cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation

This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.


Eligibility Criteria:
Inclusion Criteria:

* The patient who will receive a conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation (HSCT).
* Age is below 19 at the time of diagnosis of a disease which is HSCT indication
* Written Study Informed consent and/or assent from the patient, parent, or guardian

Exclusion Criteria:

* Female patients who are pregnant or breast feeding
* Study treatment would deteriorate patient's disease.
* The patient may have problems with study participation due to a psychotic disorder.
* Any condition that would, in the Investigator's judgement, interfere with participation in the study
Intaglio Surface of Full-arch Implant Supported Prosthesis

The purpose of the study is to determine if there is an association between the intaglio shape of full-arch implant-supported prosthesis and marginal bone level around implants. The intaglio shape can be present as concave or convex and, depending on that, it can lead to more plaque accumulation on the fitting surface of the prosthesis.

Null Hypothesis (H0): Full-arch implant supported prosthesis with an increased depth of the intaglio shape demonstrate similar marginal bone levels as prosthesis with a reduced depth of the intaglio surface.

Alternative Hypothesis (H1): Full-arch implant supported prosthesis with an increased depth of the intaglio shape demonstrate increased/reduced marginal bone levels compared to prosthesis with a reduced depth of the intaglio surface.

The investigators will review dental records from the university and call eligible individuals for an appointment. During the research visit, the investigators will take new x-rays for marginal bone level assessment and a digital scan of the prosthesis to assess the shape of the intaglio. Also, remove the prosthesis, perform clinical measurements and collect plaque samples from the prosthesis and the implant sulcus. then, implants and prosthesis will be cleaned and placed in position.

The study will have only one appointment where every measurement will be assessed in this visit.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old;
* Rehabilitated with a full-arch screw-retained supported prosthesis in the maxilla, in function for at least 1 year;
* Good overall health (ASA I or ASA II).

Exclusion Criteria:

* Individuals with motricity problems who cannot clean the prosthesis;
* Patients treated or maintained in centers outside the University of Pittsburgh;
* Incomplete dental records;
* Misfit at the prosthesis-implant interface;
* Cemented prosthesis;
* Individuals rehabilitated with over dentures;
* Individuals with uncontrolled chronic diseases or immunocompromised;
* Pregnant Patients.
ECMO for Critically Ill Patients With Respiratory Failure and/or Circulatory Failure

Extracorporeal membrane oxygenation (ECMO) had been used to treat refractory hypoxemia associated with acute respiratory distress syndrome (ARDS). There were reported good outcome associated with ECMO for ARDS caused by influenza infection from several ECMO centers. However, the outcome of ECMO support in lower ECMO experience center had not been evaluated. This study aimed to evaluate the outcome of ECMO, comparing with conventional treatment among severe hypoxemic ARDS patients who were admitted in limited ECMO experience hospital.

This registry enroll refractory hypoxemia ARDS patients who met the criteria for veno-venous ECMO, according to 2013 Extracorporeal Life Support Organization (ELSO) guideline criteria. The definition of refractory hypoxemia was partial pressure of oxygen:fraction of inspire oxygen (PaO2/FiO2) \<100 with fraction of inspire oxygen (FiO2) \>90% despite optimal mechanical ventilator support for at least 2 hours.

The ECMO team was alerted for patient evaluation. The patients, who did not consider as ECMO candidate, due to their underlying condition of terminally illness, were excluded.

The decision to initiate ECMO, or not, is dependent on the conference included the patient or the patient first relative, the attending physician and the ECMO team physicians.

Patients who ECMO is initiated will be classified into ECMO group. Patients who they or their 1st degree relative do not agree for ECMO initiation will be treated according to standard treatment for ARDS, and classified in non-ECMO group.

The patients in both groups will be follow up until they are discharged from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed ARDS according to Berlin criteria
* Refractory hypoxemia: PaO2/FiO2 \<100 with FiO2 \>90% despite optimal mechanical ventilator support and paralytic agent infusion
* Hypoxemia persist for at least 2 hours

Exclusion Criteria:

* Terminally ill patient
* Patient who sign for do not resuscitation
* Metastatic malignancy
A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease

The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.

