cyrilzakka/clinical-trials huggingface dataset:
Massively Parallel Sequencing to Identify Microbiological Organisms in Bronchoalveolar Lavage Fluid

Patients who are post hematopoietic stem cell transplantation who require a bronchoalveolar lavage (BAL) for standard clinical car will have extra fluid collected and sent for massively parallel sequencing to see if it is as sensitive for detecting a microbial pulmonary infection compared to standard cultures.

5.1 Subjects will undergo bronchoscopy and BAL based on clinical indications. Techniques and equipment will be per current clinical practice at Westchester Medical Center (WMC). The bronchoscope is usually introduced either via an artificial airway (endotracheal tube or laryngeal mask airway). The lavage is performed with sterile normal saline. The site of performing the lavage is selected based on radiologic or clinical data and on the appearance of the airways during the bronchoscopy. The typical volume of the lavage is 3 aliquots of 1 ml/kg each, with a max of 20 ml per aliquot.

5.2 When 10 ml or more of BAL fluid is received by the WMC laboratory, the BAL fluid will be divided by the WMC laboratory for all physician ordered clinical laboratory tests and for massively parallel sequencing research tests. This will ensure that sufficient BAL material is available for all clinical tests.

5.3 The BAL fluid for research will be held by the WMC laboratory and picked up by research personnel for processing at New York Medical College Genomics Core Facility.

5.4 The research portion will be further divided for isolation of viral, bacterial, and fungal nucleic acid isolation. A control sample of fluid used for the BAL will be prepared in parallel. Bacterial/fungal DNA and viral DNA and RNA will be isolated. Whole genome sequencing libraries will be generated and sequenced in batches on the Illumina MiSeq.

FASTQ files will be demultiplexed and then aligned to microbial genomes using Phylosift.11 DNA sequences present in both the patient and control samples will be discarded as contaminant. The preponderant organism(s) identified will be matched to the results of the culture based techniques used to verify the culture independent results.

Eligibility Criteria:
Inclusion criteria

* Patient age \< 30 years
* Recipient of an autologous or allogeneic stem cell transplant in the previous 365 days
* Requires a bronchoalveolar lavage for clinical indications
* Signed consent Exclusion criteria
* Lack of signed informed consent
Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H. Pylori Infection

As the antibiotic resistance increases, the eradication rate of triple therapy is decreasing. Recent guideline recommend the use of bismuth-containing quadruple therapy in areas where clarithromycin resistance is greater than 15%. However, the ideal treatment would be the tailored therapy which choose the antibiotics depending on the antibiotic resistance. This study compared the eradication rates, safety and complicance of tailored therapy compared with empirical bismuth quadruple therapy in the naive patients with H. pylori infection.

In order to be eligible for first-line H. pylori eradication therapy, at least 80% of eradication rate should be achieved by intention to treat (ITT) analysis. However, the triple therapy (PPI, clarithromycin, amoxicillin) is losing 1st-line therapy because of increasing antibiotic resistance. The most common cause of failure in triple therapy is clarithromycin resistance.

In the past, clarithromycin resistance was rarely observed in Korea, but the resistance rate has increased rapidly during the last 10 years, up to 37.3%.

As an alternative, Korean guidelines of Helicobacter pylori eradication in 2013 recommend that bismuth-containing antibiotics (not containing clarithromycin) should be considered in areas with high clarithromycin resistance as in Korea. However, there is a lack of research on the efficacy of bismuth-containing quadruple therapy as a 1st-line therapy. The aim of this prospectivce randomized study is to investingate the efficacy, conpliance, adverse events and cost-effectiveness between bismuth containing quadruple therapy and tailored therapy in areas with high clarithromycin resistance

Eligibility Criteria:
Inclusion Criteria:

* Participants with peptic ulcer, s/p ESD due to early gastric cancer/gastric adenoma, Maltoma
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H. pylori infection

Exclusion Criteria:

* Previous H. pylori eradication therapy
* Less than 18 years old
* With history of H. pylori infection treatment
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Viewing Strategy Training in Children With (Cerebral) Visual Impairment

Viewing strategies are strategies used to process visual Information. Many children with visual impairment seem to lack systematic viewing strategies. However, it is unknown how viewing strategies differ between children with normal vision and children with (cerebral) visual impairment. In addition, viewing strategy training is often adopted in clinical practice, but till date there is no scientific evidence about effectiveness of this approach.

The current project has two goals: (1) to measure viewing strategies used by children with normal vision, children with ocular visual impairment and children with CVI, and (2) to evaluate whether training viewing strategies results in more efficiënt visual Information processing.


