cyrilzakka/clinical-trials huggingface dataset:
Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception

In This experiment, the investigators would like to test following hypotheses:

repetitive cutaneous administration of pruritogens will lead to a more robust and longer lasting itch sensation compared with a single application. The aim of this project is to investigate a new itch model based on repetitive administration of three different pruritogens: histamine (histaminergic itch), cowhage, and BAM 8-22 (non-histaminergic itch).

Chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. Furthermore, there is a lack of efficient treatment options for chronic itch. In order to mimic a clinical itch condition as presented in patients, the aim of the project is to investigate a new itch model based on repetitive administration of three different pruritogens: histamine (histaminergic itch), cowhage, and BAM 8-22 (non-histaminergic itch). The hypothesis is that repetitive cutaneous administration of pruritogens will lead to a more robust and longer-lasting itch sensation compared with a single application. This proposal for a new itch model could better mimic clinical itch conditions and be used to investigate fundamental mechanisms, new anti-pruritic drugs, and their possible mechanisms of action.

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 addictive drugs
* Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis) musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids
* Skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis)
* Moles, scars, or tattoos in the area to be treated or tested.
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
A Drug-Drug Interaction Study to Study the Effect of AZD1981 on Warfarin

The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index between 19 and 30 kg/m2 and weight at least 65 kg and no more than 100 kg
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to screening
* Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study

Exclusion Criteria:

* Volunteer that is inferred to have an increased sensitivity to warfarin based on genotype of CYP2C9 and VKORC1.
* Any clinically significant disease or disorder
* Any clinically relevant abnormal findings in physical examination
Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

Based on the finding that anaphylactic reactions to Benefix ("FIX") are associated with a specific IgE, a Basophil histamine release assay was selected to evaluate and demonstrate subject sensitization to FIX.


Eligibility Criteria:
Inclusion Criteria:

Study Group:

* Written informed consent or assent, as applicable.
* Subjects with moderate to severe Hemophilia B (FIX:C \<5%), who have reported class II or class III allergic manifestations within 24 hours of a BeneFIX infusion.

Control Group:

* Written informed consent or assent, as applicable.
* Subjects with moderate to severe Hemophilia B (FIX:C \<5%)

Exclusion Criteria:

Study group:

* Subjects who had no reaction when rechallenged with BeneFIX, in the absence of prophylactic immunomodulating therapy.
* Subjects whose most recent allergic manifestations with BeneFIX occurred \>36 months prior to providing written informed consent for this study.
* Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled visit for this study.
* Subjects with immune disorders.
* Subjects unable to comply with a minimum 5-day FIX washout requirement.

Control group:

* Subjects with documented evidence of prior allergic reaction to any FIX product.
* Subjects with documented evidence of prior or current FIX inhibitor (BU \>0.6).
* Subjects have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled study blood draw.
* Subjects with immune disorder.
* Subjects unable to comply with a minimum 5-day FIX washout requirement.
Comparing the Incidence of Preeclampsia Between Pregnant Women Receiving Tdap Vaccinations at Week 28 or at Week 36

Preeclampsia is a significant medical condition occurring in 3-8% of pregnancies and impacts deleteriously both maternal and fetal health. An important discovery has been made by Dr Craig D Scoville showing that early Tdap vaccinations in pregnancy can reduce the incidence of preeclampsia by more than 50%. A prospective clinical research trial is proposed and urgently needed to validate this finding and thereby make a significant contribution in reducing the incidence of this common and severe complication of pregnancy.

A double blinded randomized prospective clinical research study is proposed to validate the hypothesis that Tdap vaccinations at week 28 in pregnancy can reduce the incidence of preeclampsia by more than 50%. This project will recruit 1600 pregnant women with appropriate informed consent in the first trimester of pregnancy, obtain detailed obstetric and health history, and then randomize these subjects so 800 women receive Tdap at week 28, and 800 women receive Tdap at week 36, and all women will be followed during their pregnancies using standard of care with special attention to preeclampsia and fetal outcomes. Blood samples will be obtained at weeks 12, 20, and 36 in order to test the anti-tetanus toxoid antibody levels, anti-diptheria antibody levels, anti-pertussis antibody levels, and also maternal cytokines (IL-2, IL-4, IL-6, IL-10, TNFa, IL-17, and IFNg), and placental biomarkers (sFlt-1, sEng, and PIGF) for preeclampsia on those patients who develop preeclampsia and compare to those who didn't and thereby better understand the biomarkers of preeclampsia and devise a better formula for positive prediction for preeclampsia. To make this change in clinical practice and save lives, this study is asking for funding from NICHD PA-18-480.

Eligibility Criteria:
Inclusion Criteria:

1. confirmed pregnancy at week 12
2. Age 18 to 42
3. Willing to participate and sign informed consent documentation
4. willing to follow study procedures with regards to randomization of Tdap and attend all routine clinic visits per obstetrician and standard of care
5. accept Tdap vaccination either at week 28 or week 36

Exclusion Criteria:

1. no history of allergic reaction or intolerance to Tdap vaccination
2. No history of cancer in past 5 years prior to this study (except for non melanoma localized skin cancers or cancer in situ) -
NeuraGen 3D Pilot Study

This is a 10-subject, 12-month follow-up, prospective, multi-center, open-label, single arm clinical trial designed to understand the initial performance characteristics and confirm the safety profile of the NeuraGen 3D Nerve Guide Matrix.

