cyrilzakka/clinical-trials huggingface dataset:
Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Juvenile onset recurrent respiratory papillomatosis (JORRP) is a rare, difficult to treat, benign tumor of the pediatric airway. Current therapy is mainly surgical, but in a significant portion of patients adjuvant therapy is required to control the disease process. Although multiple adjuvant medical therapies have been tried, success has been limited. We have seen some success in a limited amount of patients using orally administered propranolol. Our goal is to enroll a larger cohort of patients to determine the effectiveness of propranolol as an adjuvant therapy for JORRP.


Eligibility Criteria:
Inclusion Criteria:

* 1. Biopsy proven with appropriate Human Papilloma Virus typing Recurrent Respiratory Papilloma
* 2. Child under age 10
* 3. Informed consent and where appropriate informed assent
* 4. Children who have undergone at least 4 documented surgical interventions in the past year.

Exclusion Criteria:

* Parental or child refusal to participate
* Heart failure
* Atrio-ventricular heart block
* Cardiac anomalies
* Low resting heart rate
* Low resting blood pressure
* Wolff-Parkinson White Syndrome
* Unexplained syncope
* Asthma or Reactive airway disease
* Renal or liver failure
* Expected long fasting periods, \>12 hours
* Diabetes Mellitus
* Hypersensitivity to propranolol
Study of BHV-3241 in Participants With Multiple System Atrophy

The purpose of this study is to compare the efficacy of verdiperstat (BHV-3241) versus placebo in participants with Multiple System Atrophy


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of probable or possible MSA according to consensus clinical criteria (Gilman et al 2008), including participants with MSA of either subtype (MSA-P or MSA-C).
2. Able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.
3. Anticipated survival of at least 3 years at the time of Screening, as judged by the Investigator.

Exclusion Criteria:

1. Any condition that would interfere with the participant's ability to comply with study instructions, place the participant at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
2. Diagnosis of neurological disorders, other than MSA.
ZD6474(Vandetanib) + Alimta Combo Study

The main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed advanced or metastatic non-small cell lung cancer
* Failure of first-line chemotherapy
* 1 or more measurable lesion by RECIST

Exclusion Criteria:

* Previous chemotherapy or radiotherapy within 4 weeks
* Significant cardiac events, arrythmias or other cardiac conditions
* Unacceptable laboratory measurements
A Systematic Study of Assessment of Attention-Deficit/Hyperactivity Disorder (ADHD)

ADHD is one of the most prevalent psychiatric conditions, consuming a large proportion of resources in psychiatric care, often accompanied by long waiting lists to receive proper assessment. The number of ADHD cases has increased, possible due to heightened awareness of the condition. There are large prevalence differences, potentially due to variations in assessments procedures. Many clinicians and parents view the diagnostic process as too extensive, taking time from treatment and interventions. In addition, assessments may be perceived as too focused on diagnostic criteria to be fully helpful. Systematic research on how assessment procedures can be optimized is essentially lacking. It is largely unknown whether brief protocols including medical history, diagnostic interview, and rating scales differ from comprehensive protocols that also encompass neuropsychological testing regarding validity, reliability, patient satisfaction and cost-effectiveness. Further, feasible biomarkers (e.g. heart rate variability, pupil dilation and the pupillary light reflex) of the autonomic nervous system have been proposed as indicators of diagnostic status. The aim of this study is to gain knowledge about diagnostic processes to enable valid, reliable, and cost-effective ADHD assessments. Using a randomized controlled trial design (N = 240 children, 8-17 years, referred to child and adolescent psychiatric units), differences between a brief and a comprehensive ADHD assessment protocol regarding assessment outcome, reliability, validity, patient satisfaction, and future outcome taking gender into account will be examined. The investigators will explore diagnostic sensitivity and specificity of the included assessment instruments and estimate cost-effectiveness of the brief and comprehensive protocols to enable policy makers to make informed decisions. The project will provide important knowledge for patients and clinicians, and inform our understanding of mechanisms underpinning ADHD.


