cyrilzakka/clinical-trials huggingface dataset:
Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms

The purpose of this study is to examine the pharmacological effects of alcohol on acute anxiety levels in a sample of Latino drinkers, and cultural experiences influencing these relationships.


Eligibility Criteria:
Inclusion Criteria:

1. 21-65 years of age
2. moderate or heavy drinker based on a past-month AUDIT score \>= 8.

Exclusion Criteria:

1. Possibility of being pregnant (verified by urine sample);
2. Self-reported history of or treatment for alcohol/other drug problems (as required by the IRB in past human alcohol administration research);
3. Moderate risk for drug problems as indicated by SMAST scores ≥ 5 or ASSIST scores of ≥ 4 (see Measures);
4. Medical conditions that contraindicate the use of alcohol (e.g., diabetes, liver disease);
5. Current use of psychiatric meds or any meds with alcohol contraindication (e.g., antibiotics);
6. Current non-alcohol substance use disorder;
7. Active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis.
Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity

Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled.

A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.


Eligibility Criteria:
Inclusion Criteria:

* one or several cancerous or pre-cancerous lesions of oral cavity newly diagnosed or detected during a follow-up visit

Exclusion Criteria:

* pregnant or lactating women
* patients under juridical protection
Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer

Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The overall incidence of HNC continues to rise, with a predicted 30% increase annually by 2030., this increase has been recorded across both developed and developing countries.

Approximately 90% of HNCs are squamous cell carcinoma . The major risk factors of head and neck squamous cell carcinoma (HNSCC) are tobacco and heavy alcohol use and human papillomavirus infection . There has been a significant decline in smoking in high-income countries during the last few decades, which has led to a sharp decline in smoking related HNSCC . While increase in global incidence of human papillomavirus (HPV)-associated or positive (+) HNSCC Head and neck squamous cell carcinoma (HNSCC) is a highly challenging cancer, despite the advancements in treatment, the overall prognosis for HNSCC remains poor, with a five-year survival rate of around 50%.

Chemoradiation is one of the treatment options for locally advanced head and neck cancers, the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy (CRT) is the standard of care for locally advanced head and neck squamous cell carcinoma (LAHNSCC), cisplatin is contraindicated in many patients because of age, diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group.

The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.

History: age, gender, comorbidities and risk factors.

Baseline evaluation of the patients:

CT or MRI head and neck Endoscopy and biopsy will be taken. Laboratory: CBC, renal functions and liver functions Nutritional assessment Audiogram as baseline assessment Dental assessment

Our patients will receive docetaxel (15 mg per meter squared) once weekly concurrently with radiotherapy.

Follow up of the patient during the course of treatment including evaluation of the patients weekly to assess the adverse events in the form of skin toxicity, mucositis, neutropenia and renal function affection.

Follow up after finishing the course of treatment. After 6 to 8 weeks the patient will be evaluated with CT or MRI head and neck and endoscopy Then every three month we will evaluate the patient as regarding the quality of life and late toxicity up to 2 years

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years
* Pathologically proven of squamous cell carcinoma
* Patients with locally advanced disease (T3, T4)(N positive)
* Patients eligible for radiotherapy

Exclusion Criteria:

* Patients with metastatic disease
* Patients with second primary cancer
* Patients ineligible for radiotherapy
Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer

The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared to giving bevacizumab at the same time as chemotherapy improves patient overall response to treatment.

OBELICS is a two-arm phase 3 trial comparing in mCRC patients (1:1): concurrent administration of bevacizumab in combination with modified FOLFOX-6 regimen (mFOLFOX-6) or modified OXXEL regimen (mOXXEL), in which bevacizumab is administered the same day as oxaliplatin, (standard arm); and sequential administration of bevacizumab with the same chemotherapeutic regimens, in which bevacizumab is administered 4 days before oxaliplatin at each cycle (experimental arm) Oxaliplatin regimen (mFOLFOX/mOXXEL) is chosen according to local clinical practice at the beginning of the study.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of colorectal adenoma carcinoma
* Stage IV disease
* Presence of at least one measurable target lesion (according to RECIST), and not previously radiated.
* Age ≥ 18 e ≤ 75 years
* ECOG Performance status 0-1
* Life expectancy \>3 months
* Adequate recovery from surgery, with at least 28 days from surgery to date of pre-study biopsy.
* Adequate contraception for male and female patients of child bearing potential
* informed consent