Randomized multi-center, blinded intervention, two cohort , study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will undergo sham procedures and be followed for 5 years post last simulated injection.. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.

Eligibility Criteria:
Inclusion Criteria:

1. The participant is male or female, 30 to 80 years of age on the date of informed consent.
2. The participant has a clinical diagnosis of T2DM in their health record.
3. The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record.
4. The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
5. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 44 mL/min/1.73m², not requiring renal dialysis.
6. The participant has an urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g.

Exclusion Criteria:

1. The participant has a history of type 1 diabetes mellitus.
2. The participant has a history of renal transplantation.
3. The participant has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening, across 3 measurements while seated.
4. The participant has hemoglobin level less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.
Anti-αIIbβ3 Immunization in Glanzmann Thrombasthenia: Prevalence and Associated Risk Factors: Thrombasthenia Anti-αIIbβ3 Antibodies Study (TAAS)

This project aim to correlate risk factors (genetic, therapeutic and socio-demographic factors) to anti-αIIbβ3 antibodies formation following blood products transfusion (platelets or packed red cells) or pregnancy in a national cohort of GT patients.

Glanzmann thrombasthenia (GT) is a rare autosomal recessive disorder caused by the absence or the dysfunction of the αIIbβ3 integrin, the most abundant receptor on platelets that mediates platelet aggregation through its binding of adhesive proteins. GT is readily identifiable by platelet function testing, and a lack of platelet aggregation in response to all physiological agonists is unique for this disease. The ITGA2B gene encodes for the αIIb subunit, whereas the ITGB3 gene encodes for β3. Mutations causing GT can affect either ITGA2B or ITGB3. The disease is characterized by spontaneous and trauma-related mucocutaneous bleeding, with variable expression ranging from easy bruising to fatal hemorrhages. Platelet transfusions are used to control or prevent life-threatening blood loss, but can become ineffective due to naturally occurring antibodies directed against αIIbβ3. Such antibodies are produced when patient's immune system comes into contact with normal αIIbβ3 expressing platelets.

There is no currently consensus concerning the frequency, the long-term evolution, or the formation of characteristics of antibodies from GT patients in relation to the nature of the defective gene (ITGA2B or ITGB3), gene variations or other factors. Research are needed to confirm that nature of the gene defect may have a causative role in antibody development. Moreover, strength and persistence of antibodies may vary among patients with the same mutation, suggesting that other factors, such as immune modifiers genes, play a role in shaping antibody repertoire.

Monoclonal antibody-specific immobilization of platelet antigens (MAIPA) is still considered as the reference method for evaluating the presence of anti-αIIbβ3 antibodies in GT patients. All the tests will be performed by the principal investigator site (Bordeaux).

Eligibility Criteria:
Inclusion Criteria:

* All patients with a clear diagnosis of Glanzmann Thrombastenia (GT), whatever the subtype of disease.
* Affiliated person or beneficiary of a social security scheme.
* Free, informed and written consent signed by the participant, or parents or legal representant for the child population, and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Current treatment that may interfere with anti-αIIbβ3 antibodies detection, such as intravenous immunoglobulins within the previous month.
* Psychiatric, social or behavioral condition judged to be non-compatible with the respect of the protocol, including good observance of treatment and compliance to follow-up.
* Adult protected by the law.
Tranexamic Acid Versus Placebo for Blood to Reduce Perioperative Bleeding Post-liver Resection

Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss and blood transfusion requirements in the following patient populations: multisystem trauma, liver transplantation, cardiac surgery and spine surgery. Patients undergoing major liver resection are at risk of severe perioperative blood loss and may also benefit from perioperative TXA administration.

This open label, non-randomized study to evaluate the pharmacokinetic and pharmacodynamic properties of two well studied dosing regimens of TXA will provide guidance in determining the optimal TXA dosing regimen for patients undergoing major liver resection. Compelling evidence of the effectiveness of TXA comes from the large multicentred, multi-national CRASH-2 trial where TXA was administered as a 1 g bolus + 1 g infusion over 8 hours. In liver transplant surgery, the following dose regimen has been shown to have great effect:10 mg/kg/h from the start of surgery until 2 hours after reperfusion of the liver transplant.