Eligibility Criteria:
Inclusion criteria typically developing children with normal vision:

* Age 5-12 years
* linear distant visual acuity of 0.1 logMAR or better
* Verbal IQ above 70
* Absence of developmental disorders or psychiatric problems like ASS or AD(H)D

Inclusion criteria for children with ocular visual impairment:

* Age 5-12 years
* Children with linear distance visual acuity better \<=1.3logMAR and \>0.1 logMAR
* Intact central visual field (at least \> 30 degrees)
* Children with a verbal IQ above 70
* Absence of developmental disorders or psychiatric problems like ASS or AD(H)D

Inclusion criteria for children with cerebral visual impairment:

* Age 5-12 years
* Linear distance visual acuity \<=0.3 logMAR
* Having the diagnosis CVI (verified by ophthalmologists)
* Children with a verbal IQ above 70
* Absence of psychiatric problems like ASS or AD(H)D

Additional inclusion criterion for study 2 (evaluating training effectiveness): children with (cerebral) visual impairment should have an indication for viewing strategy training. Training should not be indicated if children have no problems performing academic tasks (i.e. when speed and accuracy of visual processing is within the normal range). The age range for study 2 is 5-9 years.

Exclusion criteria:

* Children with VI: linear near visual acuity \>1.0 logMAR
* Children with visual field defect \< 30 degrees
* Children with a verbal IQ below 70
* Children who attended a form of vision training in the past two years
* Children with psychiatric problems like ASS or AD(H)D
* Auditory impairment or language impairments
* Major life events during training
Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep

This will be a prospective study on labor characteristics, and obstetric and neonatal outcomes in women who accept and women who decline morphine as a form of pain management in labor. The study will also investigate patient satisfaction with this form of analgesia. The participants will be those who accept morphine and promethazine and those who decline morphine and promethazine for pain control.

Objective: Therapeutic rest in labor involves administration of parenteral analgesics in early or prodromal labor to relieve the patient's discomfort and allow for progression of labor while the patient rests. No prospective studies exist which examine the safety and clinical utility of therapeutic rest in early labor, and no published studies examine the potential benefits of therapeutic rest from the perspective of either patient satisfaction or cost-effectiveness. The investigators aim to determine whether therapeutic rest using morphine and promethazine is associated with variations in labor characteristics, or obstetric or neonatal outcomes as well as patient satisfaction with this form of pain management.

Methods: This will be a prospective cohort study. Women who are eligible for therapeutic rest (reactive non-stress test, normal amniotic fluid, in prodromal or early labor as defined by obstetric provider, and plan to discharge home after evaluation) will be recruited for the study. Participants will receive routine obstetric care by providers who are unaware of patient enrollment. A research assistant will then approach all participants in the postpartum period, prior to discharge from the hospital or with a phone call if permitted by the patient, to complete a questionnaire including patient satisfaction items. Chart review will be performed to determine differences in hospital stay and common obstetric and neonatal outcomes to compare these data among women who do and do not choose to receive therapeutic rest. These results will provide insight into a common clinical practice, helping to not only guide management at institutions where therapeutic rest is commonly utilized but also potentially encourage its initiation at hospitals were therapeutic rest is not available.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies between 37w0d and 41w6d gestation
* Presentation to triage for rule out labor as primary indication and found to be in early labor
* Offered therapeutic rest by obstetric provider with plan to discharge home after evaluation

Exclusion Criteria:

* Allergy to morphine sulfate or promethazine
* Being without an attendant to safely transport the patient home
* Present to triage for other indication (decreased fetal-movement, premature rupture of membranes, hypertension, etc.)
* Multiple gestation
* Known fetal anomaly
* Placenta previa, active maternal Herpes Simplex Virus disease, or any other contraindication to vaginal delivery
* Recommendation for direct admission to L\&D for maternal or fetal indication.
Subtotal Resection of Large Acoustic Neuromas With Possible Stereotactic Radiation Therapy

The investigators study is to investigate safety and efficacy of performing a planned incomplete removal of large acoustic neuroma tumors to decrease surgical morbidity and yet avoid tumor recurrence by post-operative radiation therapy.

