cyrilzakka/clinical-trials huggingface dataset:
18670 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Chatbot-based Intervention to Promote Vaccine Acceptance in Varansi, India

The goal of this clinical trial is to learn compare the efficacy Chatbot messaging directed to parents of infants and children living in unstable urban housing (UUH) in Varansi, India. The main questions it aims to answer are: 1) Can a Chatbot intervention be used to improve attitudes towards childhood vaccines? 2) Does an intervention in which vaccination is presented in the larger context of well-being improve attitudes towards vaccination?

Only 2/3 of Indian infants and children are fully immunized. In communities facing unstable urban housing (UUH) vaccination rates are even lower. COVID-19 introduced new challenges for community health workers in these areas, and many do not have the capacity to promote vaccination. At the same time, the pandemic also prompted more parents and caregivers to engage with smartphones to manage the child's health. The investigators believe that a WhatsApp-based Chatbot intervention may be an effective way to promote routine childhood vaccination among caregivers without creating additional burdens on community health workers. To test this, the investigators are developing the Happy Baby Programme. This programme will be disseminated as a Chatbot through WhatsApp to parents of infants and young children living in Varanasi, in the Indian state of Uttar Pradesh. In addition to testing the overall efficacy of a Chatbot messaging platform, the investigators will compare two different Chatbot messaging designs, one featuring vaccine-only messaging and a second that positions vaccines as part of a broader set of well-being practices.

Eligibility Criteria:
Inclusion Criteria:

* Speak Hindi;
* Reside in selected UUH neighborhood of Varanasi, India;
* Identify as a caregiver of a young child (\<2) OR be at least 5 months pregnant and due to giver birth during the study period;
* Child is registered with local community health workers and included on patient rosters for vaccination clinics (also known as Village Health Sanitation and Nutrition Days (VHSNDs));
* Have regular access to a phone with WhatsApp.

Exclusion Criteria:

* Only one caregiver is eligible per household
* Not meeting inclusion criteria.
Technological Contributions to Behavior Guidance Techniques

This study aims to evaluate the effects of three different behavior guidance methods on children's dental anxiety and pain perception.

This study will include 63 children aged 6-8 years who will require pulpotomy followed by a Class II composite restoration and will be divided into three groups: tell-show-do (TSD; Group 1), TSD with video modeling (Group 2), and TSD with a mobile phone application (Group 3). Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and hemoglobin oxygen saturation (SPO2) of the participants will be recorded before the procedure, after local anesthesia, after pulpotomy, and at the end of the procedure. Faces Version of the Modified Child Dental Anxiety Scale (MCDAS f), Wong-Baker Faces Pain Rating Scale (WBFPRS), and Face, Legs, Activity, Cry, Consolability (FLACC) pain scales will be applied.

Eligibility Criteria:
Inclusion Criteria:

* the patients had no previous dental treatment,
* were between ages 6 and 8 years, accepted treatment accompanied by parents,
* scored 3 (positive) or 4 (definitely positive) on the Frankl behavior scale,
* had no systemic disease,
* did not need emergency dental treatment, one of the upper molars required pulpotomy followed by a Class II composite restoration,
* had no mental or physical disabilities,
* understood the commands, and whose parents agreed to participate in the study
* signed the consent form.

Exclusion Criteria:

* Patients who did not meet the inclusion criteria included those who needed other asymptomatic root canal treatment other than pulpotomy indication,
* needed restorative treatment due to a history of dental trauma, those who did not want to be included voluntarily,
* who cried during the procedure or left the treatment unfinished,
* who were determined to be negative (2) or definitely negative (1) according to the Frankl behavior assessment scale.
Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma

The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.

Current limitations in the management of high grade brain tumors partly reside in the lack of access to pathological tissue.

Conventional biopsy devices can cause severe side effects, thus limiting the amount of tissue that can be collected for molecular characterization. The Brain-Tissue-Imprint Devices evaluated in this trial offers a unique opportunity to perform multiple non-lesion sampling in both tumor tissue and peritumoral areas. The approach relies on the use of tailored silicon chips integrated in surgical devices enabling tissue sampling through a brief "silicon to tissue contact", thus limiting potential side effects, and opening a way to extensive molecular investigation of brain tumors and their microenvironment.

Eligibility Criteria:
Inclusion Criteria:

* more or equal than 18 years old
* patient affiliated to social security or similarly regime
* informed consent form signed
* glial tumor suspicion
* Stereotaxic biopsy indication
* Karnofsky score \> 70%
* Hematological assessment :
* neutrophils \> 1500/mm3
* Platelet \> 150 000
* blood Creatinin normal
* alkaline Phosphatases and transaminases no more than two times normal
* Bilirubin \< 1.5 times normal

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Person participating in another clinical study
* Intratumoral hemorrhage MRI detected
* Treatment anticoagulant or antisludge treatments
* Active Infections and non controled or medical affection or psychiatric intercurrent non treated
* Evolutive cerebral oedema without corticoid response
* Non controled Epilepsy without antiepileptics response
* Susceptibility to Medical Device materials allergy
Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

The purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin.

