cyrilzakka/clinical-trials huggingface dataset:
Aerobic Versus Resistive Training on Functional Capacity in Acute Myeloid Leukemia

Sixty patients with AML from both sexes aged from 35-45 years were selected from hematology department in Nasser Institute Hospital where the study was conducted. Patients were randomly assigned into two groups equal in number. Group (A) underwent aerobic exercises in the form of cycling with 50-60% of maximum heart rate. Group (B) underwent resistive training conducted in the form of a series of exercises using free weights, and dumbles. Sessions were conducted three times /week for eight weeks. Six minutes' walk test (6MWT), 10 repetitions maximum test (10 RM), ventilatory function test, fatigue and quality of life (QOL) scales were used to assess functional capacity in both groups.

Aerobic Ex Group: Included 30 patients who underwent aerobic training with 50 %-60% of maximum heart rate in the form of cycling by Bicycle ergometer for eight weeks, three sessions/week.

Resistive Ex Group: Included 30 patients who underwent a resistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Patients carried out three sets of 20-30 dynamic repetitions or static isometric exercises for 40-60 seconds for each muscle group and rested 1-2 min between series. Sessions were conducted three sessions/week for eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia survivors from both sexes
* Their age ranged from 35-45 years.
* Patients were in remission stage contains less than 5% blast cells in their bone marrow, absolute neutrophil count (\>1000/microL), platelet count(\>100,000/microL),and independence from red cell transfusion.

Exclusion Criteria:

* Extramedullary leukemia
* musculoskeletal deformities
* severe anemia (hemoglobin less than 8g/dl).
* Autoimmune thrombocytopenia (platelets less than 10000UL or leucocytes count more than 3000UL).
Reflectance Confocal Microscopy of Wounds During Moh's Surgery: Feasibility Testing of a Mosaicing Algorithm for Intraoperative Imaging of Cancer Margins

The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate assessment of surgical margins in the excision of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC). The investigators will evaluate the pictures obtained by the confocal microscope to determine whether this technique may be useful in the future for helping Mohs surgeons remove cancers. In the future, patients may benefit with shorter surgery and improved care.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Mohs surgery for basal cell carcinoma (BCC )or squamous cell carcinoma (SCC). .
* Ability to sign informed consent.
* Age ≥ 18 years.

Exclusion Criteria:

* Mohs surgery located on a site that may not be convenient to confocal imaging.
* Inability to give informed consent.
* Inability to tolerate imaging procedure (i.e., remain relatively still for multiple short durations of 3-4 minutes) over a total time of 20 minutes.
Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients

To study the efficacy and safety of pitavastatin and PCSK9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy.

1. Evaluate the efficacy and safety of lipid-lowering therapy in real clinical practice.
2. To evaluate the efficacy and safety of pitavastatin in patients undergoing liver transplantation and receiving immunosuppressive therapy.
3. Evaluate the efficacy and safety of PCSK9 inhibitors in patients undergoing liver transplantation and receiving immunosuppressive therapy.
4. To compare the efficacy and safety of pitavastatin and a PCSK9 inhibitor in patients undergoing liver transplantation and receiving immunosuppressive therapy.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent to participate in the study;
* a history of liver transplantation for any reason;
* immunosuppressive therapy;
* the presence of hyperlipidemia, requiring the prescription of lipid-lowering therapy according to the clinical guidelines of the European Society for the Study of Atherosclerosis (EAS) 2019
* failure to achieve the target level of LDL-C against the background of current lipid-lowering therapy;
* if the patient within 1 month before randomization took lipid-lowering therapy, then the absence of side effects against the background of previous lipid-lowering therapy.

Exclusion Criteria:

* treatment with PCSK9 in previous 6 months;
* current treatment in the form of lipoprotein apheresis;
* heart failure IV NYHA;
* active infectious disease, severe hematological, metabolic, gastrointestinal or endocrine dysfunctions (for example, uncontrolled thyroid dysfunction) at the time of the screening or randomization visits;
* the presence of an oncological disease, with the exception of hepatocellular carcinoma, which served as the reason for liver transplantation;
* CFR\<15ml/min/1,73m2;
* pregnancy and breastfeeding.
the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs

Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Complete resection was accepted in IIa \~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
2. Patients receiving chemotherapy for the first time in 6 weeks after surgery;
3. Age from 18 Years to 70 Years;
4. The liver and renal function were normal,and no other disease.
5. Patients compliance is good ang can understand the situation of this study and signed informed consent

Exclusion Criteria:

1. Patients without clear pathological diagnosis;
2. The expected survival period is morn than 6 months;
3. Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
4. Patients with pregnancy or lactation;
5. Persons with a history of less control.
A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients

The purpose of this study is to collect real-world safety and performance data on the MIVI Neuroscience, Inc. Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke.

