cyrilzakka/clinical-trials huggingface dataset:
Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity

The study objective is to evaluate whether a novel telemedicine-based intensive treatment program for children with obesity is superior to standard on-site care. This will be a randomized, non-blinded (due to the nature of the intervention) study, where 100 children and adolescents aged 10-18 years with obesity will be divided in a 1:1 ratio to either telemedicine or on-site treatments for 6 months.

The telemedicine arm will include 30, mostly video, consultations for each participant: 3 physician appointments, 7 exercise consultations by our exercise physiologist, 10 dietary consultations by our pediatric dietitian, and 10 psychologist consultations to assist with goal setting and overall well-being. Three visits will be conducted in-office, for physician assessment, smartphone technical assistance and physical measurements (baseline, at 3 months and at the end of the 6-month period). Participants randomized to the telemedicine arm will have a step-counting rewarding app installed on their smartphone by our staff.

The in-office arm will have 6 monthly visits during the study period, with two consultations performed in each visit - one by the physician or exercise physiologist, and one by our pediatric dietitian.

The main outcome of the study is BMI standard deviation (z-score) changes, which will be evaluated after 3 and 6 months of treatment during physical office visits in both study arms.

Secondary outcomes will be:

* Body-fat percent changes, assessed by bioimpedance analysis in physical clinic visits.
* Daily step counts, measured by smartphone data/ wearable activity tracker, if available.
* Weight-related quality of life
* Retention and visit cancellation rates.
* Satisfaction of both parent and child from their allocated treatment.


Eligibility Criteria:
Inclusion Criteria:

* Obesity, defined as a BMI at or above 2 standard deviations SDs according to the WHO growth reference
* Owning a smartphone, needed for video conversations, step counting and the gamification app
* Parent consent and child's assent to participate in the program

Exclusion Criteria:

* Significant physical or mental barriers to physical activity and/or to dietary changes (such as autistic spectrum disorder that precludes dietary changes or sufficient exercise, as assessed by the PI)
Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction

Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate cancer.

It is the consequence of penile vascular damage, mainly arterial insufficiency and venous leakage associated with fibrosis of the corpus cavernous. Apoptosis of penile cells, including mesenchymal cells, smooth muscle cells and endothelial is believed to play an important role in the pathophysiology of post prostatectomy erectile dysfunction.

Bone marrow mononucleated cells (BMMNC) contain different cell types that may replace the damaged penile cells after radical prostatectomy. These are mainly: mesenchymal stem cells, endothelial progenitor cells and hematopoietic stem cell. Intracavernous injection of BMMNC may therefore find application in the treatment of post prostatectomy erectile dysfunction.

The aims of this phase I-II study is to test the safety of autologous intracavernous BMMNC injection and to evaluate benefit for the patient concerning recovery of natural erection. Patients with penile vascular abnormality (echo-doppler) and localized prostate cancer (considered as cured by radical prostatectomy) will be included in this study.

Four different doses of BMMNC will be tested.

We have shown in a rat model of post prostatectomy erectile dysfunction that BMMNC injection replace apoptotic cavernous cells and restore erectile function.

In the pig, the injection of high dose of BMMNC into the corpus cavernosus does not cause side effect. Moreover, the BMMNC remains at the injection site.

Eligibility Criteria:
Inclusion Criteria:

* Localized prostate cancer: PSA (Prostate Specific Antigen) prior to radical prostatectomy \< 10 ng/ml, histopathologic analysis of the prostate showing a prostate cancer with Gleason score ≤ 7, negative margin, absence of effraction of the prostatic capsule, pT1 or pT2 N0 or NX.
* PSA=0 ng/ml 6 months after radical prostatectomy.
* Normal erectile function prior to radical prostatectomy.
* Penile arterial insufficiency and or venous leakage (doppler) at the time of inclusion: PSV \<25 cm/sec, PSV \>25 cm/sec, EDV\>5cm/sec, RI\<0,75.

