cyrilzakka/clinical-trials huggingface dataset:
Lidocaine Serum Levels in Healthy Adult Volunteers: a Pilot Evaluation of the J-Tip Delivery System

The J-Tip device (National Medical Products, Irvine, CA, USA) is a single-use, needle-free anesthesia delivery system, approximately 10cm long and weighing 9g that allow for the rapid delivery of lidocaine hydrochloride prior to peripheral venous access procedures. First introduced in 2001, it uses compressed carbon dioxide for drug delivery into the subcutaneous space. J-Tip is now approved by the U.S. Food and Drug Administration (FDA) for both children and adults.

Designed for patients with needle anxiety and phobia, several clinical trials (Hollingsworth et al, 2000; Cooper JA et al, 2000) have shown the device to be effective with no significant untoward effects, including in children as young as 3 years old (Zempsky et al, 2008). However, two recent cases of toxic serum lidocaine levels in pediatric patients at Massachusetts General Hospital (MGH) following the use of the J-Tip device is concerning. Both patients were administered local anesthetic using the J-Tip device prior to needle-stick and toxicity screens returned with high levels of lidocaine (\>6000 mcg/L).

Currently, there is a limited amount of literature available on the safety profile of the J-Tip Delivery System and no study to date has evaluated serum lidocaine levels following its use, likely on the assumption that systemic absorption from the small amount of lidocaine within the device should be negligible. The two pediatric cases highlighted above, seem to suggest otherwise. The purpose of this pilot study is to assess the safety of the J-Tip device on a small population of healthy adults and to determine if elevated lidocaine levels are present systemically or locally. The primary outcome will be lidocaine serum levels following the administration of the J-Tip device measured at the local site and two distal sites to establish lidocaine serum levels following J-Tip administration. We expect lidocaine levels to be undetectable.


Eligibility Criteria:
Inclusion Criteria-

1. Adults (18-59 years old) without known medical illness
2. Subject has capacity to provide informed consent

Exclusion Criteria-

1. Individuals who have recently received "caine" (dental procedures, topical (orajel) or hydrocortisone/lidocaine cream) will be excluded from the study
2. History of liver or kidney problems
3. Individuals receiving chemotherapeutic agents
4. Individuals with the PORT-A-CATH® Implantable Vascular Access System
The Effect of Halophyte-based Cream on Pain and Itch

In this study the investigators wish to investigate whether halophyte-based cream applied to the skin can reduce itch applied by means of small needles from the plant mucuna pruriens (also called cowhage) or by histamine (an itch-evoking substance formed in the human body). Further, the investigators wishes to investigate whether long-term application of halophyte-based cream has a pain-relieving effect on heat/cold and pinprick stimulations.

Salt-tolerant plants (also called halophytes) can grow in saline soil or directly in salt water (e.g. along coasts). For centuries, these plants have been used in folk medicine, and among other things they are believed to have pain-relieving and anti-inflammatory effect.

Even though experiments have already investigated halophytes as a pain relieving substance, the mechanisms in relation to pain and/or itch are still unknown. Therefore, the investigators wish to investigate whether halophyte-based cream applied to the skin can reduce itch applied by means of small needles from the plant mucuna pruriens (also called cowhage) or by histamine (an itch-evoking substance formed in the human body). Further, the investigators wishes to investigate whether long-term application of halophyte-based cream has a pain-relieving effect on heat/cold and pinprick stimulations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current neurologic, musculoskeletal or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamine medications or pain killers
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Soy Formula Feedings in Healthy, Term Infants

This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects).
* Health infants reported to be tolerating a milk-based formula (Cohorts).
* Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).
Major Hepatectomy and Vascular Clamping

A major hepatectomy consists of the resection of 3 or more liver segments. Its indications are mainly secondary malignant lesions, then primary malignant lesions, benign lesions and septic resections. Around a hundred major hepatectomies are carried out every year in Strasbourg. This surgery is burdened by 4.5% mortality at day 90 and 20 to 50% morbidity. The main intraoperative risks are hemorrhage and hemodynamic instability. Surgical vascular clamping helps reduce the risk of bleeding but is responsible for sometimes major hemodynamic variations, ischemia-reperfusion syndromes and can lead to acute post-operative liver failure. Recent literature attests to the safety of liver resection without vascular clamping, which is why it is less and less practiced.

