cyrilzakka/clinical-trials huggingface dataset:
Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma

The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators have used CVT in melanoma patients and found that tumors got significantly smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of how many patients will respond to CVT. Also they want to test which genes in the tumor are turned on and which are turned off. We hope this will teach us to know in the future which tumors will respond to CVT.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histologic proof of melanoma reviewed and confirmed at MSKCC
* Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma. Patients who are potentially respectable will be eligible.
* Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment biopsy is required; a fine needle aspirate is not adequate.
* No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic therapy is allowed.
* No other concurrent chemotherapy, immunotherapy, or radiotherapy
* ECOG performance status ≤ 1
* Adequate organ function defined as follows: ANC \>1500/mm3, Platelets \>130,000/mm3, calculated creatinine clearance ≥60 ml/minute (Cockcroft \& Gault).
* Adequate cardiac function to tolerate the hydration needed for cisplatin administration.

Exclusion Criteria:

* History of CNS metastases unless brain metastases have been resected or successfully treated with stereotactic radiosurgery and the patient has been free from CNS recurrence for 3 months.
* Uveal melanoma primary
* Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been off treatment for at least 4 months and have signs of progression of disease.
* Frequent vomiting or medical conditions that could interfere with oral medication intake
* Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
* History of HIV infection even if on HAART
* Immunosuppressive drugs
* High dose vitamins and herbs
* Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.
Coronary Artery Disease (CAD) in Patients HIV-infected

HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation


Eligibility Criteria:
Inclusion Criteria:

HIV-infected patients \>= 45 years with 2 or more CV risk factors currently on ART HIV-RNA \< 50 copies \>= 12 months (one blip allowed) Asymptomatic regarding cardiac symptoms (chest pain, syncope, dyspnea) Stable ART for more than 6 months

Exclusion Criteria:

* Sign of coronary pathology (chest pain, syncope, dyspnea).
* ATCD of allergy to IV contrast agents
* Chronic inflammatory disease other than HIV
* Subject to a measure for the protection of justice
Excimer Laser With Topical Agents in Psoriasis Vulgaris

Psoriasis is a chronic, immune-mediated disease that affects approximately 2% of the population. The development and exacerbation of psoriasis involve an interaction between multiple genetic and environmental risk factors.

Psoriasis presents as well-circumscribed, erythematous plaques with an overlying silvery white scales. It has an effect on various aspects of life including mental health, productivity and relationships.

Topical therapies as corticosteroids and vitamin D3 analogs are first-line treatments for mild plaque psoriasis; which involves less than 3% of the body surface area (BSA). Moderate-to-severe plaque psoriasis is usually managed with phototherapy, systemic or biologic therapies .

The American Academy of Dermatology gives a strength recommendation for the use of combination therapies for treatment of psoriasis with superior efficacy to monotherapy .

The 308-nm excimer laser has been widely used for many dermatological diseases. In psoriasis, it shows an efficacy in the treatment of localised plaques especially on the knees and elbows.

It is indicated in moderate to severe psoriasis that affects \<10% of the body surface. Areas such as nose, ears and palpebral region can be easily accessed using the laser. It induces lymphocytic apoptosis and decreases the proliferation rate of keratinocytes . There are multiple protocols that evaluate the clinical response to Excimer laser; the induration protocol, the minimal erythema dose and the minimal blistering dose.

The induration protocol compared with the others, allows to modify the dose with treatment. With this protocol, plaques achieved Psoriasis area and severity index (PASI-75) after 10 treatments .

Tazarotene (TAZ) is a topical retinoid with retinoic acid receptor β / γ receptor specificity. It has been shown to be effective for psoriasis treatment. However, its topical application is limited by its irritation.

Studies have shown that combination with other lines may optimize the efficacy as well as minimize the local irritation due to TAZ.

Betamethasone valerate (BV) is a high-potency, synthetic corticosteroid which acts on the intracellular glucocorticoid receptor.

