cyrilzakka/clinical-trials huggingface dataset:
Periodontal Plastic Reconstruction of Soft Tissue Dehiscences After the Removal of Localized Gingival Enlargements

Non-inflammatory recessions and Miller class I-II-III. mucogingival defects after elimination of localized gingival enlargements are frequently encountered challenges in the daily practice. In Miller class II-III. recessions the lack of keratinized tissues often compromise the maintenance a proper oral hygiene, this can cause inflammation, which can result in further periodontal attachment loss. In the literature there are some approaches that aim at widening of keratinized tissues and root coverage at the same time, such as the subperiosteal envelope technique (SET) (Allen 1994) combined with a subepithelial connective tissue graft (SCTG) or a partially epithelialized connective tissue graft (PE-SCTG) (Stimmelmayr 2011). In the eradication of localized gingival enlargement postoperative complications following surgical removal, such as recurrence and subsequent gingival recessions as well as loss of keratinized tissues are commonly observed. Nevertheless, a state of the art comprehensive treatment approach has not been reported yet to overcome the above mentioned sequels. The aim of this study is to present a periodontal plastic surgical approach to definitively eliminate localized gingiva enlargements and to simultaneously correct consecutive Miller class I II-III. recessions, esthetic disturbances. (Ethical committee permission number: SE RKEB: 185/2020.)


Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years
* systematically healthy patients
* localized gingival enlargement is present that involves maximum 3 teeth

Exclusion Criteria:

* pregnant women
* medication intake that can potentially affect the oral mucosa and its healing
* heavy smokers (\>=15)
Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies

This is a Multicenter, Open-label, Phase 1b Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 years or older
* Patients must have a diagnosis of a solid tumor malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective
* Radiographically or clinically evaluable tumor
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse
* Male patients who agree to practice effective barrier contraception through 4 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
* Voluntary written consent
* Clinical laboratory values as specified in the protocol

Exclusion Criteria:

* Female patients who are breastfeeding and lactating or pregnant
* Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
* Treatment with any investigational products within 28 days before the first dose of study drug
* Prior treatment with Aurora A-targeted agents, including alisertib
* Prior treatment with MEK inhibitors, including TAK-733
* Prior treatment with BRAF inhibitors
* Systemic anticancer therapy within 21 days before the first dose
* Prior biologic or immunotherapy within 28 days before the first dose
* Major surgery or serious infection within 14 days before the first dose
* Life-threatening illness unrelated to cancer
* Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
* Cardiac condition as specified in study protocol or severe CNS, pulmonary, renal or hepatic disease
* Known GI conditions or GI procedure that could interfere with the oral absorption or tolerance of study drugs
* History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
* History of ongoing or a newly diagnosed eye abnormality
* Symptomatic brain metastases

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons
Haptonomy and Mindfulness on Psychological Well-being Levels, Perceived Stress, Fear of Childbirth

Aim: The aim of this project was to examine the effects of haptonomy application and the mindfulness-based stress reduction program (MBSRP) on the psychological well-being levels, perceived stress, and fear of childbirth in primiparous women.

Materials and Methods: This prospective, single-blind, randomized controlled study was conducted between January 1, 2024, and October 1, 2024. A total of 120 primiparous women (40: control group, 40: haptonomy group, and 40: MBSRP group) who volunteered to participate in the study were randomly assigned to three groups: the intervention group (haptonomy and MBSRP) and the control group. The haptonomy and MBSRP groups received individual and face-to-face interventions for 8 weeks. At baseline, the 4th week, and the 8th week, the "Personal Data Collection Form," "Psychological Well-Being Scale," "Perceived Stress Scale," and "Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ/A) A version" were administered, based on a literature review.


Eligibility Criteria:
Inclusion Criteria:

* Women who are married and experiencing their first pregnancy.
* Aged 18 years or older.
* Able to read, write, and understand Turkish.
* Residing in the city center where the study is conducted.
* No physical or psychological health issues for themselves or their baby.
* Experiencing a spontaneous pregnancy between 22-28 weeks of gestation.
* Have not previously undergone BFTSAP (Body-Focused Therapy and Support for Anxiety during Pregnancy) and haptonomy applications.
* Pregnant women who agree to participate in the study.

Exclusion Criteria:

* Those with a known and diagnosed psychiatric disorder.
* Individuals who have previously undergone cognitive therapy.
* Experiencing severe levels of anxiety, stress, and depression.
* Having chronic diseases (such as hypertension, diabetes mellitus, heart diseases) that existed before or have emerged during pregnancy.
* Individuals who have not attended the first two sessions of the MBSR (Mindfulness-Based Stress Reduction) program and haptonomy applications.
* Lacking a partner or relative who can provide support and assistance at home during the applications.
* Without access to technical technology support.
* Pregnant women who do not agree to participate in the study.
Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding

This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.


