cyrilzakka/clinical-trials huggingface dataset:
Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection

This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with genotype 4 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Treatment experienced and naïve subjects
* Chronic genotype 4 HCV-infection
* Not co-infected with HIV
* Screening laboratory values within defined thresholds
* Use of highly effective contraception methods
* Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.

Exclusion Criteria:

* History of any other clinically significant chronic liver disease
* Pregnant or nursing female or male with pregnant female partner
* History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Excessive alcohol ingestion or significant drug abuse
Maternal Stress, Milk Composition, and Preterm Neurodevelopment

This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.

The proposed study will address our novel hypothesis that maternal stress is associated with feeding outcomes and markers of impaired neurodevelopment for preterm infants and alters human milk and infant gut profiles in ways that affect preterm neurodevelopment.

Mothers and their preterm infants (28-34 weeks gestation at birth) will be recruited to determine if: (1) variation in postnatal stress among mothers of very preterm infants relates to the total volume or proportion of maternal milk provided to her infant in the NICU and if (2) variation in maternal postnatal stress relates to her preterm infant's neurocognitive status at NICU discharge and 4 months corrected age. This project also involves collection/storage of maternal milk and infant fecal samples for multi-omics analyses. More specifically, the study will address: (3A) Is maternal postnatal stress associated with the metabolomic and microbiome characteristics of the infant's gut and/or the milk composition?, and (3B) Do milk composition differences relate to infant neurodevelopment? The aims of the proposed study contribute to our overarching research goal, which is to improve neurodevelopmental health for preterm infants by building the health and resilience of the mother-milk-infant triad.

Eligibility Criteria:
Inclusion Criteria:

* preterm infant born between 28 0/7 and 34 6/7 weeks' gestation that are medically stable for study procedures
* mother of preterm infant meeting criteria and a) 18 to 45 years of age at the time of delivery

Exclusion Criteria:

* infants: major congenital anomalies, anticipated death, positive blood culture at birth, hypoxic ischemic encephalopathy, grade IV intraventricular hemorrhage, or plan to transfer care before discharge (35-37 weeks postmenstrual age).
* mothers: a) alcohol consumption \>1 drink per week or any tobacco consumption during pregnancy, b) known congenital metabolic, endocrine disease or congenital illness affecting infant feeding/growth
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera

This is an open-label, non-randomized study. The purpose of this study is to better understand how vaccines against typhoid fever and cholera affect the normal immune system and bacteria in the intestine. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups:

Group 1: Vivotif typhoid vaccination and/or Vaxchora cholera vaccination then endoscopy Group 2: Endoscopy, then Vivotif typhoid vaccination and/or Vaxchora cholera vaccination, then follow-up endoscopy Group 3: Endoscopy without vaccination.

Both vaccines used in this study are licensed by the Food and Drug Administration (FDA) for travelers to developing countries. Volunteers will be asked to donate tissue, blood, saliva and stool samples for studying how the body responds to the typhoid and/or cholera vaccine.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18 years and older
* 2. Already scheduled to undergo an EGD or colonoscopy for screening, surveillance, or a medically-indicated work-up at the University of Maryland Medical Center (main campus or Midtown)
* 3. Able to provide written informed consent prior to initiation of any study procedures
* 4. Healthy, as defined by considered fit to undergo outpatient elective EGD/colonoscopy by the evaluating health care provider

Exclusion Criteria:

* 1. Pregnancy or nursing mother
* 2. Known coagulopathy or bleeding disorder preventing mucosal biopsy
* 3. History of Crohn's disease or ulcerative colitis
* 4. For Subjects undergoing lower endoscopy (colonoscopy) only: Surgical removal of the ileocecal valve or any part of the small or large intestine (non-complicated appendectomy will be considered eligible)
* 5. Allergic reaction to oral typhoid or cholera vaccine in the past
* 6. Immunosuppression from illness or treatment, including

  1. immune-deficiency disorders such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)
  2. leukemia, lymphoma, or cancers (localized non-melanoma skin cancers which are deemed inactive should be considered eligible)
* 7. Receipt of any other vaccine two weeks prior to receipt of Ty21a or CVD 103-HgR
* 8. Positive urine pregnancy test (HCG) prior to colonoscopy or vaccination
Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

