) patients. The study will also investigate the safety and tolerability of sevelamer carbonate in study population and the effects of sevelamer carbonate on serum p-cresyl sulfate, indoxyl sulfate, LDL-C and uric acid.


Eligibility Criteria:
Inclusion Criteria:

* 1. Men or women, aged from 18 to 75 years old;
* 2. Provide informed consent prior to enrolling in the study;
* 3. Estimated glomerular filtration rate (eGFR) between 15-45 ml/min/1.73 m2 (calculated by CKD-EPI equation)

Exclusion Criteria:

* 1. Documented poorly controlled diabetes mellitus, poorly controlled hypertension, malignant tumour, or any clinically significant unstable medical condition;
* 2. Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation;
* 3. Known hypersensitivity to sevelamer or any constituents of the study drug;
* 4. Unable to comply with the requirements of the study;
* 5. Hypophosphatemia (serum phosphorus level \<0.87mmol/L);
* 6. Women who have a positive pregnancy test at enrollment or women who are breast-feeding;
* 7. Have been enrolled in other interventional study;
* 8. Received sevelamer or other intestinal adsorbents, or broad-spectrum antibiotic within one month prior to the screening period.
Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented metastatic renal cell cancer with a component of clear cell histology.
* Evidence of measurable disease.
* Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.

Exclusion Criteria:

* Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
* Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
Performance of CAST (Cellular Antigen Stimulation Test) in Patients With Wasp Venom Allergy: Evaluation of Neutralizing IgG Subclasses

To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom is able to neutralize the allergen, and therefore to prevent a positive CAST


Eligibility Criteria:
Inclusion criteria:

* male and female patient with allergy to wasp venom grade III and IV according to H.L. Müller
* 18-75 years
* planned SIT against wasp venom or finished 5 years SIT against wsp venom (10/10)

Exclusion criteria:

* oral corticosteroids
* chromogycin
* ketotifen
* immunosuppressive drugs within the last 2 years
Evaluation at 5 and 10 Years of Renal Transplant Patients

5 and 10 years follow-up of the oxyop study.

Oxyop (NCT02652520 PHRC) was a safety study evaluating the use of an oxygen carrier HEMO2life® as an additive in organ preservation solution in 60 transplanted kidneys. This was a national multicenter (6 centers) open-labeled safety study on HEMO2life® that included 58 recipients. The first patient was included on March 24th, 2016 and the study was completed on February 23th, 2018 (1 year of recruitment and 1 year of follow-up). Some efficacy secondary end points using a paired analysis was also analyzed (local kidney receiving HEMO2life® versus contralateral kidney transplanted elsewhere in France). Oxyop 5 and 10 years aims to analyse 5 and 10 years results.

Eligibility Criteria:
Inclusion Criteria:

* informed patients participating to the oxyop study
* Patient having completed the OXYOP M12 follow-up visit
* Patient agreeing to participate in the observational study

Exclusion Criteria:

* Opposition to the use his medical data
* patient deceased or with graft lost before M48
Detection of Motor Seizures Using WBAN

This study aims to collect the motor movement data using sensors to detect Generalized Tonic Clonic Seizures . Wearable sensors similar to smart watches will be used to detect seizures. The proposed system will consist of 3-4 wearable wireless sensor worn on the hands and legs. The data from these sensors will be send to the clod and collected to a central hub for analysis and detection of GTC Seizures.

The key of the project is digital signal processing of the movement data collected. The medical application sensors from Analog Devices will be worn around the wrist and legs of the participants. These sensors will continuously collect the motor movement data. The data will be send to the cloud from where it will be collected at a central hub for digital signal processing and detection. The data analysis results will be compared with the standard EEG results for Tonic Clonic seizures and results will be verified.

Eligibility Criteria:
Inclusion Criteria:

* subject has seizures or symptoms of seizures

Exclusion Criteria:
Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation

Primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out Phase-II, III and IV. It also aimed at to see the level of difference of glucose tolerance and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic to evaluate the potential benefit for treatment of insulin resistance and sensitivity. To see the for prevention of Diabetes Mellitus (DM) and stopping / delaying the onset of DM.

This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in the study by observing the Helsinki Declaration for clinical trials.

volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2.

On screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into A and B.

Biochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation.

Collected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done. One year followup of participants was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-59
* Impaired Fasting Glucose (100-125mg/dl)
* Impaired Glucose Tolerance (140-199mg/dl) 2h-75gm OGTT
* History of Diabetes in first degree relation with one condition
* At high risk with BMI \> 35%
* Early onset diabetic / accidental on screening (glucose \>200mg/dl)

Exclusion Criteria:

* on renal dialysis;
* an acute or terminal illness or serious mental illness;
* history of recent coronary event within the last 12 months;
* a recent history of acute medical problem or admission to hospital;
* any other severe medical conditions that need intervention / treatment
* has poor short-term prognosis (expected death in \<2 years);
* is planning to travel for longer than 6 weeks during the 6-week intervention period; or
* is with compromised liver / kidney / cardiac function
* older patients of DM taking any form of medication / intervention
Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)

The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load \< 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.


Eligibility Criteria:
Inclusion Criteria:

* Treatment naive HIV-1 infected subjects ( \< 10 days of treatment with any ARV).
* Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening.
* Subjects who have a CD4 count ≥ 50 cells/mm3.
* Men and women, ages 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate).
* Both females of child-bearing potential and males must utilize effective barrier contraception. Other contraception in addition to barrier methods is permitted; refer to the Investigator Brochure for details regarding potential interactions with ATV and some oral contraceptives

Exclusion Criteria:

* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
* WOCBP using a prohibited contraceptive method. Caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see Investigator Brochure for details
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test on enrollment or prior to study drug administration.
* Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment
* Primary HIV infection
* Medical History and Concurrent Diseases
* Active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis Physical and Laboratory Test Findings
* Screening laboratory values measured as follows:
* Grade IV glucose,
* Grade IV electrolytes,
* Grade IV transaminases,
* Grade IV hematology.
* Hypersensitivity to any component of the formulation of study drug
* Prior history of taking any ARV for more than 10 days
* Concomitant administration of tenofovir (TDF).
* Refer to Section 6.4.1 which details all prohibited therapies
SPECT-CT for Assessment of Total Knee Arthroplasty in Navigated and Non-navigated Total Knee Arthroplasty

By the comparison of two operation methods navigated and non-navigated TKR with SPECT/CT we want to show wich method has the better outcome.

With SPECT/CT we want to controll the clinical outcome of patients who underwent a navigated or a non-navigated TKR.

Eligibility Criteria:
Inclusion Criteria:

* Total Knee prosthesis (primary)
* \>18 years

Exclusion Criteria:

* pregnancy
* lactating women
* endocrine diseases
* tumour diseases
* posttraumatic osteoarthritis of the knee
* previous infection of the knee
* medicaments which influence the metabolism of the bone