cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors

The main purpose of this study is to evaluate the safety of the colony-stimulating factor 1 receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimumab in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Must have histological or cytological evidence of a diagnosis of cancer that is not amenable to curative therapy.
* Part B: Must have a type of malignancy that is being studied.
* Part A and Part B (ovarian cancer cohort only): Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies.
* Part A (all cohorts): Have the presence of measureable and /or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Part B (all cohorts): Have the presence of measurable disease as defined by the RECIST 1.1.
* Have adequate normal organ and marrow function, including the following:

  * Absolute neutrophil count ≥ 1.5 x 10⁹/Liters (L) (1500/cubic millimeters)
  * Platelet count ≥ 100 x 10⁹/L (≥100,000/cubic millimeters)
  * Hemoglobin ≥9 grams per deciliter or ≥5.6 millimoles per liter
  * Serum Creatinine ≤1.5 × institutional upper limit of normal (ULN)
  * Total bilirubin ≤1.5 × institutional ULN
  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × institutional ULN OR ≤5 × institutional ULN for participants with liver metastases
  * International normalized ratio (INR) or prothrombin time (PT) INR ≤1.5 × institutional ULN or PT ≤5 seconds above institutional ULN
  * PTT or activated partial thromboplastin time (aPTT) ≤5 seconds above institutional ULN
  * Thyroid stimulating hormone (TSH) OR free thyroxine (T4) within the normal limits
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.

Exclusion Criteria:

* Are currently receiving or have had prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 milligrams/day of prednisone, or an equivalent corticosteroid.
* Have symptomatic central nervous system (CNS) malignancy or metastasis.
* Have had any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, have any unresolved irAE Grade \>1, or any irAE that led to the permanent discontinuation of prior immunotherapy.
* Have experienced a Grade ≥3 AE or a neurologic or ocular AE of any grade while receiving prior immunotherapy.
Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer

Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization.

The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically verified colorectal adenocarcinoma.
* Patients to receive first line treatment of metastatic disease, including potentially resectable or non-resectable disease
* \> 6 months without recurrence after end of adjuvant chemotherapy for radically treated stage II or III colorectal cancer
* Disease evaluable according to RECIST 1.1, but not necessarily measurable disease.
* Age 18-75 years
* Performance status (PS) 0-1. If age 71-75, then PS 0
* Life expectancy \> 3 months
* Organ and bone marrow function as follows:

  * Neutrophil count ≥ 1.5 x 10\^9/L
  * Thrombocytes ≥ 100 x 10\^9/L
  * Total bilirubin ≤ 1.5 x upper level of normal (ULN)
  * Alanine transaminase (ALAT) ≤ 2.5 x ULN (or≤ 5 x ULN in case of liver metastases)
* Fertile women must present negative pregnancy test. Male (with a female fertile partner) as well as female patients must use secure contraceptives during and 6 months after end of treatment.
* Orally and written informed consent to treatment and biobank

Exclusion Criteria:

* Primarily resectable metastases
* Chemotherapy, radiotherapy or immunotherapy within 4 weeks
* Known neuropathy ≥ grade 2
* Serious competitive medical condition
* Other concurrent malignant disease other than non-melanoma skin cancer
* Previous serious and unexpected reactions to 5-fluorouracil, calcium folinate, oxaliplatin, irinotecan or capecitabine.
* Hypersensitivity to one or more of the active substances or auxilliary agents
One Touch® Verio®IQ European Clinical Outcomes Study

Evaluation of the clinical benefits of One Touch VerioIQ system.

Evaluation of the clinical benefits of the One Touch VerioIQ system. The system contains pattern alert technology and comes with educational material (Pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.