Different elements are identified as independent risk factors for morbidity and mortality: the presence of cirrhosis, portal embolization, history of renal or cardiac failure, duration of vascular clamping, resected liver volume, transfusion of products labile blood and associated surgical procedures.

Given the significant risk of intra- and post-operative complications, it seems relevant to analyze pre- and intra-operative data in order to highlight risk factors for vascular clamping. This would allow better anticipation of complications, patient information, adaptation of intraoperative monitoring and postoperative surveillance and perhaps a reduction in complications. This study also makes it possible to take stock of the epidemiology around hepatectomies performed at the STRASBOURG University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥ 18 years old)
* Subject operated on for a major hepatectomy at Strasbourg University Hospital during the period from January 1, 2023 to December 31/2023
* Subject who has not expressed opposition to the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* History of liver resection
Stress Reduction Therapy for Pregnant Women

Prenatal stress is associated with negative outcomes such as postpartum depression, prematurity or neurodevelopmental delays.

The aim of this study is to implement a psychological therapy to reduce stress during pregnancy.

Objective: To assess whether the group of pregnant women have lower levels of stress after attending the psychological therapy than the group attending parent craft classes.

The cognitive-behavioural therapy to reduce stress will be held in 10 sessions (1 per week) as follows:

First session: General information about pregnancy. Pregnant women will describe what can they do to reduce stress levels.

Second session: Breathing techniques and talk about how last week went. Third session: Muscle relaxation and guided imagination techniques Fourth session: Cognitive restructuring. Being able to detect thoughts and feelings Fifth session: Detect cognitive distortions Sixth session: Cognitive restructuring Seventh session: Time management Eighth session: Problems solving Ninth session: Assertively and social skills Tenth session: How to ask for help when needed and learning to say "No".

Eligibility Criteria:
Inclusion Criteria:

* Low risk Pregnant women
* Gestational age between 10-27 weeks
* Proficiency in the Spanish language

Exclusion Criteria:

* Corticoids treatment
* Gestational Diabetes
* Psychological diagnosed
A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants

The purpose of this study is to evaluate the effect of single dose intravenous rifampin on the single-dose PK of orally administered TAK-906.

The drug being tested in this study is called TAK-906. TAK-906 is being tested to evaluate the effect of single dose intravenous rifampin on the single-dose PK of oral TAK-906 in healthy adult participants.

The study will enroll approximately 12 participants. Participants will be randomly assigned to one of the two treatment sequences AB or BA:

* Sequence AB: TAK-906 25 mg, followed by a washout period of at least 7 days, then Rifampin 600 mg and TAK-906 25 mg
* Sequence BA: Rifampin 600 mg and TAK-906 25 mg, followed by a washout period of at least 7 days, then TAK-906 25 mg

This single center trial will be conducted in the United States. The overall time to participate in this study is 49 Days. All participants will make final visit 14 days after receiving their last dose of study drug for follow up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study, based on screening urine cotinine test.
2. Body Mass Index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/ m\^2) at screening.
3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the investigator or designee.

Exclusion Criteria:

1. Positive urine drug or alcohol results at screening and each check in.
2. Positive urine cotinine at screening.
3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
4. QT interval with Fridericia's correction (QTcF) interval is \>450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the investigator or designee at screening.
5. Estimated creatinine clearance \<90 milliliter per minute (mL/min) at screening.
6. Has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within the 30 days prior to the first dosing and throughout the study.
7. Donation of blood or significant blood loss (example, approximately 500 milliliter \[mL\]) within 56 days prior to the first dosing.
8. Plasma donation within 7 days prior to the first dosing.
FLT PET Imaging for Cervical Cancer

Our primary hypothesis is that \[18F\]FLT PET can identify active bone marrow in addition to metabolically active tumor.

