cyrilzakka/clinical-trials huggingface dataset:
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance

A controlled, randomized, open-label, multicenter study evaluating if early initiation of everolimus and early elimination of cyclosporine in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy

This was a prospective, multi-center, randomized, controlled, parallel group, open label study in de novo heart transplant recipients. Patients eligibility for randomization was assessed 5 days after heart transplant.. Patients fulfilling the inclusion and exclusion criteria were randomized to one of two treatment groups: either conventional treatment with Cyclosporine A (CsA), Mycophenolate mofetil (MMF), and corticosteroids (Group A), or low-dose CsA and everolimus, reduced dose MMF, and corticosteroids (Group B). After 7 to 11 weeks, CsA was discontinued in Group B, while the standard triple-drug immunosuppressive regimen was maintained in Group A.

Eligibility Criteria:
De novo heart transplant recipients who had received induction therapy with antithomocyte globulin (ATG) were eligible for inclusion.

Recipients of multi-organ transplants or a previous transplant were excluded, as were those with a donor aged \> 70 years, cold ischemia time \>6 hours, patients with severe systemic infection, recipients of ABO incompatible transplants, patients with severe hypercholesterolemia (\>350mg/dL) or hypertriglyceridemia (\>750 mg/dL), patients with past (\<5 years). In order to continue in the study after week 7-11 (period 1), patients had to complete first 7-11 weeks on randomized immunosuppression and none of the following criteria should be present: Ongoing rejection treatment or experience of one grade 3R rejection or two or more grade 2R rejections during first 7-11 weeks.
Hydrogen Peroxide Fumigation in Dental Office Environment

The study's null hypothesis posits no significant difference in bacterial levels in the dental office environment before and after implementing hydrogen peroxide (H₂O₂) fumigation. The study comprised 30 participants, 18 females and 12 males, all diagnosed with moderate caries decay (ICDAS 3 and 4) in their mandibular molars, averaging 42.2 ± 8.3 years in age. Sample size calculations for 30 microbiological plates in each group utilized G\*Power software (Kiel University, Germany), factoring in prior research, with a significance level of 0.05, effect size (d) of 0.72, 95% confidence interval, and 85% power. Aerobic bacterial content in the dental office air was assessed using the Koch sedimentation method. The study employed 60 Petri dishes with Columbia Agar and 5% Sheep Blood. During caries treatment, thirty plates were opened and sealed 40 minutes later, while another set of thirty plates was opened and closed 60 minutes post-fumigation. Measurements were taken 1 meter above the ground and 2 meters from the patient's mouth. After 48 hours of incubation at 37°C, microbiological contamination was calculated as CFUs (colony-forming units) in one cubic meter using the formula: L = a × 1000 / (πr² × k). Fumigation involved a 20-minute treatment with 6% hydrogen peroxide biosanitizer (Saniswiss, Switzerland) via a compressed air device (Fumi-Jet, Kormed, Poland). The process included 3 minutes of fumigation and a 17-minute waiting period for the chemotoxic effect, with 45 ml of 6% hydrogen peroxide sprayed in a 20 m² room.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with moderate caries decay based on the International Caries Detection and Assessment System (ICDAS 3 and 4) in their mandibular molar teeth
* received hygienist treatment two weeks before the study initiation

Exclusion Criteria:

* use anti-inflammatory medications
* non-smokers
* had systemic illnesses
* with uncompensated diabetes
* with halitosis symptoms
* with gastric diseases
Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D\&E (dilation and extraction), and 600 mcg administered 1.5 hours before D\&E.

Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design.

Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability

The investigators compared two doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation. This blinded randomized trial compared 400 mcg misoprostol administered 3 hours and 600 mcg administered 1.5 hours before abortion. The investigators analyzed results for the primary outcome (procedure time) using a non-inferiority limit of 3 or more minutes. The investigators tested two separate non-inferiority hypotheses each powered at 95% (2.5% confidence interval) for two gestational age groups: 13.0-14.3 and 14.4-15.6 weeks. Assuming 10% withdrawals, the investigators required 118 participants. Secondary outcomes included mechanical dilation, complications, provider satisfaction, and patient side effects and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Eligible for pregnancy termination at Planned Parenthood of NYC
* Able to give informed consent
* English speaking