Eligibility Criteria:
Inclusion Criteria:

* male or female at least 18 to 80 years old
* ADA guidelines for FPG and PPG appropriate
* A1C greater or equal to 8.0% and less than or equal to 10.5%
* lab A1C greater than or equal to 8.0% in the last 6-12mths
* Diagnosed with type 1 or 2 in at least last 1 year
* on stable dose of OADs for at least 3mths prior to screening
* willingness to test 7 BGM tests per day
* willing to remain on same therapy as baseline (MDI) for duration of study

Exclusion Criteria:

* unlikely to be compliant to study procedures
* has or has currently used One Touch VerioIQ
* Is on fixed doses of insulin for MDI therapy
Prevention of Adhesions Following Flexor Tendon Injury Within Zone II With Vascularized Finger Dorsal Fascial Flap

The purpose of this study was to report a new method of flexor tendon repair in zone II with combined standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger volar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair in zone II with this new technique were compared with those of 32 patients (Group B) with flexor tendon repair in zone II with standard modified Kessler technique. This new technique may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.


Eligibility Criteria:
Inclusion Criteria:

* patients requiring flexor tendon repair or reconstruction within zoneⅡ

Exclusion Criteria:
Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core)

The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.

This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Food and Drug Administration (FDA) for use.

Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G, ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G, Quick-Core, Cook Medical Inc., Winston-Salem, NC)

Secondary Objective To compare

* The number of needle passes requiring to acquire adequate specimen
* Length of core tissue obtained
* Diagnostic contribution of immunohistochemical staining
* Rates of complications

Eligibility Criteria:
Inclusion criteria:

* Solid tumors ≥ 2 cm in size.

Exclusion criteria:

* Thrombocytopenia
Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.


Eligibility Criteria:
Inclusion Criteria:

* Be a Tis, T1, N0, M0 AJC Classification
* Have negative surgical margins (\> or = 2 mm) after final surgery
* Should have adequate skin spacing between balloon surface and surface the skin (\> 7 mm)\*
* Patients with infiltrating lobular histologies should have breast MRI scanning as part of the initial staging to verify localized T1, or Tis disease
* Multifocal findings (define as 2 or more breast quadrants) on MRI scanning should be further evaluated by ultrasound and, if necessary biopsy, to exclude multiquadrant disease.

Exclusion Criteria:

* Be pregnant or breast-feeding
* Have collagen-vascular disease
* Inadequate surgical margins (\< 2 mm)
* Patients with malignant/suspicious calcifications
Effects of Preventive Treatment for Respiratory Syncytial (RS) Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants

The primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections during the infancy.

The secondary objective is to determine whether the incidence of recurrent wheezing after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy.


Eligibility Criteria:
Inclusion Criteria:

* Infants born July \~ December 2007 at 33\~35 weeks of gestation
* Infants administered at least 3 doses of palivizumab during the first 6 months of life (Palivizumab treated)
* Infants not administered any doses of palivizumab during the first 6 months of life (Palivizumab untreated)

Exclusion Criteria:

* Intrauterine growth retardation (less than -2.5SD)
* Infants with chronic lung disease (CLD) or other respiratory disease
* Infants received mechanical ventilation
* Infants with chronic heart disease (CHD) or congenital anomaly (such as immunodeficiency)
Baroreflex Activation Therapy in Heart Failure

The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 21 years
* Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks

Exclusion Criteria:

* Significant carotid plaque or stenosis
* Known or suspected baroreflex failure or autonomic neuropathy
* Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
* Heart failure secondary to a reversible condition
VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

The VRapeutic (Full-immersive game-based therapy) is new therapeutic Egyptian software. It has the potential to provide intensive, repetitive, and task-oriented training. It may increase children's motivation, enjoyment, active social participation. Children with UCP may experience varieties of associated health conditions as difficulty of movement, instability of postural balance, difficulty of motor planning and control which impact on UE function.

Ethical statement this study was approved by institutional Review Board of the faculty of physical therapy ,cairo university .Egypt (no.P.T.REC/012/004237) .

Study Design A prospective randomized controlled trial of pre-post study design with two months follow-up evaluation will be used.

Sample size estimation

will be conducted to determine the number of recruited children. G\*POWER statistical software (version 3.1.9.2) will be used using α=0.05, power 80% allocation ratio N2/N1 =1.