It also binds to membrane-bound receptors, enhancing its action. BV suppresses the production of inflammatory cytokines and reduces keratinocyte hyperproliferation.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥18 years.
2. Pattern: Patients with chronic plaque psoriasis not exceeding 10% of the body surface area.

Exclusion Criteria:

1. History of retinoid use either topical or systemic in the previous 16 weeks, phototherapy or topical psoriasis treatment within the last 4 weeks.
2. Allergy to any ingredients of tretinoin or betamethasone drugs.
3. Renal, hepatic disease, cardiovascular , Immunosuppressive therapy, endocrine and blood disease or mental illness.
4. Pregnancy, breast-feeding or women planning to become pregnant within 3 months.
5. Psoriasis exceeding 10% of body surface area or other severe types of psoriasis requiring systemic treatment.
6. Patients with other diseases and requiring treatment that would affect the study
Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer.

Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques.

The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.


Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer or ductal carcinoma in situ
* Breast conserving surgery
* Complete tumor resection
* Treatment with adjuvant radiotherapy of the breast
* Indication for boost Irradiation
* Given informed consent

Exclusion Criteria:

* Incomplete tumor resection
* Mastectomy
* Distant metastases at diagnosis
* Unable to give informed consent
Vascular Effects of Dietary Potassium

The purpose of this study is to determine if dietary potassium can attenuate the deleterious effects of high sodium on blood vessel function in healthy, salt-resistant participants.

Cardiovascular disease remains a major Public Health problem in the U.S. and is the result of diseases such as atherosclerosis and high blood pressure (BP). Several dietary factors have been implicated as risk factors including high sodium and low potassium diets. Indeed, it is well known that excess sodium can increase BP while potassium rich diets have BP lowering properties. While the role of these two nutrients on BP is widely accepted, their impact on the vasculature has received less attention. Endothelial dysfunction, characterized by impaired dilation is an important non-traditional risk factor for atherosclerosis. Data in animal models suggest that salt loading, independent of changes in BP, results in endothelial dysfunction while evidence is mounting that potassium may be beneficial to vascular health. Further, potassium may be more effective in the presence of high sodium however the role of potassium in protecting the vasculature from a high sodium diet in salt-resistant adults has not been explored. A potential mechanism responsible for sodium induced vascular dysfunction is overproduction of reactive oxygen species resulting in reduced nitric oxide (NO) production/ bioavailability. It has been suggested that potassium can counteract sodium's effect by reducing ROS. The central hypothesis is that potassium can protect against the deleterious effects of high sodium on the vasculature by reducing oxidative stress and preserving NO. In this grant, the investigators propose to use a 21-day controlled feeding study to compare the effects of a high sodium diet (300 mmol) combined with either a high (120 mmol) or moderate (65 mmol) amount of potassium and low sodium (50 mmol) combined with moderate potassium (crossover design, diet order sequence randomized) on 2 levels of the vasculature, conduit artery and microvasculature. These experiments will be performed in salt-resistant participants to study the vascular effects alone, independent of changes in BP.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* normal blood pressure

Exclusion Criteria:

* hypertension
* history of heart disease
* diabetes
* kidney disease
* obese (BMI ≥30)
* significant weight changes in the last 6 months
* use of tobacco products
* pregnant
* on a special diet (gluten free; vegan)
* take any medications for the above conditions
* endurance trained athletes
Phase 4 Study Comparing IOP Lowering in OAG or OH in Caucasian or Japanese Subjects C-02-32

The purpose of this study is to evaluate safety and efficacy of two different IOP lowering medications after six weeks of treatment in Caucasian and Japanese subjects.


Eligibility Criteria:
Adults of Caucasian and Japanese Ethnicity
Guided Self-Help for Parents of Children With Externalizing Problem Behavior

The efficacy of cognitive-behavioral based guided self-help for parents of children with externalizing problem behavior is tested in a randomized clinical trial. Parents work through cognitive-behavioral self-help booklets and additionally receive counseling telephone calls every two weeks. In the control condition parents are provided non-directive self-help booklets and additionally receive counseling telephone calls. It is hypothesized that the cognitive-behavioral treatment is superior.


