cyrilzakka/clinical-trials huggingface dataset:
Epigenetic Changes in Head and Neck Cancer

With this study, the investigators will investigate the epigenetic changes, which may contribute to the development of head and neck squamous cell carcinomas.


Eligibility Criteria:
Cancer group:

Inclusion Criteria :

* Written informed consent
* Histologically confirmed oral squamous cell carcinoma

Exclusion Criteria:

* History of cancer
* Uncontrolled comorbidity

Control group:

Inclusion Criteria :

* Written informed consent
* Normal buccal mucosal surface.
* Normal ENT-examination

Exclusion Criteria:

* History of cancer
* Uncontrolled comorbidity
Stability and Function of Cervical Spine With Grade Point Average in University Students

Spinal disorders are some of the most prevalent health concerns, especially among students

Stability of the cervical spine during head and cervical movements is an important component of cervical spine function .The deep neck flexor (DNF) (longus colli, longus capitis) muscles stabilize the neck and contribute to the control of head acceleration. Weakening of these muscles can lead to its coordination, activation, overload and poor support in the cervical structures. Further causes neck pain and altered neck position.

Studies conducted on patients with neck pain have also shown activation of these muscles and reduced resistance, associated disorders and headaches. Muscle resistance should be considered as a measure of neck function or injury.

University class, staying up late can be considered a risk factor for neck pain in students.

Eligibility Criteria:
Inclusion Criteria:

* Ages ranged from 20 to 25 years old
* Students have no health problems or complains

Exclusion Criteria:

* neck pain
* Cervical radiculopathy
* Fracture
* Previous back problems
* Students with low grade (GPA below 2)
Dose Proportionality and Food Effect of Morphine Sulfate

Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to examine the effect of food on absorption from the 30 mg tablet.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to morphine sulfate or any comparable or similar product.
Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity

We aim to explore some of the molecular factors that reduce fertility for women with leiomyomas, taking into account leiomyoma location, size, number and vascularity. Tissue samples from the endometrium and leiomyomas will be obtained during the mid secretory phase before and 3-6 months after surgical excision for a comprehensive search for key molecular derangements.

Baseline medical information and standard questionnaire to record symptoms are collected from all participants and a gynaecological examination and a 2D and 3D vaginal ultrasonography including saline infusion sonography (SIS), if indicated, are performed. Blood samples for the biobank for extraction of germ line DNA and for identification of possible biomarkers are taken.

The women with submucosal leiomyomas will undergo hysteroscopic myomectomy and the women with intramural leiomyomas will undergo myomectomy per laparoscopy or laparotomy.

For the participants with intramural leiomyomas and the fertile/infertile controls, endometrial samples are taken with an endometrial suction curette in an outpatient setting at day 19-23 of the menstrual cycle. The endometrial sampling in the group of women with submucosal leiomyomas is being done during the hysteroscopic removal of the leiomyoma, also at day 19-23 of the menstrual cycle.

3-6 months after surgery, cycle day 19-23, endometrial samples will be taken from the women who have undergone myomectomy and ultrasound examination is being performed. The women with submucosal leiomyomas will undergo a second look hysteroscopy

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 40 years
* Presence of leiomyoma(s)
* Regular menstrual cycle (28 +/- 7 days)
* Having had at least 2 normal menstrual cycles after ending the treatment if previously treated with GnRH analogue
* Signed informed consent

Exclusion Criteria:

* No treatment indication (no symptoms and/or no desire for fertility)
* Contraindication for surgery
* Known endometriosis
* Known PCOS
* Untreated hydrosalpinx
* Malignancy; gynaecological or other location
* Pre-malignant or malignant pap smear or endometrial biopsy
* Hormonal treatment including ulipristal acetat and levonorgestrel intrauterine device last three months before inclusion in the study
* Ongoing treatment with GnRH analogue
* Pregnancy last 3 months
* Ongoing lactation
Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

This study will be conducted to find out how well a patient of rheumatoid arthritis (RA) will respond to disease-modifying antirheumatic drugs (DMARDs). RA is a chronic inflammatory arthritis, which leads to joint damage \& disability if not treated properly. A DMARD is used to treat RA that slows down or prevents joint damage, as opposed to just relieve pain or inflammation by painkillers. The study will be conducted at the Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education \& Research). Patients will receive either a single DMARD (Methotrexate) or combination DMARDs therapy (Methotrexate + Leflunomide + Hydroxychloroquine). During treatment course, routine blood investigations will be carried out to monitor treatment response and side effects.

