cyrilzakka/clinical-trials huggingface dataset:
Management of Occlusal Dentinal Caries in Deciduous Molars

This study evaluated and compared the efficacy of no caries removal and sealing with a well-adapted and crimped stainless steel crown verses selective caries removal upto soft dentin and upto firm dentin in healing and/or preventing progression of moderate to deep occlusal dentinal caries.

Dental caries is a complex multifactorial disease and is one of the most prevalent diseases throughout history. It can cost a lot of money to treat and causes infection, pain and the loss of teeth. Choices for managing a carious lesion cover a spectrum of options-from complete surgical excision, where no part of the visible carious tissue is left in the tooth before a restoration is placed, to the opposite extreme, where none of the carious tissue is removed and noninvasive methods are used to prevent progression of the lesion. Thus, this study compared efficacy of no caries removal and sealing the entire lesion verses partial selective caries removal to soft and to firm dentin in healing and/or preventing progression of moderate to deep occlusal dentinal caries in previously unrestored teeth by clinical and radiographic analysis in 4-7 year old children.

Eligibility Criteria:
Inclusion Criteria:

* Children in the age group of 4 - 7 years
* Previously untreated first and second mandibular deciduous molars with moderate to deep occlusal caries i.e. caries involving middle 1/3rd to pulpal 1/3rd of dentin
* No root resorption or physiologic resorption not exceeding 2/3rd of the root length
* Children having positive and definitely positive behavior

Exclusion Criteria:

* Children with special health care needs
* Children with dental crowding limiting the child's ability to maintain oral hygiene
* Teeth with clinical and/or radiological signs or symptoms of non- vitality
* Teeth with clinical and radiological signs or symptoms of irreversible pulpitis or dental abscess (Pain, mobility, tenderness to percussion, draining sinus, pulp polyp, furcal or periapical radiolucency, root resorption)
* Mobility of the tooth
* Pathologic root resorption
* Physiologic root resorption exceeding 2/3rd of root length in preoperative x-ray
Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam

To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.

Primary Objectives

* To evaluate the steady-state PK of CVC administered with and without DTG .
* To evaluate the steady-state PK of DTG administered with and without CVC .
* To evaluate the PK of a single dose of Midazolam administered with and without steady state CVC when both are administered orally.

Secondary Objectives

* To evaluate the safety and tolerability of CVC administered with and without DTG.
* To evaluate the safety and tolerability of CVC administered with and without Midazolam.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed voluntary consent
2. Adult male and female healthy volunteers
3. Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
4. Be in good general health with no clinically relevant abnormalities
5. Agree to comply with study procedures and restrictions

Exclusion Criteria:

1. Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular as determined by investigator
2. History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed
3. Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication
4. Known or suspected hypersensitivity or allergic reaction to any of the components of CVC or DTG tablets, or midazolam syrup
5. Serum ALT, AST, or bilirubin values greater than or equal to Division of Acquired Immunodeficiency Syndrome (DAIDS) grade 1 at screening
Post-operative Sensitivity in Resin Composites

This triple-blind, randomized clinical trial was conducted at the department of Operative dentistry. A total of 60 participants were recruited and were randomly distributed into two groups A and B. After informed consent, restorative treatment was performed. In group A, adhesive with nanoparticles was used for composite restoration while in group B, adhesive without nanoparticles was utilized. Post-operative sensitivity was recorded using VAS score.

Triple-blind, randomized trial, parallel group with an allocation ratio 1:1. A total of 60 participants were recruited from the outpatient department and were randomly distributed into two groups (n=30). After informed consent, restorative treatment was accomplished using an etch and rinse adhesive strategy. In group A , titanium dioxide nano-fortified adhesive was used while in group B, adhesive without nanoparticles was utilized for composite restoration. Post-operative sensitivity was evaluated at follow-up period: one day, one week, two weeks and one month. Visual Analogue scale score was used to record the sensitivity status at follow-up intervals.

