cyrilzakka/clinical-trials huggingface dataset:
Genome-wide Pharmacogenetic Candidate Gene Single Nucleotide Polymorphism (SNP) Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype

The most reliable prognostic marker of acute myeloid leukemia(AML) is cytogenetics by karyotyping. According to cytogenetic results, the patients with AML are classified as better, intermediate and poor prognosis groups. The normal karyotype AML was reported in about 50% of all AML and classified as intermediate risk group. However, the patients with normal karyotype AML showed various prognosis. Therefore, the further studies about subgroup analysis of normal karyotype AML are needed. Recently, the understandings of human genome polypmorphism using SNP array have been accumulated. However, the advanced researches for clinical application are not enough.

The study design is a retrospective and single-center study. The patients with normal karyotyping AML who were diagnosed from 1994 to 2008 at Samsung Medical Center (South Korea) will be enrolled. The stored bone marrow samples of enrolled patients are used for genome wide scanning by SNP array.

The purpose of present study is to develop predictive pharmacogenemic biomarkers model associated wit clinical outcomes including efficacy and toxicity in patients with AML with normal karyotype treated with chemotherapy using pharmacogenetic SNP array. And secondly, to develop enrichment clinical trial based on predictive pharmacogenomic model.


Eligibility Criteria:
Inclusion Criteria:

* patients with normal karyotype acute myeloid leukemia
* 18 years or older
* patients were treated with standard chemotherapy
* patients with available medical record and stored bone marrow specimen at time of diagnosis

Exclusion Criteria:

* no definitive criteria
Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation

Exclusion Criteria:

* Contraindication to oral anticoagulation
* Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous)
* Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial fibrillation
* Severe congestive heart failure with New-York Heart Association (NYHA) class III or IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator, first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, significant sinus node disease without a permanent pacemaker implanted
* History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecs before randomization
* Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued
* Dysthyroidism or other contraindication to amiodarone

The above information are not intended to contain all the considerations relevant to a patient's potential participation in a clinical trial.
The Cellularity Yield of Three Different 22-gauge FNA Needles

Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a flexible tube with a camera and small ultrasound machine at its end )requires the use of a needle for taking the sample from the lesion or what we call "Fine needle aspiration (FNA)". Currently, FNA is done by three commercially available needles. These needles are used routinely in our institution for FNA. The data regarding the safety and the successfulness of any of these needles are lacking. We sought to compare all three commercially available needles in a prospective manner.

The following are being done only for research purposes; prior to performing the FNA, The patient will be randomized to one of the three commercially available FNA needles. At this time, all needles are considered equivalent and there is no medical necessity to pick one over another. The sample obtained by the needle will be assigned a quality score based on certain parameters of the sample such as the abundance of diagnostic cells and the presence of blood. We are going to collect certain information about your procedure such as the complications of the procedure, number of needle passes and final diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (18-88) who are undergoing EUS FNA of pancreatic or peripancreatic lesions
2. Adult patients (18-88) who are undergoing EUS FNA of submucosal masses in the esophagus, stomach, duodenum or rectum
3. Adult patients (18-88) who are undergoing EUS FNA of mediastinal masses.
4. Adult patients (18-88) who are undergoing EUS FNA of enlarged lymph nodes

Exclusion Criteria:

1. Patients younger than 18 yrs old or older than 88 yrs.
2. Pregnant patients
Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM

This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements.

This study hypothesizes that the combination regimen of remimazolam and propofol as total intravenous anesthesia in neurosurgical procedures requiring neurophysiological monitoring can reduce the incidence of hypotension compared to propofol monotherapy while providing comparable levels of neurophysiological monitoring and surgical conditions. With this hypothesis, the study aims to compare the frequency, severity, and duration of hypotension, frequency of patient movement, and appropriateness of neurophysiological monitoring between the combination therapy of remimazolam and propofol and propofol monotherapy in total intravenous anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 and above with planned neurosurgical procedures requiring neurophysiological monitoring, classified as American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3 in the United States.

Exclusion Criteria:

1. Patients who refuse to participate in the study.
2. Patients who are pregnant or lactating.
3. Patients with hypersensitivity to the investigational drugs or to soy, peanuts, or Dextran 40.
4. Patients with acute narrow-angle glaucoma.
5. Patients with alcohol or drug dependence.
6. Patients with hepatic impairment classified as Child-Pugh class C.
7. Patients with lactose intolerance.
8. Patients requiring emergency surgery.
Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers

The purpose of this study is to conduct a randomized controlled trial among 468 Non-Hispanic black mothers and their families to test the efficacy of MOTHERS AND OTHERS, a multi-component home visitation program, compared to an attention control (child safety) in promoting appropriate weight gain during infancy.

Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers will be one of the first to meet the unique needs of individual families by delivering anticipatory guidance on infant care, feeding and growth through multiple channels and to multiple caregivers. Primary modes of delivery for the Obesity Prevention Group (experimental arm) will include face-to-face counseling through 8 home visits (1 by a certified Lactation Consultant), 5 health newsletters, and approximately 160 cue-based text messages. The Injury Prevention Group (active comparator) will receive messages on child safety delivered through similar channels. Our main outcome is infant/toddler growth, captured by mean weight-for-length z-scores (WLZ) at 15 months, mean change in WLZ between 0-15 months, and likelihood of overweight (WLZ ≥ 95th percentile) at 15 months. Differences between groups are expected to be achieved through uptake of targeted health behaviors, including a greater likelihood of breastfeeding initiation, exclusivity and duration; after 6 months, higher dietary intakes of whole fruits and vegetables and lower intakes of energy-dense snack foods; age-appropriate durations of infant and toddler sleep; and, lower levels of television and electronic media exposure. We further hypothesize that these targeted health behaviors will be achieved through modifiable risk factors underpinning the intervention, namely more positive breastfeeding attitudes; higher levels of parenting and breastfeeding self-efficacy; higher levels of perceived social support; higher responsive feeding style scores; improved accuracy in perceiving infant/toddler weight status; and, diminished parental perceptions of infant fussiness.

Eligibility Criteria:
Inclusion Criteria:

* Self identifies as non-Hispanic, African-American
* Less than 28 weeks pregnant at time of screening and recruitment
* Expecting a singleton birth
* Maternal age at time of birth will be at 18-39 years
* Lives within specified distance of study site
* Not intending to leave study area before expectant child's 15th month of life
* Agreeable to referring another family member/caregiver to participate in the study

Exclusion Criteria:

* Pre-term birth (\<= 36 weeks gestation)
* Less than 18 years at time of delivery
* Delivers infant with a congenital anomaly or medical condition that significantly affects feeding (e.g., cleft lip and/or palate, metabolic disease)
* Delivers multiples
* Newborn nursery, neonatal intensive care unit (NICU), or maternity floor stay for 7 or more days after the delivery
Transforming Health and Resilience in Vulnerable Environments: Mental Health, Psychosocial Support, and Climate-Smart Farming in Nakivale

The study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. It is a cluster-randomized controlled trial involving 900 pairs consisting of refugee mothers and their children aged 36-59 months, living in Nakivale refugee settlement in Uganda. The mothers will be randomly assigned to one of three groups:

* Control group: Mothers will receive Enhanced Usual Care (EUC).
* HGI group: Mothers will receive the Home Gardening Intervention, consisting of training and supplies for home gardening.
* HGI/SH+ group: Mothers will receive both the Home Gardening Intervention and the Self-Help Plus mental health intervention.

The main goal is to see if the gardening program alone can reduce food insecurity after 12 months compared to the EUC control group. It also aims to see if reducing psychological distress by adding the mental health component boosts the effects of the gardening intervention.

Secondary goals are to look at impacts on dietary diversity, child malnutrition, and mothers' mental health levels across all three groups.

The study also gathers survey data on participant mothers' migration history, social capital, exposure to potentially traumatic events, exposure to natural hazards and environmental stressors, mental health, and parenting style. Both mothers and their children will furthermore play incentivized economic games to measure their economic preferences (time, risk, social preferences). Additionally, the study will assess children's well-being and functioning. Children will also be asked to carry out gamified tasks designed to measure their cognitive development.


Eligibility Criteria:
Inclusion Criteria (mothers):

* Psychological distress (score 5 or above on K-6)
* Ability to speak and understand Kiswahili
* Have a child aged 36-59 months
* Availability of plot of land for farming
* Access of water for farming
* Written informed consent to enter the study

Exclusion Criteria (mothers):

* Imminent risk of suicide
* Observable signs of psychosis
* Manic behaviors
* Intellectual disability

Inclusion criteria (children):

* Age 36-59 months
* Written parental consent to enter the study
* Assent to enter the study

Exclusion criteria (children):

* Intellectual disability
* Not living with mother
Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft

This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with periodontitis.
* plaque index and bleeding index of \< 30%.
* periodontal lesions with pocket probing depth \> 5 mm.
* intrabony defect \> 3 mm.
* intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion Criteria:

* patients with systemic diseases that contraindicated treatment.
* third molars.
* teeth with incorrect endodontic or restorative treatment.
An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients With Type 2 Diabetes

The purpose of this study is to assess the effect of rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.

The total duration per patient will be approximately 22 months including a 18-month double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes mellitus and a diagnosis of NASH

Exclusion Criteria:

* Excessive alcohol use
* Presence of Type 1 diabetes mellitus
* Other chronic liver disease
* Previous or current hepatocellular carcinoma
* Use of medication known to cause steatosis
* Previous bariatric surgery
* Pregnancy or breastfeeding
* Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Impact of a Neutral Formulated and Designed Package Insert on Nocebo-effect.

Background The nocebo effect describes the association between the expectation of negative effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have shown that the nocebo effect can be influenced by (risk) communication. Till today there is no study that compares different types of information on adverse events regarding the strength of the nocebo effect.

Aim The aim of this pilot randomized controlled trial is to analyse the influence of different communication types on the frequency and intensity of adverse events and adherence. To increase the relevance and applicability of the results the study intervention builds up on package inserts because these are the most widespread form of information on side effects.