Randomization The selected children will be assigned by simple randomization via closed envelopes into two equal groups (control and study); the envelope will be contained a letter indicating whether the child will be assigned to the control or to the study group.

Eligibility Criteria:
Inclusion Criteria:

* • Their ages will range from of 6 to 10 years.

  * Both genders will be included.
  * Their degree of spasticity will range from 1 to 1+ according to the Modified Ashworth Scale (Meseguer et al., 2018).
  * Their motor function will be at level I according to Gross Motor Function Classification System (Palisano et al., 2008).
  * They will be able to understand and follow the instructions.

Exclusion Criteria:

* Exclusion Criteria:

Children will be excluded from the study if they have any of the following criteria:

* Epilepsy.
* Visual or hearing problems.
* Musculoskeletal fixed deformity in upper limbs, lower limbs or spine.
* Orthopedic surgery on the involved UE.
* Botulinum toxin therapy for the affected UE within the past 6 months or within the study period.
Effect of Carum Carvi on Thyroid Hormones and TSH Level

Carum Carvi has been frequently used in traditional medicine for a variety of disease ranging from dyspepsia to Alzheimer's disease.We observed high TSH levels in few patients with thyroid cancer who receiving Carum Carvi despite being on suppressive dose of levothyroxin. TSH level returned to normal after discontinuation of the Carum carvi. This observation led to a pilot study for evaluation of the effect of carum carvi on thyroid function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Hypothyroid patients under treatment with levothyroxin
* Normal euthyroid patients with no goiter

Exclusion Criteria:

* Pregnancy or lactation
* Severe lung or gasterointestinal disease
* Heart failure or renal failure
Study of Exchange of Travoprost Intraocular Implant

The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.

This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). All subjects are required to meet eligibility criteria at Visit 1 (Screening). The purpose of this study is to evaluate the safety of the implantation and exchange of a Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Postoperatively, there are 6 follow-up visits over a 12 month period.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to attend scheduled follow-up exams for the duration of the study
* Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
* Best spectacle corrected visual acuity of 20/80 or better in each eye.
* Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.

Exclusion Criteria:

* Glaucoma status as follows:

  * Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
* Corneal status as follows:

  * Any active inflammation or edema
* Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
* Implantation of Travoprost Intraocular Implant
* Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
* Fellow eye status as follows:

  * Fellow eye actively enrolled in this trial or any other clinical trial
* Subject status as follows:

  * Pregnant or planning to become pregnant during the course of the study
Effect of Facilitated Tucking and Gentle Human Touch on Procedural Pain Among Neonates

This is a Randomized Control Trial intended to investigate the effect of two non-pharmacological interventions on procedural pain among neonates.

The Study Design is a Randomized Control Trial, intended to investigate the effect of facilitated tucking and gentle human touch on procedural pain among neonates (age 28 days). Neonatal Infant Pain Scale will be used for pain scoring, data will be collected by recording demographic variables for all neonates and then capturing a video recording for pain scoring by an independent research assistant.

Eligibility Criteria:
Inclusion Criteria:

1. Both term and preterm neonates.
2. APGAR scores of a minimum of 6 at one minute and 8 at 5 minutes
3. Admitted to the Neonatal Intensive Care Unit
4. Undergoing arterial prick for the first time.

Exclusion Criteria:

1. Documented birth asphyxia
2. Congenital anomalies
3. Neurological diagnosis,
4. ventilated with paralysis
5. Extremely premature newborns (Gestational age \< 28 weeks)
Effect of Exercise Frequency on Metabolic Control and Heart Function in Type 2 Diabetes

This study will compare two interventions with the same exercise intensities and caloric expenditure but with different exercise frequency, on metabolic control and other risk factors in individuals with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes

Exclusion Criteria:

* insulin treatment
* severe chronic diabetic complications
* liver dysfunction
* kidney dysfunction
* inflammatory diseases
* heart failure
* myocardial ischemia
* major cardiovascular event history
* physical exercise more than current guidelines for type 2 diabetes
* inability to exercise
Preventive Program in Multiple Sclerosis

This study monitor the immediate and persistent impact of a preventive complex six-month program specifically developed for newly diagnosed people with multiple sclerosis on fatigue, mental and physical fitness, and quality of life. The study determined whether changes in clinical function are related to changes in neurohormones, and whether the effect of therapy is dependent on the active approach of study participants.