Eligibility Criteria:
Inclusion Criteria:

* participants with goof general health status
* Class I and II primary Carious lesion with a minimum cavity depth of 3 to 5 mm.
* Vital and Periodontally sound teeth

Exclusion Criteria:

* Patient with Temporomandibular dysfunction
* History of spontaneous pain
* Endodontically treated teeth
* Patient on analgesics within the past two weeks
Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes

Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)

Exclusion Criteria:

* Patients with cardiovascular event within 6-months of screening
* Patients with diabetic complications
* Female subjects who are pregnant or planning to become pregnant
* Subjects with unstable medical conditions (eg, hypertension)
Multi Donor Mismatched Stem Cell Transplantation (MDT)

The proposed research focuses on the development of innovative protocol of mismatched stem cell transplantation with combined 2 different haplo stem cell transplantation (SCT) donors which are mismatched to the recipient (and preferably to each other), in a patient in need for SCT, lacking an HLA match related or an unrelated donor. This innovative protocol named multi donor stem cell transplantation (MDT) is designed to facilitate engraftment even when reduced intensity conditioning or a low cell dose are used, improve the graft vs. leukemia (GVL) effect and enhance immune reconstitution (using quantitative and qualitative parameters).


Eligibility Criteria:
Inclusion criteria:

1. Patient age 0-70 years old with leukemia in 1st remission at high risk of relapse because of unfavorable prognostic features, at 2nd CR or MDS without an readily available matched donor (related or unrelated).
2. Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching).
3. Each patient / patient's guardian must sign written informed consent.
4. Patients must have an ECOG PS ≤ 2; Creatinine \<2.0 mg/dl; Ejection fraction \>40%; DLCO \>50% of predicted; Serum bilirubin \<3 gm/dl; elevated GPT or GOT \<3 x normal values.

Exclusion criteria:

1. Not fulfilling any of the inclusion criteria.
2. Not in CR (if the indication for transplant is leukemia).
3. Active life-threatening infection.
4. Overt untreated infection.
5. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
6. Pregnant or lactating women.
7. Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia, HCV, evidence of bone marrow disease, unable to donate bone marrow or peripheral blood due to concurrent medical condition).
8. Previous autologous or allogeneic stem cell transplantation.
9. Inability to comply with study requirements.
L-Carnitine in Peritoneal Dialysis

The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy. The study hypothesis is to evaluate the possibility to formulate peritoneal dialysis solutions containing L-carnitine as an osmotic agent to partially replace glucose.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Have a diagnosis of End Stage Renal Disease and have been on Continuous Ambulatory Peritoneal Dialysis for at least 3 months
* Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing
* Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
* Have not experienced peritonitis episodes in the last 3 months
* Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (2.5% glucose)
* Have Kt/V urea measurement \> 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit
* Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
* Have a D/P Creatinine ratio at Peritoneal Equilibration Test between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit
* Have a D/P Glucose ratio at Peritoneal Equilibration Test between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit
* Be treated by the participating clinical Investigator for a period of at least three months
* Have understood and signed the Informed Consent Form.

Exclusion Criteria:

* Have a history of drug or alcohol abuse in the six months prior to entering the protocol
* Be in treatment with androgens
* Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations)
* Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT \> 2 times the upper normal limit)
* Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
* Have a history of congestive heart failure and clinically significant arrhythmia
* Have an history of epilepsy or any central nervous system disease
* Have malignancy within the past 5 years, including lymphoproliferative disorders
* Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug, particularly if patient's life expectancy is less than 1 year
* Have a history of L-Carnitine therapy or use in the month prior to entering the protocol
* Have used any investigational drug in the 3 months prior to entering the protocol
* Pregnant, lactating, fertility age without protection against pregnancy by adequate contraceptive means
Primary Prevention of Hypertension in Obese Adolescents

The purpose of this study is to examine the consequences of lowering serum uric acid in pre-hypertensive, obese adolescents pathways involved with how uric acid mediated hypertension and renal disease. The specific aims are:

1. Test the hypothesis that lowering uric acid will improve endothelial function.
2. Test the hypothesis that lowering uric acid will reduce plasma renin activity and serum angiotensin II levels.
3. Test the hypothesis that lowering uric acid will reduce markers of inflammation

The trial will be a double blinded, placebo control trial of two uric acid lowering agents. The endpoints for this trial will be, endothelial function, systemic vascular resistance, plasma renin activity, MCP-1 and CRP. Upon recruitment and informed consent, children will undergo initial screening. This will include medical history, family history, dietary history, review of systems (questionnaire used and validated in pediatric hypertension clinic) and pediatric quality of life questionnaire. They will have a physical exam, casual and ambulatory blood pressure monitoring (see below) and screening laboratory analysis that will include CBC, electrolytes, BUN, Cr, Uric acid, AST, ALT and urinary micro-albumin to creatinine ratio. Children with serum uric acid less than 5.0mg per dl will be enrolled as controls and only have baseline studies at Screening and Visit 1. Children with serum uric acid equal to or greater than 5.0mg per dl will be randomized (in a one to one to one ratio) to receive placebo, allopurinol or probenecid.

