cyrilzakka/clinical-trials huggingface dataset:
The Proposed Study Aims to Investigate the Impact of Adjunctive Vitamin D Gel Application on Gingival Crevicular Fluid Levels of Alkaline Phosphatase and Interleukin-8 in Periodontitis Patients Undergoing Phase 1 Periodontal Therapy. By Elucidating the Molecular Mechanisms Underlying the Therapeutic

The proposed study aims to investigate the impact of adjunctive vitamin D gel application on gingival crevicular fluid levels of alkaline phosphatase and interleukin-8 in periodontitis patients undergoing phase 1 periodontal therapy. By elucidating the molecular mechanisms underlying the therapeutic effects of vitamin D, this research seeks to contribute to the development of more effective treatment strategies for periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with attachment loss 3-4 mm
* periodontal pocket ≤ 5 mm

Exclusion Criteria:

* - Patients with sensitivity to the medication used in the study.
* Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study.
* Patients with systemic diseases.
* Pregnant and lactating females.
* Smokers and tobacco chewers.
* Patients not compliant with oral hygiene procedures.
Virtual Training for Latino Caregivers to Manage Symptoms of Dementia

The goal of this pilot study is to improve the STAR-Caregivers Virtual Training \& Follow-up (STAR-VTF) intervention for Latino caregivers of people living with dementia. The main objectives are to: (1) culturally adapt STAR-VTF online training modules, (2) pilot test Latino caregivers' responses to the adapted online training modules, and (3) develop an online survey to collect caregiver outcomes in a future study. Participants will receive the STAR-VTF intervention and asked to complete online surveys and participate in an exit interview to provide feedback on their experience.

The objectives of this study are to: (1) culturally and linguistically adapt the STAR-Caregivers Virtual Training \& Follow-up (STAR-VTF) online training modules for Latino caregivers of people living with dementia (PLWD), (2) pilot test Latino caregivers' responses to the adapted online training modules, and (3) develop a REDCap survey to pragmatically collect caregiver outcomes in a future study.

The study will use a single-arm pilot trial design with Latino caregivers of PLWD. The investigators will assess self-reported outcomes at baseline and 6-8 weeks post-enrollment using a REDCap survey. Outcome measures will include the Revised Memory and Problem Behavior Checklist and Preparedness for Caregiving Scale. In addition, the investigators will assess caregivers' perceived usability of the online training modules and will conduct qualitative interviews 6-8 weeks post-enrollment. The interviews will assess caregiver satisfaction with and acceptability of the adapted online training modules.

The investigators expect to enroll up to 20 participants. The primary objective of this study is to pilot test the adapted online training modules. Therefore, it is not powered to detect an effect of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Lives with a person living with dementia (PLWD) or within 5 miles
* Provides at least 8 hours of care per week
* Self-identifies as Hispanic/Latino
* Caregiver self-report of PLWD having ≥ 3 behavioral and/or psychological symptoms of dementia occurring ≥ 3 in past week

Exclusion Criterion:

* PLWD lives in assisted living or skilled nursing facilities
Prospective Trial to Evaluate Efficacy and Accuracy of a Portable Ultrasound Scanner for Non-Invasive Bladder Volume Measurement (BladderScan BVI3000) in Patients After Radical Cystectomy and Bladder Reconstruction

Thirty patients who underwent radical cystectomy and bladder substitution and thirty people with native bladders will be enrolled in the study. After meticulous explanations each person will undergo sterile catheterization of the bladder/neobladder with a 14 Fr Foley catheter. After catheterization the bladder will be fully emptied. Randomly assigned volume of sterile saline will be injected to the bladder via the catheter by one sub investigator and the bladder capacity will be measured via a portable ultrasound scanner for non-invasive bladder volume measurement (BladderScan BVI3000) by another sub investigator. The volume injected and the measured results will remain in a closed envelope till the completion of the trial. After each measurement the first sub investigator will completely empty the bladder/neobladder and the process will repeat itself for a total of six measurements for each patient or first mention of discomfort (whichever comes first), after which the bladder will be drained once more and the catheter removed.