Exclusion Criteria:

* More than one previous line of therapy for metastatic disease
* Prior treatment with bevacizumab or oxaliplatin (previous treatment with irinotecan,, cetuximab, fluoropyrimidine, folic acid are permitted)
* Primary tumor that is stenosing and/or that infiltrates the entire thickness of the intestinal wall
* Regular use of NSAIDs or aspirin
* Bleeding disorders or coagulopathy
* Concurrent anticoagulant therapy
* Suspected or cerebral metastases (to verify in the presence of symptoms)
* Neutrophils \< 2000 / mm3, platelets \< 100,000 / mm3, hemoglobin \< 9g/dl
* Creatinine \> 1.5 times the upper normal limit
* GOT and/or GPT \> 2.5 times the upper normal limit, bilirubin \> 1.5 times the upper normal limit in absence of liver metastases
* GOT and/or GPT \> 5 times the upper normal limit, bilirubin \> 3 times the upper normal limit in presence of liver metastases
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ
* Congestive heart failure, ischemic coronary events within past 12 months, uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Active or uncontrolled infection
* Any concomitant condition that, in the investigator's opinion, would contraindicate the use of any of the study drugs
* Pregnancy or lactation
* Central nervous system disorders or peripheral neuropathy \> grade 1 (CTCAE v. 4.0)
* Inability to comply with follow up procedures of the study
Comparison of Analgesic Consumption Between Perioperative ıv Dexamethasone and Added to Femoral Block

the aim of this study was to investigate compare the effect of peroperative intravenous single dose dexamethasone and the addition of dexamethasone to femoral nerve block on postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty patients

Total knee arthroplasty leads to severe postoperative pain. for postoperative pain control after total knee arthroplasty oral -intramuscular opioids ,patient controlled analgesia intravenous or epidural opioids, single -continuous femoral nerve block involving techniques are used.

Dexamethasone is a glucocorticoid of high potency and frequently used perioperative.Dexamethasone to the local anaesthetic solution administered trough in femoral nerve blocks significantly prolonged the analgesic effect of the local anaesthetics used on this blocks.If the analgesic efficacy of systemic treatment with dexamethasone is similar with the use of perineural wich is the safest way should be preferred for systemic use.

Eligibility Criteria:
Inclusion Criteria:

* between 18-65 age
* knee arthroplasty
* no known allergies to drugs
* ASA 1-2 patients

Exclusion Criteria:

* history of diabetes
* history of chronic pain treatment
* pregnancy
* severe bronchopulmonary disease
* systemic opioid and steroid use
MRI Mapping in Planning Radiation Therapy to the Base of Skull and Brain in Patients With Nonmetastatic Head and Neck Cancer

RATIONALE: Diagnostic procedures, such as specialized types of magnetic resonance imaging (MRI), may help in planning radiation therapy that does less damage to normal tissues.

PURPOSE: This phase I trial is studying using functional MRI to see how well it works in planning radiation therapy in patients undergoing radiation therapy to the base of the skull and/or brain for nonmetastatic head and neck cancer.

OBJECTIVES:

* To determine the feasibility of applying established MRI techniques to map functional anatomic regions at potential risk in irradiated normal brain tissue of patients undergoing radiotherapy to the base of the skull and brain for head and neck neoplasms.
* To determine changes in cerebral blood flow and blood volume with perfusion MRI techniques in irradiated regions of the brain as a function of the radiation dose.