Eligibility Criteria:
Inclusion Criteria:

* Age 8-17 years
* Referral for ADHD assessment

Exclusion Criteria:

* Suspected intellectual disability
* Substance abuse
* Psychosis
* Severe depression
* Parent not fluent in Swedish
* Child not living with legal guardian
* Child having protected identity
Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer

Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of the cancer tissue. All subjects in the control group were negative for ctDNA mutations。


Eligibility Criteria:
Inclusion Criteria:Patients with pulmonary nodules who underwent curative-intent resection were able to enter the study -

Exclusion Criteria:Patients who received any invasive examination or treatment prior to resection or had a history of malignancy; patients who do not attend follow up after surgery; blood samples that were contaminated; and biopsies that exhibited advanced lung cancer in pathology。

-
Metabolic Syndrome in PCOS: Precursors and Interventions

The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.

Polycystic ovary syndrome (PCOS) is one of the most common conditions of young women, and it is frequently associated with insulin resistance or metabolic syndrome (MBS). In addition, affected women have significantly elevated mean low-density lipoprotein (LDL) levels and an increased prevalence of at risk LDL levels, independent of obesity. We are directly testing the role of androgens in the metabolic abnormalities in PCOS by examining the impact of direct androgen receptor blockade by anti-androgen medications and indirect suppression of androgen production through suppression of leutinizing hormone (LH) with oral contraceptive pills (OCPs), compared with placebo, on visceral adiposity, circulating LDL levels, insulin secretion and sensitivity as measured by frequently-sampled IV glucose tolerance tests (FSIGT) and oral glucose tolerance tests (OGTT), resting energy expenditure, and maximal aerobic capacity measurement.

Note: Originally there were 2 additional study arm, Metformin only and Metformin + Flutamide. These study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints.

Eligibility Criteria:
Inclusion Criteria:

* 6 periods or fewer per year
* Overweight
* All ethnicities

Exclusion Criteria:

* Diabetes
* Heart Disease
* Chronic illness
* Regular Smokers
* Current use of Birth Control Pills, Patch, Ring, Depo
Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects

The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.

Subjects with non-cirrhotic hepatitis C will have a magnetic resonance imaging (MRI)/magnetic resonance (MR) spectroscopy and neuropsychological testing prior to starting interferon. Subjects will have repeat testing following 12 weeks of interferon therapy and again at 12 weeks post interferon therapy.

MR spectroscopy (MRS) will measure the cerebral metabolites, NAA (N-acetyl aspartate), Cho (choline), MI (myoinositol) and Cr (creatine) at 3 distinct brain regions, i.e. basal ganglia and 2 locations within the frontal cortex.

Neuropsychological testing will include tests of the following cognitive domains: executive functioning, memory, language, motor skills and will also include questionnaires pertaining to quality of life (SF-36), mood (Beck's depression inventory) and a self-rating cognitive questionnaire (Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scales \[CAARS\]).

Control subjects will include non-cirrhotic HCV subjects who are not taking interferon therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years old) of both sexes with chronic HCV infection (all genotypes).
* Subjects due to start treatment with pegylated interferon-alpha (IFN-a) for HCV eradication.
* Subjects with chronic hepatitis C who have elected not to be treated with pegylated-IFN-a
* Subjects with mild fibrosis on liver biopsy (stage 0-III/IV fibrosis)
* Subjects able to give informed consent.
* Subjects with controlled depression currently taking anti-depressant medication.

Exclusion Criteria:

* Subjects with cirrhosis on liver biopsy.
* Subjects with active alcohol or drug abuse.
* Subjects co-infected with human immunodeficiency virus (HIV).
* Subjects with structural brain abnormality, past history of cerebrovascular accident (CVA) or serious head trauma.
* Subjects with seizure disorder.
* Subjects with any contraindication to IFN therapy.
* Subjects with a poor command of the English language.
* Subjects with a contraindication to MRI, e.g. pacemaker, claustrophobia.
Obese Hypertension Study (0954-315)

This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Obese male and female patients, ages 21-75 years, with high blood pressure

Exclusion Criteria:

