cyrilzakka/clinical-trials huggingface dataset:
Trial of E10A in Head and Neck Cancer

Angiogenesis, the formation of new blood vessel from existing vessels, is essential for tumor growth and metastasis. Antiangiogenic therapies inhibit the growth of genetically stable endothelial cells, and most tumors should starve to death with little acquired resistance. Endostatin has been shown to block endothelial cell proliferation, survival, and migration. Antitumor activity of endostatin protein has been demonstrated in various murine and human tumors in animal model studies without any detectable toxicity. Endostatin gene therapy could directly express the highly bioactive protein in vivo by means of the mechanism of eukaryotic expression system as post-translational modification and folding, as well as overcoming the challenge of the long-term storage and the cumbersome daily administration of endostatin protein.

E10A is a replication-deficient recombinant adenovirus containing a wild-type human endostatin transgene constructed from serotype 5 adenovirus (Ad5). Preclinical studies demonstrated that intratumoral injection of E10A provided significant tumor growth inhibition and sustained elevation of endostatin in blood and tumor tissue in hepatocellular carcinoma, nasopharyngeal carcinoma, and tongue cancer animal models. A Phase I clinical trial of E10A we conducted showed that repetitive intratumoral injection of E10A resulted in a small and sustained elevation of endostatin in blood and had a mild antitumor activities with very limited toxicity. The major toxicity was transient and manageable fever. A randomized Phase III trial in nonsmall-cell lung cancer showed endostatin improved response rate and time to tumor progression in combination to chemotherapy. Therefore, we designed a randomized phase II trial to explore the safety and effectiveness of E10A combined with chemotherapy in the treatment of patients with head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed recurrent or metastatic head and neck squamous carcinoma or nasopharyngeal carcinoma
* the tumor was amenable to direct injection and measurement ( \> 2 cm)
* an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* a life expectancy over three months
* the absence of serious medical or psychiatric disorders
* serum creatinine \< 1.5 mg/dL; WBC count \>3,000/mm3, platelet count \> 80,000/mm3, hemoglobin \> 8 g/dL; total bilirubin value \< 1.5 times the upper limit of normal \[ULN\], ALT level \< 2.5 times ULN, AST \< 2.5 times ULN.

Exclusion Criteria:

* pregnant or breast feeding
* a history of brain metastases or a primary brain tumor
* a history of hemorrhagic diathesis
* a history of corticosteroids or immunosuppressives use within four weeks of study entry
* a history of immune deficiency disorder or organ transplant
* has evidence of active adenovirus infection or uncontrolled infection
* received any chemotherapy or radiotherapy within four weeks of study entry
Cephalic Version by Acupuncture for Breech Presentation

We want to study the efficiency of acupuncture for cephalic version of breech presentation during pregnancy.

Several randomized studies show that acupuncture may be useful in version of breech presentation, but none with a sham.

Protocol :

* Inclusion of patients with fetus in breech presentation at 32-34 weeks of pregnancy.
* Randomization. First group : acupuncture by stimulation of "67 Bladder" point.Second group : stimulation of "45 Stomach" point (sham).
* Ultrasonographic control of presentation at 35 weeks.


Eligibility Criteria:
Inclusion criteria:

* Single pregnancy at 32-34 weeks of pregnancy.
* Fetus in breech presentation.

Exclusion criteria:

* Twins.
* Story of preterm birth or any preterm birth risk
* Fetal malformations, abnormal karyotype
Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years

Main objective: To analyze the clinical and biological characteristics of patients with disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete remission, partial or stable disease for a period exceeding 3 years.

In addition, there will be a sub-genetic analysis of patients in whom there is availability a sample of primary tumor preserved in paraffin. This sub-analysis will not interfere with routine clinical practice, as the tumor samples based on which will be held on genetic profile, have been preserved in paraffin was extracted from the primary tumor to the patient.

SECONDARY OBJECTIVES:

* To determine the frequency of patients achieving partial response or stable disease for a period exceeding 3 years.
* Know the time to complete or partial remission or to achieve stabilization of the disease.
* Know the length of the complete or partial remission or time to disease stabilization of patients.
* Knowing the pattern of treatment that has achieved complete or partial remission or stabilization of disease and duration.
* Knowledge of overall survival.
* Knowing the toxicity of prolonged administration of trastuzumab.
* Identify the primary tumor genes HER-2 associated with such prolonged responses.

The source document will be in all cases the clinical history and in the case of patients selected for the sub-genetic analysis, the report resulting from it.

The study is carried out by filling a notebook of electronic data collection that gathers all available information contained in medical records.