The current standard treatment of a large tumor of the balance nerve (acoustic neuroma or vestibular schwannoma) is surgical resection. Complete removal of such tumor is associated with significant risks of hearing loss and facial paralysis whereas incomplete removal of the tumor is associated with significant risks of regrowth. Stereotactic radiation is a well accepted therapy aiming at stopping the growth of smaller acoustic neuromas before their sizes become large enough to cause problems. The purpose of our study is to determine whether the combination of subtotal resection followed by stereotactic radiation of the remnant can control large acoustic neuromas without the significant risks associated with complete resection.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with acoustic neuromas the widest diameter of 2.5 cm or larger at the cerebellopontine angle are eligible for this trial.
* Patients that are deemed good surgical candidates based on age, general health, genetic predispositions, and hearing in contralateral side would be included as the subjects of this trial.
* Although we would include patients with neurofibromatosis II in this trial, considering their genetic predisposition for recurrence, we would analyze their outcome as a separate group.

Exclusion Criteria:

* Patients who have received any form of treatment of their acoustic neuromas prior to enrollment in the study including surgery or radiation therapy.
GPur- Luminating Oral Cholesterol Kinetics Pilot Study

In healthy subjects not receiving or requiring lipid lowering therapy and who do not have diabetes, the use of clinoptilolite (GPUR) will result in a reduction of absorbed dietary cholesterol observed over 6 days of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* Not receiving or requiring lipid lowering therapy
* Willingness to give informed consent
* Able to keep a dietary log
* Willing to maintain a consistent day to day routine during the study (no major changes in lifestyle, exercise, food pattern, smoking habits, etc)

Exclusion Criteria:

* Current use of oral lipid binding agents (colesevelam, cholestyramine, ezetimibe) fibrates, niacin or statins
* Current use of dietary supplements enriched with fat soluble vitamins, mono/polyunsaturated fat (fish-oil etc.) or probiotics
* Any oral antibiotic use, currently or within the past 14 days
* Diabetes, Type I and Type II
* Currently following a restrictive diet
* GI motility disorders (irritable bowel syndrome, diabetic gastroparesis, etc)
* Prior gastric or bowel resection
* Inflammatory bowel disease (Crohns, ulcerative colitis, diverticulitis, celiac sprue, etc)
* Co-morbidities with anticipated life expectancy \< 12 months
* ESRD on dialysis
* Known intolerance to silicium or aluminum compounds
* Excess alcohol consumption (\>1 drink per day)
* Pregnancy, nursing or not taking/using contraception
* Hepatobiliary disorders or renal disease
* Plasma total cholesterol \> 240mg/dl or Triglycerides \> 265.5 mg/dl
* No plant-sterol enriched food products allowed in diet \& supplements
* BMI \> 35
Sulforadex in Healthy Human Males MAD

To determine the safety and tolerability of multiple doses of Sulforadex® in healthy male volunteers over 7 days with qd or bid dosing

This study will be conducted in a randomised, double-blind, placebo-controlled design with multiple ascending doses of Sulforadex® administered qd \[once daily\] or bid \[twice daily\]) to healthy male subjects between 18 to 45 years of age.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is a healthy male of any race aged 18 to 45 years, inclusive, at screening.
2. Subject has a BMI of 18 - 25 kg/m2 inclusive at screening.
3. Subjects must agree to use acceptable methods of contraception,
4. Subjects should not donate sperm from the time of the first administration of treatment or study medication until 3 months following administration of the last treatment or dose of study medication.
5. Subjects must be capable of understanding and complying with the requirements of the protocol and must have signed the ICF prior to undergoing any study-related procedures.

Exclusion Criteria:

1. All subjects must refrain from eating brassica vegetables or using brassica containing supplements for at least 7 days prior to the drug administration. Brassica vegetables include cabbage, cauliflower, horseradish, landcress, Ethiopian mustard, kale, collard greens, Chinese broccoli, brussels sprouts, Kohlrabi broccoli, broccoli flower, broccoli romanesco, wild broccoli, bok choy, Komatsuna, mizuna, rapini, flowering cabbage, Chinese cabbage, Napa cabbage, turnip root, rutabaga, canola/rape seed, Siberian kale, wrapped heart mustard cabbage, mustard seed (brown, black, white), tatsoi, rocket (arugula), garden cress, water cress, radish, daikon and wasabi.
2. Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
3. Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
4. ECG abnormalities in the standard 12-lead ECG (at screening) which in the opinion of the Investigator is clinically relevant or will interfere with the ECG analysis.
5. History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
6. Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti Hepatitis core antibody (anti HBc Ig G \[and anti HBc IgM if IgG is positive\], Hepatitis C virus antibodies (anti HCV), and human immunodeficiency virus HIV 1 and 2 antibodies (anti HIV 1/2).
7. Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, tricyclic antidepressants and methadone) or from the alcohol breath test at screening and on admission (Day -1).
8. History or clinical evidence of alcohol or drug abuse.
9. Mentally handicapped.
Assessment of the Nutritional Status of Pregnant Women and Optimization of Prenatal Care Services

