cyrilzakka/clinical-trials huggingface dataset:
Predict Tooth Wear

Tooth wear, resulting from gradual loss of dental hard tissue due to mechanical and chemical factors, impacts tooth structure, texture, and function. It affects quality of life, with varying prevalence (26.9% to 90.0%), and is traditionally detected visually during check-ups, often at advanced stages. Monitoring alterations in tooth shape via intraoral scanners aids early detection, but restoration remains challenging. Prevention through early detection is vital, as patients may not fully comprehend tooth structure loss until visible. Recently, statistical shape analysis (SSA) used to learn the tooth anatomy and define a reference shape (biogeneric tooth) using. However, assuring landmark consistency is challenging mostly due to biases of the operator. Recently, a robust method called MEG-IsoQuad offered automated, isotopological remeshing. Combining this with SSA holds promise for diagnostic and simulation purposes. This study aims to assess the reliability of a remeshing-SSA approach for altered and intact premolar analysis and compare machine learning algorithms for simulating the shape of the initially intact tooth or future altered one.

The clinical perspective of the current work offers possibilities to:

* Prevent future tooth wear by detecting it at an early stage; and communicate better to the patient by presenting him/her potential future altered teeth
* Simulate the adapted reconstruction for the altered tooth by simulating the initially intact one


Eligibility Criteria:
Inclusion Criteria:

* teeth avulsed presenting a tooth wear index between 0 and 3
* mature incisor, canine, premolar or molars (1st and 2nd only)

Exclusion Criteria:

* teeth avulsed presenting a tooth wear index over 3 (or presenting an oral rehabilitation representative of a similar wear)
* immature teeth or teeth without root edification
* wisdom teeth
Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for Patients With Rising Prostate-Specific Antigen (PSA)

This is a Phase II study to test the efficacy of exogenously administered GM-CSF in prostate cancer patients who have failed definitive local therapy, and have only serologic (PSA) evidence of progression.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate; stage T1-T3, N0-N1, M0
* Prior definitive therapy for primary prostate cancer consisting of:external beam radiotherapy;brachytherapy with or without pelvic external beam radiation; or radical prostatectomy with or without adjuvant or salvage radiation therapy
* Therapeutic PSA response to primary therapy below 1.0 ng/ml post radiation therapy or below 0.4 ng/ml for radical prostatectomy
* Patients treated with adjuvant or salvage radiation therapy following radical prostatectomy are eligible provided:Post prostatectomy PSA was never \> 6.0 ng/ml, last effective day of androgen deprivation is at least 3 months prior to study entry
* Recurrent PSA level elevation (between 0.4 ng/ml and 6.0 ng/ml) on two determinations at least one week apart.
* No clinical evidence of gross local recurrence or known metastatic disease other than PSA elevation. Transrectal ultrasound and/or biopsy to evaluate local recurrence is not required. All patients will receive a bone scan and CT scan of the abdomen to exclude metastases.
* Estimated life expectancy of at least 6 months.
* ECOG Performance status of 0 or 1.
* Willing and able to give informed consent.

Exclusion Criteria:

* Cryosurgery as definitive therapy of primary tumor.
* Any metastasis.
* No concurrent or prior malignancy is allowed except for the following: adequately treated basal or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
* Current systemic steroid therapy (inhaled or topical steroids acceptable).
* Prior hormonal therapy for treatment of progressive disease.
* Prior chemotherapy, immunotherapy, or therapy with other experimental agents for prostate cancer.
* Any surgery within the prior 4 weeks.
* Bilirubin and SGOT \> 2 x upper limit of normal.
* BUN and serum creatinine \> 2.0 times normal.
* No active congestive heart failure.
* If there is a history of clinically significant obstructive airway disease, a DLCO must exceed 50%.
* Active uncontrolled bacterial, viral or fungal infection until these conditions are corrected or controlled.
* Any underlying medical condition which in the principal investigator's opinion will make the administration of GM-CSF hazardous or obscure the interpretation of adverse events.
* PSA \> 6.0 ng/ml
Effects of Infant Massage on Acceptance, Commitment and Conscience of Influence of Parents With Down Syndrome Babies

This study aims to analyze whether the course of infant massage serves as a tool to improve acceptance, commitment and awareness of influence of parents of babies with Down syndrome. These variables will be measure before and after the course of infant massage in the experimental group, investigators will make measurements with the same rate in the control group, but they will receive the course after the measurements.