The sub-genetic analysis will be performed at the Hospital de la Paz. Both, the processing of samples and conducting the analysis using qRT-PCR, will be performed in this hospital.

All data are stored, ensuring the confidentiality, security and authenticity .The forms must be reviewed by the monitor.

Once recorded the data, the database will be revised and monitored to submit those records in which there are inconsistencies or missing information . Following the closure of the database will be a report which will present the results of the analysis of the data.

Eligibility Criteria:
Inclusion Criteria:

1. Women older than 18.
2. Patients with disseminated breast cancer with overexpression of HER-2 (IHC 3 + or FISH +).
3. Patients who have been treated with trastuzumab (Herceptin ®).
4. Complete remission, partial or stable disease for a period exceeding 3 years, except for exclusive cerebral progression.
5. Patients who have given their written informed consent.

Exclusion Criteria:

1- Patients with remission achieved with surgery or less than three months of treatment with trastuzumab.
Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities

The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 years
* Patient having embolization of intracranial aneurysms
* WAVE Extra Soft Coil is final finishing coil
* Penumbra SMART COIL System accounts for at least 75% of total number of coils implanted
* Informed consent obtained per Institutional Review Board/Ethics Committee (IRB/EC) requirements

Exclusion Criteria:

* Life expectancy less than 1 year
* Patient previously enrolled in the SURF Study
* Known multiple intracranial aneurysms requiring treatment during index procedure
* Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
* Participation in an interventional drug or device study that may confound the results of the study
Fitness Integrative Training for Pediatric Rheumatology Disorders

This study evaluates the feasibility of the Fitness Integrative Training program for Teens (FIT Teens 2), a combined cognitive behavioral therapy and neuromuscular exercise training program in patients with pediatric rheumatic diseases and/or joint hypermobility.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric rheumatic diseases (PRD) or joint hypermobility (JH) diagnosed by a pediatric rheumatologist or pain physician.
* Initial diagnosis ≥ 3 months ago
* Ages 10-19 years, inclusive
* Ongoing symptoms of musculoskeletal pain and/or fatigue for at least 3 months
* Functional Disability Index (FDI) Score ≥ 13 indicating at least moderate disability.
* Child has written and spoken proficiency in English and parent has written and spoken proficiency in English or Spanish (will have a certified bilingual provider or interpreter available)

Exclusion Criteria:

* Untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses) or documented developmental delay.
* Any other medical condition determined by their physician to be a contraindication for exercise.
* Childhood Myositis Assessment Scale (CMAS) ≤ 30
Habitual Diet and Avocado Trial

The Habitual Diet and Avocado Trial will evaluate the effects of providing one avocado per day for recommended consumption over a 6 month period in a cohort of approximately 1000 free-living participants with increased waist circumference in comparison with a control group that will maintain their habitual diets. Participants will be recruited and screened at 4 clinics in 4 locations: Pennsylvania State University; Loma Linda University; UCLA, and Tufts University (250 per site).

Preliminary evidence suggests that consumption of avocados can modulate body weight, food intake and markers of metabolic syndrome and may reduce visceral adiposity. Visceral adipose tissue is positively correlated with risk of cardiometabolic syndrome that predisposes to cardiovascular disease and diabetes. The Habitual Diet and Avocado Trial (HAT) aims to investigate an impactful outcome (visceral fat reduction) in a relevant population (Americans with an increased weight circumference) with a reasonable lifestyle modification (consumption of 1 avocado per day). HAT will evaluate the effect of providing one avocado per day for consumption over a 6 month period on established health parameters, including visceral adiposity, hepatic lipid content, markers of metabolic syndrome and high sensitivity C-reactive protein (hsCRP) when compared to a habitual diet. Blood specimens will be drawn and analyzed for fasting total cholesterol, triglyceride, HDL-C, glucose, insulin, hsCRP and RBC fatty acid profiles. Two non-contrast MRIs will be performed (at screening to assess eligibility and final participant visit 8 for randomized participants) to assess the volume of visceral adipose tissue and hepatic fat fraction. Four 24-hour dietary recalls will be conducted for study participants to capture dietary intake data. Questionnaires include the following: health and demographic including eating habits and physical activity; diet, food and avocado satisfaction (intervention group only); quality of life; and quality of sleep.

Eligibility Criteria:
Inclusion Criteria:

* Increased waist circumference defined as ≥35 inches for women, ≥40 inches for men
* At least 25 years old at screening
* Not currently eating more than 2 avocados per month (habitual intake in U.S.)

