cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of PSD502 (Lidocaine Prilocaine Spray) Applied to the Glans Penis up to Three Times a Day for 21 Days in Healthy Male Volunteers

The main objective of the study is to determine the safety and tolerability of repeated application of PSD502 to the glans penis in healthy male volunteers

This is a phase I, double-blind, stratified, parallel group, placebo-controlled repeat dose study in a minimum of 8 circumcised and 8 uncircumcised healthy male volunteers. Subjects will attend 2 study visits, of which 1 will be a Screening Visit (Visit 1) and the other, a consecutive 21-day treatment visit (Visit 2; Days 1-21) which commences no more than 14 days after the Screening visit. Subjects will reside in the phase I unit throughout the treatment period. The duration of each subject's participation in the study will be up to 5 weeks.

Subjects are stratified based on whether they are circumcised or uncircumcised and within each stratified group subjects are randomized to PSD502 (lidocaine prilocaine spray) or placebo in a 3:1 ratio.

Procedures during the 21 day treatment period include: visual examination of the glans penis, blood sample collection for pharmacokinetic analysis of lidocaine and prilocaine, swabbing of the glans penis for residual PSD502, vital signs and 12-lead ECG, adverse event enquiries and collection of concomitant medications. Subjects are discharged from the clinic on Day 21 following a safety evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Male, aged 18 years and over
* In generally good health in the opinion of the Investigator
* Willing and able to comply with all study procedures in the opinion of the Investigator

Exclusion Criteria:

* History of a significant medical condition that would preclude further study participation, in the opinion of the Investigator.
* Currently taking, or has taken within the 2 weeks prior to the Screening Visit, any concomitant medication that could confound interpretation of the safety data PSD502
* Suffering from an STD, or is positive for hepatitis B, hepatitis C, or HIV infection.
* Safety testing abnormalities at the Screening Visit, in particular liver function tests, that are indicative of a medical condition and that would preclude further participation, in the opinion of the Investigator.
* Significant abnormality of the glans penis that would preclude interpretation of the examination of the glans, or that could be worsened by use of PSD502.
* History of alcohol or drug abuse within 1 year prior to the Screening visit.
* Known drug sensitivity to amide-type local anesthetics.
* Use of an investigational (non-registered drug within 30 days of the Screening Visit.
* Unlikely to understand or be able to comply with study procedures, for any reason, in the opinion of the Investigator.
* History of Glucose-6-Phosphate Dehydrogenase (G-6-PD)deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g. anti-malarial agents).
* Use of class 1 (e.g. mexiletine, tocainide) and III (e.g. amiodarone, sotaolol)anti-arrhythmic drugs.
Adipocyte Function and Somtropin Deficiency

To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency.

Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.


Eligibility Criteria:
Inclusion Criteria:

* Children of both sexes aged from 5 to 12 years, Tanner stage 1, with no signs of imminent pubertal development. Amenable to treatment with recombinant somatropin in the approved indication of low growth due to GH deficiency
* Selection of recombinant somatropin by the physician in the treatment authorization request, and subsequent approval of such treatment by the relevant growth hormone committee
* Body Mass Index (BMI) within ±1 SD

Exclusion Criteria:

* Children with any of the reported contraindications for treatment with recombinant somatropin, existence of active neoplasms, progression or recurrence of intracranial lesion, etc. will not be studied
* Diabetes mellitus
* Intestinal inflammatory disease
* Celiac disease
* Uncontrolled hyperthyroidism
* AIDS
* Other diseases causing chronic malabsorption, hypercatabolism or malnutrition conditions
* Chronic liver disease
* Eating disorders: anorexia, bulimia, etc
* Long-term treatment with anti-obesity drugs or drugs causing malabsorption
Placebo Controlled Study of Sublingual Salvinorin A

In this study, our aim is to determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects. This study is an ascending-dose, placebo-controlled, single-site design in 8 Salvia-experienced subjects. Subjects will receive SA doses from 0-4000 µg. Doses will be separated by at least one day. The first two doses (0 and 100µg) will be double-blinded while the last four (250, 500, 1000, 2000 and 4000µg) will be single-blind.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 21-45
* Experienced with hallucinogenic amounts of SA
* Good physical and mental health
* Able to give adequate informed consent

Exclusion Criteria:

* Any medical or psychiatric condition which, in the investigators' opinion, would preclude safe or consistent participation
* Significant acute or chronic medical disease
* Female who is pregnant, lactating, or plans to become pregnant during the study period and within one month after study drug administration
Health Outcomes and Costs (HOC) in Lung Cancer (LC)

The purpose of this study is to evaluate the costs, health-related quality of life and preference values from lung cancer patients assisted in a Brazilian public health care unit.