OUTLINE: Patients undergo MRI perfusion imaging and functional (fMRI) (standard structural imaging sequences, diffusion tensor imaging, arterial spin labeled perfusion imaging at rest, blood oxygen level dependent, and dynamic susceptibility contrast perfusion weighted MRI) at baseline and 3 and 6 months after completion of radiotherapy. Patients may perform tasks for fMRI studies, including finger tapping, photic stimulation with a flashing light, solving math problems, comparing shapes, giving a speech, or listening to and reciting lists of words during fMRI image acquisition. Patients also undergo daily fractionated intensity-modulated radiotherapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed head and neck cancer that requires radiotherapy to the base of the skull
* No evidence of metastatic disease

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Life expectancy ≥ 1 year
* Not pregnant
* Negative pregnancy test
* Able to undergo standard CT simulation and radiotherapy treatment planning and delivery, including the capacity to comply with standard immobilization devices to the head and neck for daily irradiation
* Able to undergo standard MRI and deemed capable of complying with the immobilization needs and tasks required for functional MRIs
* No claustrophobia
* No patients with pacemakers, metal fragments in the eye, or certain metallic implants

PRIOR CONCURRENT THERAPY:

* Not specified
Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

Following resuscitation from out-of-hospital cardiac arrest (OHCA), reperfusion injury can cause cell damage in the heart and brain. Remote ischemic conditioning (RIC) consists of intermittent application of a device such as a blood pressure cuff to a limb to induce non-lethal ischemia. Studies in animals with cardiac arrest as well as in humans with acute myocardial infarction suggest that RIC before or after restoration of blood flow may reduce injury to the heart and improve outcomes but this has not been proven in humans who have had OHCA. The RICE pilot study is a single-center study to assess the feasibility of application of RIC in the emergency department setting for patients transported to the hospital after resuscitation from OHCA.


Eligibility Criteria:
Included will be those with:

1. Age 18 years or more;
2. Defibrillation by laypersons or defibrillation and/or chest compressions by EMS providers dispatched to the scene;
3. Non-traumatic etiology of arrest, defined as without concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination;
4. Spontaneous circulation upon emergency department arrival;
5. No response to verbal commands; and
6. Ongoing or planned induced hypothermia.

Excluded will be those with:

1. STEMI indicated on first 12-lead ECG obtained after restoration of circulation, defined as ST-elevation of ≥2 mm in two or more contiguous ECG leads;
2. Written do not attempt resuscitation (DNAR) reported to providers before randomization;
3. Drowning or hypothermia as cause of arrest;
4. Known prisoner or pregnant; or
5. Dialysis fistula in either upper extremity; or
6. Pre-existing amputation of upper extremity.
Serum Free Light Change in Multiple Myeloma

The purpose of this study is to evaluate the predictive role of free Kappa/Lambda ration in Multiple Myeloma post-transplant.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected with Multiple Myeloma who underwent autologous or auto/allogenic stem cell transplantation.
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
* treatment-naïve or have received no more than 3 systemic treatment regimen(s)
* Positive for translocation or inversion events involving the ROS1 gene
* Negative for translocation or inversion events involving the ALK gene
* Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
* Any prior treatment (chemotherapy, radiation \[except for palliative\], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
* At least 1 measurable tumor lesion as per RECIST v1.1
* Female or male, 18 years of age or older
* ECOG performance status 0 to 1
* Adequate organ function
* Signed and dated informed consent
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
* Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment

Exclusion Criteria:

* Current treatment on another therapeutic clinical trial
* Prior therapy specifically directed against ALK or ROS1 fusion genes
* Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
* known interstitial fibrosis or interstitial lung disease
* myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
* Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade \>/=2, uncontrolled atrial fibrillation of any grade, or QTc \>470 msec
* Pregnant or breast feeding
* Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
* Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
* Evidence of active malignancy within last 3 years
Behavioral Treatment for Cocaine Dependent Women

To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent voucher control (VC) for the treatment of cocaine dependent pregnant women or women with young children.