Exclusion Criteria:

* Does not eat avocados
* Sensitive / allergic to avocados
* Allergies to latex or oral allergy syndrome
* Not willing or unable to undergo MRI scans
* Unstable medical condition such as on dialysis for renal disease, cardiac, gastrointestinal, or hepatic disease, cancer (non-melanoma skin cancer \>5 years ago acceptable, any cancer site \>10yrs without recurrence).
* Pregnant, lactating, intention of pregnancy
* Lost or gained 10 lbs of body weight in last year
* Following restricted or weight loss dietary patterns
* Unstable anti-anxiety / anti-depressive / anti-psychotic medication use defined as dose change within last 6 months
* Oral steroid use within the last 6 months longer than 7 days
* Elevated alcohol intake (7+ drinks/week females; 14+ drinks/week males)
* Participation in another clinical intervention trial within 30 days of baseline
* PI judgment
Relationship Between Rheumatoid Arthritis Severity and Cognition in the Elderly: The Role of Nociplastic Pain

this study aims to determine if nociplastic pain mediates the relationship between rheumatoid arthritis (RA) severity and cognitive impairment in geriatric patients 100 patients aged 65-90 years with long-standing RA and assess their disease severity, cognition, and pain sensitization will be recruited. Expectations that patients with more severe RA will have worse cognitive function, and that this relationship will be mediated by higher levels of nociplastic pain.


Eligibility Criteria:
Inclusion Criteria:

* Age 65-90 years
* diagnosed with RA for 10-30 years
* meet ACR/EULAR 2010 criteria

Exclusion Criteria:

* Other inflammatory arthritides
* dementia
* severe depression
* recent corticosteroid or immunosuppressant use
A Study to Assess the Engagement and Usefulness of Care4Today Digital Platform for Disease Management in Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD) Population

The purpose of this study is to assess the engagement and usefulness of Care4Today® Connect CAD-PAD digital platform in participants with coronary artery disease or peripheral artery disease (CAD or PAD).


Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of CAD and or PAD, who are on therapy or about to initiate therapy
* Own an iPhone or Android mobile device
* Have an active email account
* Must sign a participation agreement or informed consent form (ICF) allowing data collection in accordance with local requirements
* Willing to download and use Care4Today (C4T) CAD-PAD application (app)

Exclusion Criteria:

* Any cardiovascular conditions (for example, recent stroke, high bleeding risk, severe heart failure) or non-cardiovascular condition deemed as poor prognosis by the investigator and which may percent a patient from completing the study
* Unable to read or write the language used for the C4T (English, or Spanish if Spanish version is available)
* Visual or hearing impairment or mental disability that would preclude independent app use
* Patients currently using the C4T app prior to the signing of ICF
Effects of Bobath Approach With Core Stability to Improve Balance in Stroke

Bobath technique with core stability exercises to improve balance in stroke. Randomized clinical trial study design will be followed. Data will be collected from following centers: Naseer Hospital, North Ravi Hospital, Bajwa Hoaspital,Minhaj Physiotherapy Centre, Home visits. Probability Random Sampling is used.


Eligibility Criteria:
Inclusion Criteria:

* age 30 - 65
* Both Gender
* more than 1 month or less than 6 months since onset of stroke
* GCS SCORE 11 TO 15

Exclusion Criteria:

* consist of GCS less than 10
* any pathological fracture
* diagnosed orthostatic hypotension
* Comorbidities like IHD and Rheumatologic disease.
Evaluation of Sensitization to Peach and/or Cypress in Potato Sensitized Patients in a Large Cohort

The aim of the study will be to investigate the prevalence of of sensitization to peach and/or cypress in potato sensitized patients, based on the collection of medical data from patient records consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital.

Some Gibberellin-regulated protein (GRP) in fruits and pollens have been identified as allergen, and peach GRP (peamaclein) has recently emerged as a relevant food allergen in cypress pollen-hypersensitive patients. Multiple fruit allergies might be related to cross-reactivity between GRPs. Peamaclein shares 82% identity with snakin-1 from potato. Thus, because of this hight homology the investigators want to determine the prevalence of cosensitization between these 3 allergens potato, peach and cypress.


Eligibility Criteria:
Inclusion criteria:

* Patients evaluated at the Montpellier University Hospital, Allergy Unit
* children and adult with positive skin prick test to potato from february 2013 to december 2015

Exclusion criteria:

* Patients under legal protection
* Patients under guardianship or under curatorship
* Patients not capable of understanding French
Botulinumtoxin A Treatment in Epidermolysis Bullosa Simplex and Pachyonychia Congenita

This study evaluates the clinical effect of foot injection of the bacteria protein Botulinum toxin A on plantar pain in patients with EBS (epidermolysis bullosa simplex) or PC (pachyonychia congenita).