Eligibility Criteria:
Inclusion Criteria:

Group A: Patients ages 18-75, at least 6 month after radical cystectomy and bladder substituition Group B: Volunteers same age group as group A, with native bladder as control group

Exclusion Criteria:

Group A: carrying ureteral stent of any kind, inability to catheterize patient due to severe urethral stricture, incarcerated post operative ventral hernia, after mesh repair of POVH, active urinary tract infection, acute bacterial prostatitis.

Group B: patients after partial cystectomy, incarcerated post operative ventral hernia, after mesh repair of POVH, active urinary tract infection, acute bacterial prostatitis.
Blocking Mifepristone Action With Progesterone

Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.

Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks' gestation) performed without primary surgical intervention and resulting from the use of abortion-inducing medications. The use of medications to cause abortion has been around for almost 70 years but the modern era of medical abortion treatment evolved with the development of mifepristone, a progesterone-receptor blocker with an affinity for the receptor greater than progesterone itself.

Medical abortion with mifepristone and misoprostol is highly effective; however, the risk of continuing pregnancy is still present, especially as gestation advances. While most women opt for further treatment in these scenarios, such as surgical aspiration, there are some who decide to continue the pregnancy. Thus, even following treatment, some women do change their mind.

No well-done study has evaluated whether such treatment works. Poorly controlled case series are not evidence and systematic reviews of continuing pregnancy rates after mifepristone/prostaglandin analogue treatment failure do not reflect real life outcomes. This study is also a first step to understanding if large studies evaluating mifepristone antagonization with high-dose progesterone are indicated and if placebo-controlled randomized trials can be successfully completed when evaluating this question.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant females 18 years and older at enrollment.
2. Seeking surgical abortion at 44-63 days' gestation on Study day 1.
3. Have received counseling and signed informed consent per UCD standard procedures for surgical abortion.
4. Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.
5. English-speaking
6. Willing to sign informed consent and follow study protocol.
7. Willing to experience potential expulsion of the pregnancy with mifepristone treatment.

Exclusion Criteria:

1. Medical contraindications to medical abortion.

   1. Poorly controlled hypertension (systolic BP \>160 or diastolic BP \>95)
   2. Significant anemia - known recent hemoglobin \<9.5 gm/dL
   3. Clinically significant cardiovascular disease (angina, valvular disease, arrhythmia, or congestive heart failure)
   4. Breastfeeding
   5. Coagulopathy or therapeutic coagulation
   6. Ultrasound evidence of molar or ectopic pregnancy
   7. Chronic systemic corticosteroid use
   8. Adrenal disease
   9. Sickle cell anemia with frequent/recent crises
   10. Glaucoma
2. IUD in place during conception, even if removed.
3. Peanut allergy.
4. Known intolerance of mifepristone or progesterone.
5. Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.
A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma

Four-drug combo yielded a statistically significant improvement in progression-free survival and overall survival compared to gemcitabine in patients with advanced pancreatic adenocarcinoma. Nab-Paclitaxel showed promising antitumor activity in patients with pancreatic cancer. Given the synergism of taxanes with gemcitabine, fluoropyrimidines and platinating agents the role of nab-Paclitaxel in a 4-drug regimen will be explored.

The aim of this trial is to determine the recommended dose of nab-paclitaxel in combination with cisplatin, capecitabine, and gemcitabine, PAXG regimen (Phase I), and to evaluate the feasibility and the activity of the PAXG regimen in patients with stage III and IV pancreatic cancer.

OBJECTIVES: PHASE I: to determine the recommended phase 2 dose of nab-paclitaxel in combination with cisplatin, capecitabine, and gemcitabine.

PHASE II: to evaluate the feasibility and the activity of the PAXG regimen in terms of 6-months progression-free survival in patients with stage III and IV pancreatic cancer.

OUTLINE Phase I - dose finding single institution trial, followed by a randomized open label multicenter phase II trial.