Eligibility Criteria:
Inclusion Criteria:

* Child diagnosis of ODD and/or ADHD based on DCL-ODD and DCL-ADHD respectively

Exclusion Criteria:

* Child IQ is below 80
* Child has diagnosis of pervasive developmental disorder (PDD)
* Indication for inpatient/intensive treatment for child
* Parent training while intervention period
* Planed start, change or discontinuation of psychopharmacological treatment for child while intervention period
* No parental adherence or willingness for randomisation process
* Language or reading difficulties of participating parent
Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine

The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV).

The study is a randomized, double-blind, controlled phase Ⅳ clinical trial. And 920 infants will be assigned to investigational group and controlled group in a 1:1 ratio. The investigational vaccine is manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The controlled vaccine is manufactured by Shanghai institute of biological products Co., Ltd.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 8 - 12 months old;
* Proven legal identity;
* Written consent of the guardian(s) of the volunteer

Exclusion Criteria:

* Received mumps vaccine or vaccine containing mumps virus;
* History of mumps;
* Axillary temperature \> 37.4 °C;
* History of allergy to any vaccine or vaccine ingredient;
* History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
* Autoimmune disease or immunodeficiency or immunosuppression;
* Congenital malformation, genetic defects, severe malnutrition;
* Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
* Severe chronic diseases (e.g., severe cardiovascular disease, liver and kidney disease beyond the control of drugs, or cancer)
* Severe neurological disorders (epilepsy, seizures or convulsions) or psychosis;
* History of thyroidectomy, absence of spleen, functional absence of spleen, and any condition resulting from absence of spleen or splenectomy;
* Receipt of any of the following products:

  1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
  2. Any live attenuated vaccine within 28 days prior to study entry;
  3. Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
  4. Blood product within 3 months prior to study entry;
  5. Any immunosuppressant, cytotoxic medicine, or oral corticosteroids;
  6. Any of the acute disease or attack of the chronic disease within 7 days;
  7. Pregnant in cohabitants or congenital immune diseases;
  8. Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded
Quality of Life in Patients Undergoing Colorectal Resection for Deep Infiltrating Endometriosis

The aim of this study is to evaluate the quality of life of patients undergoing colorectal resection for deep infiltrating endometriosis of the bowel. Questionnaires about pre operative status have been submitted retrospectively, while post operative questionnaires have been submitted prospectively during last follow up visit

All patients fit for the study will be asked to complete a visual analogue scales (VAS) for dysmenorrhea, deep dyspaurenia, dysuria, dyschesia and chronic pelvic pain (CPP) Patients will fill in the Endometriosis QoL Questionnaire (EHP30), the gastrointestinal well-being questionnaires Bristol Stool Chart, GSCG (Gastrointestinal Symptom Rating Scale), STAY (1 and 2), the Psychological General Well-Being Index (PGWBI), Generalized Self-Efficacy, CD-RISC - Connor-Davidson scale about their pre operative and actual status.

Surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis Perioperative and post-operative complications will be collected using the Extended Clavien-Dindo classification of surgical complications divided in early (within 30 days after surgery onset) and late (over 30 days after surgery onset).

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 45 years
* Clinical diagnosis of deep endometriosis infiltrating the bowel
* Women undergoing surgical removal with colorectal resection with or without loop ileostomy creation

Exclusion Criteria:

* History of previous or ongoing neoplastic pathology
* Contraindications to surgical intervention
* Not complete eradicating surgery
* Psychiatric disorders
* Surgical, spontaneous or pharmacological menopause - Intestinal surgery different from segmental bowel resection and colorectal anastomosis
Comparison of Medical Nutritional Supplements

The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.


Eligibility Criteria:
Inclusion Criteria:

* Male and is ≥ 60 and ≤ 90 years of age.
* Body Mass Index (BMI) \> 20.0, but \< 35.0.
* Ability to climb a flight of 10 stairs or walk an equivalent of city block without help within the 3 months prior to enrollment.
* Refrain from taking any dose of NSAIDs or acetaminophen on the day of and 24 hours prior to Visit 2 and Visit 3.
* Refrain from using any pulmonary maintenance medications on the days of Visit 2 and Visit
* Refrain from intense physical activity between visits.

