cyrilzakka/clinical-trials huggingface dataset:
Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer

This study is looking at the safety and tolerability of TNFeradeä Biologic combined with conventional once daily radiation therapy in elderly or frail patients with new onset locally advanced head and neck tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age 70 or older with an ECOG performance status 0-2,or
* Patients \> 18 years of age with ECOG performance status of 2 or greater, or
* Patients \> 18 years of age unsuitable for concurrent chemotherapy or surgery due to:
* Renal failure, or
* Severe cardiopulmonary disease, or
* Other end-organ dysfunction that precludes the use of chemotherapy but does not preclude the administration of TNFerade™ Biologic or cetuximab
* Tumor that is unresectable or inoperable and not amenable to regular concurrent chemoradiotherapy
* Patients \> 18 years of age with intermediate stage disease, stages II-III (T2-T3, N0-1MO) carcinoma of the head and neck, including oral cavity, pharynx larynx, paranasal sinuses and cervical esophagus. Selected patients with stage IV disease (T4N0-1M0) will also be considered for enrollment. Therapy is given with curative intent.
* Disease should be clinically accessible (measurable or evaluable) to keep injection via direct intratumoral injection
* Informed consent

Exclusion Criteria:

* History of malignancy in the last 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer, or localized early stage prostate cancer, with patients continually disease free, or cancers that are not felt to influence treatment for head and neck cancer and life expectancy of patient
* Overt systemic metastatic disease
* Previous radiation or chemotherapy for malignancy of the head and neck
* Clinical evidence of active infection of any type
* pregnant or lactating women
* Experimental medications within the last 4 weeks prior to Day 1
* Chronic treatment for greater than 6 months with steroids at doses above 10 mg/day prednisone (or equivalent)
* Patients receiving hormone replacement therapy or hormonal contraceptives within 2 weeks of day 1
* Patients who have undergone surgery within the last 1 month
* Allergic reaction to cetuximab
Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir

To study the safety and effectiveness of the combination of Chidamide with Chimeric Antigen Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy on HIV patients based on cART.

Despite the advent of combined antiretroviral therapy (cART), the persistence of viral reservoirs remains a major barrier to cure human immunodeficiency virus type 1 (HIV-1) infection. Recently, the shock and kill strategy, by which such reservoirs are eradicated following reactivation of latent HIV-1 by latency-reversing agents (LRAs), has been extensively practiced. It is important to reestablish virus-specific and reliable immune surveillance to eradicate the reactivated virus-harboring cells. Some studies have shown that Chidamide can highly activate the HIV reservoirs. The VC-CAR-T cells effectively induced the cytolysis of LRA-reactivated HIV-1-infected CD4 T lymphocytes isolated from infected individuals receiving suppressive cART. Our previous study demonstrated that the special features of genetically engineered CAR-T cells make them a particularly suitable candidate for therapeutic application in efforts to reach a functional HIV cure. The purpose of this study is to evaluate the safety and efficacy of Chidamide together with Chimeric Antigen Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy based on cART in HIV-infected adults whose plasma HIV has been successfully suppressed after cART.

Eligibility Criteria:
Inclusion Criteria:

1. HIV infection confirmed
2. Receiving cART more than 12 months.
3. HIV viral-load \< 50 copies/ml and CD4 cell count more than 350 cells/ul.
4. Without serious liver , heart, liver and kidney diseases.
5. The subjects know about the study and volunteer to attend the research and sign the informed consent.

Exclusion Criteria:

1. With active HBV or HCV infection, or serious opportunistic infections.
2. With serious chronic disease such like diabetes, the mental illness,et al
3. History of suffering from pancreatitis during cART .
4. Pregnant or breast-fed.
5. With poor adherence.
6. Unable to complete follow up.
Cognitive Therapy in Reducing Depression in Patients With Cancer

The purpose of this study is to learn about treatment of depression in people who have any type of cancer. Cognitive therapy (CT) helps improve depressive symptoms by targeting patient's thoughts and behaviors. People who are depressed tend to have more negative or pessimistic thoughts. CT helps people evaluate the accuracy of their thoughts. By encouraging patients to develop more balanced views, symptoms of depression begin to improve