Study to assess the effects of adding tegaserod to PPI therapy results in clinically meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on daily PPI therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* GERD symptoms for at least 6 months
* PPI therapy for at least 4 weeks
* Incomplete symptom relief on daily PPI therapy
* No erosive disease as evidenced in EGD/no change in symptom severity

Exclusion Criteria:

* Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
* Previous gastrointestinal surgery that may influence esophageal motor function
* Known primary esophageal motor disorder other than Inefficient Esophageal Motor Disorder
* Evidence of cathartic colon or a history of laxative use

Other protocol-defined inclusion/exclusion criteria may apply.
Triage Survey for Neurology Research Eligibility

TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.

TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials. Secondary objectives include identifying participant characteristics among the clinical trial-seeking population, identifying the percentage of potential participants currently taking prescribed memory medications that could exclude them from clinical trial participation, examining how changes in prescription memory medications impact performance on cognitive assessments, and identifying the percentage of potential participants whose laboratory results could exclude them from clinical trial participation.

Eligibility Criteria:
Inclusion Criteria:

* Participant and study partner (when applicable) have signed an ICF prior to study-specific procedures being performed.
* Participant and study partner (when applicable) are at least 18 years old.

Exclusion Criteria:

* Participant lacks the language skills or cognitive ability to understand the screening process.
* Participant is pregnant, breast-feeding, or planning to become pregnant.
* History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
* Participant represents an acute suicidal risk, as defined as a "yes" response to ideation on Columbia-Suicide Severity Rating Scale questions 4 or 5, or answer "yes" to behavior questions within 90 days of screening.
* Moderate or severe substance use disorder within 90 days prior to screening, according to DSM-5 criteria that in the investigator's opinion could pose undue risk to the participant.
* Any condition that in the investigator's opinion makes a participant unsuitable for the study.
* Currently employed by Adams Clinical or a first-degree relative of an employee working on this study.
Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.

To test whether giving dexamethasone with or without metronidazole in combination with abiraterone could help reverse resistance to abiraterone for patients with metastatic castration-resistant prostate cancer (mCRPC). Abiraterone and prednisone (AA/P) is a second-line therapy for mCRPC given when first-line androgen deprivation therapy fails. However, resistance to AA/P can develop. The investigators do not know exactly how cancer becomes resistant, but there is evidence that suggests it could be due to androgen production by the bacteria in your gut (gut microbiome). This study is focused on the gut microbiome as a source of androgen production that could cause AA/P resistance in mCRPC.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18 years of age and above.
* Prostate adenocarcinoma
* Absolute PSA ≥ 2.0 ng/mL at screening.
* PSA (+/- radiographic) progression after having been on abiraterone and prednisone for at least 12 weeks.
* Must be maintained on a GnRH analogue or have undergone orchiectomy.
* Participants must have a life expectancy ≥ 6 months
* Ability to swallow study medication tablets
* Willing to abstain from alcohol during and for 14 days after treatment with metronidazole
* Willing and able to collect urine and stool samples per protocol

Exclusion Criteria:

* Active infection or other medical condition that would make dexamethasone use contraindicated
* Any chronic medical condition requiring a higher systemic dose of corticosteroid
* Pathological finding consistent with small cell carcinoma of the prostate
* Has imminent or established spinal cord compression based on clinical findings and/or MRI.
* Chronic liver disease with Child-Pugh class C cirrhosis (see calculator in protocol)
* Bilirubin \&gt;3x ULN or AST and ALT \&gt;5x ULN
* Congenital prolonged QTc syndrome or QTc \&gt; 500 msec (non-paced rhythm)
* History of pituitary or adrenal dysfunction
* Uncontrolled diabetes (Hemoglobin A1c \&gt; 10%) or increasing doses of insulin within the past 4 weeks due to poorly controlled glucoses.
* Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 30 days of Cycle 1 Day 1 or currently enrolled in an investigational drug study
* Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to:

  * Any uncontrolled major infection.
  * Crohn's disease or ulcerative colitis.
  * Known or suspected toxic megacolon and/or known small bowel ileus.
  * Known allergy to any of the compounds under investigation.
* On antibacterial therapy within 30 days prior to administration of study treatment.
* Any condition or situation which, in the opinion of the investigator, would put the subject at risk, or interfere with the subject's participation in this study.
Role of 'Pentoxifylline and or IgM Enriched Intravenous Immunoglobulin in the Treatment of Neonatal Sepsis'

The investigators aim is to investigate whether adjuvant Pentoxifylline , IgM enriched IVIG or Pentoxifylline plus IgM-enriched IVIG reduced mortality from Neonatal sepsis.


