cyrilzakka/clinical-trials huggingface dataset:
Genetics of Cardiovascular Reactivity in Black Youth

To evaluate individual differences in cardiovascular responses to acute stress in Black adolescents.

BACKGROUND:

The prevalence and severity of essential hypertension (EH) are greater among Black Americans than other ethnic groups in the U.S. Blacks are at increased risk for target organ damage from elevated blood pressure, including heart disease, stroke, and endstage renal failure. There are significant ethnic differences in cardiovascular reactivity (CVR) to stress, which is a risk factor for elevated blood pressure. Studies have shown that CVR to stress is stable over time, heritable, and predictive of future elevations in blood pressure and the development of essential hypertension. These properties make measures of CVR a valuable intermediate for genetic studies of hypertensive risk.

DESIGN NARRATIVE:

The genetic epidemiology study will test the hypothesis that individual differences in CVR to acute stress in Black youth are associated with well defined polymorphisms in candidate genes related to blood pressure including: 1) alpha- and beta-adrenergic receptor genes; 2) genes involved in catecholamine metabolism; 3) genes involved in endocrine function; 4) genes involved in the renin angiotensin system. By focusing on normotensive youth at risk for developing essential hypertension, the investigators hope to identify genes associated with the onset, rather than the sequelae, of hypertension. Moreover, given that CVR to acute stress is defined as a change in cardiovascular function evoked by an environmental manipulation of stress, the research is inherently a study of gene-environment interactions.

A total of 500 unrelated Black adolescents and young adults (equal numbers of males and females), 15-21 years of age will be studied. Buccal cell samples will be collected for DNA extraction from all subjects for genetic association analyses. Impedance cardiography and blood pressure monitoring will be used to assess components of CVR to stress during video game, mental arithmetic, cold pressor, and whole body cold exposure tasks, all of which have been utilized or developed in the laboratory. Various methods will be used to evaluate genetic associations with CVR to acute stress, including analyses of single nucleotide polymorphisms and haplotypes. Supplementary analyses will evaluate potential gene-gene interactions and additional gene-environment interactions involving chronic environmental stress.

Eligibility Criteria:
African American non-hypertensive, no chronic disease which would affect blood pressure
Ultrasound Assessment of the Inferior Vena Cava in Children

This is a prospective, non-blinded observational study to compare measurement of inferior vena cava (IVC) dimensions with two placement sites of the ultrasound probe (sub-xiphoid and the side or right lateral position).


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2 patients scheduled for elective dental surgery under general anesthesia.

Exclusion Criteria:

* History of significant pulmonary disease, cardiac disease, and laparotomy.
Evaluation of the Effects of LUNII on Pre-operative Anxiety and on the Post-operative Period in Children With Cleft Lip and Palate Admitted for Alveolar Bone Graft: Pilot Study

The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.

The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.

The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.

The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.

Patients admitted for an alveolar bone graft with an iliac donor site as part of the treatment of their cleft lip and palate will be include for two reasons:

1. It is a homogeneous population - same condition, same treatment, same age at surgery, standardized procedure;
2. It is a population with long individual medical histories and, potentially, subjected to significant surgery-related stress.

Patients will be randomized into two groups: with LUNII and without LUNII.

In the LUNII group, the interactive story teller LUNII will be delivered the day before surgery during the pre-operative medical visit.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 to 6 years.
* Alveolar bone graft with iliac crest donor site in children with unilateral or bilateral cleft lip and palate
* Primary alveolar bone graft or first side when bilateral cleft
* Followed at Necker since birth and operated according to the protocol used in the department.
* Consent signed by the holder (or holders) of parental authority

Exclusion Criteria:

* Medical care different from the usual protocol applied in the service (secondary surgery, age \> 7 years)
* Known psychomotor delay, associated rare syndrome or disease, known psychiatric disorders, other surgical procedures between hard palate closure and alveolar bone graft
* Possession and/or prior use of LUNII by the child
Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children - MEIBO-ROSACEE

The aim of this study is to describe the clinical, meibographic and interferometric manifestations of phlyctenular keratitis in children.

The investigators are conducting a monocentric, transversal, epidemiologic study. 100 patients should be included: 50 children suffering from ocular rosacea, and 50 children with no palpebral or Meibomian disease. Witnesses will be matched on the age of the cases.