Patients aged ≥18 years, fulfilling the 2010 ACR EULAR criteria for RA (symptom duration less than one year) \& having moderate to severe disease activity (DAS28≥3.2) will be invited to participate. After providing written informed consent, eligible patients will be stratified into two groups. Block randomization will be done to generate random allocation sequence.

Treatment Group I will be treated with Methotrexate (MTX) monotherapy and Treatment Group II will be treated with Methotrexate + Leflunomide (LEF) + Hydroxychloroquine (HCQ) combination therapy. Concurrent treatment with non-steroidal anti-inflammatory drugs in adequate dose and oral low dose Glucocorticoids (GC) (max: 15 mg/d) will be allowed during the study.

DMARD dosages used are: MTX 25 mg/week orally (dosage after 6 weeks), LEF 20 mg/day (dosage after 2 weeks) and HCQ 400 mg/day. GCs will be given in an oral tapering scheme. All patients will be prescribed folic acid (10 mg/week) during MTX prescription.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years satisfying 2010 ACR (American college of rheumatology) - EULAR criteria for RA
2. Arthritis in one or more joint (s)
3. Symptom duration \<1 year
4. DMARD naive
5. Patients with moderate to severe disease activity (DAS28 ≥3.2)

Exclusion Criteria:

1. Disease in Remission/inactive disease (DAS28 criteria)
2. End stage disease (deformed fixed joints)
3. Patients with vasculitis or other severe extra-articular features
4. Contraindications to DMARD therapy (Chronic Alcoholism, Chronic liver disease, Evidence of acute/chronic infection, Chronic kidney disease, Patients with leucopenia (\<3.0×109/l), thrombocytopenia (\<150×109/l), aspartate aminotransferase (AST)/alanine aminotransferase (ALT)\>2× upper normal value and creatinine level \>150 μmol/l )
5. Pregnant, lactating females or inadequate contraception
6. Patients unable to come for regular follow up
Comparison of Short-term Sustained-release Opioid in Open Abdominal Urologic Surgeries

The advantage of slow-release opioid allows for less fluctuation in drug (pain killer) levels in the blood and an extended period within the effective range for pain relief. The slow-release opioids have been preferred over the short-acting opioids because of the longer duration of action, which lessens the frequency and severity of end-of-dose pain.

Herein, the investigators propose the use of low dose slow-release opioid formulation offers better pain control in the first 48 hours post-operatively in open abdominal urologic surgeries.

This will be a randomized, double-blind, controlled trial looking at all adult patients undergoing open abdominal urologic surgeries. After assessing the inclusion/exclusion criteria, the patients will be randomized into one of two groups:

Group 1: Sustained-release (long-acting) opioid on a regular basis for 2 days with immediate-release (short-acting) opioid available on an 'as required' basis

Group 2: Immediate-release (short-acting) opioid on an 'as required' basis only.

All patients will have a general anesthetic at the discretion of the anesthesiologist in the operating room and intravenous opioid will be administered in accordance with the anesthesiologists' discretion.

Pain score and analgesic consumption are the outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing open abdominal urologic surgeries
* ASA 1-3

Exclusion Criteria:

* Patient refusal
* history of chronic pain
* allergy to hydromorphone
* cannot swallow tablets
Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium

The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.

This study is an open-label, three-treatment, six sequence, three-period, single center crossover study to evaluate the pharmacokinetics of intravenous diclofenac sodium DIC075V (18.75 mg and 37.5 mg) versus oral diclofenac potassium (Cataflam® 50 mg) in healthy adult volunteers following single- and multiple-dose administration. Each treatment sequence received 1 dose every 6 hours (for a total of 4 doses per treatment sequence) with a 48-hour washout period between treatment sequences.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 and 55 years of age.