Exclusion Criteria:

* Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment
* Intrauterine fetal demise identified on pre-operative ultrasound
* Allergy to misoprostol
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers

To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs. fed (food effect for the tablet).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
2. Age ≥18 and Age ≤45 years
3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts
7. Chronic or relevant acute infections
8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
9. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration
10. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration
11. Participation in another trial with an investigational drug within two months prior to administration or during the trial
12. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
13. Inability to refrain from smoking on trial days
14. Alcohol abuse (more than 30 g/day)
15. Drug abuse
16. Blood donation (more than 100 mL within four weeks prior to administration)
17. Excessive physical activities (within one week prior to administration)
18. Any laboratory value outside the reference range that is of clinical relevance
19. Inability to comply with dietary regimen of trial site
20. Bradycardia \< 50/min, PR interval \> 200 ms, QRS interval \> 110 ms, QTcB \> 450 ms, or QT (uncorrected) \> 470 ms or any other relevant ECG findings at screening
21. A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Effect of Ketoconazole on Biliary Excretion of AZD0837

This is an explorative study and the scientific question to be investigated is if the biliary excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by co-administration with ketoconazole


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive

Exclusion Criteria:

* Significant illness, trauma or surgical procedures.
* Clinically significant laboratory abnormalities.
* Clinically significant medical history
Comparison of Three Modalities to Assess Clinical Competence of Medical Students

This study, focusing on the management of pediatric asthma exacerbations, assesses the clinical skills of medical students using three different evaluation tools: (i) the simulation game "Effic'Asthme" developed to train individuals on the management of pediatric asthma exacerbations; (ii) a multiple choice questionnaire (MCQ) on the same subject developed for the purpose of the study and (iii) high fidelity (HF)-simulation, considered as the gold-standard for its enhanced realism.

Its objective is to determine which of the simulation game or the MCQ reflects the best the clinical competence of medical students evaluated on a HF simulator.

The assessment of medical students' clinical competence has long been of concern to educational institutions. Objective structural clinical examination (OSCE) and assessments in high-fidelity (HF) simulation settings represent interesting evaluation modalities but are associated with huge costs, especially when they are used for large-scale standardized assessments. Multiple choice questionnaires (MCQ) remain the most common evaluation tool in medical schools.

Simulation games may represent an interesting compromise between the cheap but limited assessment allowed by MCQs, and the comprehensive but highly expensive assessment allowed by OSCE and HF simulation.

This study, focusing on the management of pediatric asthma exacerbations, assesses the clinical skills of medical students using three different evaluation tools: (i) the simulation game "Effic'Asthme" developed to train individuals on the management of pediatric asthma exacerbations; (ii) a MCQ on the same subject developed for the purpose of the study and (iii) HF-simulation, considered as the gold-standard for its enhanced realism.

Its objective is to determine which of the simulation game or the MCQ reflects the best the clinical competence of medical students evaluated on a HF simulator.

Eligibility Criteria:
Inclusion Criteria:

* medical students from Paris 5 University who meet the following criteria

  * Being in their fifth year of medical school
  * Having passed their pediatric exam in the previous 15 days
  * Willing to participate in the study

Exclusion Criteria:

* refusal to participate
Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors

Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular.

Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCOS
* Age 20 - 45

Exclusion Criteria:Diabetes

* Diabetes
* Hormonal treatment
* Pregnancy, lactation
* Periclimacteric
Randomized Open-Label Study of INCB047986 in Subjects With Primary Myelodysplastic Syndrome (MDS)

The study design includes a 3-dose randomization phase to determine effective doses of INCB047986 in patients with myelodysplastic syndrome (MDS) who are refractory or unlikely to respond to erythropoiesis-stimulating agents (ESAs) followed by an extension phase.

After 50% of the subjects have completed 16 weeks of treatment (10 subjects in each dose group), a planned interim analysis will be conducted to determine which, if any, dose levels warrant further investigation based on observing at least 3 responses for hematologic improvement in erythrocytes (HI-E) and adequate safety and tolerability.

Subjects who do not meet the response criteria for erythroid improvement may be treated with ESA in combination with INCB047986 for an additional 16 weeks.