Phase II: Patients will be stratified by stage (III vs IV) and CA19.9 level (\< 10 x ULN versus \>10 x ULN); Patients will be randomly assigned to receive PAXG (arm A) or gemcitabine-nab-paclitaxel regimen (arm B).

Treatment plan (phase II):

Arm A: PAXG every 4 weeks (1 cycle): cisplatin at 30 mg/m2 on days 1 and 15, nab-paclitaxel at the RP2D on days 1 and 15, capecitabine at 1250 mg/ m2 days 1-28, gemcitabine at 800 mg/ m2 on days 1 and 15.

Arm B: Gemcitabine + nab-paclitaxel every 4 weeks (1 cycle): gemcitabine at 1000 mg/m2 on days 1, 8 and 15; nab-paclitaxel at 125 mg/mq on days 1, 8 and 15.

Treatment will be administered for a maximum of 6 cycles or until there is a clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of pancreatic adenocarcinoma
* Stage III or IV disease
* Age \> 17 \< 76 years
* Karnofsky Performance Status \> 50
* Measurable disease (only for phase II part)
* Adequate bone marrow (GB \> 3500/mm3, neutrophils \> 1500/mm3; platelets \> 100000/mm3; hemoglobin \> 10 g/dl), liver (total bilirubin \< 2 mg/dL; SGOT e SGPT \< 3 UNL) and kidney function (serum creatinin \< 1.5 mg/dL;)
* Written informed consent

Exclusion Criteria:

* previous chemotherapy
* concurrent treatment with other experimental drugs
* previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease at least from 5 years
* symptomatic brain metastases
* history of interstitial lung disease
* presence of serious disease which can compromise safety (cardiac failure, previous myocardial infarction within the prior 6 months, cardiac arrhythmia, history of psychiatric disabilities)
* pregnancy and lactating
* History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
Using Hydration Monitor to Detect Changes in the Hydration Status Athletes

The study will aim to evaluate the correlation between changes in ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing an acute dehydration and rehydration. The study will also test the hypothesis that body dehydration is a generalized physiological process equally affected all body muscles by comparing the data obtained on calf and biceps muscles.


Eligibility Criteria:
Inclusion Criteria:

* male or female athletes
* ages 18-25 years old

Exclusion Criteria:

* open wounds or rashes on calf testing area
* active skin infection
* pregnant female subjects
Multimodal Analgesic Management of Naborphine Combined With Opioid Free Anesthesia in OSA Patients Undergoing Bariatric Surgery

Comparative study to explore the effect of opioid free anesthesia technology in perioperative analgesia management, clarify the effect of naborphine instead of opioids on perioperative analgesia management in morbid obesity patients with moderate and severe OSA, reduce related adverse events, and explore the latest clinical anesthetic drugs.

1. The concept of enhanced recovery after surgery (ERAS) has been applied in the perioperative period of many operations. Reducing the dosage of opioids is an important part of the concept of ERAS.
2. Opioid free anesthesia technology has been recognized in reducing nausea and vomiting, but whether it can meet the perioperative analgesic needs of patients undergoing bariatric surgery and obtain more clinical benefits still has no research supportment.
3. This study is expected to clarify the clinical effect of opioid free anesthesia technology in perioperative analgesia management of morbid obesity patients with moderate and severe OSA, reduce adverse events, and explore the latest clinical anesthesia scheme.

Eligibility Criteria:
Inclusion Criteria:

1. ASA grade I \~ III;
2. Age from 18 - 65 years old;
3. BMI ≥ 35kg / m2 in patients with OSA to undergo bariatric surgery； （4 provide written informed consent for participation.

Exclusion Criteria:

1. Age \< 18 years or age \>65 years old;
2. Pregnancy test was positive;
3. Patients with a history of drug abuse or dependence on opioids;
4. Patients with chronic pain or severe heart, lung, liver or nervous system diseases
Effect of Prone Positioning in Patients With COVID-19

COVID-19 is affecting the people around the world and the infected individuals' may either stay asymptomatic or present to hospitals with severe distress and life threatening symptoms. The objective of the study is to investigate role of Prone positioning and alternate nostril breathing in patients with Covid-19.