PRIMARY OBJECTIVES:

I. Determine the efficacy of biobehavioral/cognitive therapy for cancer patients/survivors with major depression.

II. Test for the covariation between reduction in depressive symptoms and improvements in quality of life.

OUTLINE:

Patients undergo cognitive behavioral therapy comprising progressive muscle relaxation training, behavioral activation, seeking information as a coping strategy, enhancing social support, cognitive reappraisal, assertive communication, changing depressive core beliefs, goal setting and planning for maintenance, and maintenance over 1 hour once weekly sessions for 12-20 weeks, biweekly sessions for 4-6 weeks, and monthly sessions for 2-3 months for a total of 16-26 sessions.

After completion of study treatment, patients are followed up at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of invasive cancer, any site, any stage, any time since diagnosis; history of non malignant (basal cell) or low malignant potential (e.g., in situ cervix) cancers do not meet this criterion
* Diagnosis of major depressive disorder (MDD), according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria (American Psychiatric Association, 2000)
* Able and willing to give informed consent

Exclusion Criteria:

* History of bipolar affective disorder or psychosis
* Current axis I disorder (e.g. obsessive-compulsive disorder, specific phobia) other than MDD if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered
* History of substance dependence in the past six months
* Subnormal intellectual potential (intelligence quotient \[IQ\] below 80)
* Current suicide risk sufficient to preclude treatment on an outpatient basis
* Progressive neurological or related conditions/diagnoses
* Non-ambulatory
* Life expectancy less than 60 days
The Use of Manuka Honey to Improve Healing After Third Molars Surgery

Since there is an evidence that Manuka honey is an antibacterial agent, the present study aims to confirm this characteristic and assess its effect in improving healing and reducing postsurgical symptoms, if topically applied after the surgical removal of impacted mandibular third molars

Sufficient evidence exists recommending the use of honey in the management of acute wounds and burns. Studies revealed that the healing effect of honey could be classified by its antibacterial, antiviral, anti-inflammatory and antioxidant properties of its components. Manuka honey has been shown to inhibit a wide range of microorganisms, including multiresistant strains. This unique honey is derived from flowers of manuka tree (Leptospermum scoparium) in New Zealand. Dihydroxyacetone and methylglyoxal are unique and naturally occurring constituents of manuka honey that correlate with its antibacterial activity.

Since surgical extraction of impacted molars is one of the most common operations in the oral cavity and the postoperative symptoms disturbing the patient may reduce the quality of health service, this study aims to assess the healing potential of Manuka honey in reducing these symptoms by comparing the outcome of extraction of impacted lower molars with and without topical application of Manuka honey into the extraction socket.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic, Symmetrical, Bilateral Impacted Third Molars

Exclusion Criteria:

* Uncontrolled diabetes,
* Hypersensitivity to Honey
* Alcoholism,
* Drug abuse,
* Pathological condition in the region
Antioxidant Effect of Ozonated Vegetable Oil and Vitamins in Moderately Active Subjects

The purpose of this pilot study is to evaluate the antioxidant effect of a nutraceutical formulation based on vegetable oil and vitamin complex (vitamin K2 and vitamin B9) in subjects with the same level of physical activity (LAF 1.70-1.99, normally active or moderately active).

Study design: The pilot study will enroll 20 subjects with physical activity level LAF 1.70-1.99 (normally active or moderately active).

The 20 subjects will be divided into two groups of 10 subjects following randomization. The first group will take the dietary supplement (three capsules per day) for 60 days, while the second group will take a placebo (three capsules per day) for 60 days.