This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.

Subjects will undergo a total of up to 5 FLT PET scans.

Subjects are randomized between two groups to reduce radiation exposure from the FLT PET scans. If bone marrow activity is not identified in one scan, further scans are cancelled until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy between two study arms. Data will be pooled for analysis as pre-specified in the study's statistical plan.

Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy.

Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign a written informed consent document.
* Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
* Scheduled to receive chemo-radiation for oncologic treatment.
* Karnofsky of at least 60 at time of screening
* Life expectancy of at least 6 months.
* Leukocytes at least 3,000/microL
* absolute neutrophil count at least 1,500/microL
* platelets at least 100,000/microL
* total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)
* either ALT or AST less than 2.5 times the upper limit of normal
* creatinine less than 1.5 times the upper limit of normal
* non-pregnant, non-nursing, willing to use contraception

Exclusion Criteria:

* oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
* uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
* subjects taking nucleoside analog medications such as those used as antiretroviral agents.
* patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.
Full4Health: Understanding Food-gut-brain Axis Across the Lifecourse

The primary aim of this work is, to 'relate psychological and behavioural parameters of hunger/satiety and food preference to gut hormones, neural activation and energy metabolism by dietary manipulation, across the human lifespan'.

The Full4Health project aims to further understanding of the mechanisms of hunger and satiety. The proposal integrates investigation of human volunteers and laboratory rodents throughout the life course, applying imaging and other cutting edge technologies to critical research questions. Full4Health will combine study of the mechanisms of hunger and satiety with intervention studies to validate the effects of the relevant food characteristics on the regulation of satiety/hunger. The development of cerebral responses to food through the gut-brain axis across lifespan particularly during childhood, adolescence and elderly will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate in the fMRI study
* Right-handed
* Not heavy smokers (less 10 day)
* MRI compatibility:
* no claustrophobia
* no metal in the body (including dental braces)

Exclusion Criteria:

* Heavy smokers (more than 10/day)
* Morbid obese (BMI\>40 kg/m2)
* Pregnancy
* Obesity of known endocrine origin
* Neurological disorders including Cerebral Palsy
* Alzheimers disease
* Multiple Sclerosis
* Parkinsons disease
* Medication known to influence appetite (orlistat, oral antidiabetics, insulin, digoxin, anti-arrhythmics, sibutramine, antidepressants)
* Self report fever/systemic infection
* Inability to participate in fMRI scanning sessions including contraindications to MRI
* Participation in medical or surgical weight loss programme within 1 month of selection
* History of cerebrovascular disease
* Current major depressive disorder, bipolar disorder or past history of suicide attempt or self harm
* History of drug or alcohol misuse
* History of significant cardiovascular disease
* Allergy to any of the breakfasts components.
Reactogenicity, Safety and Immunogenicity of a TB/FLU-01L Tuberculosis Vaccine

The study is a single centre, phase I, open, randomized, by intranasal and sublingual application trial that explored the safety and immunogenicity of 2 doses (Day 1 and Day 21) TB/FLU-01L tuberculosis vaccine in BCG-vaccinated healthy adult subjects aged 18-50 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy BCG-vaccinated male or female adult 18 through 50 years of age at the enrollment visit.
* Literate and willing to provide written informed consent.
* A signed informed consent.
* Capable and willing to complete diary cards and willing to return for all follow-up visits.
* For females, willing to take reliable birth control measures throughout the entire period of participation in the study

Exclusion Criteria:

* Clinical, radiological (chest X-ray) or laboratory evidence of active or past TB disease.
* Current or past administration of anti-TB therapy.
* History of contact with TB patients.
* Positive QuantiFERON-TB Gold test.
* BCG vaccination in less than 6 months prior to study.
* Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
* Recent history of frequent nose bleeds (\>5 within the past year).
* Clinically relevant abnormal paranasal anatomy.
* Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.
* Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
* Hypersensitivity after previous administration of any vaccine.
* History of chronic alcohol abuse and/or illegal drug use.
* Any clinically significant abnormal laboratory finding.
* A positive pregnancy test for all women of childbearing potential.
* Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment.
* Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
* History of leukemia or any other blood or solid organ cancer.
* Seropositive for HIV, hepatitis B surface antigen and/or hepatitis C antibodies.
* Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
* Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study.
* Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
The Effect of Emotional Freedom Techniques Application on Patients With Cancer Phobia

The aim is to examine the effect of Emotional Freedom Technique on death anxiety in patients with postoperative cancer phobia.

The hypotheses of the study are as follows:

H0: Emotional Freedom Technique has no effect on postoperative death anxiety in patients with cancer phobia.

H1: Emotional Freedom Technique has a positive effect on postoperative death anxiety in patients with cancer phobia.

Intervention Group

After coming to the clinic after surgery and after their condition was stable, the patients were given the patient introduction form, subjective discomfort unit, cancer anxiety scale and death anxiety scale as a pre-test. The researchers provided Emotional Freedom Technique (EFT) training to the patients and asked them to apply Emotional Freedom Technique. After an average of 3 days, the subjective discomfort unit, cancer anxiety scale and death anxiety scale were applied as a post-test.

Control Group

After coming to the clinic after surgery and after their condition was stable, the patient introduction form, subjective discomfort unit, cancer anxiety scale and death anxiety scale were applied as a pre-test. No intervention was made to the control group patients outside the clinical protocol. After an average of 3 days, the subjective discomfort unit, cancer anxiety scale and death anxiety scale were applied as a post-test.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age,
* Having had oncological surgery,
* Having no visual or auditory problems,
* Having no psychiatric problems.

Exclusion Criteria:

* Not accepting to participate in the study or wanting to leave,
* Being under 18 years of age,
* Having been previously diagnosed with cancer.
Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status

The purpose of this study is to investigate the effect of combined topotecan and veliparib (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown BRCA mutation status.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
2. Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
3. Platinum resistance or partially platinum sensitive disease

   * Relapsed within six months of prior first line/later lines of platinum-based therapy or
   * Relapsed within six-twelve months of prior first line/later lines of platinum-based therapy
4. Age ≥ 18 years.
5. Performance status 0-2.
6. Measurable disease by RECIST 1.1 or CA125 GCIG criteria
7. Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment):

   * WBC ≥ 3.0 x 10\^9/l or neutrophils (ANC) ≥ 1.5 x 10\^9/l
   * Platelet count ≥ 100 x 109/l
   * Hemoglobin ≥ 9.7 g/dl (6 mmol/L)
   * Serum bilirubin ≤ 1.5 x ULN
   * Serum transaminases ≤ 2.5 x ULN
   * Serum creatinine ≤ 1.5 x ULN
8. Written informed consent.
9. Tissue available for BRCAness analysis/BRCA mutation analysis.

Exclusion Criteria:

1. Prior treatment with a PARP inhibitor.
2. Patients with BRCA1/2 germline mutation.
3. Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)
4. Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.
5. Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening is mandatory.
6. Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
7. Other present or previous malignancy except curatively treated cervical cancer stage I, non-melanotic skin cancer or other cancer with minimal risk of relapse. Previous breast cancer is allowed, if disease free follow-up at least five years prior to enrollment.
8. CNS metastasis.
9. History of any chronic medical or psychiatric condition or laboratory abnormality, which is not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration (e.g. diabetes, cardiac diseases, hypertension, renal or liver disease).
10. Allergy to the ingredients of the study medication.