The study comprises:

Screening: up to 4 weeks. Treatment Phase 1: at least 16 weeks of INCB047986. Treatment Phase 2: at least 8 and up to 16 weeks of INCB047986 in combination with ESA if failed treatment in Phase 1.

Extension Phase: Subjects receiving benefit from either therapy may continue indefinitely or until the study is terminated.

Follow-Up: 30 (± 7) days after the last dose of INCB047986 is taken.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older.
* Subjects must be diagnosed with MDS according to the World Health Organization (WHO) classification for de novo or primary MDS (Vardiman et al 2009).
* Subjects who require RBC transfusions or are either refractory to or unlikely to respond to ESA therapy should meet one of the following criteria:

  * ESA failure as defined by no improvement in Hgb of at least 1.5 g/dL after 8 weeks of at least 40,000 IU per week of EPO (or equivalent).
  * Have a serum erythropoietin (EPO) of ≥ 500 IU and Hgb level \< 10.0 g/dL.
  * Transfusion dependence defined as requiring at least 4 units of packed red blood cells (RBCs) for a Hgb of \< 9 g/dL over the 8 weeks prior to screening.
* Subjects may not have received hypomethylating agents or immunosuppressive therapy for their MDS prior to this study.

Exclusion Criteria:

* Subjects at high risk for transformation to acute leukemia as evidenced by poor karyotype or peripheral blood blasts \> 10%.
* Subjects with severely compromised bone marrow function as evidenced by trilineage cytopenias with anemia (Hgb \< 10 g/L, platelets \< 100 × 109/L, and absolute neutrophil count (ANC) \< 1.8 × 109/L).
* Subjects who harbor the 5q deletion chromosomal aberration.
* Subjects with chronic myelomonocytic leukemia (CMML).
* Women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
* Subjects with impaired liver function, end stage renal disease on dialysis, or clinically significant concurrent infections requiring therapy.
* Subjects with unstable cardiac function.
* Invasive malignancies over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, Stage 1 or 2 treated prostate
Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery

The study is conducted to evaluate the effects of dexmedetomedine in subtenon's block in conjunction to general anesthesia under sevoflurane anesthesia on emergence agitation, intraoperative hemodynamic stability, postoperative pain, nausea and vomiting in patients undergoing strabismus surgery.

Emergency agitation is a clinical status of postoperative excitement or emergence delirium when the patient is awake but is disorientated. It is described as mental disturbances that consist of confusion, hallucinations and delusions which is manifested by restless involuntary physical activity and thrashing about the bed. Its incidence has been observed especially in pediatric ophthalmology care units due to many factors such as pain, mental status, time of operation, age, lack of ability to see outside, and a history of previous hyperthermia. Strabismus surgery is one of the most frequently performed pediatric ocular operations. However, it can cause unfavorable side effects during intraoperative and postoperative periods. Typically, the major problems associated with strabismus surgeries include increased risk of the oculocardiac reflex, postoperative pain, nausea and vomiting. Subtenon's block is one of the regional anesthetic techniques used in ocular surgery. Dexmedetomidine has been used as an adjuvant to local anesthetics for regional anesthesia in various clinical fields including the subtenon's block.There is evidence that dexmedetomidine decreases the incidence of agitation after sevoflurane anesthesia in children undergoing different surgical procedures. Therefore, this study is conducted to evaluate the effect of dexmedetomedine in subtenon's block on emergence agitation in pediatric strabismus surgery under sevoflurane anesthesia.

This prospective, randomized, clinical study includes 100 children who are scheduled for elective strabismus surgery under general surgery in Mansoura ophthalmology center. Informed written consent is obtained from parents of all subjects in the study after ensuring confidentiality.The study protocol is explained to parents of all patients in the study who are kept fasting prior to surgery. Patients are randomly assigned to two equal groups according to computer-generated table of random numbers using the permuted block randomization method.The collected data are coded, processed, and analyzed using SPSS program. All data are considered statistically significant if P value is ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) I and II patients.
* Scheduled for strabismus surgery.