Methods Patients It is planned to include 60 patients in the study.

Intervention

* Modified package insert: simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.
* Verbal information about side effects: The patient is informed verbally about side effects and does not receive any package insert.

Control Package insert according to EU (European Union) Directive 2001/83 / EC (European Commission) (usual package insert).

Outcomes

* Number of patient reported adverse events (primary outcome).
* Adherence (correct initiation of therapy, correct intake amount, premature discontinuation of therapy).
* Resource use (e.g. provider contacts).

Type of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.


Eligibility Criteria:
Inclusion Criteria:

* elective orthopaedic surgery
* planned intake of ibuprofen 600 mg to treat postoperative pain
* postoperative pain medication other than Ibuprofen 600 (Opioids, Opiate, Paracetamol) no longer than 1-2 days postoperative (until discharge)
* at least 18 years
* able to speak German
* no cognitive deficits
* written informed consent

Exclusion Criteria:

* serious comorbidity
* pain medication prior to surgery
* other medication with similar side effects
* polytrauma
* planned inpatient rehabilitation \> one week after hospital discharge
Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder

Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops returning from combat zones. A majority of these veterans will report difficulty maintaining or initiating sleep. The purpose of this research will be to conduct a prospective, randomized, wait list controlled, small scale feasibility study to examine if the use of an auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis: Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or standard therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* Male gender
* veteran of OIF/OEF
* comorbid mental health problems such as depression, anxiety are allowed
* self-reported sleep disturbance (defined as having one or more of the following-sleep onset latency greater than 30 minutes, two or more awakenings per night, total sleep time less than six hours per night, presence of nightmares.
* sleep disturbances must have started after a deployment

Exclusion Criteria:

* Axis I mental disorders incompatible with active military service
* History of moderate to severe traumatic brain injury
* Sleep Apnea
* Current use of Continuous Positive Airway Pressure Devices
* Significant Co-morbid conditions (heart, lung, liver disease, etc.)
* Other treatment programs that involve cognitive processing therapy
* No concurrent use of acupuncture during study
* taking any anticoagulation medication
* essential tremors
Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach

RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach.

PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.

OBJECTIVES: I. Evaluate the response of gastric lymphoma of mucosa-associated lymphoid tissue (MALT) to treatment for Helicobacter pylori infection with antibiotics (amoxicillin, clarithromycin, tetracycline, and metronidazole) and with gastric acid inhibitors (omeprazole and bismuth subsalicylate). II. Correlate response with endoscopic tumor grade and clinical and pathological parameters. III. Assess the incidence of H. pylori infection in patients with gastric MALT lymphoma.

OUTLINE: All patients are treated on Regimen A; those receiving tetracycline on Regimen A are switched to Regimen B for their second course; those receiving amoxicillin for their first course receive tetracycline for their second course. Regimen A: Antibiotic Therapy with Gastric Acid Inhibition. Amoxicillin (or Tetracycline in penicillin-allergic patients); Clarithromycin; with Bismuth Subsalicylate; Omeprazole. Regimen B: Antibiotic Therapy with Gastric Acid Inhibition. Tetracycline; Metronidazole, METRO, NSC-50364; with Bismuth Subsalicylate; Omeprazole.

PROJECTED ACCRUAL: 75 patients will be entered over 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Suspected gastric lymphoma or documented gastric lymphoma of mucosa-associated lymphoid tissue (MALT) that is stage IE Gastric MALT lymphoma with perigastric lymph nodes identified on endoscopic ultrasound eligible at MDACC and Houston VA Medical Center only No indication for expeditious treatment with chemotherapy, radiotherapy, or surgery based on clinical condition, underlying illness, or tumor stage

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No contraindication to endoscopy or biopsy No pregnant or nursing women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: No concurrent chemotherapy or radiotherapy
Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Eligibility Criteria:
Inclusion Criteria:

* All women above 18 years of age
* Less than 12 weeks of gestation.
* Pregnancy is confirmed by pregnancy test or ultrasound scan.
* missed abortion
* Normal general and gynecological examination.
* The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy

Exclusion Criteria:

* Hemodynamically unstable.
* Suspected sepsis with temperature 38 °C.
* Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, respiratory illnesses, recent liver disease or pruritus of pregnancy.
* Presence of intrauterine contraceptive device (IUCD).
* Suspect or proven ectopic pregnancy.
* Failed medical or surgical evacuation before presentation.
* Known allergy to misoprostol.
A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients

The aim of the project is to evaluate differences between intermittent and indwelling catheterisation in patients with hip surgery.

Specific objectives are to determine whether:

* frequencies of urinary tract problems in hospital and up to one year after discharge differ between patient groups treated with intermittent and indwelling catheterisation respectively.
* costs and health-effects differ between the patient groups.
* experiences of urinary catheterisation differ between the patient groups


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hip fracture surgery or hip replacement due to arthrosis
* Age 50 years and above

Exclusion Criteria:

* Patients with an indwelling catheter in situ
* Cognitive impairment