During the treatment period (60 days), the two groups will undergo follow-ups at days 0, 15, 30 and 60 within which clinical and hematochemical examinations will be conducted. At the end of the 60 days, after the wash-out period (two weeks), as per the cross-over design the group previously taking the dietary supplement will be on placebo (three capsules per day) for 60 days, while the group previously taking placebo will take the dietary supplement (three capsules per day) for 60 days. Again, follow-ups will be at 0, 15, 30 and 60 days.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes;
* Aged between 18 and 60 years, naïve to taking antioxidant supplements;
* Absent of chronic diseases and current therapies;
* willing and able to understand and sign an informed consent;
* willing to follow a dietary pattern developed according to the LARN (Reference Intake Levels of Nutrients and Energy for the Italian Population) guidelines that establish reference intake levels for Average Energy Requirement (AR) and Macronutrients (Carbohydrates, Lipids and Protein) for the Italian adult population \[LARN Tables\*\];
* Hematobiochemical examinations in normal range: blood count, lipid status, renal and liver function, inflammatory status (Tnfα, C-reactive protein, ESR), glycemic profile (Fasting blood glucose, HbA1C, insulinemia, Homa Index);
* BMI in the normal range (18-24.99);
* Physical activity level LAF 1.70-1.99 (normally active or moderately active)

Exclusion Criteria:

* Chronic diseases (chronic renal failure, chronic hepatocellular failure, autoimmune diseases, chronic inflammatory bowel disease, diabetes mellitus, end-stage neoplasms, symptomatic chronic ischemic heart disease)
* Severe hypertension;
* High-grade hypercholesterolemia;
* Age \< 18 years;
* Poor compliance;
* Intake of dietary supplements containing antioxidants;
* Untreated hypothyroidism;
* Pregnant and lactating women;
* Underweight subjects (BMI ≤18.49);
* Overweight subjects (25≤ BMI ≤30);
* Subjects with obesity (BMI ≥30);
* Subjects with different levels of physical activity: very active (LAF 2.00-2.40) and sedentary (LAF 1.40-1.69).
Pharmacokinetic (PK)Research on Chinese Children of Hemophilia

The study start on June 30, 2018. The Severe(F Ⅷ\<1%) hemophilia A children without F Ⅷ inhibitor combining were recruited to Test the concentration of the drug in the blood to provide better treatment.

Through the integration of two technologies, pharmacokinetics and comprehensive evaluation system, we can improve the individualized prevention and treatment of hemophilia in Chinese children and achieve precise customization of treatment plans. Rational use of medical resources, but also fully achieve the prevention and treatment goals.

Eligibility Criteria:
Inclusion Criteria:

* FⅧ\<1% ,
* 1-14years old,
* There have been at least one history of bleeding in any joint of the knee, elbow, or ankle.
* A blood product containing FVIII is applied.
* There were no inhibitors at the time of enrollment, and there was no inhibitor-positive history and family history.
* Clinical visits are available on a regular basis and data is available, and preventive treatment is available prior to enrollment.
* The child was enrolled in the group and the guardian agreed.

Exclusion Criteria:

* Combining other disease researchers believes that it is not suitable for enrollment.
* FVIII inhibitor was found.
* Refuse to participate in research
Glycemic Load, Metabolism & Obesity in Pregnancy

The purpose of the study is to determine if a low glycemic load diet reduces the gain of body fat and insulin resistance during the last half of pregnancy in obese women.

Obese women will be recruited to participate in the study between 14-18 weeks gestation. After determining usual dietary intakes, visceral fat thickness, and the metabolic response to a 100g oral glucose tolerance test (OGTT) at 20 weeks gestation, 45 of the women will be randomly assigned to a low glycemic load (GL) diet and 65 women to a regular low fat diet (current standard care). They will follow their assigned diet for the last 20 weeks of gestation. A dietitian will advise the women and will monitor them throughout the study. At 28 and 34 weeks gestation, the women will come to the General Clinical Research Center (GCRC) at San Francisco General Hospital in the fasting state and the hormonal and metabolic response will be measured to another 100g oral glucose tolerance test (OGTT), and total body fat will be measured. Additional measurements include: 1) longitudinal measurements of maternal visceral fat thickness and fetal size and adiposity at 20 and 34 weeks gestation by ultrasound, 2) collection of cord blood and placental tissue, and 3) measurement of neonatal body composition by dual-energy x-ray absorptiometry and anthropometry at 2-3 weeks of age. Birth outcome data for mother and infant will be collected. To determine the metabolic response to the study diet, 25 women from each of the two diet groups will be assigned to a metabolic subsample for measuring rates of hepatic glucose production and lipolysis at 34 weeks.

