cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of BMMNC in Patients With Chronic Renal Failure

This Study is single arm, single center trial to check the safety and efficacy of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)for the patient with CRF

Chronic kidney failure, also called chronic kidney disease, describes the gradual loss of kidney function. Kidney failure is a medical condition in which kidneys fail to filter metabolic wastes and toxins out of the body and a series of symptoms will be developed .It is common, frequently un recognised and often exists together with other conditions (for example, cardiovascular disease and diabetes). When advanced, it also carries a higher risk of mortality. The risk of developing CKD(Chronic Kidney diseases ) increases with increasing age, and some conditions that coexist with CKD become more severe as kidney dysfunction advances CKD can progress to established renal failure in a small but significant percentage of people. This classification divides CKD into five stages. Stages 3-5 may be defined by glomerular filtration rate (GFR) alone, whereas stages 1 and 2 also require the presence of persistent proteinuria, albuminuria or haematuria, or structural abnormalities.

Stem cells have two important characteristics that distinguish them from other types of cells. First, they are unspecialized cells that renew themselves for long periods through cell division. The second is that under certain physiologic or experimental conditions, they can be induced to become cells with special function such as the beating cells of heart muscle or the insulin- producing cells of the pancreas as well as the neurons of brain.So our approach is to prove safety and efficacy of stem cell in CRF

Eligibility Criteria:
Inclusion Criteria:

* Age limit: 18 -65
* willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell transplantation.
* To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
* willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

* Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
* Women who are pregnant or lactating
* Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
* Suffering from Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
* Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
* Hemoglobin level below 7g %
* estimated glomerular filtration rate (eGFR) of \< 45ml/min
SFIB vs Anterior QLB in Total Hip Arthroplasty

Quadratus lumborum block (QLB) is a facial plane block defined to provide analgesia from T7-L3 dermatomes. There are articles reporting that it is an effective analgesic method in hip surgeries. Suprainguinal fascia iliaca block (SIFIB) also blocks components of the lumbar plexus and provides effective analgesia in hip surgeries. The investigators aim to compare the effectiveness of QLB and SIFIB in patients undergoing primary total hip arthroplasty (THA).


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II-III
* Scheduled for total hip artroplasty surgery under spinal anesthesia

Exclusion Criteria:

* Patients who did not want to participate in the study
* Patients with cognitive dysfunction who cannot evaluate the NRS score and cannot use PCA
* Known local anesthetics and opioid allergy,
* Pregnancy or lactation
* Patients with a contraindication to spinal and regional anesthesia
* Presence of multiple fractures
Propolis Extract, Nanovitamin C and Nanovitamin E on Desquamative Gingivitis

Objective: To evaluate the effectiveness of a gel containing nanovitamin C, nanovitamin E and propolis extract compared to a placebo in the treatment of desquamative gingivitis (GD) in patients with mucocutaneous diseases with gingival involvement. The possible improvement in the quality of life of these patients after treatment will also be evaluated.

Study design: Double-blind, randomized controlled study.

Patients: GD patients are being selected from the Postgraduate 'Specialist in Oral Medicine' of the Faculty of Dentistry, Complutense University of Madrid.

Allocation: Patients are being randomly assigned to the study group (dental prophylaxis + oral hygiene instructions + use of propolis gel for 4 weeks) or to the placebo group (dental prophylaxis + oral hygiene instructions + use of placebo gel for 4 weeks ). Both the study gel and the placebo are being used for brushing their teeth and for application in areas with GD.

Variables: The severity of the GD will be collected according to the scale of Arduino et al. 2017 and the periodontal variables (plaque index, probing bleeding index and probing depth). Pain during treatment will be recorded using a 10 cm visual analog scale (VAS). The quality of life in relation to oral health will be recorded using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. These variables will be collected on day 0, 2 and 4 weeks after using the study gel or placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age.
2. Patients with a clinical and histological diagnosis of some mucocutaneous disease. Patients diagnosed with oral lichen planus will be selected according to the American Academy of Oral and Maxillofacial Pathology, pemphigus vulgaris and / or scarring pemphigoid according to the 2015 World Workshop on Oral Medicine.
3. Patients who present GD, that is, erythema, epithelial desquamation, atrophy, painful erosions or ulceration of the free and / or attached gingiva, which is not related to the local accumulation of plaque.

Exclusion Criteria:

1. Being in cancer treatment with head and neck radiotherapy, chemotherapy or immunotherapy.
2. Being diabetic.
3. Being on topical corticosteroid treatment in the previous 4 weeks or systemic treatment in the previous 8 weeks.
4. Those patients who do not present the anterosuperior sector (from canine to upper canine) or the anteroinferior sector (from canine to lower canine) will also be excluded.
5. Pregnant or breastfeeding.
6. Being a smoker.
7. Use of rinses for plaque control.
8. Being medicated with drugs associated with gingival enlargement such as cyclosporine, calcium channel blockers and phenytoin.
9. To have taken antibiotics and / or anti-inflammatories 3 months before the study.
10. Taking medications capable of producing lichenoid reactions.
11. Patients who do not want to sign the informed consent.
12. Patients with periodontitis according to the consensus criteria of Papapanou et al. 2018 or patients treated for unstable periodontal disease according to the classification of Chapple et al. 2017.
Comparison of Binocular Spectacle Prescription Versus Patching Therapy in Refractive Amblyopia Patients

This study will examine on Refractive Amblyopia patients, whose amblyopia started due to longstanding uncorrected refractive errors.