Eligibility Criteria:
1. Women ages 18-45
2. Pregnant and equal to or more than 24 weeks of estimated gestational age
3. States an intent to breastfeed for at least 6 months
4. States a plan to use the LNG-IUS postpartum
5. Anticipates a vaginal delivery
6. HIV negative
7. Intend to stay in the Chapel Hill area for at least 6 months after birth
8. No medical or personal conditions which in the judgment of study staff preclude participation in the study
9. Have no allergies to any component of the LNG-IUS
10. No known uterine anomalies
11. Fluent in English
12. No history of ectopic pregnancy
13. No known or suspected carcinoma of the breast
14. No known acute liver disease or liver tumor (benign or malignant)
15. No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear
16. No active pelvic inflammatory disease
17. No known hypersensitivity to any component of the LNG-IUS
18. No genital bleeding of unknown etiology
19. No history of solid organ transplantation

Additional eligibility criteria for entry into the randomized trial, as assessed postpartum

1. No endometritis or chorioamnionitis
2. Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes)
3. No fever greater than or equal to 38°C during the intrapartum or postpartum period
4. Did not receive medications other than pitocin and/or misoprostol to control postpartum bleeding
5. Did not have a documented estimated blood loss of greater than 750mL intrapartum
6. Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage
7. Did not have a third or fourth degree laceration at delivery.
8. The infant must be greater than 35 weeks EGA at birth as determined by physical exam at birth
9. The infant must weigh at least 2727 grams
10. Must have been a singleton birth
11. Infant not in the intensive care nursery
12. The infant has not been diagnosed with a condition which would preclude long term feeding
Romiplostim in Chemotherapy-Induced Thrombocytopenia

Prospective interventional randomized controlled trial to assess safety and efficacy of romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with solid malignancy

Chemotherapy-induced thrombocytopenia (CIT) frequently complicates cancer treatment causing delays in treatment and dose reduction for subsequent administration of cancer-directed treatment.

Romiplostim is a potential agent that can improve platelet counts, allowing the resumption of chemotherapy, decreasing the need for platelet transfusions, and increasing the nadir platelet counts thus improving dose intensity.

Eligibility Criteria:
Inclusion Criteria:

Age: 1- 18 years. Patients diagnosed with solid malignancy based on clinical, histopathological features, and /or immunohistochemical staining.

Patients with chemotherapy-induced thrombocytopenia defined as either

* severe thrombocytopenia either clinically with high bleeding score or laboratory by platelet count reaching critical level \< 20x10e9/L requiring platelet transfusion at time of chemotherapy cycle nadir.
* delayed recovery of platelet count: a platelet count of less than 100 x10e9/L for 3 weeks from the first day of chemotherapy cycle administration or the previous dose was reduced by \>20% due to low platelet count \<100×10e9/L.

Exclusion Criteria:

* Patients with second primary neoplasm.
* Patients with relapsed/refractory solid malignancy.
* Presence of primary or metastatic liver cancer.
* History of a prior symptomatic venous thromboembolic event (VTE) or arterial ischemic events.
* Patients with thrombocytopenia due to other etiologies e.g., underlying inherited thrombocytopenia.
A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children

The purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.


Eligibility Criteria:
INCLUSION CRITERIA:

Subject has diagnosis of partial seizures with/without secondary generalization, supported by:

* Observed ictal events consistent with partial seizures: With/ without secondary generalization; Documented by reliable observers
* 1 of following 2: EEG at some time in past demonstrating focal abnormalities consistent with partial seizures; OR, in absence of demonstrable EEG abnormality: MRI/CT scan evidence of a focal CNS lesion consistent with partial seizures
* On stable dose of 1 or 2 antiepileptic drug(s) (AED) other than valproate, for at least 1 month
* Not taking valproate or is currently receiving valproate resulting in a trough concentration of less than 40 mcg/mL
* History of at least 4 partial seizures/month in 2 months prior to screening
* Parent/caregiver is able to keep an accurate seizure diary

EXCLUSION CRITERIA:

* History of any of following: Lennox-Gastaut syndrome; Primary generalized seizures; Infantile spasms; Mixed seizure disorders including atypical absence; Myoclonic or atonic seizures; Pseudoseizures or Epilepsia Partialis Continuans (EPC)
* Has had status epilepticus in the past 6 months
* Has significant history of any of following that would confound study results: Cardiac (including clinically important abnormality on ECG); Renal; Psychiatric (including psychosurgery); Oncologic; Endocrine; Metabolic; Pancreatic; Hepatic disease (including clinical/serological history of hepatitis); Urea cycle disorder
* Has: Expanding CNS neoplasm; Active CNS infection; Demyelinating disease; Degenerative neurological disease; Progressive encephalopathy; or any Progressive CNS disease
* Has platelet count less than or equal to 100,000/mcL
* Has blood chemistry ALT/AST value(s) greater than or equal to 2 times upper limit of normal at screening
* Requires anticoagulant drug therapy
* Not expected to be able to maintain same dose of all pre-study AEDs, excluding valproate, throughout study
* Receiving systemic chemotherapy
* Has taken lamotrigine, felbamate, or pemoline, within past 3 months prior to screening
* Has been on ketogenic diet within 30 days prior to screening
* Considered by investigator to be non-responder to valproate for treatment of epilepsy (e.g., Despite adequate trial with serum concentrations of 60 mcg/mL or greater, subject continues to have inadequate seizure control)
Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (\>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.

Exclusion criteria:

1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

   * Affect the safety of the patient throughout the study
   * Influence the findings of the studies or their interpretations
   * Impede the patient's ability to complete the entire duration of study
3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
Infant Respiratory Interface and Accessories Evaluation Study

Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneously breathing infants who require non-invasive respiratory support
* Parent(s)/guardian(s) at least 18 years of age

Exclusion Criteria:

* Parent(s)/guardian(s) unable to give written informed consent
* Neonate or infant not requiring non-invasive support
* Suspected or confirmed abnormalities or trauma to the skull or airway
Efficacy and Safety of Hippophae Rhamnoides L. Leaf Extract on Body Fat

Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year. In vitro and animal studies elucidated Hippophae rhamnoides L. Leaf Extract as a novel anti-obesity agent. However, the efficacy and safety of Hippophae rhamnoides L. Leaf Extract supplementation on body weight regulation in humans are lacking.

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Hippophae rhamnoides L. Leaf Extract on body fat. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index.

Eligibility Criteria:
Inclusion Criteria:

* age between 19 and 65 years,
* BMI 25\~29.9 kg/m2 or Waist circumference ≥ 90(men), ≥ 85(women),
* subjects giving written informed consent

Exclusion Criteria:

* BMI ≥ 30 kg/m2
* Significant variation in weight(more 10%) in the past 3 months
* Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker
* History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnancy or breast feeding etc,.
The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics

The long-term goal of our PIC is to develop effective strategies that can be applied clinically at the point-of-care to prevent, intercept, or detect PDAC at an early stage, thereby reducing PDAC burden and saving lives.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Moffitt Cancer Center patients presenting with a pancreatic cyst, and/or inherited syndrome that predisposes them to pancreatic ductal adenocarcinoma (PDAC)
* Moffitt Cancer Center patients undergoing evaluation for localized/early stage PDAC.
* Moffitt Cancer Center patients with a combination of PDAC risk factors such as a history of chronic or new-onset diabetes, pancreatitis, obesity, tobacco exposure, toxin exposure and/or heavy alcohol consumption.
The Effect of Niacin Administration on Oxidative Stress in Patients With Hypercholesterolmia, as Measured by the Use of a Novel Biomarker

1. Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease in oxidative stress and a decrease in the atherogenecity in blood samples of the patients.
2. A possible correlation between oxidative stress in hypercholesterolemic patients taking niacin to clinical hypercholesterolemia parameters is possible.
3. Using a novel biomarker will enable a precise detection of the change in the oxidative stress in hypercholesterolemic patients.


Eligibility Criteria:
Inclusion Criteria:

* Hypercholesterolemia,
* age above eighteen

Exclusion Criteria:

* Treatment with fibrates,
* Pregnant/Breast feeding women
Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia

Cell therapy is an innovative treatment with significant efficacy in hematologic and certain autoimmune diseases. Although it offers potential benefits for autoimmune hemolytic anemia (AIHA), it may result in cognitive and other potential impairments, which can adversely affect patients' cognition and behavior.

Brain function and psychological assessment are essential for the early detection of potential impairments, allowing timely interventions to prevent complications and ensure patient safety. This study aims to comprehensively evaluate the physical and psychological impacts of cell therapy on AIHA patients to develop safer and more effective treatment strategies that enhance their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AIHA
* Subjects will receive cell therapy such as CAR T-cell therapy
* Male or female, aged 18-65 years
* Willing and able to comply with the requirements for this study and written informed consent

Exclusion Criteria:

* History of psychiatric illness
* History of severe brain disease
* Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
Cook Iliac Branch Graft Post-market Registry

The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance.


Eligibility Criteria:
Inclusion Criteria:

* CE-Marked Cook Iliac Branch Graft (e.g., Zenith® Branch Endovascular Graft-Iliac Bifurcation, Zenith® Helical Branch Endovascular Graft)
* Registry data are de-identified with respect to patient.

Exclusion Criteria:

* Patient for whom this device would not normally be considered standard of care.