cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure

the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery

This clinical study will be carried out to compare the efficacy of ceramic soft tissue trimming bur versus the conventional surgical scraping technique in the management of gingival hyperpigmentation.

This study will be conducted to assess:

Primary objectives:

1. Clinical outcome of the gingival depigmentation procedure.
2. Assessment of postoperative pain using the visual analogue scale.
3. Patients' satisfaction will be assessed using the patient satisfaction questionnaire (short-form, PSQ-18) and the global aesthetic improvement scale.

Secondary objectives:

1. Operating time.
2. Wound healing.

Eligibility Criteria:
Inclusion Criteria:

* Males and females within age range of 20-50 years.
* Systemic (medically) free individuals.
* Gingival pigmentation score \> 3 on Hedin melanin index15.
* Patients with good oral hygiene.
* Patients with thick gingival phenotype.

Exclusion Criteria:

* Smokers.
* Teeth with compromised periodontium.
* Pregnant and lactating females.
* The vulnerable group: patients with mental or physical disabilities.
* Medications that cause gingival pigmentation.
* Pathologies that cause gingival pigmentation.
Relaxin and Placental Volume in Placenta Accreta Spectrum

This retrospective case-control study investigated the potential role of circulating relaxin levels and estimated placental volumes (EPV) in the pathogenesis and diagnosis of placenta accreta spectrum (PAS) disorders. It compared these parameters in patients diagnosed with PAS versus healthy controls.

This study aimed to compare relaxin levels in umbilical cord and peripheral blood and estimated placental volumes (EPV) between PAS cases and controls. Additionally, subgroup analysis was conducted to evaluate relaxin levels and EPV among PAS subtypes (accreta, increta, and percreta).A retrospective case-control study was conducted at a tertiary referral center, analyzing data from January 2022 to December 2022.

Eligibility Criteria:
Inclusion Criteria:

Women aged 18-45 years Confirmed histopathological diagnosis of PAS (case group) Complete medical records Healthy pregnant women undergoing cesarean delivery (control group)

Exclusion Criteria:

Multifetal gestation Emergency surgeries Incomplete medical records
CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment

The investigators aim to investigate the incidence of migraine attacks after calcitonin gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody treatment for the prevention of migraine.

Calcitonin gene-related peptide (CGRP) plays a role in migraine pathophysiology. Infusions of CGRP can trigger migraine-like attacks in migraine patients and antibodies against CGRP or the CGRP receptor significantly reduces the number of migraine days per month when administered regularly. Some patients however, do not experience migraine attack after CGRP infusion, and some do not experience migraine reduction with antibodies. The underlying mechanisms of these effects are largely unknown.

The purpose of this study is to examine CGRP-induced migraine in patients who have evaluated the efficacy of anti-CGRP monoclonal antibody treatment for migraine using a purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to examine migraine susceptibility to CGRP in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine according to the international classification of headache disorders version 3-beta
* Subject has tried anti-CGRP antibodies for migraine
* Women of childbearing potential are on safe contraception

Exclusion Criteria:

* Women of childbearing potential who do not use contraception. Includes non-hysterectomized women who have not been menopausal for at least two years. Safe contraception includes condoms, intrauterine devices, p-pills, surgical sterilization or gestagen injections.
* Daily drug intake apart from contraceptives and preventive medication for migraine.
* Ingestion of any drug 4 half-lifes before study start apart from contraceptives.
* Pregnant or breast-feeding women
* Migraine on the study day or less than 48 hours before CGRP infusion.
* A history of cardiovascular and/or cerebrovascular disease
* Systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg on study day.
* Systolic blood pressure \<90 mmHg and/or diastolic blood pressure \< 50 mmHg on study day.
* A history of mental illness
* A history of any illness or condition that is deemed relevant for participation by the investigator.
Cell Free DNA and Its Integrity Using ALU Sequences as a Biomarker for Diagnosis of Breast Cancer

Breast cancer (BC) is the most common cancer in women worldwide, and is the leading cause of death from cancer among women globally. Mammography is the standard method for early detection of BC in many countries, with over 1.3 million annually new diagnosed cases.In Egypt, breast cancer is the most common cancer in females accounting for 38.8% of all female cancers.