Patient and controls will undergo a classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, the child will go through a meibographic and interferometric evaluation of his two inferior eyelids. This evaluation is made by an optometrist with the Lipiview device, and lasts a few minutes.

Eligibility Criteria:
Inclusion Criteria:

* Recruited from a specialized ophthalmologic consultation Rothschild Ophthalmologic Foundation, Paris, France.
* Cases : suffering from ocular or oculo-cutaneous rosacea
* Witnesses : without any present or past palpebral or meibomian disease

Exclusion Criteria:

* Unable to achieve the meibographic and interferometric examination (Lipiview)
Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment

The primary objective is to validate that the Immunoscore® test (IS0 to IS4) is able to identify patients with high risk (IS 0-1) of relapse or death whichever occurs first among Stage III patients under oxaliplatin-based adjuvant therapy.

Then the prognostic value of Immunoscore® Colon to predict disease free survival (DFS) will be assessed in Stage III patients under Oxaliplatin treatment in each arm of the IDEA trial (6- months and 3-months treatment).

Finally, the additive value of the Immunoscore® test to stratify the DFS will be evaluated among standard clinical and biological parameters and tumor features.

Adult patients of both genders who have underwent surgical resection of stage III colon carcinoma and randomised to receive a 6-month or 3-month adjuvant therapy with modified FOLFOX 6 or CAPOX in the IDEA France trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient and tumor characteristics; 3-year clinical Follow-Up
* Data regarding other markers (eg. MSI)
* FFPE blocks available, including core tumor + invasive margin regions

Exclusion Criteria:

• Bouin fixative

Sample type:

• adjacent FFPE slices (4 μm each) per case (although only one slide is required for CD3 and one for CD8, with center of tumor (CT) and the invasive margin(IM) cut from FFPE blocks no more than 4 months before the Immunoscore® testing
Effect of Oxidant Gel and Anti-oxidant Gel on Wound Healing After Gingival Depigmentation

To evaluate effect of Oxidant (Oxygen Releasing Oral Gel) with Coe-Pak versus Anti-oxidant (Nano-emulsion complex propolis and vitamin C gel) with Coe-Pak on wound healing, pain, patient satisfaction after gingival depigmentation

Gingival depigmentation is considered a periodontal plastic surgery, in which gingival hyperpigmentation is eliminated. The scalpel surgical method is one of the most cost-effective methods, easiest and does not need broad equipment. However, scalpel surgery leads to bleeding during and after surgery, and the surgical area has to be covered with periodontal dressing for 7-10 days. Periodontal dressings are used around the necks of the teeth and surrounding tissue to cover the wound. Non-eugenol dressings are now the most commonly used periodontal dressings include Coe-Pak, Cross Pack, Peripac, Septopack, PerioCare, Perio Putty and Periogenix. Anti-oxidant gel (Nano-emulsion complex propolis and vitamin C - NBF GINGIVAL GEL®) is a high efficiency nano bio fusion gel containing propolis, nano vitamin C, E and herb extract. Anti-oxidant power of nano Vitamin C (NBF GINGIVAL GEL®) is ten times more effective in hundred times smaller amounts, than Vitamin C by itself. Vitamin C collaboratives with Vitamin E and preserves cell membranes integrity. Propolis has antioxidant effect due to its radical scavenging ability, which was more efficient than antioxidant effect of vitamin C. it also enhances synthesis of collagen due to the presence of iron and zinc elements. it has proven to increase healing of epithelial tissues. The presence of oxygen in Oxygen Releasing Oral Gel (blue®m gel) enhances cellular metabolism, collagen synthesis, antibacterial activity, angiogenesis, revascularization, and the release of growth factors, it also helps keratinized tissue formation and has antimicrobial effects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years with anterior maxillary or mandibular physiologic gingival pigmentation
* Systemically healthy patients
* Good oral hygiene, Plaque index less than 15%.
* Cooperative patients able and accept to come for follow up appointments

Exclusion Criteria:

* Any interim intervention that may have affected any of the outcomes of interest.
* Pregnant and lactating females.
* Smokers
* Patients reporting systemic conditions that may cause hyperpigmentation (eg.Addison's disease) or on medications (eg. Corticosteroids)
* Patients reporting systemic conditions that may compromise healing (eg. Diabetes)
* Patients with poor oral hygiene.
* Any known allergies
A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors

This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors, carrying the HLA-A\*02:01 allele.