Exclusion Criteria:

* Smoked or used tobacco or nicotine products in the past six months or expects to during the study.
* Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs.
* History of previous and/or present peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or for HIV antibodies, or history of asthma.
Building Physician Resiliency Through CREATION Health: A Research Study

The purpose of this study is to determine whether a standardized application of a physician-oriented CREATION Health curriculum is associated with reductions in burnout and perceived stress and improvements in well-being and empathy

This is a prospective, non-randomized study of a convenience sample of Centura Health physicians.This study will not include any drugs or devices. The physician-oriented intervention will consist of a two-day weekend retreat that focuses on the application of CREATION Health principles in order to reduce burnout and perceived stress and improve well-being and empathy. There will be one four-hour session about each of the following CREATION Health principles: Choice, Trust, Interpersonal Relationships, and Outlook.

Eligibility Criteria:
Inclusion Criteria:

* Physician employed by Centura Health or credentialed physician with privileges at Centura Health
* Adult ≥ 18 years old
* English language proficiency
* Able to provide informed consent
* Resides in the Denver, Colorado area
* Willing to commit to the timeline of the study

Exclusion Criteria:

* Plans to reside outside of the Denver, Colorado area within the 8 months
Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)

The purpose of this clinical trial is to establish the safest doses for the combination of a farnesyl transferase inhibitor, R115777 plus topotecan in patients with advanced solid tumors, previously treated or beyond standard therapy of clinical benefit. Maximum tolerated dose, dose limiting toxicity and the activity of this combination will be assessed.

This chemotherapy regimen is a two-pronged attack at the way cancer cells replicate. R115777 is a compound that may inhibit cancer cell growth by interfering with the p21 ras oncogene, while topotecan, a topoisomerase-1 inhibitor, works on cancer cells not subject to control by the ras oncogene. Animal studies suggest that the combination may be synergistic. Another advantage is that R115777 can be taken by mouth.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced solid tumors with previous treatment or beyond standard therapy of significant clinical benefit
* Therapy with no more than 3 prior chemotherapy regimens
* Radiotherapy to less than 25% of bone marrow volume (no pelvic radiation)
* Adequate organ function
* Recovery from the effects of prior chemotherapy and radiation therapy, with at least a 4 week interval. All prior toxicities should have resolved to baseline prior to entry into the study.
* Good performance status
* Anticipate life expectancy of at least 6 months
* Not pregnant or lactating.
* Sexually active men and women of childbearing age must use adequate contraception.
* Be able to give signed, written informed consent.
* No gastrointestinal condition that could affect the absorption of the drug
* No active infection requiring systemic medical therapy one week prior to chemotherapy
The Pain Perception Threshold in Attention Deficit Disorder With Hyperactivity

The aim of this study was to evaluate whether the disease subtype affects the presence of chronic pain and pain perception threshold in pediatric patients followed up with the diagnosis of attention deficit and hyperactivity disorder, and to evaluate the factors that may be related to pain perception threshold in disease subtypes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with attention deficit and hyperactivity disorder according to DSM-5 diagnostic criteria
* Being between the ages of 6-17
* Being at a clinically normal mental level

Exclusion Criteria:

* Having verbal and visual communication problems
* Having a history of perinatal complications or physical head trauma
* Having comorbid psychiatric disorders other than oppositional defiant disorder and conduct disorder
* Known history of chronic physical and neurological disease (such as cerebral palsy, diabetes, epilepsy, autoimmune diseases, liver and kidney failure)
* Presence of substance or alcohol use disorder
* Having a genetic disorder diagnosis
Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.


Eligibility Criteria:
Inclusion criteria:

* Chronic HCV genotype 1 infection
* No previous treatment for HCV infection
* African American ethnicity
* Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit
* A liver biopsy within 3 years prior to baseline

Exclusion criteria:

* HCV genotype different from genotype 1 or co-infection with other HCV genotype
* Co-infection with Hepatitis B or HIV
* Any other cause of relevant liver disease other than HCV
* Presence or history of hepatic decompensation
* Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (\> ULN) in past 6 months

Other protocol-defined inclusion/exclusion criteria may apply
Comparative Study Between Socket Shield Technique Versus Allograft Buccal Sheet Technique on Alveolar Bone Resorption After Immediate Implant Placement

22 patient where divided randomly into 2 groups : control group did dental implant utilizing socket shield , while study group did dental implant with allogenic bone graft there is no significant bone loss between the two groups after 4 month follow up


Eligibility Criteria:
Inclusion Criteria:

- patient has remaining root in upper anterior without lesion

Exclusion Criteria:

periapical lesion under the tooth
Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL

Primary Objective:

To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients.