Eligibility Criteria:
Inclusion Criteria::

* All infants thought/diagnosed to have late or early onset sepsis.

Exclusion Criteria:

* Pentoxifylline or Pentaglobin has already been given
* Pentoxifylline or Pentaglobin is thought to be needed or contra-indicated
* Major congenital anomaly
* Intraventricular hemorrhage (Grade 3 veya 4)
* Congenital infections
* Inborn errors of metabolism
Early Life Interventions for Childhood Growth and Development In Tanzania

This study aims to assess growth and cognitive effects of treatment with azithromycin and nitazoxanide and/or nicotinamide (vitamin B3) supplementation nicotinamide.

Children living in rural sub-Saharan Africa experience massive challenges to child thriving, with poor linear growth and delays in child development. In a cohort of 211 children living in the rural Haydom area of Tanzania (participating in the Interactions of Malnutrition \& Enteric Infections: Consequences for Child Health and Development "MAL-ED" Study), 70.6% had stunted growth at 18 months. This rate of moderate and severe stunting (length-for-age z-score \[HAZ\] \<-2 standard deviations) was the highest of the 8 study sites in MAL-ED.

This enormous deficit is likely associated with high rates of enteric infections with Campylobacter, E. coli pathotypes, Cryptosporidium, and Giardia, organisms susceptible to azithromycin and/or nitazoxanide. Infections such as these occur frequently in developing areas and are often associated with environmental enteropathy, including ongoing enteric inflammation and loss of enterocyte integrity, leading to possible bacterial translocation and poorer absorption of ingested nutrients. The consequences of these infections, enteric dysfunction and poor nutrient absorption frequently include growth stunting, learning delays, and an overall loss of human capital.

Emerging evidence suggests a potential role for the tryptophan-niacin pathway (including the end-product nicotinamide, an isoform of vitamin B3) in decreasing mucosal inflammation and affecting enteral microbiota. At the Tanzania site of MAL-ED, serum levels of tryptophan were related to subsequent linear growth, further suggesting importance of the tryptophan-niacin pathway. What is not clear is whether early childhood growth and development could be improved by targeting enteric infection and the tryptophan-niacin pathway by 1) delivering antibiotics against specific bacteria and/or 2) providing vitamin B3 as nicotinamide/niacinamide.

The main analysis will be intention-to-treat but a secondary analysis will be per protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Maternal age ≥18
2. Infant ≤ 14 days

Exclusion Criteria:

1. Maternal inability to adhere to protocol
2. Multiple gestation
3. Severe illness (significant birth defect, hospitalization, severe neonatal illness)
4. Birth weight \<1500 g
5. Lack of breastfeeding at enrollment (and lack of intention to continue breastfeeding at time of enrollment).
Pre-study to Evaluate IENFD Induction in Patients With Taxane-induced CIPN

This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects.

This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects. After the subjects sign the informed consent, the study physicians will judge the inclusion and exclusion criteria. Subjects meeting the inclusion requirements will register at the study center according to the requirements of the study physicians, and skin samples will be collected by specialized researchers.

Eligibility Criteria:
Inclusion Criteria:

Received taxane adjuvant chemotherapy for breast cancer for curative purposes and completed chemotherapy before entering the study; Persistent peripheral neuropathy of the lower extremities;

CIPN Severity:

The presence of at least one of the following symptoms on both lower extremities in a gloved and sock glove pattern: pain or burning, numbness, or tingling.

Examination of the lower extremities showed needling loss of both legs; Neurological symptoms occur after exposure to taxane and cannot be attributed to any other neurological disease; NRS rating ≥ 4.