Exclusion Criteria:

* Non localized prostate cancer.
A Multicenter Study of the Pigmentation in the Trabecular Meshwork After Two Years of Treatment With TRAVATAN 0.004% Ophthalmic Solution

The purpose of this study was to assess the pigmentation in the trabecular meshwork of patients who had been treated for at least 2 years with TRAVATAN compared with patients without exposure (or less than 1 month) to a prostaglandin analogue (PGA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma without pseudoexfoliation or pigment dispersion component;
* Either two or more years of dosing with Travatan, or no prior exposure (less than 1 month) to a topical ocular prostaglandin;
* Requires a trabeculectomy;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pseudoexfoliation or pigment dispersion;
* History of chronic or recurrent severe inflammatory eye disease;
* History of or current ocular infection or ocular inflammation within the past 3 months in either eye;
* Greater than one month but less than two years of exposure to TRAVATAN;
* Pregnant, breast-feeding, not using highly effective birth control;
* Other protocol-defined exclusion criteria may apply.
Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients

Patient satisfaction with healthcare is increasingly being utilized as a metric to reflect provider and hospital quality of care. Furthermore, at the core of a healthcare team and healthcare system is the desire to provide patients with the best possible care in order to achieve the best possible outcomes. Providers have the duty to identify areas of needed improvement within the domains of treatment. An area of need that is ubiquitous within medicine is pain control; in this case acute postoperative pain control is the targeted condition. Studies have already shown that better control of acute postoperative pain leads to shortened hospital stays, reduced hospital costs and patient morbidity, improved patient satisfaction and a reduced likelihood of developing chronic pain. Research within the field of pain management has definitively revealed that a combination of different medication regimens can control acute postoperative pain better than narcotics alone. In particular, the medication gabapentin has been shown to improve acute postop pain in many kinds of surgical settings, and it is a safe medication with arguably fewer side effects than narcotics. The investigators know that certain groups of post surgical otolaryngology patients can be at risk for high levels of postoperative pain. Given all of this information, physicians have a responsibility to utilize medications such as gabapentin to do a better job of controlling patient's pain. This investigation is a quality improvement project designed to elucidate the benefits of gabapentin in pain management in patients undergoing surgery of the head and neck mucosal surfaces. It will provide much needed data in an understudied population and ultimately will improve the practice of pain management, patient satisfaction and quality of care delivered in the Barnes otolaryngology department.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing definitive mucosal head and neck resection including oral cavity, oropharynx, larynx, and hypopharynx
* At least one night of planned inpatient stay

Exclusion Criteria:

* Incapable of giving informed consent
* Age less than 18
* Glomerular Filtration Rate (GFR) less than 30
* Allergy to gabapentin
* Baseline gabapentin or lyrica use
* Chronic opioid use for over six months
Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing to provide informed consent
* Karnofsky performance score greater than 60
* Life expectancy greater than 6 months
* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
* Controlled primary tumor defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
* Total number of metastases 4-10
* All sites of disease can be safely treated based on a pre-plan

Exclusion Criteria:

* Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma.
* For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
* Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases must be discussed with one of the study PIs.
* Malignant pleural effusion
* Inability to treat all sites of disease
* Any single metastasis greater than 5 cm in size.
* Any brain metastasis greater than 3 cm in size or a total volume of brain metastases greater than 30 cc.
* Metastasis in the brainstem
* Clinical or radiologic evidence of spinal cord compression
* Dominant brain metastasis requiring surgical decompression
* Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin
* Pregnant or lactating women
Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder

The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a diagnosis of idiopathic overactive bladder, without incontinence.
* The subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit.
* The subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit.

Exclusion Criteria:

* Bladder outlet obstruction (on urodynamic assessment).
* Post-Micturition Residual Volume \> 150 ml (ultrasound assessment).
* Evidence of a urinary tract infection at Screening or Baseline in the study.
* Active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.
Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients

A large number of dentoalveolar (tooth extraction) procedures performed by Oral and Maxillofacial Surgeons utilize intravenous sedation. Procedures commonly performed may include surgical removal of teeth, bone grafting, surgical placement of dental implants, and removal of cysts or tumors from the jaws, among others. Obtaining peripheral intravevenous (IV) cannulation often proves to be a very stressful and anxious event for the patient. The anxiety and stress from the venipuncture alone affects not only the psychological stability of the patient, but also the patient's physiology. The Buzzy vibration external stimulation device has shown to be an effective tool in pediatric venipunture procedures. The aim of this study is to investigate the effects of the Buzzy stimulation device in pain and anxiety reduction during peripheral intravenous cannulation in an adult population.