Although TXA is not currently approved for use in patients undergoing major liver resection, Health Canada has allowed the use of tranexamic acid for use in this research study.


Eligibility Criteria:
Inclusion Criteria

* Patient undergoing anticipated open or laparoscopic major liver resection (\> 2 hepatic segments), as assessed by the operating surgeon
* Age ≥ 18 years.

Exclusion Criteria

* Previously enrolled in this study
* Platelet count less than 100,000/mm3
* Severe anemia (hemoglobin levels less than 90 g/l)
* Documented arterial or venous thrombosis at screening or in past three months
* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
* Hepatectomy associated with planned vascular or biliary reconstruction
* Known disseminated intravascular coagulation
* Severe renal insufficiency (CrCl\<30)
* History of seizure disorder
* Pregnant or lactating
* Hypersensitivity to tranexamic acid or any of the ingredients
* Unable to receive blood products (i.e. difficulty with cross matching, refuses blood transfusion, or a past history of unexplained severe transfusion reaction)
* Receipt of chemotherapy within 4 weeks of scheduled operation
* Patients undergoing resection for living donor liver transplant.
New Dermal Filler for Chin Correction and Augmentation

Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GP0109 for augmentation and correction or retrusion in the chin region in Canada


Eligibility Criteria:
Inclusion Criteria:

* subject willing to comply with the requirements of the study
* subject intent to receive treatment for augmentation and correction of retrusion in the chin region
* subject with mild or moderate (grade 1 or 2) on the GCRS

Exclusion Criteria:

* subjects presenting with know allergy to HA (hyaluronic acid) filler or amide local anesthetics
* subjects with any previous facial surgery below the nasal line or previous HA filler or collagen below the nasal line within 12 months
* subjects in any other interventional clinical study within 30 days before baseline
Assessing the Impact of a Mode of Vitamin D Supplementation (Sequential Dose vs Daily Dose) on the Incidence of Hypercalciuria in Subjets Aged From 2 to 18 Years

Recommendations for vitamin D supplementation for subjets between 2 and 18 years offer strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months. Data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training Randall plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin D, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 to 17 years included
* Obtaining informed consent of the parents signed
* Participants aged 18 years included
Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.

Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.

Eligibility Criteria:
Inclusion Criteria:

* weekly fecal incontinence

Exclusion Criteria:

* fecal impaction
* inability to complete a baseline 1-week bowel diary
* rectal prolapse
* any prior radiation to the pelvis
* colo-rectal cancer
* rectal fistula
* inflammatory bowel disease
* neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
* constipation (\<2 bowel movements/week) or total colectomy
Intermittent Oro-esophageal Tube on Feeding Hesitancy in Stroke Patients

The aim of this clinical trial is to compare Feeding Hesitancy of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Feeding Hesitancy of the two groups.

The study will last 15 days for each participant. The aim of this clinical trial is to compare Feeding Hesitancy of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Feeding Hesitancy of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs.

Exclusion Criteria:

* complicated with other neurological diseases;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
The Relationship Between Ultrasonographic Findings and Sleep Quality in Carpal Tunnel Syndrome

The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients and to compare the findings with healthy controls.

Carpal tunnel syndrome is the most common form of entrapment neuropathies. Anatomically, the roof of the carpal tunnel consists of carpal bones, it is located under the transverse carpal ligament, and there are 9 tendon packs of the forearm flexors and the median nerve. Clinically, sensory (paresthesia and hypoesthesia), motor deficits and pain occur in the distribution of the median nerve secondary to mechanical compression and local ischemia.

With the increase in the severity of the disease, entrapment neuropathy, whose symptoms are more pronounced at night, negatively affects the daily life of the person. Waking up at night due to paresthesia is one of the diagnostic criteria for carpal tunnel syndrome. However, the mechanism linking CTS with insomnia is unclear.