The costs will be assessed by micro-costing approach. All procedures involved in lung cancer at diagnosis, staging, treatment and best supportive care will be assessed.

The health-related quality of life will be assessed by EORTC-QLQ-C30, EQ-5D and EORTC-QLQ-LC13 in all different stages of lung cancer.

An utility measure will be considered. The preference values will be assessed via discrete choice experiment. Two scenarios will be designed and the lung cancer patients will be asked about the preferences.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of lung cancer disease
* Able to understand the overall concept of study and sign the written informed consent

Exclusion Criteria:

* Illiterate
* Visible cognitive impaired
* Non-primary lung tumor
Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)

The purpose of this study is to determine whether S-1 and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
2. Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
3. Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.
4. Treatment with FOLFIRI and FOLFOX is not indicated.
5. Age \>65 years
6. Life expectancy of at least 3 months
7. ECOG PS of 0, 1, or 2
8. Adequate function of major organs as defined below:

   1. Hemoglobin \>9.0 g/dL
   2. White blood cell count \>3,500/mm3, \<12,000/mm3
   3. Neutrophil count \>1,500/mm3
   4. Platelet count \>100,000/mm3
   5. Total bilirubin \<1.5 mg/dL
   6. AST and ALT \<100 U/L (\<200 U/L in patients with liver metastasis)
   7. Serum creatinine \<1.2 mg/dL
   8. Creatinine clearance estimate by the Cockcroft-Gault method \>50 mL/min
9. Able to take capsules orally.
10. No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
11. Voluntary written informed consent.

Exclusion Criteria:

1. Serious drug hypersensitivity or a history of drug allergy
2. Active double cancer
3. Active infections (e.g., patients with pyrexia of 38℃ or higher)
4. Uncontrolled hypertension
5. Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
6. Moderate or severe ascites or pleural effusion requiring treatment
7. Watery diarrhea
8. Treatment with flucytosine
9. Metastasis to the CNS
10. Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
11. Severe mental disorder
12. Continuous treatment with steroids
13. Urine dipstick for proteinuria should be \<2+
14. Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
15. Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
16. Long-term daily treatment with aspirin (\>325 mg/day)
17. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
18. Judged ineligible for participation in the study by the investigator for safety reasons.
Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma

Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the common clinical practices oncologist are now facing. So, we need to seek adequate regimens for them. Gemcitabine is well known to be one of active third generation agents in terms of both efficacy and tolerability. Gemcitabine alone have been recommended as first line treatment for elderly NSCLC patients, especially in the aspect of tolerability. However, gemcitabine alone is suggested to be suboptimal to control their disease. Therefore, we plan to make an optimal regimen containing gemcitabine for the elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer Stage IIIB/IV
* No prior chemotherapy
* Existence of measurable disease. The measurable disease should not have been irradiated
* Life expectancy of more than 3 months
* Age ≥ 70 years
* Performance status (ECOG):1 or 2
* Adequate bone marrow function (Absolute neutrophil count \>1500/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3)
* Adequate liver (Bilirubin\<2 times upper limit of normal and SGOT/SGPT\<3 times upper limit of normal) and renal function (creatinine\<1.5mg/dl)
* Informed consent

Exclusion Criteria:

* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* Currently/recently taken warfarin, phenprocoumon or phenytoin
* Hypersensitivity history to any drug
Treatment of Egg Allergy in Children Through Oral Desensitization (EGG OIT)

The purpose of this study is to determine if children with egg allergy can be desensitized to egg protein and if this desensitization can help them outgrow their egg allergy at an earlier time than normal. Our hypothesis is that children with egg allergy can be orally desensitized to egg protein and that this desensitization will help them outgrow their egg allergy at an earlier time than normal.

Egg allergy in children under 5 years of age is extremely common. Egg, along with milk and peanuts, cause 80% of the food allergy reactions in children in the United States. Children have allergic reactions to egg ranging from mild urticaria to systemic anaphylaxis. The current therapy for children with egg allergy is to place the child on an egg-free diet until the allergy is outgrown. Because egg protein is a part of a significant number of processed foods it is difficult to totally avoid all egg proteins. Accidental ingestions leading to reactions to egg can occur with a bite of a cookie (\~70 mg of egg protein) or a bite of a cake (\~55 mg of egg protein). Children typically do not outgrow their egg allergy for several years. Therefore it would be helpful if a specific form of therapy would make children outgrow their allergic reactions to egg sooner. Egg protein is given to children in this study in small increasing amounts to desensitize them to the egg protein with the goal of helping them to outgrow their allergy.