The patients who were newly diagnosed with MS underwent a six-month preventive comprehensive program, which included individual physiotherapy focused on the treatment of functional disorders of the loco-motor system and therapy on a neurophysiological basis, group psychotherapy and controlled aerobic training. The participants were examined three times - before the start of the physiotherapy program, immediately after its completion and six months apart. Influence on physical fitness (spiroergometric examination), fatigue (Modify Fatigue Impact Scale, fatigue scale for motor and cognitive functions), depression (Beck scale for evaluation of depression), admission of disease RS (Inventory of admission of multiple sclerosis, quality of life) life and selected neurohormones (dehydroepiandrosterone-DHEA, dehydroepiandrosterone sulphate - DHEAS, cortisol).

Eligibility Criteria:
Inclusion Criteria:

* definite MS
* stable clinical status in the preceding 3 months
* imumnomodulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natalizumab)
* Expanded Disability Status Scale (EDSS)≤6
* predominant motor impartment
* six months or more without any physiotherapy
* ability to undergo ambulatory physiotherapy

Exclusion Criteria:

* other neurological disease or conditions disabling movement
Swedish Spinal Stenosis Study

A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis \>3mm. Monitoring is performed with clinical results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null hypothesis is that there is no difference in results between the two interventions.


Eligibility Criteria:
Inclusion Criteria:

* Pseudoclaudication in one or both legs and backpain (VAS\>30)
* MRI with 1-2 adjacent stenotic segments (area \<0.75 mm2)between L2 and sacrum
* Duration of symptoms \>6 months
* Informed consent

Exclusion Criteria:

* Spondylolysis
* Degenerative lumbar scoliosis (Cobb angle \>20 deg)
* History of lumbar spinal surgery for spinal stenosis or instability
* Stenosis not caused by degenerative changes
* Stenosis caused by herniated disc
* Other specific spinal conditions, Mb Bechterew, malignancy, neurologic disorders
* History of vertebral compression fractures in affected segments
* Psychological disorders where the surgeon considers participation inappropriate(dementia, drug abuse)
Cost-effectiveness of Outpatient Versus Hospital Cardiac Rehabilitation

The hypothesis is that home based clinical rehabilitation (CR) is less expensive than hospital based CR with similar clinical effectiveness. The investigators will compare the results of two forms of CR on

1. direct and indirect healthcare costs
2. effectiveness on mortality, morbidity, modifiable risk factors control, functional capacity measured by exercise testing, health related quality of life and satisfaction rate
3. cost/effectiveness analysis

The main reasons for patients not to participate in a cardiac rehabilitation program that usually develops by group in the hospital or in a gym, are problems of access to hospital, disgust for participating in a group activity and problems in reconciling their work and / or home with the program schedule. These problems could be overcome by outcome cardiac rehabilitation and thus could increase the number of patients benefit from treatment in either the environment extra or intra-hospital.

Low and medium coronary patients sent to cardiac rehabilitation program at our center within the first 12 weeks after presenting with acute coronary syndrome or been revascularized will be included in the study. The prescription of intensity of effort is based on heart rate reached during the stress test for the initial evaluation in all cases, although at home-program heart rate will be monitored using heart rate monitor and / or by the Borg scale. In this way outpatient group patient could performed training sessions individually and at the time of day that best suits their capabilities. The other program components: control of risk factors, health education and counseling will be identical in both groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* patients referred to cardiac rehabilitation program in the first twelve weeks after an acute coronary syndrome (myocardial infarction or unstable angina) or after percutaneous or surgical revascularization
* who have no contraindication to participate in the program

Exclusion Criteria:

* contraindication to participate in the program
* high-risk criteria for home cardiac rehabilitation.