The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where tension-free closure can be achieved by flexion of the digit or extremity.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject has one, single level, digital nerve injury that:
* Involves complete traumatic nerve section of the common or proper nerve of the palmar aspect of hand.
* Occurred less than and up to 21 days prior to the nerve repair surgery detailed in this protocol.
* In the opinion of the investigator, has a gap which can be easily closed without placing undue tension on the ends of the nerves with the device (i.e., the gap must be shorter than the maximum length of the device being used).
* Subject has adequate vascular perfusion of the target hand as assessed by the investigator
* Subject can accommodate immobilization of the injured hand post-operatively.
* Subject's contralateral hand is intact and of normal function.

Exclusion Criteria:

* Nerve to be repaired is a mixed motor nerve
* Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
* Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve.
* Subject's hand injury or general physical presentation of the target hand is of a nature which would prevent adequate measurement of functional nerve healing assessments.
* Subject has gross contamination of the wound in which the nerve to be studied in this protocol resides (i.e., presence of glass, metal, other large debris).
* Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome).
* Subject has an active infection of the area around the nerve defect.
* Subject has unstable vital signs.
* Subject has a disorder known to affect the peripheral nervous system (PNS) such as:
* Subject has any systemic disease which may confound study results Subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study.
* Subject is known to have had or will require radiation or other therapy to the target hand or limb which may impact nerve healing.
* Subject has a history of injury to or a congenital abnormality of the target hand or limb which may impact nerve healing or confound study results.
* Subject is pregnant (determined either by the subject's confirmation or a formal test).
* Subject has participated in another clinical trial using an investigational drug or device within 30 days prior to the nerve repair surgery detailed in this protocol.
Cryogenic Preservation of Spermatozoa

The reference technique for the conservation of gametes is storage in liquid nitrogen but new vats of nitrogen vapor (storage over liquid nitrogen) or in dry phase (storage in an insulated compartment of liquid nitrogen in a tank Liquid nitrogen) also allow the storage of flakes. The purpose of this work is to evaluate the dry-phase cryopreservation technique of liquid nitrogen compared with liquid-phase storage, depending on the duration of cryopreservation.

Objective: To evaluate the effects of cryopreserved sperm in dry and liquid phase nitrogen at 3 and 6 month on sperm numeration, motility, vitality, morphology, acrosomal integrity and DNA fragmentation.

Design: Experimental study, investigator was blinded to the type of Cryopreservation.

Patient(s): Semen samples were collected from patients who came in laboratory for semen analysis

Intervention: Samples were frozen with a programmable freezing unit. Each semen sample was divided into two aliquots. One aliquot was plunged into liquid nitrogen and the other was stored in dry-phase nitrogen for 3 or 6 month. Thawing was performed at room temperature.

Eligibility Criteria:
Inclusion Criteria:

* Men undergoing routine semen analysis for infertility for reproductive medicine of university hospital in Clermont-Ferrand

Exclusion Criteria:

* women
Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities

To evaluate the reliability of different non-invasive skin probe measurements.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick skin type I to VI with about 15% of phototypes V/VI.
* Subject agreeing to complete all study required procedures.
* Subject having given freely and expressly his/her informed consent.

Exclusion Criteria:

* Pregnant or nursing woman or planning a pregnancy during the study.
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Subject in a social or sanitary establishment.
* Subject participating to another research on human beings or being in an exclusion period for a previous study.
* Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
* Subject who underwent tissue augmentation with dermal fillers including HA, calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg, face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the face within 12 months before study entry or was planning to undergo any such treatment during the study.
* Subject who underwent treatment with botulinum toxins in the face or neck within 6 months of study entry or was planning to undergo such treatment during the study.
* Subject who ever received semi-permanent fillers or permanent facial implants (eg, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the face or was planning to be implanted with any of these products at any time during the study.
* Subject with current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face that could interfere with measurements.
* Subject having changed, started or stopped any hormonal treatment or any treatment likely to have an impact on skin condition (over-the-counter or prescription, oral or topical, anti-wrinkle products on the face), within 30 days prior to enrollment or is planning to begin using such products during the study.
Phase II Study of Epirubicin, Cisplatin and Capecitabine (ECX) Versus Cisplatin and Capecitabine (CX) for Advanced Gastric Cancer (AGC)

Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.


Eligibility Criteria:
Inclusion Criteria:

* Aged 75 years or less
* Adenocarcinoma of stomach
* Advanced, metastatic, or recurrent
* No prio chemotherapy for advanced disease
* Adequate performance status
* Adequate major organ functions

Exclusion Criteria:

* Severe comorbid illness or active infections
* Pregnancy or lactating women
* GI obstruction or malabsorption syndrome
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.

In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks

In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.