Eligibility Criteria:
Inclusion Criteria:

* Between 1 to 16 years of age
* Diagnosed egg allergy by CAP FEIA to egg of 5 kU/l or greater (2 kU/l or greater if 2 years old or less) or have had a positive allergic reaction to egg within 6 months.
* Having eaten egg in his/her diet prior to diagnosis
* A family that will be able to be compliant with all study visits
* All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

* History of anaphylaxis to egg
* Medical history that would prevent a DBPCFC (double-blind placebo-controlled food challenge) to egg. The medical history that would prevent the DBPCFC to egg would be a prior history of an open egg challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an FEV1 \< 80% of predicted, or FEV1/FVC \<75%, with or without controller medications
* Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
* Diagnosed corn allergy
The Clinical Outcome of Ultra-low Oxygen Tension on Post Thawed Human Blastocyst

The clinical outcome of Ultra-low oxygen tension on post thawed human blastocyst

In vitro, Embryo development depends on several factors as temperature, pH, and oxygen in the surrounding environment of the embryo. Impaired culture conditions are highly correlated with poor embryo development. Oxygen is a powerful regulator of embryo function , as it is responsible for cell respiration, energy production and rapid cell growth . Increased levels of oxygen is associated with an increase in the levels of ROS , which leads to unfavorable culture conditions, as it might affect the stability of cell membrane, DNA, and protein function .

In the female reproductive tract, oxygen concentration fluctuates between 2-8%, which is considered to be at its highest level in the fallopian tube, while the lowest level is in the uterus . Pre-implantation embryo crosses the uterotubal junction after the time of compaction on Day 3, where it is exposed to a shift in oxygen tension to 2%. This variation may have a role in the metabolic reactions of the embryo, and in its preparation for implantation process.

Some studies suggested that culturing embryos with oxygen tension below 5% may have an embryological advantage mimicking nature.

Embryological laboratories routinely use low Oxygen tension (5%). Our purpose is to investigate if ultra-low oxygen tension (2%) has an advantage over low oxygen tension (5%) for post thawed human embryo regarding clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

Single or Multiple Embryo transfer embryo transfer. Female age 18-40. Embryo vitrified on day 5 or day 6 of insemination.

Exclusion Criteria:

Use of sperm donation. Use of Oocyte donation. Use of gestational carrier. Uterine congenital anomalies. Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previously known uterine infection.

Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation.
Evaluation of Viscosity of a Vaginal Moisturizer

To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women

A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the research product.

It will be necessary 33 female research participants, aged between 45 and 70 years menopause with complaint of vaginal dryness.

The participant will remain in the study for one day, making use of the research product in the Research Center.

Participants will be divided into 2 groups so that each group observes the viscosity (flow) of the test product in a different anatomical position (lying down and standing) immediately after application of the product, after 15 and 30 minutes.

Participants will respond to a subjective assessment using a standardized questionnaire to capture possible feelings of discomfort during the study.

A gynecologist will be available to monitor the participants throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Menopausal participants for at least 6 months;
* Participants with complaints of vaginal dryness;
* Skin integrity in the region of product analysis;
* Agreement to comply the procedures of the trial and attend the clinic on the days and times determined for applications and / or evaluations;
* Understanding, agreement and signing of the Informed Consent Term.

Exclusion Criteria:

* Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to selection;
* Pathologies and / or active skin lesions (local and / or disseminated) in the evaluation area;
* Immunosuppression by drugs or active diseases;
* Decompensated endocrinopathies;
* Relevant clinical history or current evidence of alcohol or other drug abuse;
* known history or suspected intolerance to products of the same category;
* Intense sun exposure up to 15 days before evaluation;
* Gynecological treatment up to 4 weeks before evaluation;
* Other conditions considered by the researcher to be reasonable for disqualification of study participation.
Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders

The purposes of this study is to examine the feasibility of implementing an internet-based treatment for insomnia among veterans with substance use disorders, some with co-morbid serious mental illness, and to develop potential methods to support and encourage veterans while they self-administer this treatment. Our hypotheses are that the implementation of an internet-based therapy will be feasible and that a method of support can be devised, and tested in the future.


