cyrilzakka/clinical-trials huggingface dataset:
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)

The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B \& C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma participants.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B \& C - enrollment closed)
* Participants may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B \& C - enrollment closed)
* Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D)

Exclusion Criteria:

* Known central nervous system lymphoma
* Participants with nodular lymphocyte-predominant Hodgkin Lymphoma
* Prior allogeneic stem cell transplantation (SCT)
* Chest radiation ≤ 24 weeks prior to first dose
* Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
Tertiary Care With or Without Manual Therapy for Chronic Migraine

The aim of this study is to determine if adding manual therapy to care as usual reduces the discomfort from chronic migraine compared to care as usual alone


Eligibility Criteria:
Inclusion Criteria:

Female adults 18 years of age or older with a good command of English (to enable informed consent) Existing patients with chronic migraine as diagnosed by a clinical interview with a neurologist in line with the International Classification of Headache Diagnosis criteria (ICHD) Undergoing care as usual from the neurologist

Exclusion Criteria:

Currently having or had manual therapy for neck, shoulder in the last six weeks.

Having a condition contraindicated for manual therapy including but not limited to inflammatory disorders, severe osteoporosis and tumours.

Identification of any medical 'red flags' by the neurologist including

* Evidence of any central nervous system involvement for example:
* Facial palsy (presence of ptosis/Horner's syndrome)
* Visual disturbance (presence of blurred vision, diplopia, hemianopia)
* Speech disturbance (presence of dysarthria, dysphonia, dysphasia such as expressive or receptive)
* Balance disturbance (presence of dizziness, imbalance, unsteadiness, falls)
* Paraesthesia (presence, location such as upper limb/lower limb, face)
* Weakness (presence, location such as upper limb/lower limb)
* Known major psychiatric or psychological conditions not under control
Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer

Investigators will examine the impact of the Breast Cancer Index (BCI) result on patients' anxiety / fear of recurrence and satisfaction with decisions regarding endocrine therapy.

The investigators' objective is to assess patient decision-making, anxiety and patient satisfaction with recommendations made by an oncologist before and after the BCI test results are known. In addition, a chart review will be performed annually for five years to assess disease status and medications. Specifically, if extended endocrine therapy was recommended the chart review will record if participants are taking the medication and, if not, why the treatment was discontinued.

Eligibility Criteria:
Inclusion Criteria:

Each patient must meet all of the following criteria in order to be considered for enrollment:

* Histologically confirmed ER positive, stage I-III breast cancer who have been treated with curative intent and completed at least four years of adjuvant endocrine therapy.
* Life expectancy ≥ 5 years.
* Must be able to provide informed consent.
* Willing to consider continuation of endocrine therapy beyond 5 years.

Exclusion Criteria:

* A patient must not be enrolled if any contraindication exists for extended adjuvant endocrine therapy as identified by the treating oncologist.
The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation

The purpose of this study is to investigate the impact on ovarian reserve after single- port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change.

With the recent development of surgical instruments techniques, minimally invasive surgery is more feasible in various field of surgery. Laparoscopic surgery has potential benefit of decreased patient discomfort, short hospital stay, superior cosmetic results and decreased convalescence time. Recently, various efforts have been continued for minimally invasive surgery, one of the recently emerging concepts is single port surgery. Several studies have demonstrated that single-port laparoscopic surgery is feasible and safe in gynecology.

However, some limits could be occurred, such as the occurrence of less freedom degrees between the instruments and limits surgical vision, thus limiting surgeon's movements. So, two-port laparoscopy combined access through umbilical and additional suprapubic incision have been used and reported. In case of single port access laparoscopic ovarian cyst enucleation, due to limits of surgeon's movements, cyst enucleation or bipolar electrocoagulation of the ovarian parenchyma adversely affected ovarian function.

Some studies reported that after laparoscopic cyst enucleation, there had been shown marked reduction of ovarian function compared with surgery by laparotomy. Therefore we attempt to investigate the impact of single port laparoscopy that have limits of surgical procedures on ovarian reserve after ovarian cyst enucleation.

To evaluate ovarian reserve change, we will use the anti-mullerian hormone. It is produced by granulosa cells of preantral and small antral follicles and has been recently acknowledged as the useful, reliable, and sensitive hormonal serum marker of the ovarian primordial follicle pool. In addition, the AMH level represents a stronger independent marker of ovarian reserve without significant fluctuation during the menstrual cycle, which progressively decreases with age.

Therefore, this prospective study is performed to compare the differences in ovarian reserve after single-port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change. Serum anti mullerian hormone is measured at preoperative and at postoperative 1week, 1 and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age: 21-45 years Ultrasound
* CT, MRI diagnosis as ovarian cyst , need to cyst enucleation
* Size of cyst : between 3cm and 10cm
* Regular menstrual cycles defined as cycle length between 25 and 35 days
* Agreement to be enrolled in the study.

Exclusion Criteria:

* Previous ovarian surgery
* suspicious of malignancy
* Postmenopause
* Use of oral contraceptive drug, GnRH agonist /antagonist, or other drugs related with ovarian function in last 3 months
* Known endocrine disorder
Weight Loss Maintenance in Primary Care

After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.