Breast cancer (BC) is the most common cancer in women worldwide, and is the leading cause of death from cancer among women globally. Mammography is the standard method for early detection of BC in many countries, with over 1.3 million annually new diagnosed cases.In Egypt, breast cancer is the most common cancer in females accounting for 38.8% of all female cancers. Whereas radiological screening programs have been successfully applied in detecting breast cancer in earlier stages, no valuable blood biomarkers have been yet identified for that purpose. However, false-positive recall rates vary according to age, breast density, and postmenopausal hormonal therapy, among other. For women with dense breasts, the accuracy of mammography is decreased. Circulating serum marker for monitoring of BC have been in development for several decades. Conventional tumor markers, such as cancer antigen 15-3 (CA15-3), carcinoembryonic antigen (CEA)), and circulating tumor cell count (CTC), are clinically available, however, their usefulness is mostly limited to patients with advanced and metastatic BC (MBC). Hence, there is a need for developing new biomarkers which can be used as valuable tools in identifying high risk patients, to predict disease prognosis and thus have an impact in patient management.Cell free DNA (cfDNA) are short fragments of nucleic acids present in the circulation. Multiple studies also have indicated elevated levels of cf DNA in breast cancer. The ALU(Arthrobacter luteus) sequences were chosen, as they are the most abundant and active repeated elements in the human genome, typically 300 nucleotides in length, accounting for more than 10% of the genome. DNA integrity was calculated as the ratio of (ALU247/ALU115). As the annealing sites of ALU115 are within the ALU247 annealing sites, thus the ratio of ALU247 to ALU115 is termed as DNA integrity. It characterizes the fragmentation pattern of circulating cell free DNA. The DNA integrity is "1" if template DNA is not truncated and "0" if DNA is completely truncated to fragments smaller than 247 bp (base pair). Thus it has been assessed for its diagnostic and prognostic potential role in breast cancer patients

Eligibility Criteria:
Inclusion Criteria:

* All patients enrolled before initiation of any treatment.

Exclusion Criteria:

* Any other malignant or benign tumors.
* Active inflammatory or autoimmune diseases.
* Renal or liver diseases.
Lenvatinib in Second Line Endometrial Carcinoma

The primary objective of this multicenter, randomized phase II trial is to assess the efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to doxorubicin in advanced or recurrent endometrial cancer.

The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib activity and establishing a cutoff value as potential selection criteria for phase III.

Other secondary objectives are to assess the tolerability and safety of lenvatinib in this setting and overall survival, response and disease control.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects age ≥18 years at the time of informed consent
* World Health Organization (WHO) Performance Status of 0 or 1
* Patients with histologically confirmed endometrial cancer including serous-papillary and clear cell histologies. Uterine carcinosarcomas are allowed.
* Radiographic evidence of disease progression according to RECIST 1.1 after 1 prior systemic, platinum-based chemotherapy regimen for metastatic or primary unresectable endometrial carcinoma for which no surgical or radiotherapy treatment options exist.
* Patients with disease progression following platinum-based chemotherapy administered as either adjuvant or neoadjuvant treatment are also eligible.
* Patients may have received prior radiotherapy and / or adjuvant chemotherapy for early high-risk disease
* Patients may not have received prior treatment with anthracyclines
* Blood samples available for retrospective central assessment of Ang-2 level
* Patients may have had prior therapy providing the following conditions are met:
* Surgery and radiation therapy: wash-out period of 14 days and subjects must have recovered adequately from any toxicity and/or complications from radiotherapy and major surgery prior to starting therapy.
* Systemic anti-tumor therapy or any investigational agent: wash-out period of 21 days (or 5 x half-life)
* Recovery from any toxic effects of prior therapy to ≤ Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.) except alopecia
* Adequate contraceptive measures
* Signed written informed consent

Exclusion Criteria:

* Inadequate hematologic, renal and hepatic functions
* Abnormal cardiac function
ClinicCompanion. Compared to the Use of a Goniometer

In this study, the goal is to find out if the clinicCompanion™ is effective in measuring range of motion when compared to the goniometer. Currently, the goniometer is an approved device to measure range of motion by the FDA, but the clinicCompanion™ is not.

The study procedure will test the range of motion of the subjects shoulders two different ways: using a goniometer and using the clinicCompanion™. Both tools are designed to measure the degree of movement subjects are able to do. Researchers will take 12 measurements on each arm for each device, for a total of 24 measurements per device. That is a total of 48 measurements for both devices.

Eligibility Criteria:
Inclusion Criteria:

* new or established clinic patients from PI's medical practice at Aurora St. Luke's Medical Center
* 18 years of age and older

Exclusion Criteria:

* no use of limbs
* amputees
Cooling Pillow for Atopic Dermatitis

The purpose of this study is to see if using a cooling pillow at night will help sleep quality in people with atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD by dermatologist
* AD located on the head and neck
* Investigator Global Assessment (IGA)score \>3 at time of enrollment
* Able to read, write, and understand study materials
* Age 18 or older

Exclusion Criteria:

* Concurrent non-AD skin disease on the head and neck
* Active skin infection on the head and neck, or conditions that may interfere with evaluation of the skin
DF(Oat Bran) Intervention on Inflammation, Intestinal Flora, Disease Activity and Quality of Life in Patients With RA

The goal of this clinical trial is to test in Rheumatoid arthritis. The main question it aims to answer are:

* To verify the effect of dietary fiber supplementation on reducing the level of inflammation;
* To verify the effect of dietary fiber supplementation on improving disease activity and quality of life in patients with rheumatoid arthritis .To verify the effect of dietary fiber supplementation on regulating the production of anti-inflammatory short-chain fatty acid in the gut of patients with rheumatoid arthritis.

