cyrilzakka/clinical-trials huggingface dataset:
Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health

The purpose of this study is to see whether it is feasible to conduct a study to determine if the use of hyaluronic acid (HLA) vaginal gel (HyaloGYN®) improves vulvovaginal health.

This study aims to look at whether or not HyaloGYN® is effective in women with a history of hormone receptor positive cancer and experiencing vaginal and/or vulvar symptoms of estrogen deprivation following their breast and endometrial cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* History of breast cancer or endometrial cancer confirmed at MSKCC or outside pathology report
* Breast cancer patients must be at least 3 months post-active treatment (including chemotherapy, radiation therapy, endocrine therapy, and/or maintenance therapy), but not greater than 5 years post-active treatment (exception: AIs are required, and monoclonal antibodies are allowed)
* Breast cancer patients must be currently on adjuvant aromatase inhibitors
* Endometrial cancer patients must be at least 3 months post-active chemotherapy and/or maintenance therapy treatment but not greater than 5 years post-active chemotherapy and/or maintenance therapy treatment. They must be at least 4 weeks post-radiation therapy (EBRT or IVRT) but not greater than 5 years post-radiation therapy.
* Endometrial cancer patients must have underwent surgical treatment (total abdominal hysterectomy (\[TAH\]/BSO)) and radiation therapy (external beam radiation therapy \[EBRT\] or IVRT)
* Currently have no clinical evidence of disease
* Menopausal at study entry as described by:
* Surgical menopause (TAH/BSO), or
* Age ≥ 50 years and cessation of menstruation for at least 1 year, or
* Age \<50 years and cessation of menstruation for at least 1 year with estradiol level in post-menopausal range, or
* Rendered post-menopausal with the use of LHRH agonist
* Patients who are new visits to Female Sexual Medicine Program or patients are not consistently using any vulvovaginal health promotion strategies (e.g., pelvic floor exercises, dilator therapy, moisturizers) recommended by the Female Sexual Medicine Program Reporting being bothered by vulvovaginal symptoms of estrogen deprivation (i.e., vulvovaginal dryness or discomfort \[pain with intercourse or examination\])
* Without history of other cancers (excluding non-melanoma skin cancer)
* Women at least 18 years of age
* Able to read and speak English
* Able to participate in the informed consent process

Exclusion Criteria:

* Inability to provide informed consent
* Vaginal bleeding of unknown etiology within 12 months of study entry
* Currently taking hormone replacement therapy \[local or systemic\] (Patients must discontinue for 2 weeks in order to be eligible prior to study enrollment)
Treatment of Anal Fissure by Activated Human Macrophages

Chronic anal fissure is a linear tear in the distal anal canal. Most chronic fissures require intervention to heal. Surgical sphincterotomy is currently performed. However, the procedure permanently weakens the internal sphincter and may be associated with permanent complications such as incontinence. Current topical treatment or " chemical sphincterotomy" is effective in the short term for about 70% of the patient more than 50% of them will suffer from recurrence. Number of studies support the hypothesis that local ischemia is the reason for failure to heal in anal fissure. Treatment of refractory wounds by macrophage suspension is an innovative method since 1995, macrophage suspensions have been used successfully in more than 1400 patients in several hospitals in Israel without any side effect.Macrophages have key function in almost every stage of wound healing. They help in the digestion of bacteria, in a later stage, they secret IL-6, which influences endothelial cell proliferation and the initiation of angiogenesis.

The study hypothesis is that local injection of activated human macrophages into chronic anal fissure may induce fissure healing.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive symptomatic adults with chronic idiopathic anal fissure

Exclusion Criteria:

* Pregnant women
* Acute fissures
* Anal fissures of various causes ( i.e.,hemorrhoids, fistula in ano, inflammatory bowel disease)
* Immunosuppressed patients
Combination Chemotherapy Followed by Stem Cell Transplant in High-risk Neuroblastoma Patients

Improvement of event free survival of high-risk neuroblastoma patients by introduction of two additional topotecan containing chemotherapy cycles into the multimodal standard treatment (induction chemotherapy, myeloablative therapy, radiation, surgery as indicated, and consolidation therapy).