There will be a comparison of two treatment methods i.e. Patching and Binocular Spectacle Prescription used to cure amblyopia patients. In binocular spectacle correction, we will slightly blur the good eye and fully correct the amblyopic eye so that binocular functions stimulate and improve after the treatment. Literature suggests that Patching improve monocular functions but there is no significant improvement in binocular functions.

Eligibility Criteria:
Inclusion Criteria:

* Anisometropic amblyopia
* Anisometropia \> 1.00 D( difference between eyes in SE)
* Astigmatism \>1.50 D
* VA in amblyopic eye 20/40 -20/200(6/12-6/60) or less than 20/200
* VA in the better eye or fellow eye 20/30 (6/9) or better

Exclusion Criteria:

* Strabismic amblyopia
* Deprivation amblyopia
* Isoametropic amblyopia
* History of ocular trauma, IOL implant
* Media opacity
* Any ocular/retinal pathology
* Optic nerve pathology
* Ptosis
* Any gaze control abnormalities
Effect of Television Cartoons in Patients Younger Than 3.5 Years During Echocardiography

The objective of this study is analyze the influence of TV entertainment in children less than 3 years of age during echocardiography in order to achieve a complete and accurate test.

This is an experimental study in children with suspected congenital or acquired cardiac disease. An examination room was prepared with a TV on the ceiling that was positioned in a way that would provide unobstructed viewing for children during the echocardiography procedure.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who were referred to pediatric cardiology consultation.
* Patients younger than 3.5 years.
* Signed informed consent by parents.

Exclusion Criteria:

* No signed informed consent by parents.
Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis

This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* PATIENTS:
* Male or female, age equal to or above 18 years undergoing chronic haemodialysis
* Stable and adequate haemodialysis treatment three months prior to enrolment
* HEALTHY SUBJECTS:
* Matching an individual of the patient group by: Gender and age (± 5 years)
* Matching an individual of the patient group by weight (after dialysis, ±10%)
* Creatinine clearance above 80 ml/min
* Subjects must be in good health in accordance with their age as determined by a medical
* history, physical examination, vital signs, ECG (electrocardiogram), routine haematology and clinical chemistry

Exclusion Criteria:

* Use of cuprophane membranes
* Active malignant disease
* Diabetes
* Critical illness as defined by the need of respiratory or circulatory support
* Known or suspected allergy to the trial product
* Pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
* using inadequate contraceptive measures
* Blood Pressure (pre-dialysis) above 180/110
* Chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
* Treated with immunosuppressive agents
Remote Pulmonary Function Testing and Nurse Coaching in ALS

Comparison of respiratory outcomes in patients receiving telemedicine-guided remote pulmonary function testing (rPFT) with or without the additional support of nurse coaching. This is a randomized controlled study which assesses the effects rPFT and coaching on respiratory outcomes and quality of life.

This is a two-arm, randomized study to determine 1) whether weekly monitoring of respiratory function can lead to timelier initiation of NIV and 2) whether structured nurse coaching leads to improved self-efficacy for managing disease and better maintenance of respiratory health. For enrollees in both arms, standard FVC and MIP measurements obtained approximately every three months by the respiratory therapist during ALS Clinic are supplemented with self-administered rPFTs performed weekly. Enrollees in the rPFT+NRHC (nurse respiratory health coaching) arm will additionally receive monthly coaching with the study nurse via telehealth. Outcomes include measures of quality of life and self-efficacy for managing disease.

Eligibility Criteria:
Inclusion Criteria:

Patients:

1. Possess a diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria \[Brooks2000\].
2. Be 18 years of age or older.
3. Have a caregiver available to participate in the study
4. Symptom onset within the last three years.
5. Have a computer and home internet service sufficient for engaging in telemedicine sessions.
6. Have a second device capable of downloading the spirometer application from an app store (Android- or iOS-based smartphone or tablet).

Caregivers:

1. Be 18 years of age or older, of either gender.
2. Be able and willing to provide informed consent.

Exclusion Criteria:

Patients:

1. Use of NIV or diaphragm pacer at time of obtaining informed consent.
2. FVC ≤50% predicted or MIP \> -60 cm of water.
3. ALS Functional Rating Scale (ALSFRS-R) \[Cedarbaum1999\] score on day of screening of ≥2 on items for speech, swallowing, and salivation. These items are indicators of bulbar dysfunction, which limits the reliability of PFT administration.
4. Cognitive impairment, as judged by the ALS clinic neurologist, that prevents participation in the study.