Therefore, the investigators aim to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients Allergic to Penicillin.

Exclusion Criteria:

* Patients with previous H. pylori eradication therapy.
* Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent
Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder

The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).

The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).

As secondary endpoints, the migration behavior of the humeral components over time will be determined by radiostereometric analysis (RSA), the further clinical-functional results and the satisfaction of the patients treated will be investigated. Clinical outcomes are measured using standardized and reproducible clinical scores (Oxford Shoulder Score -OSS and Short Form Health 36-SF-36 v1.0 ) at each time of examination.

Other endpoints include revision rate within the follow-up period, surgical time (incision to suture), and delays in surgical procedures due to instrumentation.

The times of data acquisition are the admission day before the operation to determine the preoperative status, the discharge day and the follow-up appointments after 3 months, 6 months, 12 months and 24 months to determine the postoperative status and course.

Eligibility Criteria:
Inclusion Criteria:

1. Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
2. Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
3. Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.
4. Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed.
5. Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).

Exclusion Criteria:

1. Previous operation on the rotator cuff of the affected shoulder
2. Dysfunctional rotator cuff
3. Infection of the affected shoulder joint or systemic infection
4. Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure
Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients

Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.

Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation. The latter is known to interfere with iron metabolism, inducing iron storage instead of using it for hemoglobin synthesis. The discover of a new regulatory hormone of iron metabolism, hepcidin, may help us to better understand the link between inflammation and iron functional deficit. The aim of our study is to observe the variation of usual iron metabolism biological markers and of hepcidin, in order to define the better marker of iron loss in these clinical situations.

Eligibility Criteria:
Inclusion Criteria:

* Anemia (haemoglobin \< 10 g/dL)
* Hospitalization in ICU for an expected duration of 7 days or more
* Or, day one post cardiac surgery

Exclusion Criteria:

* Chronic anemia (Hb \< 9 g/dL for more than one month before hospitalization)
* Iron metabolism disease
Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED

This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects, age ≥ 18 years;
* Minimum 6 month history of mild to severe erectile dysfunction;
* Subject is in a monogamous, heterosexual relationship for at least 3 months;
* Subject agrees to make at least 4 attempts at intercourse per month;
* Subject is willing and able to provide informed consent.

Exclusion Criteria:

* Allergy or hypersensitivity to PDE5 inhibitors;
* History of dose-limiting AEs during therapy with a PDE5 inhibitor or hx of consistent treatment failure with other PDE5 inhibitors for therapy of ED;
* Current or expected use of organic nitrates at any time during the study;
* Previous or current antiandrogen therapy;
* Use of prescription or over-the-counter drugs known to inhibit the activity of CYP3A4 at any time during the study;
* Androgen replacement therapy that has not been stable for at least 3 month;
* Initiation or change in dose of any alpha-blocker within 14 days prior to randomization;
* ED as a result of spinal cord injury or radical prostatectomy;
* Untreated hypogonadism or low serum total testosterone
* History of or predisposition to priapism;
* Any penile implant;
* Elevated PSA, other evidence of prostate cancer, or previous radical prostatectomy;
* History of any malignancy (except basal cell carcinoma or squamous cell carcinoma of the skin successfully treated by curative excision);
* History of type 1 or type 2 diabetes;
* Uncontrolled hypertension;
* Hypotension;
* Orthostatic hypotension;
* Significant cardiovascular disease;
* Abnormal ECG;
* Hepatic or renal impairment;
* Positive STD screen;
* Clinically evident penile lesions, abrasions, or anatomical deformities;
* Urinary tract or bladder infection;
* Use of any treatment for erectile dysfunction other than study drug at any time during the study;
* Participation in another investigational study within 30 days of screening or at any time during this study;
* Previous participation in any other investigational study of avanafil;
* History or current drug, alcohol, or substance abuse;
* Any history of bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity or antidepressant use that has not been stable for at least 3 months;
* Partners who are \< 18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have any gynecologic problems or major medical conditions that would limit participation in sexual intercourse;
* Evidence of any other condition by history, physical examination, or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.
Impact of 50% Nitrous Oxide Inhalation on Pain and Anxiety Induced by Lumbar Puncture: a Double-blind Randomized Controlled Trial

This study is designed to evaluate the analgesic effect of nitrous oxide (N2O) on the pain induced during lumbar puncture.

Nitrous oxide (N2O) has analgesic and anxiolytic properties that are known for more than a century. Nonetheless, it's use during lumbar puncture in adults has never been investigated properly.

Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.

Patients with scheduled lumbar puncture realized for diagnosis purposes will be randomized in 2 groups. One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure. The second group will inhale compressed air during the same period of time. Neither the investigator realizing the lumbar puncture, nor the patient will know which type of gaz they are inhaling (double-blinding).