The experimental group was supplemented with dietary fiber for 12 weeks, and the control group was fed with the Mediterranean diet. Before and after the intervention, 1 tube of 3ml blood and 1 soybean-sized stool were taken and a questionnaire was made

Rheumatic arthritis (RA) is caused by chronic inflammation and joint injury caused by imbalance of pro-and anti-inflammatory mediators in the joints. Studies have shown that dietary fiber (DF) can be fermented by gut bacteria into anti-inflammatory short-chain fatty acid that may reduce joint inflammation, relieve symptoms and improve quality of life. The subjects were Randomized controlled trial to supplement DF12W individually, the intervention group to supplement DF12W, and the control group to supplement DF12W with routine diet, the differences of disease activity (DAS28 score) , inflammatory markers (TNF-a, IL-6, Mir-146a, Treg, ESR, CRP, etc.) and quality of life (SF-36) between the two groups were compared. The changes of intestinal flora were examined to verify the hypothesis. This study laid a good scientific foundation for dietary recommendation of RA patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria, with a course of ≥ 2 years, and no changes in anti rheumatic drugs within 8 weeks prior to intervention;
* Age: 18-75 years old;
* DAS28-ESR ≥ 2.6 points, and fully controlled and treated with medication during screening visits;
* Sign an informed consent form and be able to complete the experiment according to the protocol.

Exclusion Criteria:

* Patients with mental illness, cognitive impairment, severe heart, lung, brain failure, serious complications, pregnancy, or life-threatening diseases;
* Patients with severe visual or auditory impairment and inability to understand research information;
* During the past 8 weeks of treatment with disease modifying anti rheumatic drugs (DMARDs), patients with food intolerance, allergies, and unwillingness to consume the intervention food in the study;
* In the past 10 years, there has been a history of tumors and eating disorders (such as neurogluttony, anorexia, binge eating, etc.);
* Participated in other intervention studies in the past three months.
Noom Health for Weight Management

The goals of the study are to use the Noom mobile app to help individuals with weight loss and weight loss maintenance. This project will test the comparative efficacy of Noom Health vs. Noom Digital Health for weight loss, quality of life, psychosocial functioning, and self-reported health status. It is expected that use of Noom Health will show post-intervention success relative to Noom Digital Health as well as long-term success with weight loss maintenance. Data is expected to show that participants who are older, have less support, have more health conditions, and with more psychosocial problems will benefit more from Noom Health. It is also expected that confidence in the ability to lose weight will produce more successful results in Noom Health vs. Noom Digital Health.

A total of 600 subjects will be enrolled in a randomized-controlled trial comparing the Noom app (Noom Health) to a digital control (Noom Digital Health) with 6 months of intervention and 6 months active maintenance in both groups. Measures will include demographics, psychosocial measures, height/weight, waist circumference, weight loss history/practices, health care practices/utilization, and quality of life.

Participants will complete informed consent and interviews via a HIPAA-compliant videoconference (Zoom) and other questionnaires via a REDCap interface. All participants will complete screening/baseline procedures to determine eligibility and initial information. Subsequently, they will be randomized to one of the groups for a 6-month intervention and 6- month maintenance period (12 months total).

In Noom Health, participants will be encouraged to use the app multiple times per day to log eating episodes, physical activity and weight. Coaches will also interact with participants directly through the app. In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.

During the intervention, participants will complete monthly satisfaction surveys. Additionally, follow-up measures will be conducted at 7 time points (Screening/Baseline, 1 month, 4 months, 6 months, 12 months, 18 months, 24 months, and 30 months).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be interested in the Noom app
* BMI \> 27 kg/m2
* Ages of 18 and 60 at entry to the study
* Speak English

Exclusion Criteria:

* Contraindication to smartphone use (e.g., seizures from prior smartphone use, do not own a smartphone)
* Acute suicide risk
* Pregnant or planning to become pregnant during the study
* Current Noom use
Embryoscope and Reproductive Outcome

cases with embyos cultured in the standard incubator and evaluated only by morphology are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model

cases with embyos cultured in the standard incubator and evaluated only by morphology (control group) are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model(study group)

Eligibility Criteria:
Inclusion Criteria:

* Patient age:25-40 years old
* BMI:18-30
* patients with first or second ICSI trial

Exclusion criteria:

* AMH \<1
* severe male factor(total motile sperm \<1 million)
* frozen embryo transfer cycles
* patients with endocrinopathies or thrombophilia
* patients on medical treatment which may interfere with results
* hydrosalpinx
A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hATTR-PN

The objective of the study was to characterize adverse events (AEs) occurring within one day of TEGSEDI administration to adult participants with hATTR-PN overall and in individual participants with respect to time course of AE onset, vital sign changes, preventive measures, treatment required, risk factors, and subsequent adverse outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Satisfy one of the following:

   1. United States (US) Participants: Adult participants (≥ 18 years old) diagnosed with hATTR-PN and prescribed TEGSEDI according to the United States Prescribing Information (USPI).
   2. Canadian participants: Adult participants (≥ 18 years old) diagnosed with stage 1 or stage 2 hATTR-PN and prescribed TEGSEDI according to the Canadian Product Monograph (CPM).
2. Must have given written informed consent for participation in this study.
3. Must provide access to their previous medical records.
4. Are about to initiate or have recently initiated treatment with TEGSEDI and have not received more than 9 doses in total.
5. Be willing to complete required testing and report any AEs and/or changes in medications.
6. Satisfy one of the following:

   1. Females: Non-pregnant and non-lactating; abstinent, or if engaged in sexual relations of childbearing potential, participant is using an acceptable contraceptive method from time of signing the informed consent form (ICF) until 13 weeks after the last dose of TEGSEDI administration
   2. Males: Abstinent or if engaged in sexual relations with a female of childbearing potential, participant is utilizing an acceptable contraceptive method from the time of signing the ICF until 13 weeks after the last dose of TEGSEDI administration

Exclusion Criteria:

* None
Pharmacokinetics in Patients With Newly Diagnosed High-Grade Glioma Receiving Temozolomide and Radiation Therapy

RATIONALE: Studying samples of blood in the laboratory from patients receiving temozolomide may help doctors learn how temozolomide works in the body. It may also help doctors learn more about how a patient's genes may affect the risk of developing thrombocytopenia.

PURPOSE: This clinical trial is studying the pharmacokinetics in patients with newly diagnosed high-grade glioma receiving temozolomide and radiation therapy.

OBJECTIVES:

* Compare the pharmacokinetic (PK) profiles of temozolomide (TMZ) in patients who develop severe thrombocytopenia vs PK profiles in patients who do not develop severe thrombocytopenia while receiving standard first-line therapy for management of newly diagnosed high-grade gliomas.
* Determine if patients who develop thrombocytopenia have any single nucleotide polymorphisms in the O6-methylguanine-DNA methyltransferase gene.

OUTLINE: This is a pilot, prospective, multicenter study.

Patients receive oral temozolomide once daily on days 1-42. Patients also undergo cranial radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for pharmacokinetic and pharmacogenomic analysis, genotype analysis, plasma temozolomide levels, and MGMT repair gene polymorphism analysis.

After completion of study treatment, patients are followed for 1 month.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed high-grade glioma (WHO grade III or IV)
* Must be scheduled to receive standard first-line therapy (cranial radiotherapy and temozolomide)

PATIENT CHARACTERISTICS:

* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.7 mg/dL
* Bilirubin ≤ 1.5 mg/dL
* Transaminases ≤ 4 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

* No prior hormonal therapy for brain tumor
* No prior biological agents (including immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy)
* No prior immunotherapy
* No prior chemotherapy
* No prior radiotherapy, including cranial radiotherapy
* Concurrent glucocorticoid therapy allowed
* No concurrent carbamazepine
* No other concurrent experimental therapy
* No other concurrent cytotoxic therapy
A Targeted Falls Prevention Program in Rehabilitation In-Patients

Falls are a major complication in patients treated in rehabilitation departments, yet studies evaluating different interventions to reduce falls-risk are rare and inconclusive.

The aim of the present study is to evaluate the efficacy of a multidisciplinary fall-prevention program to reduce falls and injury in stroke patients treated in a rehabilitation department.

All stroke patients consecutively admitted to the department of rehabilitation at Hadassah-Hebrew University Medical Center for a period of one year will be eligible for inclusion. Upon receiving an informed consent subjects will be randomized to the intervention group or the control (convention care) group.

There are no exclusion criteria. The Intervention includes group education on risk of falling and safe mobility and transfers; physical therapy of balance training at the patients' bedside twice weekly and medical assessment of medication use (anxiolytics/hypnotics, neuroleptics, antihypertensives and other vasodilators), orthostatic hypotension, urinary frequency/incontinence, delirium and visual problems.

Intervention therapy will not be given as an extra time, rather at the same treatment time as the control group.

Primary outcomes are rate of falls and related injuries.


Eligibility Criteria:
Inclusion Criteria:

* All stroke patients admitted to rehabilitation

Exclusion Criteria:

* None