Caregivers: None
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions

STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions)

STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis

STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft

REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA) Application as a bone regeneration system, pivotal phase


Eligibility Criteria:
Inclusion Criteria:

1) Bone defect in the hindfoot or ankle requiring fusion using open surgical technique with supplemental bone graft/substitute, requiring one of the following procedures:

* Ankle joint fusion
* Subtalar fusion
* Calcaneocuboid fusion
* Talonavicular fusion
* Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
* Double fusions (talonavicular and calcaneocuboid joints)

Exclusion Criteria:

1. Previous fusion surgery of the proposed fusion site.
2. The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage \> 10mg/day).
3. Pregnant or a female intending to become pregnant during this study period.
4. Morbidly obese (BMI \> 45 kg/m2)
Lipid Lowering Effect of Plant Stanol Ester in a Spoonable Non-dairy Product

The aim is to determine the effect of investigational products on serum LDL cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l)
* Plasma triglyceride levels ≤ 4.0 mmol/l
* Age 18-65 years

Exclusion Criteria:

* Intolerance to oats or other ingredients of the test products
* Severe obesity (BMI ≥ 32 kg/m2)
* Consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, PCSK9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. Statin treatment is allowed at stable dose.
* Consumption of plant stanol or plant sterol containing food products or supplements such as Benecol, Becel pro.active, Keiju Alentaja or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample)
* History of malignant diseases like cancer within five years prior to recruitment
* History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
* Diagnosed type 1 or type 2 diabetes requiring medical treatment
* Celiac disease
* Medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. Orlistat, Victoza)
* Alcohol abuse (\> 4 portion/per day) or recreational drug abuse
* Pregnancy or planned pregnancy or lactating
* Clinically significant abnormalities in screening labs
* Participation in another clinical trial in the preceding 3 months
OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut

This is a phase 1, multi-center, randomized, double-blind, placebo-controlled study in adult participants with peanut allergy. Participants will be randomized in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The treatment group will be blinded to the investigator, participants, and the Intrommune study team.


Eligibility Criteria:
Inclusion Criteria:

Participant must be 18-55 years of age inclusive, at the time of signing the informed consent.

Female participants of childbearing potential or male participants with female partners of child-bearing potential must utilize highly effective birth control method(s) throughout the study and for 30 days after the final dose of study drug. Acceptable methods of contraception include: complete abstinence, male or female condoms with spermicide, oral or implanted contraceptives, or vasectomy.

For female participants of child-bearing potential: Negative serum beta human chorionic gonadotrophin (HCG) pregnancy test at screening.

Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Meets at least one of the following conditions

* Positive skin prick test (SPT) (wheal at least 3 mm greater than control) AND/OR Peanut specific IgE \>0.35 kU/L
* Convincing clinical history of allergic reaction to peanut within 1 hour of ingestion for at least 3 months prior to screening.
* Failed an oral food challenge (OFC) of \< 100mg of peanut protein at screening.
* Participant willing and able to undergo the procedures required by the protocol, including, assessment completion, protocol compliance, and participation in the placebo dosing period(s).

Exclusion Criteria:

* History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or oxygen saturations \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
* Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions
* Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
* Psychiatric disorders that the Investigator believes will interfere with study assessments
* Uncontrolled asthma, defined by at least one of the following conditions:

  * - FEV1 \<80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) \<75% of predicted, with or without controller medications.
  * - Inhaled corticosteroids (ICS) dosing of \>500mcg daily fluticasone (or equivalent ICS based on NHLBI dosing chart.
  * - One hospitalization in the past year for asthma
  * - An ER visit for asthma within six months prior to screening
* Planned dental surgery during from screening until study exit
* Moderate or advanced periodontal disease.
* Current pregnancy or lactating
Study of Olverembatinib (HQP1351) in Patients With CP-CML

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

The hypothesis suggests that in Part A, olverembatinib leads to a higher MMR rate compared to bosutinib in CP-CML patients without the T315I mutation; and in Part B, olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I mutation.

Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this study must meet all of the following criteria.

1. Age ≥ 18 years old.
2. Diagnosis of CML-CP
3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
5. Written informed consent obtained prior to any screening procedures.
6. Patients with adequate organ functions

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria.

1. For Part A only: T315I mutation at any time prior to starting study treatment.
2. Active infection that requires systemic drug therapy
3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
6. Pregnant or nursing (lactating) women.
Assessing a Length Artificial Intelligence Algorithm to Estimate Length of Children

An exploratory study to explore the possibility of using computer vision algorithms to estimate a child's length using images taken by a healthcare professional or parents.

This is an exploratory, observational, pilot study that aims to evaluate the performance of a Length Artificial Intelligence (LAI) algorithm in a real world setting. Images will be collected by parents or healthcare professionals, together with physical length measurements. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of the using the algorithm will be collected for improvements.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 0 to 18 months old.
2. Parent(s) should have access to the internet and a smartphone or tablet to complete study questionnaires, take images and upload images.
3. Parent(s) should be able to comprehend the content of the study and to complete the study questionnaires in English.
4. Written consent from parent.

Exclusion Criteria:

1. Parent(s) incapable of completing the study questionnaires and uploading of the images using smart phone or tablet with internet.
2. Children unable to undergo length measurement (e.g. children with structural abnormalities of the lower limbs or orthopedic conditions such as club foot, hip dysplasia, etc).