In the present study, investigators propose to study the effects of infant massage in the levels of acceptance, commitment and awareness of influence of parents of babies with Down syndrome. The measuring instrument of acceptance, commitment and awareness of parental influence will be the "This is my baby Interview". Two groups of intervention will be analysed, the experimental, in which parents have participated and applied the knowledge learned in the course of infant massage, and control, which does not receive the infant massage course during the study. Parents and babies of both groups have been evaluated twice, at the beginning of the intervention (pretest) and at the end after five weeks (postest). The study population consists of father or mother of 32 infants with Down syndrome between 4 and 8 months old.

Eligibility Criteria:
Inclusion Criteria:

* Parents with babies with Down Syndrome between 4 and 8 months old.

Exclusion Criteria:

* Parents with babies without Down Syndrome.
Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography

Cerebral arteriography is a reference examination in medical imaging. This examination is performed to allow the diagnosis and therapeutic management of patients with vascular pathologies.

It is most often accompanied by a situation of stress, anxiety and apprehension related to the course of the examination or the announcement of the results.

These situations generate physiological reactions in patients, making the performance of cerebral arteriography more complex. In order to improve the quality of care for patients undergoing this invasive examination, it is proposed to use two non-medicinal techniques known for their soothing and relaxing properties: aromatherapy and music therapy alone or in combination. These two techniques will help to establish a common thread from the preparation of the patient before the examination to his return to the post-interventional surveillance room.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old)
* Patient who is scheduled for a cerebral arteriography with local anaesthesia
* Patient who capable to read and understand the patient information and consent.
* Patient capable to read and sign the consent form
* Patient with social insurance
* Woman of childbearing age with effective contraception (see WHO definition), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
* Negative urine pregnancy test

Exclusion Criteria:

* Patients who have had a previous cerebral arteriogram
* Patient with allergy to iodinated contrast medium
* Patient with severe renal insufficiency
* Patient requiring sedation and artificial ventilation
* Patient who is deaf and/or hard of hearing
* Patient with a known allergy to essential oils
* Patient with anosmia

  * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship,
  * Pregnant or breastfeeding woman
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

Eligibility Criteria:
Key Inclusion Criteria:

1. 65 years of age or older at time of randomization
2. Moderate aortic stenosis
3. Subject has symptoms or evidence of cardiac damage/dysfunction
4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Key Exclusion Criteria:

1. Native aortic annulus size unsuitable for the THV
2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
3. Aortic valve is unicuspid or non-calcified
4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification
5. Pre-existing mechanical or bioprosthetic aortic valve
6. Severe aortic regurgitation
7. Prior balloon aortic valvuloplasty to treat severe AS
8. LVEF \< 20%
9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing PEP

Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. We hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP) compared with indomethacin alone (IN).


Eligibility Criteria:
Inclusion Criteria:

1. Patients underwent diagnostic or therapeutic ERCP
2. With native papilla
3. With difficult cannulation (cannulation time \>10min or cannulation attempts \>5 times or inadvertently PD cannulation ≥1)
4. Receiving post-ERCP rectal indomethacin

Exclusion Criteria:

1. Patients with indications of PD cannulation
2. No attempt of cannulation due to inaccessible papilla
3. Non-difficult cannulation
A Single Dose Study of LY3023703 in Healthy Participants

This is a phase I study of LY3023703 in healthy participants. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Participants will remain in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy individuals based on the history and physical examinations as determined by the investigator
* Body mass index between 18.5 and 32.0 kilograms per square meter (kg/m\^2), inclusive

Exclusion Criteria:

* Have known allergies to LY3023703 or any components of the formulation, celecoxib, or sulfonamides. Participants with known aspirin allergy, allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs), or allergies or intolerance to other selective microsomal prostaglandin E synthase (mPGES-1) inhibitors should also be excluded
* Have the presence of active peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, or chronic diarrhea, or positive Helicobacter pylori serology
* Use NSAIDs, celecoxib, aspirin, or acetaminophen (at doses greater than 1 gram per day) within 14 days of screening
Description of Abdominal and Gluteo-femoral Subcutaneous Adipose Tissue Cell Population in Women - GLUTAB

The purpose of this study is to compare, in healthy women, the adipose tissue composition between abdomen and thigh and then determine whether differences exist independently of the state of obesity.