The purpose of this study is to demonstrate the safety and performance of the MIVI Neuroscience, Inc. CE Marked Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke. The study is an observational study collecting Q Aspiration Catheter use that will enroll a maximum of 50 subjects at a maximum of 5 sites in Spain. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit. This study is designed for observational data to be collected and reported.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 85 years;
* Diagnosis of acute ischemic stroke with mechanical thrombectomy procedure \< 8 hours from onset of symptoms/ last known well;
* Large Vessel Occlusion on CT or MRI in the anterior cerebral vasculature up to A1, M1, or M2 or the posterior cerebral vasculature;
* ASPECTS 6 - 10 or volume of diffusion restriction \< 50 mL;
* Use of the Q Aspiration Catheter as the first line treatment according to the IFU;
* Signed informed consent by patient or legally authorized representative.

Exclusion Criteria:

* Occlusions in multiple vascular territories, extracranial occlusion or tandem occlusion;
* Evidence of dissection in the carotid or target artery for treatment;
* Evidence of recent/fresh haemorrhage on presentation;
* Unwilling to agree to a 3-month follow up visit.
Aliskiren in Patients With Idiopathic Membranous Nephropathy

The goal of this proposal is to conduct a pilot study to access the antiproteinuric effect of aliskiren in patients with idiopathic membranous nephropathy. Patients will be treated for 3 months with aliskiren aiming to achieve the maximum tolerated dose and blood pressure (\>100 but \<125 mmHg systolic BP \>75% of the readings).

In patients with nephrotic syndrome, including patients with membranous nephropathy (MN), conservative therapy consists of restricting dietary protein intake, and controlling blood pressure (target blood pressure is ≤ 125/75 mmHg), hyperlipidemia, and edema. Angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) are effective anti-hypertensive agents that can reduce proteinuria and slow progression of renal disease in both diabetic and nondiabetic chronic nephropathy patients and for these reasons they are the preferred agents to treat hypertension in proteinuric renal diseases.

Recent studies suggest that renin inhibition with aliskiren may be renoprotective and reduce proteinuria in patients with type 2 diabetes. Similar observations have also been reported in patients with membranous nephropathy and proteinuria in the range of 1-3 g/24h. These observations suggest that aliskiren may have powerful antiproteinuric. However, it is important to emphasize, that none of the patients in these studies had proteinuria greater than 3.0 g/24h. Thus, the antiproteinuric effect of aliskiren in patients with heavy proteinuria (e.g. \>4g/24h) is unknown.

Eligibility Criteria:
Inclusion Criteria

* Idiopathic MN proven by diagnostic kidney biopsy.
* Age ≥18 years but ≤ 80 years.
* Proteinuria as measured by urinary protein/urinary creatinine \> 4.0 on a spot sample aliquot from a 24-hour urine collection.
* Estimated GFR ≥ 30 ml/min/1.73m\^2 using the 4 variable Modification of Diet in Renal Disease (MDRD) equation.

Exclusion Criteria

* Age \<18 years.
* Estimated Glomerular Filtration Rate (GFR) \< 30 ml/min/1.73m\^2, or serum creatinine \>3.0 mg/dl.
* Patient must be off prednisone, calcineurin inhibitor or mycophenolate mofetil for \> 1 month and alkylating agents for \> 6 months.
* Patients with presence of active infection or a secondary cause of MN (e.g. hepatitis B, HIV, systemic lupus erythematosus (SLE), medications, malignancies).
* Type 1 or 2 diabetes mellitus. Patients who have recent history of steroid induced diabetes but no evidence of diabetic nephropathy on renal biopsy performed within 6 months of entry into the study are eligible for enrollment.
* Pregnancy or nursing for safety reasons.
* Acute renal vein thrombosis documented prior to entry by renal US or CT scan.
* Previous therapy with Aliskiren
A Study of RG-012 in Subjects With Alport Syndrome

This is a Phase 1, open-label, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of RG-012 administered to subjects with Alport syndrome.