Eligibility Criteria:
Inclusion Criteria:

* Inability to sleep within 30 minutes of going to bed or awakening during the night for 30 minutes for greater than or equal to 3 days per week
* Above Criteria occurring every week for greater than or equal to 3 months
* At least one symptom of daytime impairment: (reduced motivation, sleepiness, fatigue, lack of concentration, performance at home, work, social life, relationships impaired)
* Able to provide valid consent
* Willing to participate in an internet-based cognitive behavioral therapy for insomnia
* English speaking

Exclusion Criteria:

* Self-reported or provider diagnosed sleep apnea or related nighttime respiratory problem, restless legs syndrome or related nighttime movement disorder
* Acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month (suicidality, homicidally, mania, psychotic decompensation)
* Current treatment or treatment within the last month for opiate addiction with methadone maintenance or buprenorphine.
* Has a conservator E. Shift work interfering with the establishment of regular sleep patterns F. Previous or ongoing cognitive behavioral therapy for insomnia
Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)

The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence Syndrome (NAS).

Neonatal abstinence syndrome is a condition that affects newborns who are exposed to chronic opioid drugs while they are in a mother's uterus (womb) prior to birth. The current standard of care treatment includes morphine sulfate. Buprenorphine is a drug used in adults to treat narcotic dependence and withdrawal, but has not yet been approved for use in newborns as a treatment alternative for Neonatal Abstinence Syndrome. This investigation is designed to measure if sublingual (under the tongue) buprenorphine is able to reduce hospital length of stay and decrease number of days of drug treatment currently required in treatment of NAS. Another goal will be to understand buprenorphine as a cost effective treatment for NAS.

Eligibility Criteria:
Inclusion Criteria:

* Infants of corrected gestational age ≥37 weeks
* Chronic opioid exposure in utero
* Signs and symptoms of NAS requiring treatment
* 2 consecutive Finnegan scores ≥8 or any single score ≥12

Exclusion Criteria:

* Concomitant maternal benzodiazepine or alcohol use 30 days prior to enrollment
* Life-threatening congenital malformations
* Intrauterine growth retardation
* Seizure activity or congenital neurologic abnormalities
* Concomitant neonatal use of Cytochrome P450 inhibitor or inducers prior to treatment
* Inability of mother's consent due to altered mental status or comorbid psychiatric disorder
* Neonatal administration of morphine prior to enrollment into study
Management of Women Who Experience Domestic Abuse: Study Comparing Psychological Outcomes at the Maison Des Femmes in Saint-Denis and a Convential Shelter

ach year, it is estimated that an average of approximately 219,000 women in France suffer physical and/or sexual violence at the hands of their partner or ex-partner. These figures do not take into account other types of violence such as psychological or economic violence. Domestic violence has a major impact on the physical, sexual and psychological health of women victims. For example, the prevalence of post-traumatic stress disorder in these women varies between 33 and 84%, with an average prevalence of 61%, compared with only 2.2% in the French population as a whole. Multidisciplinary medical, social and legal support for these women is essential. In France, there are major territorial disparities in terms of the distribution of facilities for victims of domestoc violence, and not all women victims have the same access to care depending on their place of residence.

The Maison des Femmes in St Denis has been open since 2016. It offers a unique range of sanitary, social and judicial services through cooperation with police and justice departments, for women who have been subjected to any type of violence.

This facility is unique in France, and the number of consultations continues to increase, and was more than 8,500 in 2018. The Maison des Femmes model is intended to be exported to other departments, but first the model needs to be validated, beyond its obvious attractiveness (illustrated by the number of consultations and the fact that it attracts women from throughout the Ile de France region) by comparing it to other facilities in terms of its effect on the management of the women.

This is a cross-sectional prevalence study that estimates the frequency of post-traumatic stress disorder among women who are victims of domestic violence who used the services offered at the Maison des Femmes or other dedicated structures, at the initial consultation and 6 months later.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18 and over,
* Consulted for domestic violence at the Maison des Femmes, St Denis health centre or Aubervilliers health centre.
* Able to understand the objectives of the study and to respond to the survey
* Having been informed and not having objected to participating in this study.

Exclusion Criteria:

* Unable to understand the objectives of the study and to respond to the surveys.
* Consulting for another reason.
* Protected adult under a measure of safeguard.