Enrollees in this study will be patients who will undergo dental surgery with intravenous sedation. The patients who are enrolled will receive an IV either with or without the Buzzy. The Buzzy is a small vibration device which will be placed next to the IV placement site.

The participants will be randomized into two groups, those who use the Buzzy system (experimental), and routine IV start (control). Prior to knowing their group, all patients will answer the "Before Intravenous Catheterization" portion of the form in order to eliminate bias. After this portion is complete, their group (experimental vs control) will be determined from opening a blinded envelope.

A tourniquet will be placed, followed by the Buzzy stimulation device (if in the experimental group). An alcohol swab will be used and then a 22 gauge IV catheter will be inserted, connected to fluids, and secured with tape. The antecubital fossa or the dorsal hand/wrist will be the only sites used in the study. All participants will fill out the post-insertion questions on the form and those patients that used the Buzzy system will then fill out the several specific questions related to the experimental group. This will conclude the patient's involvement in the study. The patient will then continue with treatment as planned. We will plan to exclude cases where the IV is not obtained on the first attempt, if a smaller or larger gauge IV catheter is required, or if an insertion site not listed above is required. The case will be excluded if adjunctive steps are taken to obtain IV access (i.e. Oral sedation, nitrous oxide, heat packs).

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and 40.
* Eligible for third molar removal with sedation.

Exclusion Criteria:

* Not eligible for surgery.
* Not eligible for sedation.
Potato Consumption and Energy Balance

A randomized, clinical trial will be performed to assess changes in body weight and fat mass with daily potato consumption versus a calorie-matched snack of almonds.

This is a 30-day randomized, controlled trial with 3 arms: 1) non-potato food (almonds), 2) standard white potato French fry, 3) standard white potato French fry with potential glycemia-modulating spice/seasoning mix added.

Free-living study participants will be assigned to consume one of the 3 foods (calorie matched) each day for a 30-day period. Body composition (via dual energy x-ray absorptiometry; DXA), and blood chemistry will be assayed at baseline and study completion, along with a sub-sample of subjects participating in a meal-based tolerance tests at study completion.

Eligibility Criteria:
Inclusion Criteria:

* 18- 50 years old
* Body mass index (BMI) 20- 35
* No dietary restrictions or allergies
* Weight stable
* Access to camera through smartphone, computer or tablet

Exclusion Criteria:

* Pregnancy or anticipating pregnancy or lactation
* Nut or food allergy
* Diagnosed diabetes (Type 1 or 2)
* History of weight control surgery (bariatric or liposuction)
* Consumes \>1 serving of potatoes daily before enrollment
* Weight loss or gain \>5% within past 6 months
* Medical conditions or medications that would prevent the ability to comply with treatment assignment and/or affect energy balance
* Dependence on others for food procurement or preparation
Patient Reported Outcome Measures After Treatment of Skin Cancers on the Face

This study is to evaluate the psychological well-being in patients diagnosed with skin cancer (melanoma and Squamous Cell Carcinoma (SCC) in the face) at the time of diagnosis and after treatment. Patients diagnosed with primary melanoma and/or SCC and/or infiltrative basal cell carcinoma on the face subjected to surgical treatment (excision or Mohs Surgery) will be included. All patients will receive questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* individuals diagnosed with melanoma, SCC and/or infiltrative basal cell carcinoma on the face for surgical treatment and planned for excision or Mohs surgery
* patients who are able to give informed consent

Exclusion Criteria:

* Electrodesication and curettage of the tumour
Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma

This pilot study of scalp cooling with Penguin cold caps will examine the effectiveness of scalp cooling to reduce the development of hair loss in 30 participants with multiple myeloma undergoing high-dose chemotherapy with melphalan and autologous peripheral blood stem cell transplant at Cedars-Sinai Medical Center. The investigators will also assess the potential impact of hair loss versus the discomfort and inconvenience of the scalp cooling procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* ECOG performance status ≤2
* Confirmed multiple myeloma diagnosis
* Hair covering ≥75% of scalp on physical exam at screening visit
* Planning to undergo SOC high-dose chemotherapy with melphalan (dose to be used = 140 - 200 mg/m2 (with rounding per CSMC guidelines)) followed by an autologous peripheral blood stem cell transplant.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Prior or current use of any scalp cooling treatment
* Hair covering \< 75% of the scalp on physical exam at screening visit.
* Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia
* Current spinal or neck injury that may interfere with the subject's participation for the full duration of the study, in the opinion of the treating investigator
* Skin conditions such as psoriasis, eczema, malignancy, or other condition on the scalp that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Current use of oxaliplatin
* Current use of any other investigational agents
* Contraindication to melphalan
The Study of the Effectiveness of Tissue Equivalent on the Basis of Cultured Cells to Heal Skin Blemishes

In Russia the treatment nonhealing skin defects often limited to surgical interventions, despite having developed modern methods of treatment of non-healing ulcers and other skin imperfections. During the many years of research we have developed a skin equivalent comprising living cells.

During pilot trial showed that the skin equivalent provides healing skin defect within 1-4 weeks in 95% of patients.


Eligibility Criteria:
Inclusion Criteria:

* The presence of non-healing ulcer at least a month, an area of not less than 3 cm2 or smaller area of deep defects;
* Availability of burns II or III level;
* Epidermolysis bullosa;
* Availability of post-burn scars
* Defects in the skin after surgery

Exclusion Criteria:

* Acute and chronic diseases in the acute stage;
* Autoimmune diseases of connective tissue (collagen);
* Immunodeficiency states;
* System of inflammatory diseases of the skin;
* Conduct an aggressive corticosteroid therapy;
* Acute coronary syndrome;
* Acute disorders of cerebral circulation;
* Availability of local inflammation in the acute stage;
* Pregnancy;
* Breast-feeding.
* Positive results of the following tests: Anti-HIV-1 and -2, HIV-1Ag, anti-HTL VI and-II, anti-HbcorAg, HBs-Ag, anti-HCV, anti-CMV, anti-Toxoplasma gondii, RW, Neisseria gonorrheae, Chlamydia.
Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

This is an open label, non-randomized, single-arm continuation protocol study using ZEN003694. Patients who have completed participation in their original ("parent") ZEN003694 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with ZEN003694 in the continuation protocol. The patient must have been enrolled in a Zenith Epigenetics sponsored ZEN003694 therapeutic study to be eligible for participation in this continuation protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Protocol-defined completion in a parent ZEN003694 trial
2. Patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol
3. ECOG performance status of 0 or 1
4. Acceptable ZEN003694 tolerability, in the judgment of the investigator
5. Initiation of dosing in this continuation trial to occur within two weeks (14 days) of completing dosing in the parent trial, unless more time is approved by the sponsor in writing

Exclusion Criteria:

1. Concurrent participation in another clinical investigational treatment trial
2. Require addition of or change to a new concomitant therapy to adequately treat the malignancy under study
3. Discontinued ZEN003694 or withdrew consent to participate in original Zenith Epigenetics-sponsored ZEN003694 study
4. Any other reason that in the opinion of the Investigator would prevent the patient from completing participation or following the study schedule
Validation of Nicom Device to Measure Stoke Volume Variation

The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing general anesthesia with an expected duration exceeding two hours
* gastrointestinal surgery, urological or gynecological surgery.

Exclusion Criteria:

* Difficulty of venous access.
* Contraindication for the use of oesophageal Doppler
* Contraindication for the use of Nicom
* Contraindication for the use of bispectral index
* Pregnant or lactating women