The findings of this study may help to explain the mechanism contributing to a beneficial role of gluteo-femoral fat contrasting with a deleterious role of abdominal fat on cardiovascular and metabolic dysfunctions.


Eligibility Criteria:
Inclusion Criteria:

* women between 15 and 45 years old
* with genital activity
* stable weight during the previous 3 months
* BMI from 20 to 28
* regular menstrual cycles (28 +/- 2 days) during the previous 3 months
* reliable means of contraception (systemic hormonal contraception, intrauterine contraceptive device, tubal ligation)
* using the same way of contraception during the previous 3 months
* normal clinical examination
* able to be compliant with the schedule of protocol assessments
* willing and able to provide written informed consent
* affiliated to a National Health Service
* agreeing to being registered on the national file for subjects participating in biomedical research

Exclusion Criteria:

* Exclusions related to significant medical disturbances :
* type I and II diabetes
* early menopause
* serious psychological disorders
* uncontrolled thyroid disorders
* know allergy to local anesthetics especially Xylocaine
* abnormal laboratory results
* medical history that, in the opinion of the investigator, makes the subject unsuitable for enrollment
* positive test result for HIV, HCV and/or HBV virus
* positive pregnancy test
* Exclusions related to subject lifestyle :
* smoking \> 10 cigarettes per day
* smoking cessation during the previous 3 months
* weight fluctuation (\>3kg) during the previous 3 months
* alcohol abuse
* coffee or tea consumption \> 6 cups per day
* high consumption of drinks comprising xanthine bases (\>0.5 liters/day)
* consumption of drinks (water or herbal teas) \> 2 liters per day
* Exclusions related to previous or concomitant treatments :
* anticoagulant
* neuroleptic or antidepressant
* medication with draining, lipolytic, appetite suppressant and/or slimming effect
* local or systemic corticosteroid therapy on the test areas
* hormonal treatment other than contraception
* diuretic
* local treatment against cellulitis (mesotherapy,phosphatidylcholine injection, mechanical process)
* thighs liposuction \< 2 years
* chronic treatment with anti-inflammatory
* Exclusions related to the subject :
* unwillingness or inability to comply with the requirements of the protocol
* previous participation in a clinical trial within 30 days
* inability to understand and sign the consent due to linguistic or psychic issues
* subject deprived of liberty or under guardianship, tutorship or judicial protection
* female who are currently pregnant or breastfeeding or female considering becoming pregnant while in the study
Safety and Efficacy of Nemolizumab in PN

The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo nodularis.

This is a randomized, placebo-controlled, double-blinded, parallel group, multicenter study to evaluate the safety and efficacy of nemolizumab over a 12-week treatment period in patients suffering from prurigo nodularis compared to its placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female of at least 18 years at screening
2. Clinical diagnosis of PN for at least 6 months with:

   * Prurigo lesions on upper limbs with or without lesions on the trunk or lower limbs
   * At least 20 nodules on the entire body with a bilateral distribution
3. Severe pruritus defined as follows on a Numerical Rating Scale (NRS)

   * At the Screening visit 1: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous 3 days
   * At the Baseline visit: Mean of the worst daily intensity of the NRS score is ≥ 7 over the previous week; NOTE: NRS score should be measured on at least 5 days during the week preceding the baseline visit.
4. Female subjects must fulfill one of the criteria below:

   * Female subjects of non-childbearing potential (postmenopausal \[absence of menstrual bleeding for 1 year prior to screening, without any other medical reason\], hysterectomy or bilateral oophorectomy);
   * Female subjects of childbearing potential who agree to a true abstinence (when in line with the preferred and usual lifestyle of the subject), or to use an effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration:

Exclusion Criteria:

1. Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease
2. Unilateral lesions of prurigo (e.g only one arm affected)
3. Cutaneous bacterial or viral infection within 1 week before the baseline visit.
4. Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit, or during the screening period, unless completely resolved at the screening/ baseline visits respectively,
5. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the subject at Chronic pruritus resulting from another condition than PN such as scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease
Leadership, Engagement, and Youth Activism Program with Mindfulness (LEAP)

The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities and to address barriers to equity, through the acquisition of civic leadership and development skills as well as mindfulness practice, LEAP-M: Leadership, Engagement, and youth Activism Program with Mindfulness.