Experimental intervention (6 weeks + duration of the control intervention):

2 x N8 cycle (topotecan, cyclophosphamide, and etoposide) followed by standard arm treatment (i.e., control intervention)

Control intervention (total duration 70-76 weeks):

3 x N5 cycle (cisplatin, etoposide, and vindesine) 3 x N6 cycle (vincristine, dacarbacine, ifosfamide, and doxorubicine), myeloablative chemotherapy with autologous stem cell transplantation (melphalan, carboplatin, etoposide) 9 x retinoic acid cycles (6 months, 3 months break, 3 months) supportive care (PCP/fungal prophylaxis, transfusions, antibiotics, G-CSF)

Eligibility Criteria:
Inclusion Criteria:

* neuroblastoma
* stage 4 neuroblastoma and age ≥1 - 21 years or MYCN amplification and age ≥6 months - 21 years
* informed consent obtained

Exclusion Criteria:

* Participation in other trials
* Pregnancy, lactation, or insufficient contraception for girls in childbearing age,
* Any concomitant non-protocol anticancer therapy,
* Incomplete initial staging.
Barriers to Peritoneal Dialysis Selection

The purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. This understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a timely enough manner so that each patient can start dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients (20% or less of kidney function remaining) will be asked to participate in the study with the goal of having 150 patients participate in the study.

Hypotheses:

1. 50 % of patients will have made a modality decision when interviewed and patients in the action stage of behavior will be more likely to make a modality selection than patients in earlier stages of behavior change. Barriers to modality selection will act at several levels including patient, provider and health system level and will vary by behavioral stage of change
2. 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD, education, and income will likely be barriers to home dialysis choice.


Eligibility Criteria:
Inclusion Criteria:

* All patients of age greater than or equal to 18 years at MHMC who are late stage CKD

Exclusion Criteria:

* Patients who have acute renal failure and then recover renal function to levels of eGFR (estimated glomerular filtration rate) 20 mL/min/1.73m2 and in whom the nephrologist feels will not progress to ESRD in 2 years
* Patients who are not candidates for peritoneal dialysis
* Pregnant women
A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders

The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. A PSG system will be recording the PSG data.

Subjects suspected of having sleep disorders who are referred to a sleep study will be screened for potential participation in the study, according to the inclusion and exclusion criteria. Additionally, patients with comorbidities associated with central sleep apnea may be referred from cardiology related divisions, and screened for participation in the study. Recruited patients will be asked to sign an informed consent form. Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate case report forms.

The subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG. A PSG system will be recording the signals and manual scoring will be performed blinded - without access to WP data. The WP analysis will be done automatically.

Eligibility Criteria:
Inclusion Criteria:

* Age between 12-99
* Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are referred to undergo an overnight sleep study in the clinical sleep laboratory
* Subjects suspected of having sleep disorders or with comorbidities relevant to central sleep apnea.

Exclusion Criteria:

* Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
* Finger deformity that precludes adequate sensor appliance.
The Effect of Remifentanil on Rebound Pain

The investigators will evaluate the influence of intraoperative remifentanil infusion on the postoperative hyperalgesia in patients receiving rotator cuff repair after brachial plexus block for postoperative analgesia.

The study will include 68 patients undergoing rotator cuff repair. All patients will receive brachial plexus block for postoperative analgesia, followed by general anesthesia. In the experimental group, remifentanil infusion will not be used intraoperatively, and in the control group, remifentanil will be infused. After surgery, both groups will be given the same postoperative pain management using patient controlled analgesia(PCA), and pain patterns will be assessed using the Numerical rating scale (NRS) at 4 hour intervals for 24 hours. The primary end point of this study is the total dose of PCA medication over 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I,II,III
* Patients undergoing arthroscopic rotator cuff repair surgery under general anesthesia after interscalen brachial plexus block for post operative analgesia
* Age ranges from 20 to 70

Exclusion Criteria:

* Patients who didn't agree to study
* Patients can't control PCA(Patient-Controlled-Analgesia) independently
* Patients who have conciousness disorder or can't express their pain level by NRS(Numeric Rating Scale) system
* Patients who have severe respiratory disease or hepatic failure
* Patinets who have known neuropathy or coagulopathy
* Pregnancy
* Patients with allegies to the drugs used in this study
The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities

The purpose of this study is to translate and culturally adapt the quality of life profile for spinal deformities (QLPSD) to Turkish language and test the validity and reliability of Turkish version of QLPSD in patients with adolescent idiopathic scoliosis.