Exclusion Criteria:

* Systemic corticosteroids within the 3 months prior to enrollment.
* Blood thinner or anticoagulant medication within 1 week prior to enrollment.
* Glomerular filtration rate (eGFR) of \< 40 mL/min/1.73m2.
* Antibiotics within 1 week prior to enrollment.
* Major surgery less than 3 months prior to enrollment in the study.
* Active malignant disease or treated within the last 6 months for cancer.
* Immunodeficiency disorder.
* Diabetes
* Myocardial infarction 3 months prior to enrollment.
* Chronic obstructive pulmonary disease
* History of allergy to any of the ingredients in the study products.
* Conditions precluding ingestion or absorption of the study product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
* Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition.
* Pursuing weight loss or weight gain.
* Medications/dietary supplements/substances that could modulate metabolism or weight.
Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment

This open-label study will evaluate hydroxyzine, a first-generation antihistamine, combined with varenicline, to help smokers abstain from smoking during a 12-week trial period by diminishing the nausea, stress, anxiety, and sleep disturbances associated with the use of varenicline and with nicotine withdrawal.


Eligibility Criteria:
Inclusion Criteria:

1. Has signed the consent form and is able to read and understand the information provided in the consent form.
2. Is 19 to 65 years of age (inclusive) at screening.
3. Smokes at least 10 commercially available cigarettes per day for the last 12 months.
4. Has an expired air carbon monoxide reading of at least 10 ppm at screening.
5. Express a desire to quit smoking within the next 30 days at screening.
6. Willing and able to comply with the requirements of the study.
7. Participant owns a smart phone with text message and data capabilities.

Exclusion Criteria:

1. Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
2. PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
3. High blood pressure (systolic \> 150 mmHg or diastolic \>95 mmHg) at screening.
4. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
5. Coronary heart disease, structural cardiac disease, cardiac dysrhythmias, abnormal ECG (e.g. prolonged QTc), syncope, cardiac chest pain, or history of heart attack or heart failure.
6. Has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study.
7. Taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc.
8. Positive urine drug test for cocaine, marijuana, opiates, amphetamines or methamphetamines.
9. Use of smokeless tobacco (chewing tobacco, snuff), cigars, pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of enrollment.
10. Pregnant or nursing (by self-report) or has a positive pregnancy test.
Conditioning Brain Responses to Improve Thigh Muscle Function After Anterior Cruciate Ligament Reconstruction

The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury can be improved through a form of mental coaching and encouragement, known as operant conditioning.

Thigh muscle weakness is a common result after anterior cruciate ligament (ACL) injury and reconstruction surgery. Therefore, reducing thigh muscle weakness after ACL injury and reconstructive surgery is important as the quadriceps muscles act as shock absorbers that protect the knee joint. If significant weakness is present in the quadriceps, the knee is exposed to increased forces and often results in degeneration of the structures in the joint leading to osteoarthritis. Thus, it is important to investigate activation and strength rehabilitation methods for the quadriceps muscles. This research study is being done to learn if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury can be improved by conditioning brain responses (elicited by non-invasive transcranial magnetic stimulation) using a form of training called as operant conditioning.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-45 years
* suffered an acute, complete ACL rupture
* have undergone ACL reconstructive surgery
* willingness to participate in testing and follow-up as outlined in the protocol

Exclusion Criteria:

* have suffered a previous ACL injury;
* have undergone previous major surgery to either knee;
* have a history of recent significant knee injury (other than ACL) or lower-extremity fracture;
* have a history of uncontrolled diabetes or hypertension;
* be pregnant or plan to become pregnant;
* have metal implants in the head;
* have electronic devices in their ear or heart (e.g., cochlear implants or cardiac pacemakers);
* have unexplained recurrent headaches;
* have a recent history of seizures;
* be taking drugs that reduce seizure threshold;
* have a history of repeated fainting spells;