A national survey in Niger found that women and children are at risk of undernutrition and that many pregnant women don't visit health centers during pregnancy as often as is recommended. The aim is to assess the nutritional and health status of pregnant women in the Zinder region and to understand their knowledge, attitudes and practices related to health and nutrition during pregnancy. In collaboration with the Medical District of Zinder the prenatal care services will be optimized and the programmatic impact on gestational weight gain and anemia prevalence will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant

Exclusion Criteria:

* Pregnant women, who have severe illness warranting immediate hospital referral
Assessing Folic Acid in High-Risk Pregnancy for Neural Tube Defects

Aim of this study is to investigate and statistically reveal the prevalence and awareness of folic acid usage in pregnant women who have at least one of the risk factors for neural tube defects, to express the level of knowledge of the determined population on this subject and to present ideas to increase awareness in the society.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* Under 45 years of age
* Having at least one of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth defect with aneuploidy, history of GDM or known DM) for Case Group.
* Singleton pregnant women

Exclusion Criteria:

* under 18 years old
* Above 45 years old
* Multiple pregnancies
Does Testosterone Improve Function in Hypogonadal Older Men

This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men age \> 60 years. The goal is to assess the safety and efficacy of TRT in men age \> 60 years.


Eligibility Criteria:
Inclusion Criteria:

age 60-80 yrs serum total testosterone \< 300 ng/dL serum bioavailable testosterone \< 70 ng/dL

Exclusion Criteria:

unable to provide informed consent history of prostate or breast cancer untreated sleep apnea
Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene

Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Female caucasians
* Age 18 - 45 years old
* BMI 18.5 - 26 kg/m2

Exclusion Criteria:

* Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin
* Pregnancy/lactation period
* Meno-/postmenopausal
* Smokers
An Open-label, Multidose Dose-escalation Study to Understand the Safety of CRISPR Gene-editing Therapy and Its Long-Lasting Effects in DMD Patients (MUSCLE)

Duchenne muscular dystrophin (DMD) is an X-linked, fatal muscle-wasting disease caused by mutations in the DMD gene encoding the dystrophin proteins, with symptom onset before age of 6 years in boys. These mutations abolish dystrophin production in the muscle, leading to dystrophin deficiency at the myofiber membrane, continued fiber degeneration, the need for assisted ventilation, respiratory inflammation, loss of walking ability in their teens, followed by respiratory and cardiac decline, and eventually premature death before the age of 30.

Currently, there are only glucocorticoids for the standard supportive therapy of DMD, which can improve disease symptoms but do not change the outcome of the disease, Three antisense oligonucleotide (ASOs) medicines have been approved to treat DMD with exon 45-55 hotspot region mutations. However, they can only restore trace amounts of dystrophin protein, which is insufficient to bring real clinical benefits. Gene replacement therapy has been approved using adeno-associated virus (AAV) vectors to deliver the "mini-dystrophin" gene. Yet, mini-dystrophin gene-expression versions of truncated dystrophin functionality are sacrificed and limited.

HG302 uses a single AAV vector to deliver the CRISPR/hfCas12Max DNA editing system in the human DMD exon 51 splice donor site. Preclinical studies have shown that a single intravenous injection of HG302 significantly restores dystrophin protein expression in muscle fibers and rescues their muscle function in humanized DMD mice to wild-type levels, with long-lasting and durable efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Males ≥ 4 and ≤8 years at the time of signing informed consent, with clinical diagnosis of DMD;
* DMD gene mutation types are deletions in exons 52, 52-61, or 52-63;
* Able to walk at least 10 meters independently;
* Willing to cooperate with muscle biopsy test;
* Acceptable hematology, clinical chemistry, and urine laboratory parameters.

Exclusion Criteria:

* Presence of active infection;
* Presence of DMD-associated cardiomyopathy manifestations;
* Respiratory insufficiency requiring invasive or non-invasive ventilation;
* Serious infections such as pneumonia, pyelonephritis, or meningitis within 4 weeks prior to receiving trial drug infusion;
* Prior central nervous system surgery within 6 months before enrolment;
* Use of any investigational drug, or exon-skipping drug (whether investigational or not) 6 months prior to Screening;
* Previous treatment with any gene therapy or cell therapy (e.g., stem cell transplantation);
* Any other conditions that would not allow the potential subject to complete follow-up examinations during the study and would, in the opinion of the investigator, make the potential subject unsuitable for the study.