cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Cyclophosphamide and Combination of Methotrexate + Calcineurin Inhibitor for GVHD Prophylaxis

The purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor

We propose a study in which 150 patients will receive graft versus host disease prophylaxis with cyclophosphamide 50 mg/kg on day +3 and day +4 after bone marrow transplantation, and 150 patients will receive the usual combination of methotrexate and calcineurin inhibitor. The study was designed to last for 4 years. The primary endpoint is the rate of patients alive, in remission and without immunosuppression, one year after transplant. The assignment for each arm of the study will be done through simple randomization.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman 18 to 60 years of age.
* The patient should have a HLA matched donor
* The patient must need a bone marrow transplant for a malignant disease (Acute leukemia, myelodysplastic syndrome, myeloproliferative disease or myelodysplastic/myeloproliferative disease)
* Patients want to participate in the study, and able to give informed consent.

Exclusion Criteria:

* Previous auto o allogeneic hematopoietic stem cell transplant
* Performance Status \>2 (ECOG).
* Pregnancy
* HIV positive
* Active Infection
* Cardiac disease with ejection fraction \< 45%
* Lung disease with FEV1, FVC ou DLCO \<50% of predicted values.
* Renal Insufficiency with creatinine clearance \< 60 ml/minute.
* Liver disease with bilirubin levels \> twice the reference value or ALT or AST \> three times the normal reference.
Efficacy of Digital Problem Solving Application in Reduction of Anxiety, Depression and Substance Use Disorder Symptoms

The focus of this study is the impact of usage of a mobile application to support problem-solving therapy on symptoms of anxiety, depression and substance use.

Tribal communities have a problem. They experience a disproportionate rate of substance use and mental illness. Research shows that customized digital tools designed with the community, integrating local culture and resources are more effective in reducing symptoms of anxiety and depression. However, the cost of design and development renders quality app creation for small markets infeasible. Digital Support for Problem-Solving Therapy in a Tribal Community (DSPT) solves this problem through dramatically reducing software design time by using AI for task analysis and to combine tasks, service programs' geographic coordinates and hours and applying the proprietary 7 Gen Blocks software components to reduce development time. The resulting mobile application will be used by intervention groups on two reservations. At baseline, three months and six months post, both the intervention and randomly assigned control group (total N =100) will complete standardized, validated measures of depression, anxiety and substance use disorder symptoms. All participants will be enrolled members in a federally recognized tribe, over 18 years of age and have a diagnosis of an anxiety, depression or substance use disorder.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of anxiety, depression or substance use disorder. Resident on or near Turtle Mountain or Spirit Lake reservation. Enrolled in federally recognized tribe.

Exclusion Criteria:

* Literacy below fourth-grade level. Diagnosis of personality disorder or schizophrenia, or other impaired perception of reality.
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment

The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).

Patients receive a treatment regimen of adefovir dipivoxil, abacavir, efavirenz, and amprenavir for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Had an HIV level of at least 2,000 copies/ml after 6 months of treatment with at least 1 PI other than amprenavir (meaning you failed PI treatment).
* Are at least 13 years old (need consent of parent or guardian if under 18).
* Are able to complete the study.
* Agree to use effective barrier methods of birth control, such as condoms, during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have certain serious medical conditions, including AIDS-related cancers (except Kaposi's sarcoma) that require treatment during the study.
* Have ever taken or are allergic to adefovir dipivoxil, ABC, APV, EFV.
* Are participating in another anti-HIV drug trial during this study.
* Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system.
* Have been diagnosed with hepatitis within the past 30 days.
* Abuse alcohol or drugs.
* Are pregnant or breast-feeding.
* Have ever taken NNRTIs.
* Have ever taken ddI or d4T.
* Have received chemotherapy or radiation therapy within 30 days prior to study entry.
One Year Clinical Evaluation of Milled BioHPP Polyetheretherketone (PEEK)-Based Versus Metal Ceramic Single Crowns

Although the metal-ceramic system is still widely used to fabricate crowns and fixed partial dentures and is considered as the standard treatment in dentistry, aesthetic concerns have stimulated the development of new dental tooth-colored systems as PEEK.

BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.

The aim of this study is to evaluate the clinical performance of milled BioHPP PEEK-based single crowns and compare them to metal-based single crowns.