Eligibility Criteria:
Inclusion Criteria:

* BMI of 30, or BMI of 27 with weight-related comorbidities
* Access to a telephone and voice mail/answering machine
* MUST be seeing a primary care physician working with us on this study (in the greater Philadelphia area)

Exclusion Criteria:

* Previously/currently diagnosed with an eating disorder
* Current bi-polar, depression, substance abuse, or dependence disorder
* Living with someone already enrolled
* Enrolled in another weight loss program
* Current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease)
* Myocardial infraction within the past three months
* Unstable angina
* Nephrotic syndrome/malabsorptive disease
* Gout attack within the past year
* Lactating/pregnant (or planning within next two years)
* Current/recent history of cancer, neurological disease, high creatinine levels, active hepatic disease
Erythropoietin Treatment in Patients With Systolic Left Ventricular Dysfunction, Mild Anemia and Normal Renal Function

Erythropoietin Treatment in Patients with systolic left ventricular dysfunction, mild anemia and normal renal function


Eligibility Criteria:
Inclusion Criteria:

* Ischemic heart disease
* Systolic lv dysfunction
* Mild anemia
* Normal renal function
* Stable condition

Exclusion Criteria:

* Pregnancy
* Unstable condition
* Under 18 years old
Snow Physical Properties and Human Ventilatory Response

Sufficient oxygenation is critical for completely buried avalanche victims to avoid life-threatening consequences during hypoxic exposure. Snow contains a remarkable capacity to maintain air availability; it was suspected that the snow physical properties affect the development of hypoxia and hypercapnia. The aim of this study was to evaluate the influence of different snow physical properties on the development of hypoxia and hypercapnia in subjects breathing into an artificial air pocket in snow. Twelve male healthy subjects breathed through an airtight face-mask and 40cm tube into an artificial air pocket of 4L. Every subject performed three tests on different days with varying snow characteristics. Symptoms, gas and cardiovascular parameters were monitored up to 30min. Tests were interrupted at SpO2 \<75% (primary endpoint); or due to subjective symptoms like dyspnea, dizziness, and headache (i.e. related to hypercapnia). Snow density was assessed via standard methods and micro-computed tomography (CT) analysis, and permeability and penetration with the snow micro-penetrometer (SMP).


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with an age above 18yr-old, physically active.
* Volunteers have been informed and have signed consent.

Exclusion Criteria:

* Lack of consent.
* Chronic previous illness of the respiratory tract or of the cardiovascular system.
* Acute disease at or immediately prior to the test (eg, flu-like infection, fever of unknown origin).
* Eurac employees.
Comparison Between Enlite and Flash Glucose Monitoring

1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose.
2. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Enlite sensor has been worn for 1 month.
3. The development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena.
4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within target,% under target, amount of hypoglycemia) in the month prior to sensor switching will be compared to the same data recorded by the Enlite sensor during the first month of use.


Eligibility Criteria:
Inclusion Criteria:

* Children (5 to 18 years)
* Diagnosis of type 1 diabetes mellitus
* Treatment is an insulin pump and wearing a FreeStyle Flash Libre glucosesensor

Exclusion Criteria:

-
Follow-up of Immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Volunteers After 6 Months

In the spring of 2009, a recently emerged novel influenza A (H1N1) virus was first identified in Mexico and USA and it has continued to spread globally. The rapid global spread of a novel influenza A (H1N1) 2009 virus prompted the World Health Organization (WHO), on 11 June 2009, to declare the first influenza pandemic in 41 years. In Taiwan, a clinical study to assess the immunogenicity and safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in healthy volunteers has already been completed. In the previous study, we found that a single 15 mcg HA dose of the AdimFlu-S (A/H1N1) vaccine induces a protective immune response in most adults, including those \> 60 years of age (\>70%). Our current study aims to follow-up subjects who received Influenza Virus Vaccine, AdimFlu-S (A/H1N1), six months ago. These subjects' serum samples were tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI). The seroconversion is defined as the post-vaccination serum HAI titer had at least 1:40 for subjects who had seronegative pre-vaccination or a four-fold or greater increase in HAI titers for subjects who had seropositive pre-vaccination serum. The immunogenicity of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in adults after half a year will be analyzed and discussed among the subjects with serum HAI titer had at least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection.


Eligibility Criteria:
Inclusion Criteria:

* subjects with serum HAI titer had at least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection
Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet

This study seeks to determine whether the Lactic Acid blood level in a critically ill patient must be drawn with a non-tourniquet venipuncture. The null hypothesis is that there is no significant difference in Lactic Acid blood level in critically ill patients in a sample taken from either with a tourniquet or a non-tourniquet veni-puncture.

Monitoring of Lactic acid level is helpful in both identifying potentially serious ill patients as well as identifying in the ICU patients with high morbidity and mortality.