A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Relapsed AML
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy \> 3 months
* ≥ 18 years old
* Previously untreated for current AML relapse
* Adequate organ function
* Written informed consent

Exclusion Criteria:

* Pregnant or breast-feeding women
* Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days
* Currently receiving another investigational drug
* Currently receiving other anti-cancer agents
* Uncontrolled infection
* HIV positive
* Received previous therapy with either Mylotarg or 5-azacitidine
G-POEM vs PEG-J in Gastroparesis Patients

Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up.

Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM.

Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment.

Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point.


Eligibility Criteria:
Inclusion Criteria:

* Patients with GP
* 13C octanoic acid test or gastric scintigraphy (minimal 4-hour measurement) within the past twelve months
* 18 years old

Exclusion Criteria:

* \< 18 years old
* Medical history of stomach surgery in which resection of antrum and/ or pylorus took place
* Medical history of surgical or laparoscopic pyloromyotomy
* Gastric bypass
* Current opioid use
* Pregnancy
Microbiome and Genetic Analysis of Familial IBD

Inflammatory bowel disease(IBD) is a chronic inflammatory condition for gastrointestinal tract.

Regarding its pathogenesis, there has been numerous studies to reveal the complex association between genetic and environmental factors.

In Korea, the incidence of IBD is growing rapidly but genetic studies solely including patients with Korean descent were not sufficient enough.

Therefore, the investigators planned to conduct genetic and fecal microbial analysis for the 60 individuals from 30 Korean IBD families to find out the pathogenesis of IBD.

Under the hypothesis that more risk variants will be observed among the familial IBD patient than in IBD patients without any other affected family members, the investigators designed genetic and fecal microbiome analysis for 60 patients form 30 families.

After extracting the DNA from blood samples, whole genome sequencing will be performed and data will be comprared with the previously reported variances. Novel variances or incidence of specific variances will be measured.

Genome-wide single nucleotide polymorphism array using Immunochip will be performed to search common genetic variants and to calculate genetic risk score of IBD.

In this study, fecal microbiome is a surrogate marker for the enviromental aspect of pathogenesis of IBD. The investigators assumed that family members are sharing similar mode of lifestyle therefore we're presumed that their fecal microbial composition is alike.

Comparing genetic and microbial datas altogether with the data from unaffected family member(Healthy internal control), investigators expecting to explain the genetic and enviromental aspect of IBD pathogenesis.

Eligibility Criteria:
Inclusion Criteria:

* 60 individuals from 30 families of Crohn's disease or ulcerative colitis.
* Unaffected 30 individuals from each family as healthy internal control.

Exclusion Criteria:

* Person with history of using antibiotics or probiotics within previous 4 weeks.
Regional Anesthesia EMG Study

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies.

This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies. The hypothesis is that EMG monitoring can be utilized to objectively measure neuraxial blockade, including onset, resolution, density, and dermatomal level.

Eligibility Criteria:
Inclusion Criteria:

* Group 1 (GA + penile block): age 5 years or below getting: circumcision or circumcision revision
* Group 2-5 (SA or GA + CA): age 5 years or below getting: penile or scrotal surgery, inguinal hernia repair, Achilles tendon lengthening, other applicable urological procedures
* Group 6 (GA only): age 5 years or below getting: operative dentistry, urological or ENT procedures

Exclusion Criteria:

* parent refusal
* systemic infection
* spine or CNS abnormalities
* medication allergy
* adhesive allergy
The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction

This pilot project is a randomized controlled trial where induced patients receive an intervention of oxytocin discontinuation once in the active stage of labor (≥6 cm dilation). The intent is to reduce uterine hyperstimulation and fetal distress, therefore, lowering cesarean sections (CS) in first time mothers at term (≥ 37 weeks), with a cephalic presenting singleton fetus, without increasing maternal or neonatal morbidity. If REDUCE-I pilot trial suggests a safe reduction in CS rates and patient satisfaction, application for a multi-centre randomized controlled trial would follow.

This pilot project is a randomized controlled trial of a proposed intervention to modify management of labor inductions once in the active first stage of labor. The intervention will take place at Foothills Medical Centre (FMC). Randomization will be computer generated, participants will be stratified by need for cervical ripening and randomization will be blocked. Participants will be primiparous women 18 years old or older, at term (≥ 37 weeks) with a cephalic presenting singelton fetus undergoing induction of labor with oxytocin. Once patients are in the active first stage of labor, study medication will be initiated (identical vials of oxytocin or saline prepared by the Alberta Health Services Research Pharmacy). Treatment period will continue until delivery. If the frequency of contractions are reduced to less than 2 in 10 minutes or there has been no change in dilation for 4 hours, then oxytocin can be restarted.

Royal Alexandra Hospital in Edmonton will be used as a contemporaneous non-intervention control site.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women undergoing induction of labor with oxytocin.
* Primiparous
* 18 years old or older
* at term (≥37 weeks)
* cephalic presenting
* singleton fetus

Exclusion Criteria:

* Multiple pregnancies
* known fetal congenital or chromosomal anomalies