Eligibility Criteria:
Inclusion Criteria:

1. From 18-50 years old, be able to read and sign the informed consent document.
2. Have no active periodontal or pulpal diseases, have teeth with good restorations
3. Psychologically and physically able to withstand conventional dental procedures
4. Patients with teeth problems indicated for single posterior crowns:

   1. Badly decayed teeth
   2. Teeth restored with large filling restorations
   3. Endodontically treated teeth
   4. Malformed teeth
   5. Malposed teeth (Tilted, over-erupted, rotated, etc.)
   6. Spacing between posterior teeth
5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

1. Patient less than 18 or more than 50 years
2. Patient with active resistant periodontal diseases
3. Patients with poor oral hygiene and uncooperative patients
4. Pregnant women
5. Patients in the growth stage with partially erupted teeth
6. Psychiatric problems or unrealistic expectations
7. Lack of opposing dentition in the area of interest
Erector Spinae Plane Block Versus Intraarticular Injection for Postoperative Analgesia in Shoulder Arthroscopy

To improve the outcome after surgery, effective pain control is needed. The aim of the current study was to compare the efficacy of ultrasound guided erector spinae plane block versus the intra articular injection of local anesthetic for post-operative analgesia in patients undergoing shoulder arthroscopy.

Sample size calculation:

Calculation of sample size was done to detect a 15% difference in the VAS score between two groups detected that at least 27 patients were needed at an α error of 0.05 and 80 % power of the study. The number will be increased to 30 patients to avoid a 10% dropped out patients.

Statistical analysis Statistical analysis will be done by Statistical Package for the Social Sciences (SPSS) v25 (IBM Inc., Chicago, USA). Normality of data will be checked with Shapiro-Wilks test and histogram. Quantitative variables will be presented as mean and standard deviation (SD) and will be compared by unpaired student T test. Categorical variables will be presented as frequency and percentage (%) and will be analysed by the Chi-square test. P value \< 0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II
* Posted for elective shoulder arthroscopy

Exclusion Criteria:

* Coagulopathy
* Allergy to local anesthetics
* Chronic use of narcotics
* Necessity for an intra articular drain after surgery
* Patients refusal to participate
Coronary Calcification Study - Intravascular Lithotripsy for Calcified Lesions

The aim of this prospective randomised study is to compare the safety and efficacy of novel intravascular lithotripsy (IVL) to the standard therapy of calcified coronary lesions.

The study will include a total of 40 patients with calcified coronary lesions who will be randomised 1:1 to the treatment with IVL (Shockwave; Shockwave Medical, Inc, Santa Clara, USA) or the standard therapy (non-compliat high-pressure or Scoreflex predilatation, rotational atherectomy, etc). Appropriate preparation of the lesions will be followed by DES implantation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Informed, written consent by the patient
* Ability to comply fully with the study protocol
* Negative pregnancy test (and effective contraception) in women with childbearing potential

Angiographic inclusion criteria:

* Native coronary artery lesion with diameter stenosis ≥50% suitable for PCI
* Heavy calcification, defined as calcification within the lesion on both sides of the vessel assessed during angiography
* Reference vessel diameter (RVD) ≥2.5 mm with lesion length \<32 mm
* TIMI flow 3 of the target vessel at baseline
* No visible thrombus at target lesion site

Exclusion Criteria:

* Cardiogenic shock or haemodynamic instability requiring mechanical circulatory support
* Active malignancy or other comorbidities with a life expectancy of 12 months
* Limited the possibility of control coronaro angiography (e.g., advanced renal failure)
* Known allergy to contrast agents (that cannot be adequately premedicated) or required concomitant dual antiplatelet therapy
* Current problems with substance abuse (e.g., alcohol or drugs)
* Subject is participating in another investigational drug or device clinical study
Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children

This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine intravenously for 50 minutes after surgery as as sedation drug.

Dexmedetomidine, an alpha-2 adrenergic agonist, is being effectively used for procedural sedation or sedation at intensive care unit. However, the safety and efficacy profile are not yet established for children. Although there have been some studies regrading it, still there is no public guideline, therefore making it difficult to use dexmedetomidine in children.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients planned to undergo mechanical ventilation at intensive care unit after surgery
* Pediatric patients planned to be extubated within 4 hours after surgery for neurological examination
* Patients whose parent of legal guardian agreed to enroll in the study after having enough time to review the complete explanation about the study.