The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It contains 21 items in five dimensions: psychosocial functioning (7 items), sleep disturbances (4 items), back pain (3 items), body image (4 items), and back flexibility (3 items). Responses to items use a 5-point Likert scale. The possible score range is 21-105.

The QLPSD has shown good validity and reliability. English, French and Persian versions of the QLPSD have been developed and validated. Good reliability and ease of use are mentioned in these versions. The QLPSD was designed to examine adolescents with spinal deformities and measure the effect of orthotic and surgical treatments on QoL. This questionnaire is practical and suitable for patients with spinal deformities. As a result we choose to translate the QLPSD into Turkish as it is less costly, practical and time consuming than developing a new tool. QLPSD may be preferred during follow-up of the results of conservative and / or surgical treatments for spinal deformities.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 10-16 years old
* Cobb angle 10-40 degrees
* Being treated with conservative treatment for spinal deformities
* Being accepted to answer the questionnaire

Exclusion Criteria:

* Being not accepted to answer the questionnaire
* Having any mental disorder to prevent participation the study
Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

The study investigates whether the use of eye movement recordings can provide a reliable diagnostic of previously undiagnosed mild traumatic brain injury (blast and impact) in Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans.

Eye movements are recorded for Operations Enduring Freedom or Iraqi Freedom (OIF/OEF) veterans with mild traumatic brain injury (mTBI) and compared to the eye movements of those without mTBI. By analyzing and characterizing the differences between the two groups, a diagnostic measure of mTBI through the use of eye movements can be developed.

Eligibility Criteria:
Inclusion Criteria:

* OIF/OEF Veteran;
* Neuropsych diagnosis of MTBI

Exclusion Criteria:

* chronically abusing alcohol or illicit drugs.
* uncorrected vision prevents subject from effectively viewing the stimuli, unless they can wear contact lenses during the recording session.
* inability to make normal eye movements (i.e.: saccades, smooth pursuit) required by study paradigms. Note: Deficit can be caused by taking medications that can potentially affect eye movements or any neurological condition that can interfere with making normal eye movement.
* psychological or psychiatric conditions that preclude sustained concentration or ability to perform the tasks.
A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants

The purpose of this study is to evaluate the relative bioavailability of JNJ-64304500 after administration of two different formulations in healthy participants.


Eligibility Criteria:
Inclusion criteria:

* Male or non-childbearing potential female (according to their reproductive organs and functions assigned by chromosomal complement)
* For Han Chinese participants, they need to have resided outside of China for no more than 10 years and have parents and maternal and paternal grandparents who are of Han Chinese ethnicity
* Have a body weight in the range of 60 kilograms (kg) to 90 kg and within a body mass index range between 18 and 30 kilogram per square meters (kg/m\^2), inclusive
* Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening.
* Healthy on the basis of clinical laboratory tests performed at screening.

Exclusion criteria:

* History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to) liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has a QT corrected according to Fridericia's formula (QTcF) interval greater than (\>) 450 milliseconds (msec) for males, and \>470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at predose (Day -1)
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Had major illness or surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or until Day 113 (Participants who had minor surgical procedures conducted under local anesthesia within 4 weeks before screening may participate)
* Plans to undergo non-major elective surgery within 4 weeks prior to study intervention administration through the end of the study
Propolis in Primary Herpetic Gingivostomatitis

The purpose of the present study is to investigate the efficacy of 5% propolis gel in the treatment of primary herpetic gingivostomatitis in children and its effect on salivary IFN-γ levels.


Eligibility Criteria:
Inclusion Criteria:

* clinical manifestations suggestive of PHGS
* positive culture for HSV-1

Exclusion Criteria:

* negative culture for HSV-1
* allergic to honey or its products
* patients diagnosed with any systemic diseases, immunosuppressed or immunocompromised patients
Thrombin Generation Test in Patient With Liver Cirrhosis

Cirrhotic patients are patients with high morbidity and mortality, it is very important for determining the prognosis of these patients. The importance increases when these patients waiting for a liver transplant. The Model for End-Stage Liver Disease (MELD) is a reliable measure of mortality risk in patients with end-stage liver disease. It is used as a disease severity index to help prioritize allocation of organs for transplant. MELD uses the patient values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.