Eligibility Criteria:
Inclusion Criteria:

* \>35% body fat
* 18 to 40 years of age
* speak English or Spanish

Exclusion Criteria:

* have diabetes prior to pregnancy
* diagnosed with GDM in current pregnancy
* smoke
* abuse alcohol or drugs
* have a metabolic disease
Global Postural Re-Education And Neck Isometric Exercises In Cervical Radiculopathy RADICULOPATHY

Cervical radiculopathy is a common neurological disorder that is caused by compression of the nerve, inflammation of nerve roots, or space-occupying lesions. Cervical radiculopathy is the most common health-related problem worldwide. The conservative approach like education, specific exercises, and spinal manipulation is usually given for chronic cases with good outcomes.

Cervical Radiculopathy is a condition in which a nerve is entrapped between the bones and causes numbness and tingling. Neck isometric exercises are a basic treatment plan for strength training. Global postural reeducation is a technique the manual cervical traction along with body alignment that helps to reduce symptoms more rapidly. This whole procedure is completed more easily, without a machine and satisfying for the patient.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 35 years.
2. Both genders, Males and females
3. One-sided upper limb pain or numbness
4. Any 2 out of 4 tests are positive Spurling test, Distraction test, Ipsilateral cervical traction test, and Upper Limb test

Exclusion Criteria:

1. Bilateral upper limb pain
2. Previous history of cervical surgery
3. Cervical spine
4. Injection therapy in the past 2 weeks
5. Being Pregnant women
Influence of Injection Rate of Intrathecal Mixture of Local Anesthesia on Hypotension in Cesarean Section

Hypotension is the most common complication of neuraxial anesthesia in obstetric patients and its prevalence in cesarean section is about 50-90%. Maternal hypotension causes unpleasant symptoms such as nausea, vomiting, loss of consciousness, respiratory depression, and cardiac arrest. Hypotension may reduce placental perfusion and result in fetal acidosis and neurological injury. Several techniques have been proposed to prevent hypotension.

The recommended spinal block height to ensure patient comfort for Cesarean delivery is T4-6. Clinically, it is desirable that the spread of local anesthetic through the cerebrospinal fluid (CSF) achieves a sensory level no higher than the T4 dermatome to avoid extensive sympathetic block. It is also important that the spinal block level be no lower than T6 to avoid patient discomfort during peritoneal manipulation and uterine exteriorization. The effect of injection speed on spread of spinal anesthesia is controversial. Several studies have demonstrated more extensive spread with faster injection while others report either greater spread with slower injection, or no difference. Slow injection of hyperbaric bupivacaine 10 mg over 60 and 120 sec has been shown to reduce the incidence and severity of hypotension during Cesarean delivery under spinal anesthesia.

Patients admitted to undergo elective c-section under spinal anesthesia will be randomized using the sealed envelope technique to Group I who will receive intrathecal injection in a slow speed 1ml in 15 sec and group II who will receive 1ml in 5 sec.

The baseline pulse rate, blood pressure, respiratory rate, and oxygen saturation will be recorded intraoperatively. The presence of preoperative hypotension, nausea and vomiting, and level of block at 5 and 10 mins post intrathecal injection will be assessed .

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiology physical status 1 and 2
* and scheduled for elective c-section surgery under spinal anesthesia

Exclusion Criteria:

* Patients with cardiac and psychological problems
* Patients who take sedatives or narcotics
Reduction of the Dietary Glycemic Index (GI) by L-Arabinose and Indigestible Dextrin

This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on dietary glycemic index.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as based on medical history and physical examination
* BMI is less or equal to 30 kg/m2
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Impaired Glucose Tolerance
* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 1 of this study
* Renal or hepatic dysfunction
* Heart disease
* Under medication
Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity

Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL.

Prospective study design among subjects with MGD and qualifying for IPL therapy.

Study testing done at baseline visit when subjects are scheduled for IPL therapy. Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).