Exclusion Criteria:

* Parental refusal of consent.
* Contraindication to use of supraglottic airway device as gastroesophageal reflux and oropharyngeal pathology.
* Hyperactive airway disease or respiratory diseases.
* Children with developmental delays, mental or neurological disorders.
* Bleeding or coagulation diathesis.
* History of known sensitivity to the used anesthetics.
* Previous surgery in the same eye
Psychological Effects of Tai Chi Training

The general purpose of this study is to examine the effect of tai chi training on cognitive function in young adults. The investigators will test subjects enrolled in a semester-long tai chi course along with control subjects. The specific aims are to measure duration of practice, cognitive function, physical balance, and Attention Deficit Hyperactivity Disorder (ADHD) indicators. The investigators primary hypotheses are that, compared to controls, subjects in the tai chi course will show improvements in (1a) spatial working memory and (1b) response inhibition. The investigators secondary hypotheses are that, among the subjects participating in the tai chi course, these cognitive improvements will correlate with (2a) improvements in balance and (2b) duration of tai chi practice, and that, among all participants, (2c) ADHD indications will correlate with cognitive measures.


Eligibility Criteria:
Inclusion Criteria:

* Able to perform balance and cognitive tests

Exclusion Criteria:
Using Massage of Maxillofacial and Oral Cavity to Prevent Radioactive Oral Mucositis

A total of 160 cases of nasopharyngeal carcinoma patients who met the inclusion criteria were randomly assigned to two groups. The experimental group was given massage of maxillofacial and oral cavity plus routine oral care and functional exercise. The control group was given routine oral care and functional exercise. Analyze the difference of incidence of severe acute radioactive oral mucositis in these two groups.

160 nasopharyngeal carcinoma patients were enrolled and randomly assigned to two groups in a 1:1 ratio. The experimental group was given massage of maxillofacial and oral cavity plus routine oral care and functional exercise, the control group was only given routine oral care and functional exercise. Assess the condition of oral mucosa, according to the grading standard of RTOG acute radiation injury, everyday during radiotherapy. After radiotherapy, follow up the condition of oral mucosa one time per month for a total three times. Then analyze the incidence difference between two groups.

massage method：The duration of the massage lasts from the first day of radiotherapy to three months after the end of radiotherapy，5 times a day（After getting up, before breakfast, lunch, dinner and going to bed). massage of maxillofacial includes the left and right cheeks, the upper jaw, the lower jaw, and around the mouth. Oral Massage includes the tongue, hard palate, the gums, and the bucca. Each part lasts 1-2min，repeating 3 cycles each time. Patients who could finished at least 75% are included in the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed by pathology with nasopharyngeal carcinoma;
2. ECOG PS: 0-2;
3. Gender is not limited, Age between 18 years old and 70 years old.
4. Clear consciousness, no mental illness or cognition impairment;
5. The expected survival time is more than 12 months;

Exclusion Criteria:

1. Patients with other severe diseases affecting the quality of life or the treatment process;
2. Unwilling to actively cooperate with investigators;
3. Patients with previous oral diseases;
4. Patients who have received head and neck surgery and radiotherapy;
5. A history of psychotropic substance abuse or a mental disorder;
6. Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment;
7. Women who are pregnant or in lactation;
8. Other situations that may affect the results of the clinical study.
Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer

The purpose of this study is to determine the most suitable dose of Oxaliplatin that can be safely given in combination with a low fixed dose of Capecitabine and a limited volume of radiation in patients with non-small cell lung cancer.

The purpose of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of Oxaliplatin in combination with Capecitabine and radiation in subjects with non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven non-small cell lung cancer
* inoperable Stage III A or B NSCLC
* must have measurable disease by RECIST criteria
* no more than one prior chemotherapy for advanced disease
* ECOG Performance Status of 0, 1, or 2
* must be able to swallow pills or have a working gastric feeding tube and no evidence of malabsorption
* negative serum beta-HCG test and under active contraception (for females of childbearing potential)
* no known allergies to any of the study drugs
* willingness to sign an informed consent

Exclusion Criteria:

* women who are pregnant or breastfeeding
* ANC of less than 1500/mm3
* platelet count of less than 100,000/mm3
* estimated creatinine clearance of less than 50 cc/min (as measured by the Cockcroft-Gault equation)
* bilirubin of less than 2mg/dl
* SGPT of greater than 2x nl
* peripheral neuropathy of Grade 2 or higher
* more than one previous chemotherapy and previous radiation therapy to the chest
* a history of CHF/MI or other significant cardiac history within the last six months