Eligibility Criteria:
Key Inclusion Criteria:

* Unresectable and/or metastatic solid tumors that have received standard-of-care (SOC) therapies previously and have no other SOC options available
* Confirmed HLA-A\*02:01 haplotype
* Confirmed MAGE-A4 expression
* Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Life expectancy of \>/=12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Absence of rapid disease progression, threat to vital organs or non-irradiated lesions \>2 cm in diameter at critical sites
* No significant ongoing toxicity from prior anticancer treatment
* Adequate hematological function
* Adequate liver function
* Adequate renal function
* If applicable, willingness to use contraceptive measures.

Key Exclusion Criteria:

* History or clinical evidence of CNS primary tumors or metastases
* Another invasive malignancy in the last 2 years
* Uncontrolled hypertension
* Significant cardiovascular disease
* Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection
* Current or past history of CNS disease
* Dementia or altered mental status that would prohibit informed consent
* Active auto-immune disease or flare within 6 months prior to start of study treatment
* Expected need for regular immunosuppressive therapy or with systemic corticosteroids
* Insufficient washout from prior anti-cancer therapy
* Prior treatment with a bispecific T-cell engaging or adoptive cell therapy.
Social Effects of Alcohol

In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction

The study will use a within-subject crossover design with four sessions, in which participants receive alcohol or placebo across sessions. During the four sessions, the participants will engage in a conversation with a stranger, and emotional responses and feelings of connection will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* non-problem alcohol consumption of 2-20 drinks per week
* high school diploma or equivalent
* BMI between 19 and 26
* verbal fluency in English

Exclusion Criteria:

* High blood pressure
* Any medical condition requiring regular medication
* Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
* Women who are pregnant or trying to become pregnant.
SWISS_EVIDENCE - Compartment Compressibility Monitoring Using CPM#1

Compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life-threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages.

Even though compartment syndrome is a well described medical condition, the appropriate treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own risks. Furthermore, and of most critical importance is the timing for the intervention of a fasciotomy. The concerned limb may already have had severe, sometimes even irreversible, tissue damage due to high intra-compartmental pressure within 6 to 10 hours.

The standard diagnostic method for compartment syndrome is an invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. Commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and user errors are common.

Compared to the invasive modalities, the Compremium Compartmental Compressibility Monitoring System (CPM#1) shows promising advantages for the clinical application. Not only is the technology used for the CPM#1 device safe and non-invasive for the patient with minimal training required for the healthcare professionals, but it has also demonstrated high intra- and inter-observer reproducibility (as per bench tests and clinical settings with prototypes, to be confirmed in clinical studies like this one). The use of the CPM#1 device therefore facilitates the measurements, as it is based on pre-existing ultrasound methods and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Male and female
* Age between 18 and 84

Exclusion Criteria:

* Previous surgery to or fracture of the lower leg
* Peripheral arterial or venous disease
* History of compartment syndrome
* Limb anomalies
* General muscle disorder
* Participants under the influence of excessive alcohol, consumption of narcotics or benzodiazepines prior to procedure
* Participants under the effect of analgesic (\< 12 hours)
Eltrombopag for Enhancing Platelet Engraftment in Pediatric Patients Undergoing Cord Blood Transplantation

Platelet recovery is significantly hampered following umbilical cord blood transplantation (UCB). Thus, after UCB transplantations, patients are platelet transfusion-dependent for prolong periods of time.

Eltrombopag is a thrombopoietin-receptor agonist that initiates thrombopoietin-receptor signaling and thereby induces proliferation and maturation of megakaryocytes.

We will evaluate the safety and efficacy of eltrombopag for enhancing platelet engraftment in pediatric patients undergoing cord blood transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥ 1 year and \< 18 years old.
2. Patients receiving unmanipulated single or double UCB allogeneic grafts.
3. Malignant and non malignant indications for transplantation.
4. Myeloablative and reduced intensity conditioning regimens.
5. Patients must meet all other pre-transplantation criteria of the transplantation center including acceptable tests of heart, liver, kidney, and lung function (standard screening for transplantation per PI, and co-investigators).
6. Written informed must be obtained from the patient's guardian, and accompanying informed assent from the patient for children over 6 years old.
7. Able to comply with study protocol.