In this quasi experimental study, 30 patients aged 40-80 years of either gender with a confirmed diagnosis of COVID-19 receiving supplemental oxygen were recruited from DHQ Hospital Faisalabad. patients were grouped into two A \& B. We collected baseline data on demographics and anthropometrics. After baseline data collection, all the patients were helped into the prone position, which was maintained for a minimum duration of three hours. After that patients in group B performed alternate nostril breathing for 10 minutes with help of physiotherapist. Clinical data were re-collected on 3rd day of intervention one hour after returning to the supine position in group A and after alternate nostril breathing in group B. The main study outcome was the variation in oxygenation (partial pressure of oxygen \[PaO2\]/ fractional concentration of oxygen in inspired air \[FiO2\]) between baseline and resupination, and General psychological state through GAD-7 General anxiety disorder questionnaire.

Eligibility Criteria:
Inclusion Criteria:

Age: 40-80 Gender: Both GCS score:15

Exclusion Criteria:

* COPD Intubated ARDS Smoker Neurological Disorder
Nilotinib in Cognitively Impaired Parkinson Disease Patients 001

This pilot study will test Nilotinib's ability to alter the abnormal protein build up in Parkinson disease and Diffuse Lewey Body Disease patients . Patients will receive Nilotinib at different doses for 6 months. Patients will then be tested to see if there is change in three areas: 1) has the disease symptoms changed. 2) has levels of a specific misfolded protein changed in the fluid around their brain and spine. 3) Have inflammatory markers changed in the patient's blood and fluid around their brain and spine. If successful, this drug could be used to slow down or stop the progression of disorders that involve abnormal collection of misfolded proteins. However, the main purpose of this pilot study is to check for the safety of using this medication at this level.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 40 to 90 with Idiopathic Parkinson's Disease (Significant Sinemet response) on a stable medication drug regimen L-dopa and/or Dopamine agonist (at least 1 month before enrollment with no new medication change) and with moderate to severe cognitive impairment (MOCA ≤24).

Inclusions criteria:

1. Written informed consent
2. Capability and willingness to comply with the study related criteria
3. Patients between the age of 40-90 y
4. Diagnosis of PD according to the UK Brain Bank Diagnostic Criteria
5. Early PD subjects with MMSE between 23-30.
6. Hoehn and Yahr stage \<2
7. Stable treatment (\>4 weeks) with MAO-B inhibitor (Selegeline up to 10mg/d or rasagiline up to 1 mg/d) allowable
8. Patients not needing dopamine agonist or levodopa therapy presently or at least for the next 6 months
9. Idiopathic PD with NO genetic mutations (autosomal recessive or dominant)
10. Detectable levels of CSF for blood and CSF Alpha-Synuclein

Exclusion Criteria:

1. Patients with a known genetic form of PD that does not involve alpha-synuclein.
2. Unwillingness to undergo lumbar punctures
3. Immeasurable CSF α-synuclein.
4. Presence of dementia or severe cognitive impairment that would not permit the patient to give adequate feedback for potential side effects.
5. Unwilling to be in an off state for UPDRS assessment.
6. Pre-menopausal women
7. Patients with autosomal recessive (PARKIN, PINK1 or DJ1) or dominant mutations (LRRK2)
8. Patients with hypokalemia, hypomagnesaemia, or long QT syndrome.
9. Concomitant drugs known to prolong the QT interval
10. Strong CYP3A4 inhibitors
11. Any drugs or foods that may interact with Nilotinib as stated in the Package Insert (PI).
12. Medical history of liver and pancreatic diseases.
13. Clinical signs indicating syndromes other than idiopathic PD, including supranucelar gaze palsy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar sings, early severe autonomic involvement, Babinski's signs.
14. History of any cardiovascular disease, including hypertension, myocardial infraction or cardiac failure, angina, arrhythmia.
Masticatory Efficiency in Children