Exclusion Criteria:

* History of hypersensitivity to any drugs including dexmedetomidine.
* Underlying cardiovascular/circulatory disease
* Underlying liver / kidney disease
* Patients under hemodialysis
* Obesity of BMI \> 35
* Patients planned to receive patient-controlled analgesia including opioids
* Patients whose parent or legal guardian declined to enroll in the study
* Other conditions deemed unsuitable for the study
Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation

The purpose of this study is to assess the concentration of besifloxacin compared to gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the drug instilled topically into the study eye. Conjunctival biopsies will be performed at specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic suspension four times a day for 5 days.


Eligibility Criteria:
Inclusion Criteria:

* Willing to avoid all disallowed medications for the appropriate washout periods.
* Have a best corrected visual acuity of 0.60 logMAR or better in each eye as measured using an ETDRS chart.

Exclusion Criteria:

* Have a known allergy and/or sensitivity to the test articles or its components or any therapy associated with the trial.
* Monocular.
* Have previously participated in a conjunctival biopsy study.
* Be currently enrolled in an investigational drug or device study or have uses of an investigational drug or device within 30 days of entry into this study.
* have a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
A "Pre-Enrollment" Protocol for HIV-Infected Adolescents

PRIMARY: To identify, characterize, and co-enroll HIV-infected adolescents into existing and future ACTG (or other NIH-sponsored) HIV treatment protocols through the systematic and recurrent assessment of eligibility. To assess the ability of adolescents enrolled in ACTG 220 to adhere to ACTG (or other NIH-sponsored) HIV treatment protocols; and to define factors that influence the adolescent's ability to enter or adhere to study protocols.

SECONDARY: To describe the nature, stage, and progression of HIV infection in adolescents.

Little is known about HIV-infected adolescents as a group and, as a result, small numbers of them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage enrollment of HIV-infected adolescents whose socio-demographic profile has made access to NIH-sponsored research unlikely.

Little is known about HIV-infected adolescents as a group and, as a result, small numbers of them are currently enrolled in ACTG drug studies. Creative approaches are needed to encourage enrollment of HIV-infected adolescents whose socio-demographic profile has made access to NIH-sponsored research unlikely.

At entry and at every subsequent visit, participants are systematically evaluated for eligibility and willingness to enter ACTG (or other NIH-sponsored) HIV treatment protocols from a menu developed and updated by the Pediatric Adolescent Working Group of the ACTG. A survey of participant attitudes, behaviors, and beliefs is administered and updated semiannually. Participants attend clinic visits every 3 months and are followed for a minimum of 6 months, until the end of the study. They receive periodic physical exams, STD and gynecologic or genitourinary evaluations, HIV symptom assessment and related diagnoses, TB evaluation, and laboratory tests (hematology and immunology).

Eligibility Criteria:
Inclusion Criteria

Participants must meet the following criteria:

* HIV infection.
* NOT currently enrolled in an ACTG treatment protocol.

Exclusion Criteria

Co-existing Condition:

Participants with the following condition are excluded:

* No legal provision for consent to participate in clinical research can be determined.
WATCHMAN Implantation During Hybrid Ablation

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Stroke remains the most feared complication of AF with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality. The left atrial appendage (LAA) is the origin for more than 90% of the emboli in non-valvular AF. The WATCHMAN™ Left Atrial Closure Device (WATCHMAN Device, Boston Scientific) reduces the risk of stroke by closing off the LAA. During hybrid procedures for AF, LAA occlusion with epicardial devices is known to be difficult and not free of risks.It thus will be interesting to study the safety and feasibility of endocardial WATCHMAN Device implantation in a hybrid ablation approach.


Eligibility Criteria:
Inclusion Criteria:

* Documented paroxysmal or (long-standing) persistent non-valvular atrial fibrillation,
* Eligible at least for short-term OAC therapy,
* No other conditions that would require long-term OAC therapy, suggested by current standard medical practice, and thus is eligible to stop OAC if the LAA is sealed,
* Calculated CHA2DS2-VASc score of 1 or more,
* 18 years of age or older, able and willing to provide written informed consent.