Secondary Objectives:

* To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events.
* To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.

The estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.

Eligibility Criteria:
Inclusion criteria :

* Male or Female.
* Age ≥ 18 years.
* With Type 1 diabetes mellitus.
* Being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year.
* Have an glycated hemoglobin (HbA1c) measurement of 7.5% - 10.0% at study entry.
* Patients who have signed an Informed Consent Form.

Exclusion criteria:

* Type 2 diabetes mellitus.
* Known hypoglycemia unawareness
* Repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months.
* End-stage renal failure or being on hemodialysis.
* Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.
* Known hypersensitivity / intolerance to insulin glargine or any of its excipients.
* Patients treated with glucagon like peptide agonists.
* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening.
* Pregnant or lactating women.
* Women of childbearing potential with no effective contraceptive method.
* Participation in another clinical trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
3M Veraflo™ Cleanse Choice Complete™ (VFCCC) Clinical Study

The purpose of this external clinical study is to demonstrate the safety and performance of the Veraflo™ Cleanse Choice Complete™ Dressing Kit which will be used in conjunction with the V.A.C.® Ulta™ Therapy Unit, utilizing V.A.C. Veraflo™ Therapy instillation functions.


Eligibility Criteria:
Inclusion Criteria

* Subject is at least 22 years old at time of consent.
* Subject OR Legal Authorized Representative is able to provide informed consent.
* Subject has been confirmed to have a chronic, acute, traumatic, sub-acute, or dehisced wound, partial-thickness burn, ulcer (such as diabetic, pressure or venous insufficiency), flap or graft.

Exclusion Criteria:

* Subject is pregnant prior to application of the initial dressing\*

  \*Women who have had surgical sterilization by a medically accepted method (i.e. tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for \> 12 months will not be required to undergo pregnancy testing.
* Subject has been diagnosed with a malignancy in the wound.
* Subject has untreated osteomyelitis.
* Subject has an untreated systemic infection.
* Subject has active cellulitis in the peri-wound area.
* Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane.
* Subject has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
* Subject has had radiation directly to the wound area.
* Subject has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
* Subject has necrotic tissue with eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, Veraflo™ Therapy may be used.
* Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days of Visit 1.
* Subject has non-enteric or unexplored fistula.
* Subject has a wound with any unexplored tunneling present.
* Subject has inadequate hemostasis at the wound site, as determined by the investigator.
* Subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves.
Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage

This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage (PPH).


Eligibility Criteria:
Inclusion Criteria:

* Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
* Female Adult subjects (\>18 years of age).
* Diagnosis of PPH with suspected uterine atony placental bed bleeding, placenta accreta or previa within 24 hours after vaginal delivery.
* Subjects with coagulation disorders can be included
* Minimal Estimated Blood Loss (EBL), to be determined when investigator is ready to have the Celox™ PPH package opened. 500 ml of EBL for vaginal delivery or 1000 ml for caesarean section.
* Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post the Celox™ PPH use.
* Subjects with PPH of cervical or vaginal origin.

Exclusion Criteria:

Subjects who present with, uterine rupture or for any other conditions outside of atonic post-partum haemorrhage needing other interventional methods or surgery including uterine artery embolization (UAE).

* Pregnancy or incomplete multiple pregnancy
* Unresolved uterine inversion.
* Current cervical cancer.
* Current purulent infection of the vagina, cervix, uterus.
* Planned c-section with closed cervix.
* Patients requiring trans-abdominal insertion of Celox™ PPH.
The Association of G9a Protein and the Outcome of Patients With Cervical Cancer

G9a protein was approved to be highly associated with recurrence of breast cancer, gastric cancer, hepatocellular cancer, prostate cancer and lung cancer. Therefore, the aim of this study was to clarify the association and G9a protein and cervical cancer by analyzing the immunohistochemical staining of G9a protein to the histopathologic specimen of cervical cancer and clinical data.


Eligibility Criteria:
Inclusion Criteria:

* cases with cervical cancer