This study aims to evaluate the association of masticatory efficiency with different conditions of the stomatognathic system (transitioning from primary to secondary dentition, dental caries, malocclusion, tooth loss, prosthodontic treatment) in the paediatric population. Also, to assess the correlation between masticatory efficiency and nutritional status. The study will be conducted on children between 3 and 14 years of age. Masticatory efficiency will be evaluated by the optical scanning method. Participants will chew a standardized silicone tablet controlled by the examiner for 20 masticatory strokes. By scanning the comminuted particles, data on each particle's size will be obtained. Enhanced masticatory performance is presented by a decrease in the chewed particle areas and an increase in the number of chewed particles.


Eligibility Criteria:
Inclusion Criteria:

* children of both genders aged 3 to 14, with:

  * full healthy dentition
  * bilateral dental caries stage 4,5 or 6 by ICDAS criteria
  * reduced number of occlusal contacts
  * dentures
* signed informed consent by participant's parents
* verbal consent of the children

Exclusion Criteria:

* uncooperative behavior
* symptoms of temporomandibular joint dysfunction
* parafunctional habits
* systemic disturbances that can impact mastication
* ingestion of medicines that could interfere directly or indirectly with muscular activity
* tooth anomalies of structure, number or form
* periodontal disease
* tooth mobility
Chromogranin-A-Derived Peptides and Periodontitis in Diabetic Patients

Periodontitis is a chronic disease of the supporting tissue of the teeth, characterized by bleeding and inflamed gingival, resorption of alveolar bone. This disease has a significant impact of the quality of life as the teeth become progressively mobile and may fall out spontaneously if no treatment is provided. Periodontal disease has been cited as the sixth complication of diabetes mellitus.Chromogranins / secretogranins are a family of proteins present in nervous endocrine and immune cells, released with catecholamines during stress situations. Chromogranin A (CGA) is the major member of this family.The aim of this study is to determine the level of CGA and its derived peptides in the gingival crevicular fluid (GCF) of health or diabetic patients with and without periodontitis.Then, we want to determine the antimicrobial activity of these peptides.


Eligibility Criteria:
Inclusion criteria:

* Patients from 20 to 80 years old
* A minimum of 10 teeth
* Healthy volunteers or diabetic patients with or without periodontitis

Exclusion criteria:

* a course of antibiotics
* a fungicidal therapy
* a corticotherapy
* a hormone therapy
* a pregnancy
* persons under guardianship
An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia

This is a multicenter, open-label, single-arm, expanded access treatment study designed to provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab administered in combination with chlorambucil. This study will enroll patients with previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CD20-positive CLL (per IWCLL guidelines, Hallek et al 2008)
* Previously untreated CLL requiring treatment according to the IWCLL guidelines (Hallek et al 2008), as assessed by the investigator
* Adequate baseline bone marrow function unless it due to underlying CLL disease No previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy
* Patients who are not appropriate to receive more intensive chemotherapy in the judgment of the investigator
* Life expectancy of \> 6 months

Exclusion Criteria:

* Treatment with any other investigational agent or participation in another clinical trial within 28 days prior to the start of Cycle 1
* Transformation of CLL to aggressive B-cell malignancy History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Known hypersensitivity to chlorambucil or any of its excipients
* History of other malignancy that could affect compliance with the protocol or interpretation of results Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1
* Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
* Known infection with human immunodeficiency virus (HIV) or Human T-Cell Leukemia Virus 1 (HTLV-1) seropositive status
* Positive hepatitis serology
* Women who are pregnant or lactating
* Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly
* Effective contraception is required while receiving obinutuzumab. For women, effective contraception is required to continue for \>= 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for 6 months after the last dose of chlorambucil treatment.
* Vaccination with a live vaccine a minimum of 28 days prior to the start of Cycle 1