Study drug (or placebo) will be administered for 2 months. During the first week, subjects will take one tablet (placebo, 150mg allopurinol or 250mg probenecid) twice daily. At the end of one week subjects will be instructed to increase to 2 tablets (placebo, 300mg allopurinol or 500mg probenecid) twice daily. Data collection will occur during screening, after one and two months on the study drug and one month after completion of the study drug.

Eligibility Criteria:
Inclusion Criteria:

Children between the ages of 11 and 18

body mass index greater than the 95th percentile for age

Blood pressure between 75th and 95th percentile for age, gender and height percentile

Exclusion Criteria:

hypertension at the time of screening

allergy to one of the study medications

liver function abnormality (AST or ALT greater than twice the upper limit of

normal for the laboratory)

history of renal stones

renal insufficiency (Schwartz formula calculated GFR less than 70ml per min per 1.73m2 BSA)

positive urine pregnancy test

diabetes

organ transplant recipient

currently treated with an angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), diuretic, other medications known to alter serum uric acid level

lack of ability to comply with the study protocol
Far Infrared Therapy on Peripheral Artery Disease in Hemodialysis Patients

The prevalence of peripheral artery disease (PAD) defined as ankle-brachial index (ABI) less than 0.9 was about 15\~30% in patients with end stage renal disease (ESRD), which was higher than those with normal renal function. A lower ABI and a higher brachial-ankle pulse wave velocity (baPWV) are good markers to predict the risk of PAD and atherosclerosis respectively. In addition, baPWV\>2,100 cm/s was shown to be related to potential PAD. ABI \<0.9 was positively associated with vascular access failure in hemodialysis (HD) patients and our previous study has demonstrated that far infrared (FIR) therapy can improve access flow and unassisted patency of atrioventricular (AV) fistula.

The aims of this study are to evaluate (1) the frequency of and (2) risk factors associated with abnormal ABI and PWV as well as (3) the effect of FIR on ABI and PWV and markers related to endothelial dysfunction in HD patients.

In this study, 300 HD patients will be enrolled to receive ABI and baPWV and about 90 patients (30% according to the literature review) who have abnormal ABI (\<0.9) or baPWV (\>2100 cm/sec) will be randomly allocated to FIR group (receiving FIR therapy for 40 minutes thrice weekly) and control group (without FIR therapy). In patients with abnormal ABI or baPWV, the effect of single or one-year treatment of FIR on the following items will be studied: (1) ABI, (2) baPWV and (3) markers related to endothelial dysfunction \[including low and high density lipoprotein cholesterol (LDL and HDL), asymmetric dimethylarginine (ADMA), hypersensitive C-reactive protein (hsCRP), matrix metalloproteinase-9 (MMP-9)\]. The effect of FIR on PAD or cardiovascular events during one year of follow-up will also be studied.

This study will allow us to identify the frequency of and the risk factors associated with abnormal ABI \& PWV as well as the effect of single or one-year FIR therapy on ABI \& PWV in HD patients.

Eligibility Criteria:
Inclusion Criteria:

* In this study, we will include 300 patients who have received 4 hours of maintenance HD therapy three times weekly for at least 3 months

Exclusion Criteria:

* Patients with life expectancy less than 1 year
* Patients with history of active malignancy
AI and VR Devices for Eating Behavior Rehabilitation

Eating disorders (ED) affect the relationship with food and body image. Virtual reality (VR), combined with artificial intelligence (AI), offers new clinical solutions, overcoming traditional cognitive behavioral therapy (CBT). The ARCADIA VR project aims to develop devices to treat ED through personalized VR systems (e.g. Enhanced Body-Swap for anorexia, Emotional Rescripting for bulimia) and AI predictive algorithms to monitor severity, risk and efficacy of treatments. These approaches promise better and faster results, improving diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR (APA, 2013) and ICD-11, confirmed by a public hospital setting
* Body Mass Index (BMI) between 16 and 32
* Disorder present for at least 6 months
* No other concurrent psychotherapeutic interventions during the study
* All participants with a previous diagnosis will be re-evaluated and confirmed through assessment and consent by expert professionals in the research team (i.e., a neuropsychiatrist and a clinical psychologist)
Tissue Retractors for Radiation Therapy of Head and Neck Tumors

The rate of therapy-associated side effects during and after radiotherapy of head and neck tumors is essential. The most effective approach to reducing acute toxicity is to cut out healthy tissue from the radiation field. The distance between the tumor and normal tissue can be individually increased using personalized, 3D printer-based tissue retractors (GWR). Even the smallest geometric changes lead to a significant dose reduction in normal tissue and significant advantages for the patient.