The maximal pain level that occurred during the procedure will be evaluated on a Numerical Rating Scale (NRS). NRS will also be used to evaluate the maximal anxiety induced by the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients coming in the neurology department for a scheduled lumbar puncture
* 18 to 60 years.
* no previous use of nitrous oxide

Exclusion Criteria:

* contra-indication to nitrous oxide use
* Body Mass Index\>35
* Mini Mental State Examination \<26/30
* Temperature \>38°C
* Confusion
* Patient unable to communicate verbaly
Metformin for HIV Inflammation

This proposal seeks to assess the impact of 24 weeks of metformin on non-calcified plaques and calcified plaques assessed by coronary CT angiography, and on whether these changes can be explained by metformin-induced phenotypic and secretory changes of monocytes.


Eligibility Criteria:
Inclusion Criteria:

* HIV+
* on suppressive ART stable for \> 1 year
* Age \> 45 years
* Ability and willingness to provide written informed consent

Exclusion Criteria:

* Uncontrolled chronic medical condition or cancer
* Acute illness within 2 weeks of entry
* Diagnosis of diabetes or impaired fasting glucose
* Chronic diarrhea
* Known hypersensitivity or contraindication to metformin use
* Hepatitis C co-infection
* Serum B12 level below the reference normal range as listed by the commercial laboratory (Diagnostic Laboratory Services)
* Pregnancy, or intent to become pregnant
* Any immunomodulator, HIV vaccine, any other vaccine, or investigational therapy within 30 days of study entry.
* Current or past history of coronary artery disease or congestive heart failure
* Resting heart rate \> 100 beats/min
* Presence of conduction abnormalities or pathologic arrhythmia on EKG
* The following lab values: Hemoglobin \< 9.0 g/dL; Absolute neutrophil count \< 1000/μL; Platelet count \< 50,000/μL; and AST (SGOT) and ALT (SGPT) \> 5x ULN
* Calculated creatinine clearance (Cockcroft and Gault) \< 60 ml/min
* Patients over 450 lbs
* History of iodine allergy or X-ray contrast allergy
* History of allergy to metoprolol
* Active or recent past history (within past 2 years) of illicit substance or alcohol use or abuse which, in the judgment of the Investigator, will interfere with the patient's ability to comply with the protocol requirements
* Patients in whom there are other reasons that the CAC/CTA procedure is contra-indicated or who are at higher risk of adverse events
* Patients, who, in the opinion of the Investigator, are unable to comply with the dosing schedule and protocol evaluation or for whom the study may not be advisable
Omega-3 Fatty Acids and Health Effects

The investigators want to study health effects from omega-3 fatty acids, from fishoil with different quality.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals.

Exclusion Criteria:

* Pregnant women, lactating women, chronic diseases and smoking.
Liquid Biospy for Urinary Cancers

The project aims to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

Bladder cancer (BCa) is the 9th most common cancer worldwide, with an estimated prevalence of around 2.7 million cases and an incidence around 350.000 new cases/year. The proper management of BCa remains an unmet clinical need, because one of the main problems in BCa treatment is the inability to efficaciously prevent high-grade non-muscle invasive bladder cancer (NMIBC) relapse and progression, which occur in 80% and 45% of patients respectively. Indeed, as a consequence of the lack of efficient established prognostic, diagnostic and predictive biomarker of high-risk NMIBC, Bca patients undergo multiple treatments and cystoscopic assessments along their life, with consequent poor quality of life and high healthcare costs.

Circulating Tumor Cells (CTCs) in blood represent an invaluable source of tumor material that can be easily collected yhrough a simple blood draw and may represent the clonal component of the primary tumor that left the primary site.

For this reason, the aim of this study is to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of urothelial neoplasia, naive for therapy

Exclusion Criteria:

Absence of previous neolpastic disease or genetic diseases
A Study to Assess the Efficacy of Erlotinib for Leptomeningeal Carcinomatosis in EGFR Mutation Positive Non-small Cell Lung Cancer

To assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18
2. Histologically or pathologically proven non-small cell lung cancer (NSCLC)
3. Leptomeningeal carcinomatosis confirmed by CSF cytology
4. A patients with EGFR mutation (including exon 19 deletion, L858R)
5. ECOG performance status 0-3
6. Expected life time more than at least 4 weeks
7. A patients who signed the informed consent prior to the participation in the study
8. Chemotherapy-naïve patient is eligible
9. Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases

Exclusion Criteria:

1. A pregnant or lactating patient
2. A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
3. A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study
4. A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer
5. A patient with active interstitial lung disease, except simple lymphangitic lung metastasis
6. A patient with history of allergic reaction to gefitinib or erlotinib
7. The following laboratory test results:

   * Number of absolute neutrophils counts (ANC) \< 1.0ⅹ109/L
   * Number of platelets \< 50 ⅹ109/L
   * AST, ALT \> 2.5 ⅹupper limit of normal
   * Total bilirubin \> 1.5 ⅹupper limit of normal
   * Serum creatinine \> 1.5 ⅹupper limit of normal
8. A patient with serious disease as followings

   * Uncontrolled cardiac arrhythmia
   * History of myocardial infarction within 6 months prior to the initiation of study
   * Neurological or psychiatric disorder including dementia or uncontrolled seizure
9. A patient who refused to sign the informed consent