Epidermolysis bullosa simplex (EBS) is the most common subtype of epidermolysis bullosa and mutations in keratin genes (KRT 5/14) are responsible for this condition. Painful blisters and keratoderma of the feet are common and the blisters in EBS typically get worse in the summer due to sweating and increased environmental heat. Since 2010, also the related condition pachyonychia congenita (PC) is included in the study. The primary objective of the study is to evaluate the clinical effect of Botulinum toxin A (Dysport®), injected in the foot, on plantar pain in patients with EBS or PC. Quality of life, pain in feet, effect duration, plantar sweating and safety of the treatment will also be studied.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent received from patient
* Informed consent received from patient´s parents (when patient \< 18 years)
* A solid EBS-diagnosis based on genetic analysis and/or phenotype. The EBS-diagnosis will be performed by Professor Anders Vahlquist, Swedish Centre of Genetic skin disorders, Uppsala.
* Age \> 16 years
* Patients must be previously untreated with Btx A
* If female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control

Exclusion Criteria:

* Contraindication to Btx A
* Contraindication to general anaesthesia
* Use of aminoglycosides, tetracyclines , spectinomycin, lincomycin, polymyxin or muscle relaxants
* Pregnancy or lactation
* Patients unwilling to meet the requirements of the protocol
* Other medical or social reasons for exclusion at the discretion of the Investigator
Serratus Anterior Plane Block Versus Erector Spinae Plane Block With Dexmedetomidine Added to Bupivacaine for Ultrasound-Guided Pain Management After Mastectomy

This study aimed to compare the serratus plane block versus the erector spinae plane block with dexmedetomidine added to bupivacaine for acute pain management after breast surgeries.

Approximately 40-60% of breast surgery patients endure severe acute postoperative pain, with over 10% of patients experiencing severe pain for six to twelve months (post-mastectomy pain syndrome).

Dexmedetomidine has analgesic properties, which could be related to the stimulation of α2 adrenoceptors, inhibition of nerve conduction through C and Aδ fibers, and the local release of encephalin.

Serratus plane block (SPB) is an effective approach for breast surgery analgesia due to its simplicity of delivery, minimal risk of adverse effects, and ability to provide significant pain relief.

The erector spinae plane block (ESPB) is one of the emerging regional techniques for managing postoperative pain. ESPB can be given unilaterally during modified radical mastectomy.

Eligibility Criteria:
Inclusion Criteria:

* Women aged \>20 years.
* Patient's approval.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Patients underwent breast surgeries.

Exclusion Criteria:

* Known allergy to local anesthetics, opioids, or dexmedetomidine medications.
* Advanced heart block, ventricular dysfunction.
* Skin infection at the site of injection.
* Pre-existing chronic pain.
* Coagulopathies, significant liver or renal insufficiency.
Factors Associated with Falling in Parkinson's Disease

The objective of this study will be to identify multidisciplinary fall risk factors in persons with stage 3 idiopathic Parkinson's Disease compared to age and sex-matched healthy adults. Both the relative contribution of each independent factor, as well as the interaction between these factors, will be examined. The study will include multidisciplinary assessments, including locomotor, speech, auditory, vestibular and opthalmologic assessments.


Eligibility Criteria:
Parkinson's Disease group

Inclusion criteria:

* Persons with idiopathic PD diagnosed by a medical doctor according to the United Kingdom PD Brain Bank Criteria
* Aged between 18 and 75 years-old
* Stage 3 on the Hoehn and Yahr scale in the on-medication state
* On a stable dose of PD medication (at least one week)
* Able to stand and walk on a treadmill without support for at least 3 minutes
* Able to give consent

Exclusion criteria:

* Atypical parkinsonism
* Unpredictable symptom fluctuations
* Previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
* Duodopa pump therapy
* Dementia (Montreal Cognitive Assessment (MoCA) \< 21)\[1\]
* Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
* Concurrent neurological disorders (e.g. stroke)
* Comorbidities that affect gait or balance (e.g. peripheral neuropathy)
* Acute illness
* Epilepsy or history of seizures
* Depression (MDS-UPDRS item 1.3 ≥ 2)
* Body weight over 120 kilograms
* Pregnancy
* Participation in other ongoing experimental trials

Healthy control group

Inclusion criteria:

* Age and sex-matched healthy adults

Exclusion criteria:

* Symptomatic orthostatic hypotension (e.g. frequent syncope episodes)
* Body weight over 120 kilograms
* Pregnancy
* Participation in other ongoing experimental trials