The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CTS according to the criteria of the American Academy of Neurology

Exclusion Criteria:

* Patients with radiculopathy, brachial plexopathy, thoracic outlet syndrome and traumatic nerve injury that may affect the median nerve
* History of Carpal tunnel surgery
* Pregnancy
* Malignancy
* Thyroid diseases
* Amyloidosis
* Systemic lupus erythematosus, Rheumatoid arthritis, Systemic sclerosis, Gout, Dermatomyositis, Polymyositis
* Obstructive sleep apnea
Glycated Hemoglobin Targets and Glycemic Control in Indonesian Diabetic Patients

This study aims to compare uric acid, lipid, and kidney profile along with management and complications of Indonesian diabetic patients with good and poor glycemic control based on glycated hemoglobin profile.

Adult patients (≥ 18 years of age) with type 2 diabetes which are diagnosed under ICD-10 coding of E-11 were included in this study. The inclusion criteria are patients with primary diagnosis of E11and have visited the clinic at least twice with a complete record of glucose, uric acid, lipid and kidney profile. Participants were grouped into 2 groups - good and poor glycemic control based on their glycated hemoglobin (HbA1c) levels. Good glycemic control is defined according to the American Diabetes Association and the Indonesian Association of Endocrinologists (PERKENI) cut off of HbA1c \< 7.0.

Data such as age, sex, ethnic, education, BMI, glucose, uric acid, lipid, and kidney profile as well as comorbidities and type of drug used were collected from the patients' medical records. Comorbid conditions were defined as either concomitant hypertension, dyslipidemia, chronic kidney disease, hyperuricemia, or combinations of them as diagnosed in the medical records. Diabetic complications of interest include macrovascular (heart disease, stroke), microvascular (nephropathy, retinopathy, neuropathy) and a combination of both as well as infection (urinary tract infection, pneumonia). These complications were also based on the medical records. Management modalities included were lifestyle modification, use of oral antidiabetic medications or insulin, or both.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes
* Must have visited the clinic at least twice, one before and one post-therapy

Exclusion Criteria:

* Type 1 Diabetes, Gestational Diabetes and other secondary diabetes types
* Unavailability of HbA1c results - pre and post-therapy
* Incomplete records of glucose, uric acid, lipid and kidney profile, comorbidities and management.
IDO2 Genetic Status Informs the Neoadjuvant Efficacy of Chloroquine (CQ) in Brain Metastasis Radiotherapy

This research is being done to determine if a short course of Chloroquine (five weeks) before, during and after whole brain radiation therapy (WBRT) will improve the overall survival of subjects being treated for brain metastases.

Hypothesis one: A short course of chloroquine one week prior and four weeks after initiation of WBRT is tolerable and significantly increases the median survival time of patients suffering from brain metastasis as assessed one, three, six, nine, twelve and 24 months post radiotherapy, when compared to historic controls.

Hypothesis two: The presence of one or both single-nucleotide polymorphisms (SNP)s in the gene coding for the immunoregulatory enzyme indoleamine 2,3-dioxygenase 2 (IDO2) improves the clinical outcomes of WBRT or the response to CQ co-treatment.

3.2. Specific Aims:

The specific aims of this study are:

1. Determine patients physical profiles prior WBRT and at regular intervals afterwards up to 24 months after radiotherapy.
2. Record the status of patient metastases (i.e. number, location, size)
3. Determine patients' KPS values.
4. Record the incidence and causes of mortality of patients.
5. Determine the genotype of IDO2 for each patient.
6. Following data analysis, test the validity of the two hypotheses.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed primary solid malignancy
* Patients with single or multiple brain metastases
* Patients with metastasis diameter \< 5 cm
* Age \> 18
* Clearance from the patient's physician that treatment with chloroquine should not pose a problem to the patient

Exclusion Criteria:

* Patients with a history of hypotension, cardiomyopathy, epilepsy, seizures
* Patients with impaired renal function
* Patients with psoriasis, porphyria
* Patients with known hypersensitivity to 4-aminoquinoline compounds
* Pregnancy, nursing
* Prior radiotherapy
* During the chloroquine treatment, patients complaining from visual or auditory disturbances, and patients suffering from acute gastrointestinal problems i.e. Anorexia, nausea, vomiting, diarrhea, abdominal cramps