This is a Phase 1, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of RG-012 administered to subjects with Alport syndrome. During this open-label study, all eligible subjects will receive RG-012. The study consists of two parts (Part A and Part B). During Part A, half of the participants will receive a single dose of RG-012 and half will receive 4 doses of RG-012 (one dose every other week for 6 weeks). All subjects will undergo two renal biopsies, one before and one after receiving RG-012, to assess the effect of RG-012 on the kidney. After completing Part A, subjects will be able to enter Part B of the study. During Part B, all subjects will receive RG-012 every other week for 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, ages 18 to 65 years
2. Confirmed diagnosis of Alport syndrome
3. eGFR between 40 and 90 mL/min/1.73m2
4. Proteinuria of at least 300 mg protein/g creatinine
5. For subjects taking an ACE inhibitor or an ARB, the dosing regimen should be stable for at least 30 days prior to screening
6. Willing to comply with contraception requirements

Exclusion Criteria:

1. Causes of chronic kidney disease aside from Alport syndrome (such as diabetic nephropathy, hypertensive nephropathy, lupus nephritis, or IgA nephropathy)
2. End stage renal disease (ESRD) as evidenced by ongoing dialysis therapy or history of renal transportation
3. Any other condition that may pose a risk to the subject's safety and well-being
4. Female subjects who are pregnant or lactating
Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application

The main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients
* 2 to 10 years old.
* with light to moderate with no signs of acute/ sub-acute eczema or in activity.
* Subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens.
* Subjects can present light to moderate dryness.

Exclusion Criteria:

* Subjects presenting any serious systemic disease
* Subjects with medical history regarding serious asthma
* Subjects with known or suspected allergy to one of the investigational products
* Subjects with acute atopic eczema or in activity, needing systemic antibiotics
* Subjects with signs of active infections on skin
* Subjects whose parents or legal guardian seem to have difficulty in understand the informed consent form (ICF)
* Female subjects who are not in pre-menarche period.
* Subjects who need topic corticoids or any other medication that can interfere on Atopic Dermatitis during the study.
* Patient with a wash-out period for treatment less than:
* injectable corticoids: 60 days
* systemic corticoids: 15 days
* topic corticoids: 8 days
* topic immunomodulator: 8 days
* antihistaminic : 48 hours
Normal Liver Stiffness by MR Elastography

Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.

MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring of liver disease in the pediatric population. There is, however, little data specific to the use of this technique in children with existing data and techniques largely extrapolated from adult studies. Existing studies suggest that liver stiffness values may be different between children and adults \[Etchell, Xanthakos\]. As such there is an unmet need for uniquely pediatric data in both healthy and diseased cohorts. To address the need for such data, the investigators plan a multi-site, prospective study of healthy pediatric (\<18 years of age) volunteers to determine normal liver stiffness measured by MR elastography across the range of MRI equipment.

Eligibility Criteria:
Inclusion Criteria:

* Age 7-17 years
* No documented history of liver diseases
* English speaking

Exclusion Criteria:

* NPO less than 4 hours
* Body mass index \<10th or \> 85th percentile for age
* Documented history of liver disease
* Pregnancy
* Inability to lie still for duration of the MRI
* Inability to breath hold for the duration of the 15-20 second MR elastography sequence
* Standard contraindication to MRI (implanted hardware, etc.)
* Requirement of sedation or general anesthesia for MRI
* Abnormality of any measured liver function test
* Liver fat fraction \>5% by MRI PDFF
Effect of Alveolar Bone Grafting

This study included patients who underwent secondary alveolar bone grafting by harvesting graft from the anterior iliac crest, in Oral and Maxillofacial Department, Faculty of Dentistry, Ankara University, Turkey, during the period from January 2012 to March 2016. All patients were operated using the same technique and by the same surgical team. Patients will be interviewed to fill Short-Form Health Survey (SF-12) and Postsurgical Patient Satisfaction Questionnaire (PSPSQ) 6 months postoperatively. The questionnaires will be used to assess the relationship between health quality and patient satisfaction. Also, grafted sites will be evaluated with respect to fistula, the presence of cleft palate, and infection.The descriptive statistics and Pearson correlation analyses will be made using PSPSQ scores and SF-12 PCS and MCS scores.