Exclusion Criteria:

1. Indications for transplantation

   1. Patients with primary myelofibrosis.
   2. French-American-British classification (FAB)M7 acute myeloid leukemia. Acute leukemia secondary to a myeloproliferative neoplasm.
   3. Patients with persistent acute leukemia (\>5% bone marrow blasts) at the time of transplantation.
2. Patients with prior thromboembolic event. Patients with previous catheter related thrombosis will be eligible if more than 3 months elapsed.
3. Hypersensitivity to eltrombopag.
4. Liver enzymes abnormalities:

Alanine aminotransferase (ALT) levels \> 3 times the upper limit of normal (ULN) or serum bilirubin \> 1.5 ULN (unless due to Gilbert's syndrome or hemolytic bilirubin).

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Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers

This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a washout period of 14 days

The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 14 days. During each session, the subjects will be administered a single dose of 5mg amlodipine (one LANDI-Amlodipine Tablet 5mg or one Norvasc Tablet 5mg) under fasting and FED conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers of 18-40 years old, male or female.
2. Body mass index (BMI) ranges from 19.0 to 25.0 kg/m2, body weight ≥ 50 kg for male and 45 kg for female.
3. No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities; No preparation allergies, serious infection or injury, etc.
4. Medically healthy subjects with clinically normal laboratory profiles and ECGs.
5. Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until 3 months of last dose administration
6. Subjects are fully informed and voluntarily consent to participate in this study.

Exclusion Criteria:

1. History of allergy or hypersensitivity to amlodipine
2. Significant history of neurological, cardiovascular, digestive, respiratory, urinary, hematological, dysmetabolism or other diseases (such as psychosis) which is unfavorable to the study
3. History of postural hypotension
4. Blood donation or lost more than 400mL blood within 3 months prior to the study
5. Use of medications within 2 weeks before the study
6. Volunteer in any other clinical drug study within 3 months prior to this study
7. Drug abuse or alcohol abuse (220ml beer /day or \>5 times in 2 hours)
8. Smoker (\>10 cigarettes/day)
9. A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test
10. Abnormal chest X-ray results with clinical significance
11. Women of childbearing potential, pregnant and lactating women.
12. Other unfavorable factors diagnosed by investigators.
Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D

Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.

During a 4-week washout period, participants stopped taking cinacalcet or other vitamin D receptor activators (VDRAs). (Participants who were naive to cinacalcet or VDRAs did not have to wash out). At randomization, participants entered a 28-week open-label treatment period, during which they received either cinacalcet or paricalcitol. Participants who were assigned to receive paricalcitol were dosed according to the approved label in their respective geographic regions (i.e., IV at sites in the US and Russia and oral at sites in Europe). Supplemental cinacalcet was administered to participants in the paricalcitol arms who developed hypercalcemia (defined as \>= 10.5 mg/dL). The evaluation period was from Weeks 21 to 28.

Eligibility Criteria:
Inclusion Criteria

1. Male or female patients \>= 18 years old.
2. Patient was diagnosed with Stage 5 chronic kidney disease (CKD) and had been receiving intravenous (IV) or oral vitamin D receptor activators (VDRAs) or cinacalcet during the 8 weeks prior to the screening period or naïve patients who had not received VDRA or cinacalcet within 8 weeks of screening.
3. Patient was on maintenance HD (hemodialysis) 3 times weekly (TIW) for at least 3 months prior to screening and was expected to remain on HD for the duration of the study.
4. For entry into the Pre-Treatment Washout Period (for patients who were not naïve to VDRAs and cinacalcet), the patient had to have screening laboratory values of:

   * iPTH level 130 to 700 pg/mL
   * Serum Total Alkaline Phosphatase level \>= 40 U/L
   * Calcium level \<= 10.0 mg/dL (2.49 mmol/L)
   * Calcium-phosphorus product (CaxP) \<= 75 mg2/dL2 (US) and \<= 70 mg2/dL2 (non-US)

Exclusion Criteria

1. Patient had a history of parathyroidectomy.
2. Patient had a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the investigator.
3. Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of cytochrome P450 (including grapefruit and/or grapefruit juice) 3A (CYP3A) or drugs metabolized by cytochrome P450 2D6 (CYP2D6) (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants) within 2 weeks prior to study drug administration. Commonly used beta blockers such as metoprolol and carvedilol are allowed but are metabolized by CYP2D6; thus, an adjustment to a lower dose may have been required.
4. Patient was known to be human immunodeficiency (HIV) positive.