Blood tests that we use today in daily practice to evaluate the coagulation system (PT, PTT) do not check actually the functioning of the system, but examine the level of clotting factors and therefore only verify that the side of Anticoagulant of the equation and not the side of the procoagulant .

To examine the coagulation system function tests have been developed, One of them is the thrombin generation. The purpose of the trial is to determine whether thrombin generation test can be a prognostic indicator in patients cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

Cirrhosis patient MELD ( Model For End-Stage Liver Disease) above 12

Exclusion Criteria:

Pregnant women
Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area

Open clinical study to evaluate the soothing and re-epithelizing activity of a single application of two cometic formulations ("P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO") on experimentally induced erythema by repeated tape stripping on the forearm (volar surface) of 20 healthy volunteers.

Study products activity was assessed in comparison to placebo ("P926P - LICHTENA DermAD CREMA VISO - PLACEBO") and versus untreated control area.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers of both sexes
* TEWL value on tested skin areas immediately after tape stripping \>15g/m2-h
* volunteers in a good general state of health in the Investigator opinion
* volunteers not taking drugs or undergoing surgical procedure
* volunteers who are giving a written informed consent.

Exclusion Criteria:

* Pregnancy (only for female subjects)
* lactation (only for female subjects)
* TEWL value on tested skin areas immediately after tape stripping \<15g/m2-h
* change in the normal habits in the last month
* participation in a similar study during the previous month
* known allergy to one or several ingredients of the products on trial.
* Dermatitis
* presence of cutaneous disease on the tested area, as lesions, scars, malformations
* clinical and significant skin condition on the test area.
* Diabetes
* endocrine disease
* hepatic disorder
* renal disorder
* cardiac disorder
* pulmonary disease
* cancer
* neurological or psychological disease
* inflammatory/immunosuppressive disease
* drug allergy.
* Anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
* using of drugs able to influence the test results in the investigator opinion.
A Multi-Center Controlled Screening Trial of Safety and Efficacy of Lithium Carbonate in Subjects With Amyotrophic Lateral Sclerosis (ALS)

This is a Phase II screening study of lithium carbonate in ALS. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease. Since there is no placebo in this study, all patients will be taking lithium carbonate.

This is a Phase II Screening study. There is no placebo (inactive or 'fake' drug) in this study, meaning that all participants will be taking lithium carbonate. The purpose of this study is to find out if lithium carbonate is safe to be used in people with ALS and if it can slow the progression of the disease.

A recent article was published in a highly regarded medical journal that showed a positive effect of lithium carbonate on an ALS type mouse. The researchers then studied a very small number of people with ALS, giving 16 people lithium carbonate with riluzole and giving 28 people only riluzole. The people who took lithium remained stronger for a considerably longer period of time. However, the study was very small and we cannot really tell if lithium works unless a larger study is performed. It is not well understood why lithium carbonate might be helpful but it is believed that it may play a role in protecting the motor nerves from the damage of ALS.

If you choose to participate, you will need to go to your study clinic for research study visits 7 times in one year and you will have 4 telephone interviews during that time. These visits and phone calls could take up to 17 hours in total.

Caution: Lithium is an FDA approved drug used for some psychiatric disorders. It is not FDA approved for ALS. Lithium has many potentially serious side effects and must only be taken under close supervision of your physician.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of laboratory-supported probable, probable, or definite ALS
* Vital capacity of at least 75% of predicted
* Onset of weakness within 3 years prior to enrollment
* If patients are on riluzole, they must be on a stable dose for at least 30 days prior to baseline visit
* Women of childbearing potential must be surgically sterile or using an effective method of birth control and have a negative pregnancy test
* Willing and able to give informed consent

Exclusion Criteria:

* Diagnosis of other neurodegenerative disease
* Need tracheotomy ventilation or non-invasive ventilation 23 or more hours/day
* Clinically significant history of any unstable medical condition in past 30 days
* History of renal
* History of liver disease
* Current pregnancy or lactation
* Use of lithium within thirty days of enrollment
* Significantly limited mental capacity
* History of recent drug or alcohol abuse
* Use of any investigational drug within 30 days prior to enrollment