When a patient arrives to an Emergency Department and that patient is hypotensive (BP less than or equal to 90 systolic), the nursing staff often starts an IV and if possible draws the patient's initial blood tests off that first IV site; or if the patient has had an IV started in the field by EMS, the nursing staff will draw blood from another site using a tourniquet. This initial work up by the nursing staff takes 15 -20 minutes before a physician may see the patient. Since the present standard Lactic Acid test must be drawn either by arterial puncture or venipuncture without a tourniquet, this test is rarely done as part of their (the RNs) initial blood draws.

This simple impediment of needing to repeat the venipuncture without a tourniquet, especially in patients who often have venous access difficulty, delays the identification of appropriate patients for early and aggressive management- particularly those with sepsis.

Our hypothesis is that this requirement for a non-tourniquet blood draw is unnecessary.


Eligibility Criteria:
Inclusion Criteria:

* Blood pressure systolic of 90 or less
* Non pregnant by history

Exclusion Criteria:

* Pregnant by history
* Comfort care only
Pronation During Veno-venous Extra Corporeal Membrane Oxygenation

The Acute Respiratory Distress Syndrome (ARDS) is defined by a recent (within 1 week) respiratory failure, not fully explained by cardiac failure or fluid overload. ARDS is also characterized by bilateral opacities at the chest imaging, with an alteration of the oxygenation while positive end-expiratory pressure equal or greater than 5 cmH2O is applied. Severe ARDS is characterized by a high mortality. In the most severe ARDS patients, venovenous extracorporeal membrane oxygenation (vv-ECMO) is increasingly accepted as a mean to support vital function, although not free from complications.

In patients with severe ARDS, prone position has been used for many years to improve oxygenation. In these patients, early application of prolonged (16 hours) prone-positioning sessions significantly decreased 28-day and 90-day mortality. More recently, prone position and ECMO have been coupled as concurrent treatment. Indeed, the addition of prone positioning therapy concurrently with ECMO can aid in optimizing alveolar recruitment, and reducing ventilator-induced lung injury. Nowadays, few data exist on respiratory mechanics modifications before and after the application of prone position in patients with severe ARDS receiving vv-ECMO. The investigators have therefore designed this observational study to assess the modifications of mechanical properties of the respiratory system, ventilation and aeration distribution, and hemodynamics occurring during ECMO before and after prone position in patients with severe ARDS.


Eligibility Criteria:
Inclusion Criteria:

* all adult patients with a diagnosis of severe Acute Respiratory Distress Syndrome receiving veno-venous ECMO

Exclusion Criteria:

* mechanical ventilation for 7 days or longer
* pregnancy
* body mass index (BMI) \> 45 kg/m2
* chronic respiratory failure with long-term oxygen therapy or domiciliary non-invasive ventilation
* cardiac failure resulting in veno-arterial ECMO
* history of heparin- induced thrombocytopenia
* cancer with a life expectancy of less than 5 years
* moribund condition or a Simplified Acute Physiology Score (SAPS-II) value of more than 90;
* current non drug- induced coma after cardiac arrest or presence of an irreversible neurologic injury
* decision to withhold or withdraw life--sustaining therapies
* presence of pneumothorax and/or pulmonary emphysema
* recent (1 week) thoracic surgery
* presence of chest burns
* inclusion in other research protocols
* refusal of consent.
Perception, Cognition, and Gait in Parkinson's Disease

The investigators are examining how aspects of daily function are perceived in persons with PD and in those who interact with them on a regular basis. If eligible, participants will receive a set of online questionnaires by email. The questionnaires will take about 1 hour to complete, and can be done at the participant's convenience. The investigators are looking for volunteers who have a diagnosis of Parkinson's disease without dementia (age 40 or older and proficient English speakers). If a spouse, family member, significant other or other close associate is available (age 18 or older, proficient English speakers), the investigators will send them questionnaires as well. There is no monetary or other compensation for this study. For more information, please contact the Vision and Cognition Laboratory at vcognition@gmail.com or 617-358-1377.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease without dementia OR close associate of someone with Parkinson's disease
* 40 years or older
* Proficient English speaker
* Access to a computer
* 8+ years of education

Exclusion Criteria:

* Co-existing active neoplasm, serious cardiac disease, other serious chronic medical illness
* Prior intracranial surgery
* History of traumatic brain injury
* Psychiatric or neurological diagnoses other than Parkinson's disease
* History of alcoholism or other drug abuse
* History of treatment with electroshock therapy
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
* Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs.
* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm.

Exclusion Criteria:

* Disease duration of \> 10 years from the onset of symptoms and an EDSS score at screening \< 2.0.
* Female participants who are pregnant or breastfeeding, or intending to become pregnant.
* Male participants who intend to father a child during the study.
* A diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (SPMS).
* Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML).
* History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
* Presence of other neurological disorders that could interfere with the diagnosis of MS or with the assessments of safety or efficacy during the study.
* Clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease.
* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
* History of alcohol or other drug abuse within 12 months prior to screening.
* History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of HIV infection.
* Inability to complete an MRI scan.
* Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening.
* Receipt of a live-attenuated vaccine within 6 weeks prior to randomization.
* Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.