Exclusion Criteria:

Pregnant or lactating women. Presence of any neuropathy other than CIPN. According to the investigator's judgment, there are skin diseases in the affected skin area that may interfere with the evaluation of neuropathic pain symptoms, or diseases at the skin biopsy site that may affect the epidermal nerve morphology, or other factors.

The presence of non-CIPN pain may interfere with study evaluation and/or peripheral neuropathic pain self-assessment.
Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics Study of BAY88-8223 in Japanese Patients

This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety, biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in Japanese patients with castration-resistant prostate cancer and bone metastases.


Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 20 years of age
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Presents with at least 2 bone metastases, confirmed by scintigraphic imaging within the previous 4 weeks
* Patients who has failed initial hormonal therapy using either an orchiectomy or a Gonadotropin releasing hormone (GnRH) agonist in combination with an antiandrogen must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks
* Progressive castration resistant metastatic disease
* Castrate level of testosterone (\<50 ng/dL), treatment to maintain castrate levels of testosterone must be continued

Exclusion Criteria:

* Has received an investigational drug in the 4 weeks before or is scheduled to receiving one during or in the 8 weeks after study drug administration.
* Has received chemo-, immuno-, or radiotherapy within the last 4 weeks prior to entry in the study, or has not recovered from acute adverse events as a result of such therapy
* Has received prior hemibody external radiotherapy
* Has a need for immediate external radiotherapy
* Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last 24 weeks prior to administration of study drug
* When receiving bisphosphonates, has changed the dose within 4 weeks before administration of study drug
A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD

This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.

The study consists of two distinct treatment phases. The first is the 6-week open-label, treatment optimization phase during which subjects are titrated to an optimal daily dose of HLD200. Subjects are then randomized to receive either optimal HLD200 or matched placebo treatment for an additional week prior to final testing during a laboratory school day.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children (6-12 years at study entry)
* Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
* Able to swallow treatment capsules
* Available for entire study period
* Provision of informed consent (from the parent\[s\] and/or legal representative\[s\]) and assent (from the subject)
* Female subjects of childbearing potential (i.e., post-menarche) required to have a negative result on urine pregnancy test (and will be given specific instructions for avoiding pregnancy during trial).

Exclusion Criteria:

* Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease
* Presence of any significant physical or organ abnormality
* Any illness during the 4 weeks before this study
* Comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder)
* Known history of severe asthma (in the opinion of the investigator) unless deemed currently controlled
* Known history of severe allergic reaction to MPH
* Known history of seizures (except febrile seizures prior to age 5), anorexia nervosa, bulimia or current diagnosis or family history of Tourette's disorder
* Subject who are severely underweight or overweight (in the opinion of the Investigator)
* Any clinical laboratory value outside of the acceptable ranges, unless deemed NCS significant per the Investigator
* Positive history for hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV)
* Positive screening for illicit drug use, and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject
* Use of prescription medications (except ADHD medications) within 7 days and over-the-counter medications (except birth control) within the 3 days preceding study enrollment, unless deemed acceptable by the Investigator and Clinical or Medical Monitor
* Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment
* Current suicidal ideation or history of suicidality determined as a significant finding on the C-SSRS by the investigator (Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children).
Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios

In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of Naída Link M90 hearing aid and Naída CI M90 sound processor on sound perception. This design was shown to be successful in previous studies for the evaluation of sound coding strategies. Furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population that uses the investigational device is not large in general.


Eligibility Criteria:
Inclusion Criteria:

* CI users with a CII, HiRes90K (Advantage) or HiRes Ultra implant system

  * Bilateral users: two implant systems
  * Bimodal users: hearing aid contralateral
* Minimum of 18 years of age
* Minimum of six months experience with their implant system
* Minimum of six months experience with the Naída CI Q-Series sound processor
* Ability to give feedback on sound quality
* Speech intelligibility with the HSM sentence test in noise at 10 dB SNR \> 10% as obtained during previous visits in the clinical routine
* Fluent in German language

Exclusion Criteria:

* Difficulties additional to hearing impairment that would interfere with the study procedures
* Concurrent participation in other study
* Pregnant and breast-feeding women