Subjects willing to come for follow up visits as scheduled and may not have instilled any artificial tears 2 hours prior to study measurements.

No history of ocular infection or corneal degeneration/dystrophy No history of corneal refractive surgery and/or change in ocular medications in the last 2 months

Eligibility Criteria:
Inclusion Criteria:

* Dry eye
* MGD

Exclusion Criteria:

* No history of ocular infection or corneal degeneration/dystrophy
* No history of corneal refractive surgery
* No change in ocular medications in the last 2 months
Study of Affective Forecasting Skills in Post-traumatic Stress Disorder

Post-traumatic stress disorder (PTSD) is associated with a marked tendency to have exaggerated and persistent negative beliefs and expectations about oneself or the world . Although posttraumatic stress symptoms have been shown to be associated with a tendency to negatively anticipate the future, affective forecasting skills (i.e., the ability to predict one's own emotional reactions in response to a future event) have never been explored in PTSD . The hypothesis that the PTSD is associated with a negative affective forecasting bias, characterized by a tendency to predict more intense emotional responses to future negative events.


Eligibility Criteria:
Inclusion Criteria:

* Understanding and being able to express themselves in French
* Understanding of informed consent and signature of the study participation form
* Giving informed, dated and signed consent
* Benefiting from health insurance coverage
* Normal or corrected visual and auditory acuity to achieve normality
* Group 1 : DSM-5 PTSD criteria, assessed using CAPS and PTSD Checklist for DSM-5 (PCL-5, Weathers \& al., 2013)
* Group 2: PTSD Criteria A only

Exclusion Criteria:

Refusal of participation after clear and fair information on the study.

* Visual or auditory sensory disability to participate in the study.
* Personal history of neurological disease or current neurological disease.
* Personal history of current psychiatric disorder or psychiatric disorder (excluding PTSD in patients in the experimental group), assessed via the MINI.
* Pregnant or breastfeeding women
* Consumption of toxic substances other than tobacco and alcohol.
* Minors or adults under guardianship, under judicial protection, persons deprived of liberty.
* Groups 2 and 3: personal history of psychiatric disorder or current psychiatric disorder and taking psychotropic drugs
* Group 1: personal history of psychiatric disorders or current psychiatric disorders other than anxiety, depressive, trauma and stress-related disorders and treatment with psychotropic drugs not stabilized
Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Their Nutrition Intake

To understand breast milk composition during different lactating stages.


Eligibility Criteria:
Inclusion Criteria:

* Chinese lactating mother 0-270 days after delivery (inclusive).
* Healthy with neither acute disease nor history of hereditary disease, gestational diabetes, hypertension, other concomitant diseases, and disability.
* Parents/ caregiver is willing to comply with the study procedure.
* Having received oral and written information about the aims and procedures of the study.
* Having obtained the her informed consent.

Exclusion Criteria:

* Subjects who are currently taking, or have taken in the last 4 weeks, or will take any medication.
* Subject who has history of psychopath and have no the dietary memory.
* Subjects who are suffering food allergy.
* Insufficient breast milk output according to the corresponding period after delivery.
* Alcoholic.
* Smokers.
* Subject who cannot be expected to comply with the study procedures.
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
The Effect of Vision Therapy/Orthoptic on Motor & Sensory Status of the 3 to 7 Years Old Strabismic Patients

Vision therapy (VTO) is a group of non-surgical treatment helping patients in 3 subjects;1)increasing the the visual acuity 2)improving the mechanical skills resulting in increasing the power of extraocular muscles,biocular vision,peripheral vision 3) increasing the perceptual skills making the brain to percept the colour and visual memory better.In this study we are going to compare the effect of vision therapy /orthoptic on motor \& sensory of the 3 to 7 years old strabismic patients


Eligibility Criteria:
Inclusion Criteria:

* 3\<age\<7
* Congenital isotropia

Exclusion Criteria:

* Muscular disease
* General ocular and systemic disease
* Seizure
* Visual Acuity \< 60/20
* Nystagmus
* Follow up less than 3 months after surgery