Subjects were randomly assigned to 1 of 4 treatment groups (CRA+VBRT, CRA+VC, TSF+VBRT, TSF+VC). VBRT voucher value increased for each successive cocaine-free urine sample obtained twice weekly during the 1st 12 weeks and was faded from the final earned value to $5 during the last 12 weeks. All subjects earned vouchers for attendance at scheduled twice weekly counseling sessions. Manual-guided CRA and TSF were provided by experienced clinicians.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women meeting DSM IV criteria for cocaine dependence
* Women meeting DSM IV criteria for cocaine dependence with custody of a young child

Exclusion Criteria:

* Opioid dependence
* Psychosis
* Severe depression
* Current treatment with any anti-depressant or anti-psychotic medication
* Medical instability
* Inability to understand or read English
A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index (BMI) below or equal to 35.0 kg/m2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects

The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe low back pain for ≥6 months
* Treating CLBP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] analgesic rescue medications permitted on top of the stable daily maintenance dose of ≥30 mg MSE opioid analgesic, but must be included in the total daily MSE calculation and in combination with the stable daily maintenance dose not to exceed 160 mg MSE per day)
* Stable health, as determine by Principal Investigator
* Females are practicing abstinence, using a medically acceptable form of contraception, or post-menopausal, biologically sterile, or surgically sterile for more than 1 year
* Willing and able to comply with all protocol required visits and assessments

Exclusion Criteria:

* Current cancer related pain or received chemotherapy within 6 months of screening
* Subjects with history of other chronic painful conditions
* Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
* Allergy or contraindications of any opioid or acetaminophen
* Surgical procedure for relief of pain within 6 months
* Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
* QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
* History of long QT syndrome or a family member with this condition
* Moderate to severe hepatic impairment
* Moderate to severe renal impairment
* Current or past history of alcohol abuse
* Positive urine toxicology screen for drug of abuse
* History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values
Laser-Assisted Gingival Depigmentation

This randomized clinical trial evaluated the recurrence rates of physiological gingival pigments during 24 months follow-up and the patient perceptions after the ablative depigmentation using two laser wavelengths; Diode 940 nm and Er,Cr:YSGG 2780 nm.

This study aim to compare the clinical outcomes, the rate of repigmentation, and the patient perceptions after laser-assisted gingival depigmentation with diode 940 nm and Erbium, chromium-doped yttrium, scandium, gallium and garnet (Er,Cr:YSGG) 2780 nm. Two pigmentation index were used to compare between the treatment outcomes of using Diode laser or Er,Cr:YSGG.

The depigmentation procedure essentially involves ablation of epithelial layer of buccal gingiva containing melanin pigmentation.

Sixty healthy patients (22 males and 38 females, aged 21 to 43 years) who presented with a chief complaint of having dark-brown to black gingival hyperpigmentation between April 2015 and September 2018. Participants were randomly divided into 2 groups (30 patients each). Randomization was carried out using randomization table; by a computer-generated randomization list (SPSS v23.0) with allocation ratio 1:1.

All of the patients were selected according to the study inclusion and exclusion criteria.

Data collection was done by a dental specialist who was blinded about the provided treatment. Data collections included the clinical examination at baseline and follow up appointments. To achieve blinding, three calibrated external experts, blinded to the provided treatment classified the degree of gingival pigments and gingival topography according oral pigmentation index (DOPI) and melanin pigmentation index.

The periodontal surgery was performed by a periodontist specialised in laser dentistry. The periodontist did not interfere with the treatment option.

Descriptive statistics and statistical analysis was done by an external expert using SPSS Statistics software(SPSS v23.0) . Nonparametric tests, Kruskal-Wallis test was used to compare between the two groups according the time intervals.

The patients who did not show in all the study follow up's appointments were dropped from the data analysis.

Patients were asked to evaluate the procedure by using a self-administered questionnaire. The patients were recalled after 1 week, 1 month, 12 months and 24 months.

Eligibility Criteria:
Inclusion Criteria:

• All patient exhibiting physiologic pigmentation of score2 or more according to Oral pigmentation index (DOPI)

Exclusion Criteria:

* Pathologic hyperpigmentation
* Participants with a systemic condition that could affect tissue healing (e. g., autoimmune diseases)
* Pregnancy and lactation
* History of smoking
* Previous mucogingival surgery at the region to be treated
* No contraindication for the laser treatment.