The postsurgical patient satisfaction questionnaire (PSPSQ) was designed to assess each patient's overall satisfaction with the procedure(s), functional improvements, and recognized or perceived negative effects of the procedures. One of the most commonly used measures of HRQoL is SF-36, which has been reduced to 12 items with the minimal loss of information to form SF-12 . HRQoL was assessed using SF-12 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.

Eligibility Criteria:
Inclusion Criteria:

patients who were undergone alveolar cleft surgery before at our hospital at least 6 months after surgery

Exclusion Criteria:

patients who don't accept to join questionnaire
Bioequivalence Study of Idalopirdine Tablets 60 mg

This study aims to establish bioequivalence between two tablet formulations of idalopirdine


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women

  -≥18 and ≤55 years of age
* body mass index (BMI) of \>18.5 and \<30 kg/m2

Exclusion Criteria:

* Pregnant and lactating women

Other protocol defined inclusion and exclusion criteria may apply
Analgesic Use and Effectiveness for Dental Procedures

Opioid analgesics prescribed by dentists may contribute to the larger national issue of the use and abuse of the drug. On occasion dental pain may be sufficiently severe to support the use of opioids. This study used both dentist and patient input to evaluate the use of opioid and over-the-counter analgesics following one of seven coded common dental procedures. The study includes a five day patient follow up assessment of the effectiveness of the analgesic. Baseline questionnaires were completed by eligible participants, and they responded to the day 5 follow up questionnaires.

Specific Aims The overall objective of the proposed study is to determine (1) the pattern of analgesic prescriptions (Rx and OTC) and recommendations (OTC) in dental practices; and (2) the effectiveness of and side effects associated with these medications as measured by patientreported outcomes (PROs).

Specific Aim 1: To document (a) dentists' postprocedural prescriptions and recommendations for analgesic medication: and (b) the effectiveness of these medications and side effects associated with their use as measured by PROs.

Specific Aim 2: To analyze by procedure class and anticipated pain severity the PROs of Rx and OTC analgesic medications.

Specific Aim 3: Determine the incidence of analgesic side effects of Rx and OTC analgesic medications.

The outcomes of Specific Aims 1-3 will be:

* The distribution of dentists' Rx/OTC prescriptions/recommendations by dentists for anticipated pain severity.
* The effectiveness of different types of Rx and OTC analgesics (e.g., Rx NSAIDs vs. OTC NSAIDs, Rx NSAIDs vs. Rx narcotics) by procedure class and anticipated pain severity.
* The incidence of analgesic side effects for Rx and OTC analgesics. Analysis of the results and methods of the proposed research will furthermore serve as guidance in designing a randomized PBRN clinical trial comparing the efficacy of and complications associated with two or more analgesics.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of erupted second molar teeth.
2. Scheduled for treatment in one procedure of the following six procedure classes:

   extraction, endodontic therapy, pulp capping, crown preparation, periodontal surgery, abscess treatment
3. Expected by the P-I to experience postoperative pain sufficient to require an analgesic
4. Permanent dentition (erupted 2nd molar teeth)
5. Capacity to judge pain level
6. Ability and willingness to give verbal consent

Exclusion Criteria:

1. Under treatment for medical disorders, including dementia, Parkinson's disease, depression, severe anxiety, or any other medical condition, that, in the opinion of the P-I, would affect the subject's judgment of postoperative pain
2. Current participation in another dental or medical research study.
Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study

This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

The study will be composed of two groups of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime \& Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

Eligibility Criteria:
Inclusion Criteria:

* must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
* reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
* Teeth to be vital and asymptomatic prior to treatment
* No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.

Exclusion Criteria:

* Devital or sensitive teeth
* Teeth with prior endodontic treatment of any kind
* Teeth with a history of direct or indirect pulp capping procedures
* Patients with significant untreated dental disease to include periodontitis and rampant caries
* Pregnant or lactating women
* Patients with a history of allergies to any of the materials to be used in the study
* Patients unable to return for the recall appointments