Exclusion Criteria:

* Current New York Heart Association Class IV Congestive Heart Failure,
* Current thrombocytopenia (\< 100x10E9/L) or anemia (hemoglobin \<6.2 mmol/L),
* Active infection or sepsis,
* Resting heart rate \> 110 beats per minute,
* Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days,
* Recent myocardial infarction (within 3 months),
* Transient case of AF (i.e., secondary to recent cardiac surgery (within 3 months)),
* Planned cardioversion 30 days post implant of the WATCHMAN Device,
* Implanted mechanical valve prosthesis,
* History of obliterated LAA,
* History of heart transplantation,
* Symptomatic carotid disease (i.e., carotid stenosis \>50% associated with ipsilateral transient or visual ischemic attack evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months),
* Necessity to use long-term OAC,
* Contraindication for use of OAC or dual anti-platelet therapy,
* Contraindication for use of aspirin,
* Pregnancy or planned pregnancy during the course of the investigation,
* Life expectancy less than 2 years,
* Participation in any other clinical study involving an investigational drug or device.

Echocardiographic Exclusion Criteria (as assessed via transthoracic echocardiography (TTE) or TEE) for this study are:

* Left ventricular ejection fraction (LVEF) \< 30%,
* Intracardiac thrombus as visualized by TEE within 2 days prior to implant,
* High risk patent foramen ovale,
* Current atrial septal defect and/or previous atrial septal repair or closure device,
* Significant mitral valve stenosis (i.e., MV 4. 5 cm2),
* Existing pericardial effusion of \>3 mm,
* Complex atheroma with mobile plaque of the descending aorta and/or aortic arch,
* Cardiac tumor.
Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)

Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety of a topical formulation of ranpirnase in subjects with genital warts.

The study consists of the evaluation of 4 weeks exposure to the study product; designed as randomized, double blinded, against vehicle to study the effects of 1 mg/ml concentration of ranpirnase on anogenital warts.

The dermal reaction are scored on a scale that describes the amount of erythema, edema, and other features indicative of irritation.

The clinical response are be scored on the basis of the percentage of the reduction of the lesions in size and number.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 lesions
* Accept to follow study instructions / signature of IC
* Abstain from sexual intercourse for 6 hours after applying the study product during the time of the study.

Exclusion Criteria:

* Any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrollment (i.e., the randomization visit)
* Non pregnant. For women in reproductive age it would be required pregnancy test, and the use of double barrier contraceptives.
* Any of the following conditions:
* Known allergy to the study product
* Internal (rectal, urethral) warts that required or were undergoing treatment;
* A dermatological disease (e.g., psoriasis) or skin condition in the area, which may interfere with the evaluation.
* Imiquimod 5% cream (Aldara®)
* Any marketed or investigational HPV vaccines
* Sinecatechins (Veregen)
* Interferon or interferon inducers
* Cytotoxic drugs
* Immunomodulators or immunosuppressives
* Oral or parenteral corticosteroids (inhaled/intranasal steroids are permitted)
* Oral antiviral drugs (with the exception of HAART, oral acyclovir and acyclovir related drugs) for suppressive or acute therapy herpes; or oseltamivir for prophylaxis or for influenza)
* Topical antiviral drugs (including topical acyclovir and acyclovir related drugs) in the areas under treatment
* Podophyllotoxin/Podofilox in the treatment areas
* Any topical prescription medications in the treatment areas
* Dermatologic procedures or surgery in the treatment areas
Gastric Accommodation and Gastroesophageal Reflux

Gastroesophageal reflux events generally happen during relaxation of lower esophageal sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead to reflux events. To test this hypothesis, a study was designed to measure the gastric accommodation in patients undergoing esophageal impedance monitoring.

Gastroesophageal reflux events happen during relaxations of lower esophageal sphincter not related to swallowing, called transient. These transient lower esophageal sphincter relaxations (tLESR) are generally triggered by gastric distension and its physiological purpose is to vent the stomach. The gastric accommodation is a physiological process in which the gastric fundus actively relaxes during a meal in order to accommodate it.

This study is driven by the hypothesis that impairment of the gastric accommodation may facilitate triggering tLESR and, therefore, reflux events. We aim to evaluate the relation between gastric fundic relaxation and the number of gastroesophageal reflux events in children. We also aim to evaluate if there is a relation between the gastric emptying and the number of reflux episodes.

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD\* symptoms

Exclusion Criteria:

* continuous feeding
* previous fundoplication