* Patients cannot have any other severe cardiac conditions
Rheumatoid Arthritis Patients and Porphyromonas Gingivalis

Rheumatoid arthritis (RA) is the most frequent joint inflammatory disease inducing joint destruction strongly correlated with anti-citrullinated protein antibodies citrullinated anti-peptide (ACPA). Precise RA etiology remained unclear with a described association between RA and periodontal disease. The missing link could be a gram-negative anaerobic bacterium called Porphyromonas gingivalis (P. gingivalis), which is heavily involved in periodontal disease and able to induce gingival citrullinated protein via an enzyme called peptidyl arginine deiminase (PAD). DNA of P. gingivalis was detected in synovial tissue and in peripheral blood mononuclear cell. To improve knowledge of P. gingivalis involvement in RA, the investigators will compare its effect on various cell type with comparison with another oral bacteria Provatella intermedia.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 ans
* RA or osteoarthritis with joint surgery planned
* Informed consent approved and signed

Exclusion Criteria:

* Pregnancy
Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain

The primary objective of this trial is to evaluate analgesic efficacy of Fentanyl Sublingual Spray compared with placebo in participants with postoperative pain after a bunionectomy.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  3. the analysis of results
Mothers and CareGivers Investing in Children

The incidence of childhood obesity in the United States has steadily increased over the past 30 years but has begun to level off in recent years. Epidemiological evidence indicates that obesity may transmitted across multiple generations. The current study seeks to: 1) evaluate the extent to which mothers and other important caregivers affect their mothers' parenting; 2) examine whether an intervention aimed at improving diet quality and enhancing responsive feeding to improves parental responsivity and feeding behavior and infants' weight trajectories over time; 3) examine the effects of early life feeding and caregiver sensitivity on health and development; and 4) examine feasibility of food distribution along with the feeding intervention.

The incidence of childhood obesity in the United States has steadily increased over the past 30 years, but has begun to level off in recent years. Children from minority groups may be disproportionately affected, such that Hispanic and non-Hispanic Black children have greater weight for recumbent length compared to White children. Similarly, socioeconomic status (SES) may affect child weight status. Epidemiological evidence indicates that obesity may transmitted across multiple generations. Genetics are a factor in determining weight status, but parents are largely responsible for regulating children's dietary environments. Grandparents increasingly provide care for their grandchildren, yet few studies have examined grandparent involvement or the role that grandparents or other significant caregivers play in feeding the child.

The objective of the current study is two-fold: 1) to evaluate the extent to which mothers and other caregivers affect mothers' parenting surrounding feeding their infant, beginning when the infant is first introduced to solid foods; and 2) to examine whether an intervention aimed at providing both mothers and and other important caregivers with hands-on training regarding healthy foods and responsive and sensitive feeding behaviors improves mothers' and other caregivers' responsive and sensitive behaviors and infants' weight trajectories over time. The researchers will collect both self-report data on diet, child temperament, mothers and caregiver mental health, stress and support. Observational assessments will be obtained to code co-caregiver behavior and caregiver responsiveness during feeding.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with babies aged 4 to 5 months
* Other caregivers assisting the mother with the baby.
* Babies aged 4 to 5 months

Exclusion Criteria:

* Babies with metabolic or feeding issues.
* Mothers younger than 16 years of age.
Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients

This is a multi-center, prospective, open label study of the Duodenal Glycemic Control™ procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and initial performance of the DiaGone™ system.

This study is a multi-center, prospective, open label trial of type 2 diabetes patients sub-optimally controlled on at least one oral anti-diabetic medication.

Subjects who meet all inclusion and exclusion criteria after screening are hospitalized and go through the Duodenal Glycemic Control™ treatment.

Duodenal Glycemic Control™ treatment is conducted by a gastroenterologist, in an endoscopic suite, with an off-the-shelf endoscope, using the DiaGone™ system.