The goal of our proposal is to determine whether the Leadership, Engagement, and youth Activism Program with Mindfulness.(LEAP-M) curriculum, which was developed with youth of color, is a feasible and effective intervention for fostering civic leadership, civic development, and wellbeing. We seek to understand whether LEAP-M can support wellbeing for youth of color as a strategy to combat structural racism at the school- and neighborhood-levels, increase youth mental, emotional, and behavioral (MEB) health and decrease health disparities in youth of color.

The LEAP-M study will determine whether a 14-session program designed to provide leadership and mindfulness skills to youth of color is an effective and feasible intervention. The curriculum consists of 14 two-hour sessions delivered after school. The comparison group will take part in EnvisionIT, a college and career readiness program designed for students in grades 6 through 12. EnvisionIT aims to prepare students with essential transition skills, digital literacy, and college and career readiness. The comparison group will also have 14 two-hour group sessions. Both LEAP-M and EnvisionIT will be delivered by trained facilitators. All participants in LEAP-M and EnvisionIT will be assessed at two time points assessing program outcomes; facilitators will also complete interviews post-intervention and provide feedback on data fidelity and acceptability following each session. This record reports on the UG3 pilot phase and will be amended for a UH3 phase.

Eligibility Criteria:
Inclusion Criteria:

• Adolescents ages 14-18 in grades 9-12 enrolled in collaborating sites, either at Metropolitan Council for Educational Opportunity (METCO) in Boston, MA, or University of Illinois/Chicago Public School.

Exclusion Criteria:

* Adolescents who are not available to commit to the intervention schedule.
* Adolescents who are not in grades 9-12.
* Parents/guardians with preferred language other than English or Spanish.
A Phase 1 Study of MORAb-004 in Patients With Solid Tumor (Study: MORAb-004-J081-103)

This is a multicenter, multiple doses, open-label Phase 1 study of MORAb-004 in subjects with solid tumors. Subjects may have any solid tumor without intracranial involvement or metastases that has failed standard chemotherapy.

This study will be conducted in 2 parts: 1) Part 1 will be the dose escalation portion of this study to assess the tolerability and the safety profile of MORAb-004. Dose will escalate in different cohorts as follows: 2, 4, 8 and 12 mg/kg weekly dosing each as a 4-week cycle with no intra-subject escalation. Individual participants may have additional cycles at the same dose until disease progression unless the participants meet the discontinuation criteria.

2) Part 2 will comprise cohort expansions to further characterize the safety and tolerability of MORAb-004 and to assess preliminary efficacy and the pharmacokinetic/pharmacodynamic relationship of MORAb-004 in gastric cancer and hepatocellular carcinoma (HCC). Three dose levels will be expanded based on the safety profile that was obtained in the dose escalation portion of this study (Part 1): 4 mg/kg (administered on a weekly basis), 8 mg/kg (administered on a weekly basis) and 12 mg/kg (administered every OTHER week).


Eligibility Criteria:
Inclusion criteria:

1. Provide written informed consent,
2. Japanese male and female subjects aged at 20 or older at informed consent,
3. Have malignant solid tumor, without intracranial involvement or metastasis, diagnosed by standard pathology criteria that has failed or are resistant to standard chemotherapy,
4. Performance status (PS) is 0 to 1 by Eastern Cooperative Oncology Group,
5. With no carry-over effect and no adverse drug reaction of prior treatment which may affect the safety evaluation of MORAb-004, except for Grade 1 or 2 neuropathy and alopecia,
6. Survival expectation is 12 weeks or longer after starting MORAb-004 administration

Exclusion criteria:

1. Have clinically significant cardiovascular disease,
2. Scheduled for laparotomic surgery due to trauma or other reasons for during the study,
3. Have clinically significant hemorrhagic event or history, or event with high risk of hemorrhage,
4. Receiving chronic systemic anticoagulation,
5. Have evidence of other active invasive malignancy
6. Females who are lactating or pregnant at Screening or Baseline