The current randomized phase II study evaluates the use of GWR with regard to acute toxicity. In addition, quality of life, long-term toxicity as well as local control and overall survival 12 months after radiotherapy are evaluated.

The most effective approach to reducing acute toxicity after radiotherapy is to cut out healthy tissue from the radiation field. GWR can increase the distance between the tumor and normal tissue. Even the smallest geometric changes lead to a significant dose reduction in normal tissue and significant advantages for the patient. Adequate immobilization also reduces unwanted movements, especially of the tongue.

The GWR are manufactured as combinable modules according to the "modular principle". This improves reproducibility and flexibility and reduces development and manufacturing costs. The study is being conducted as a monocentric, prospective, randomized phase II study. A total of 34 patients who meet the inclusion criteria are examined for acute toxicity after radiotherapy of a malignant head and neck tumor. The primary goal of the study is to reduce acute toxicity through individual immobilization of the jaw and tongue. Secondary study goals are the evaluation of quality of life and long-term toxicity as well as local control and overall survival twelve months after radiotherapy. In both groups, radiation therapy is carried out in accordance with guidelines using image-guided radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a malignant head and neck tumor
* Clinical target volume of radiotherapy may include portions of at least one region: oral cavity; Upper jaw; Lower jaw; Oropharynx; Hypopharynx; large salivary glands
* Indication for radiotherapy alone (postoperative or definitive)
* Age ≥ 18 years
* Karnofsky performance score ≥ 60
* Completed wound healing after tumor resection
* The patient's consent and written consent
* Ability of the patient to assess the nature and scope as well as possible consequences of the clinical study
* Adequate contraception in women of childbearing potential and in men

Exclusion Criteria:

* Pre-radiation in the head and neck area
* Multifocal, diffuse growing tumors
* Inadequate regression of toxicities from previous therapies
* Jaw clamp (cutting edge distance ≤ 2 cm)
* Simultaneous systemic tumor therapy during radiation (especially chemotherapy and immunotherapy)
* Indications that the participant is unlikely to adhere to the study protocol (e.g. lack of compliance)
* Missing written declaration of consent
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)

This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy (nHCM).


Eligibility Criteria:
Key Inclusion Criteria:

* Male or nonpregnant female, age ≥18 years.
* Body mass index (BMI) ≥18 to \<38 kg/m2; weight ≥50 kg at Screening.
* Diagnosed with hypertrophic cardiomyopathy at the time of Screening consistent with current American College of Cardiology Foundation/American Heart Association Guidelines
* LVOT peak gradient ≥30 mmHg measured at rest and ≥50 mmHg post-Valsalva as determined by echocardiography at Screening (Part A, B and D oHCM only).
* LVOT peak gradient \< 30 mmHg measured at rest and \< 50 mmHg measured during the Valsalva maneuver as determined by echocardiography as assessed by the Investigator at Screening (Part C and D nHCM only).
* Maximal exercise peak LVOT gradient \< 50 mmHg as determined by echocardiography as assessed by the Investigator (historical documentation \< 12 months prior to dosing or confirmed at Screening) (Part C and D nHCM only).
* Documented left ventricular ejection fraction (LVEF) ≥0.60 at Screening.
* New York Heart Association (NYHA) Classification I-III at Screening.

Key Exclusion Criteria:

* Invasive septal reduction \<180 days prior to Screening.
* Documented current or history of obstructive coronary artery disease at any time or myocardial infarction \<180 days prior to Screening.
* Known Stage B or higher aortic valve stenosis or regurgitation
* Documented current or history of cardiac amyloidosis (age ≥ 60 years requires exclusion of cardiac amyloidosis by radionuclide scan or MRI performed at Screening or historical scan \<3 years prior to Screening).
* A history of syncope or sustained ventricular tachyarrhythmia \<180 days prior to Screening.
* A history of sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator (ICD) discharge \<180 days prior to Screening
* Atrial fibrillation (AF) at Screening; a current diagnosis of permanent AF; paroxysmal or persistent AF \<90 days of Screening, or electrical cardioversion or ablation for AF \<90 days of Screening.
* Fridericia-corrected QT interval (QTcF) ≥480 ms or any other ECG abnormality considered by the Investigator to pose a risk to participant safety.
* Current or prior use of any cardiac myosin inhibitors
* A history of diabetes with a hemoglobin A1C ≥ 7.5% at the Screening Visit (Part C and D nHCM only)