Patients are followed for 6 months for AE and SAE. Patients are followed for 12 months for glycemic control parameters.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are ≥ 18 years and ≤ 75 years of age.
* HbA1c at 7.5%-12%
* On oral glucose lowering drugs in a stable medication regimen
* Fasting plasma glucose level at ≥125mg/dL
* BMI 25-40 Kg/m2

Exclusion Criteria:

* Diagnosed Type I diabetes
* Serum C peptide \<1ng/ml
Combining LHu With Ultrasound Monitoring in IUI

Intra-uterine insemination (IUI), generally in combination with ovarian stimulation, is one of the most commonly used treatments for infertility. Accurate timing of insemination, in order to coincide with ovulation, has an important impact on the success rate. Optimal timing of insemination is achieved either by monitoring follicular growth through serial ultrasound measurements followed by the administration of human chorionic gonadotropin (hCG) or by the detection of urinary luteinizing hormone (LH). However in cycles where follicular growth is monitored there is a possibility of premature LH rise before the administration of hCG, which may affect the outcome of the treatment. The goal of the study is to determine if adding the testing of urine LH in conjunction with ultrasound monitoring leads to an increase in pregnancy rates in IUI cycles when compared to ultrasound monitoring alone.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing IUI treatments for:

  * Unexplained infertility (including endometriosis stage 1-2)
  * Mild male factor (\>5x106/ml motile sperm as determined by total sperm concentration x % A+B motility in the latest spermogram)
  * Donor insemination
* Natural or stimulated cycles with clomiphene citrate or letrozole
* At least 1 patent tube on hysterosalpingogram, hysterosonogram or laparoscopy within the last two years
* Antral follicular count ≥10 and FSH\<10

Exclusion Criteria:

* Polycystic ovarian syndrome or any cause of oligo or anovulation
* Patients taking other infertility medication (metformin, 17B estradiol, progesterone or gonadotropins)
* Presence of an ovarian cyst or a follicle \>20 mm on the first ultrasound or any reason for immediate HCG administration
* A previous sperm washing result with less than 5x106/ml motile sperm
* Previous inconclusive uLH test or inability to perform uLH testing
Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT

The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe, well tolerated and immunogenic. The present study is intended to extend the follow-up of the volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and cellular immune responses. The results of the present study will be key for the design of future phase II trials, particularly for the definition of the optimal schedule for boosting immunizations.

All individuals (27) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. During these visits, which are performed within the schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to the routine virological, hematological and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation to the phase I clinical trial ISS T-001
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)

This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.


Eligibility Criteria:
Inclusion:

1. Patients with primary hypercholesterolemia \[Heterozygous Familial Hypercholesterolemia (heFH) or non-FH\] with moderate, high or very high CV risk and a history of statin intolerance
2. Provide signed informed consent

Exclusion:

1. Calculated serum LDL-C \<70 mg/dL (1.81 mmol/L) and very high CV risk at the screening visit
2. Calculated serum LDL-C \<100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the screening visit
3. A 10-year fatal cardiovascular disease risk score \<1% at the screening visit

(The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens

This is a 48 week study for HIV-infected patients who have failed several regimens including PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of the 4 groups will contain capravirine in different doses combined with Kaletra and nucleosides and one of the groups will be a combination of Kaletra and nucleosides without the capravirine.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected male or female at least 18 years of age
* HIV RNA level \>1000 copies/mL at screening
* Subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and least 2 nucleoside reverse transcriptase inhibitors
* Adequate renal function
* Adequate hematological function
* Adequate liver function

Exclusion Criteria:

* Women who are pregnant or lactating
* No previous experience with Kaletra
Effect of Ultrasound Positioning Assisted Cheek Needle Therapy on Postoperative Recovery Quality of Patients with Radical Resection of Lung Cancer

To explore the effect of ultrasound positioning assisted buccal acupuncture on postoperative pain and recovery quality of patients undergoing thoracoscopic radical resection


Eligibility Criteria:
Inclusion Criteria:

1. Tracheal intubation under general anesthesia
2. Young and middle-aged patients aged 18-65 years
3. BMI: 18.5-28kg /m2

Exclusion Criteria:

1. head and facial trauma, infection, disease
2. more than 2 kinds of coronary heart disease, hypertension, stroke, diabetes, immune disease and other diseases before surgery