cyrilzakka/clinical-trials huggingface dataset:
Wearable Monitoring Systems for Swallowing Function and Disorders

Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders. The proposed research will develop and validate a set of mechanically compliant, easy-to-use, and inexpensive wearable tele-monitoring systems, for future use in the rehabilitation of swallowing disorders (dysphagia). The hypothesis is that the newly developed wearable sensors will have equal or better performance than traditional wired sensors used today in clinical practice. Factors related to signal quality and patient reported outcomes (e.g., satisfaction/comfort level, adverse effects etc.) will be examined.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for healthy adults:

* Age 18-30 OR 50-90 years of age
* No history of dysphagia
* No history of a neurological disorder
* A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA):
* A score of \<3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).

Inclusion criteria for patients with dysphagia:

* Age 18-90 years of age
* Diagnoses of dysphagia as a result of a neurological disorder (e.g., stroke, Parkinson's disease).
* A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA).
* A score of ≥3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).

Exclusion Criteria:

• Significant cognitive impairment (a score in the moderate-severe range on MoCA):
Revision Meniscal Transplants; Lateral and Medial

During the period 1989-1999, a number of patients underwent a meniscal transplantation. A few transplants were not successful. These patients form the population of this study. They all underwent a Total Knee Prosthesis (TKP) or unicompartmental knee prosthesis (UKP) after the failure of the transplants The goal of this study is to evaluate their current medical condition, to perform a survival analysis, and to determine the clinical outcome.

The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and SF-36)and clinical examination.


Eligibility Criteria:
Inclusion Criteria:

* failed Meniscal transplantation between 1989 and 1999
Arterial Spin Labeling Blood Flow MRI for Evaluation of Response to Antiangiogenic and Targeted Therapies of Renal Cell Carcinoma (RCC)

The purpose of this study is to assess magnetic resonance imaging (MRI) as a tool to track tumor growth for renal cell carcinoma while the participant is receiving clinical treatment therapy with sunitinib or pazopanib. An MRI is a sophisticated type of scan that uses powerful magnets to make clearer images or to focus on detailed medical information in the participants abdomen and pelvis. This imaging done for this study will use the ASL MRI technique that allows us to see blood flow changes which possibly may indicated tumor growth.

* MRI's will be performed at specific time points during the participants treatment for renal cell carcinoma with the drug sunitinib or pazopanib. These ASL MRI's will be performed at baseline, 2 weeks upon initiation of therapy with sunitinib/pazopanib, after cycle 2 and/or cycle 4 of therapy, and at the end of therapy.
* The MRI tests for all participants will be done at Beth Israel Deaconess Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with metastatic renal cell carcinoma and who will initiate sunitinib or pazopanib
* Enrolled on protocol 06-105, "Collection of specimens and clinical data from patients with renal cell carcinoma treated with targeted therapies," or receiving Pazopanib as part of routine clinical care.
* Found to have tumors that are 2.5cm or greater as determined by CT imaging
* Candidate lesions for ASL MRI should be 2.5cm or greater. Order of preference of lesion location will be as follows: abdominal lesions, bone lesions and chest lesions

Exclusion Criteria:

* Contraindication to MRI
Study to Evaluate the Duration of Treatment With Ertapenem in Acute Attacks of Sigmoid Diverticulitis

The purpose of this study is to compare the efficacy (by assessing the clinical success of treatment) of intravenous antibiotic therapy with ertapenem in patients with acute attacks of sigmoid diverticulitis for 4 vs. 7 days.


Eligibility Criteria:
Inclusion Criteria:

* At least three of the following signs or symptoms of an acute attack of sigmoid diverticulitis must be present: \*Fever (body temperature \> 38°C, sublingual), \*Abdominal tenderness, \*Leukocytosis (leukocytes \> 10,000/µl) and left shift of the differential blood count (\>1% band forms), \*Elevated CRP (\> 20 mg/l)
* Evidence of sigmoid diverticulitis by contrast enema
* CT evidence of wall thickening in the sigmoid intestine
* Decision in favor of conservative therapy on the basis of the case history and diagnosis

Exclusion Criteria:

* Contraindication for the use of the study medication or other beta-lactam antibiotics, e.g. patients with advanced renal impairment or patients requiring hemodialysis
* Antibiotic therapy in the two weeks prior to the start of the study
* Patients with an advanced incurable disease
* Patients with a hematologic/oncologic disease (leukemia, lymphoma)
* Patients on immunosuppressants
* Complications of sigmoid diverticulitis leading to an immediate indication for surgery
* Patients who have hypersensitivity to beta-lactam antibiotics
* Female patients who are pregnant or nursing or who could become pregnant during the study
* Participation in another clinical study or use of another study drug within the four weeks prior to enrollment in the study or use of another drug during the study
* Each patient can be enrolled only once in the study
Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy

The primary objective of the preSponge randomized controlled trial (RCT) will be to assess the potential protective effects of preemptive endoscopic negative pressure therapy (ENP) on postoperative morbidity in high-risk patients undergoing total minimally invasive transthoracic esophagectomy with gastric pull-up reconstruction and high intrathoracic anastomosis (thoracoscopic and laparoscopic Ivor Lewis esophagectomy).


Eligibility Criteria:
Inclusion Criteria:

We will include adult patients (≥18 years of age) with resectable esophageal cancer (adenocarcinoma or squamous cell carcinoma) with high risk for anastomotic leakage (AL) who provided informed consent and are scheduled for minimally invasive transthoracic Ivor Lewis esophagectomy. Robotic-assisted procedures will also be included.

Patients considered at high risk for AL must have at least one of the following risk factors:

* American Society of Anesthesiologists Classification (ASA) score \>2
* Diabetes (insulin dependent or HbA1c ≥ 6.5%)
* Chronic pulmonary disease (first second of forced expiration (FEV1)/Forced volume vital capacity (FVC) ratio ≤ 70%)
* Heart failure (left ventricular ejection fraction (LVEF) \<55%)
* Preexisting cardiac arrhythmia (pacemaker or paroxysmal supraventricular tachyarrhythmia)
* Chronic kidney disease stage 4-5 (glomerular filtration rate (GFR) \< 30ml/min/1.73 m2)
* Chronic liver disease with treated portal hypertension (porto-caval pressure gradient ≥5-≤10mmHg, including patients with transjugular intrahepatic portosystemic shunt (TIPS))
* Previous radiotherapy or chemo-radiation ≥50Gray (Gy) (salvage esophagectomy)

Alternatively, patients must have at least two of the following risk factors:

* Arteriosclerosis score 2 according to van Rossum et al.13 (aorta and coeliac axis)
* Malnutrition (Body mass index (BMI) ≤ 18.5kg/m2)
* Obesity (BMI ≥ 35kg/m2)
* Heart failure with preserved ejection fraction (LVEF \>55%)
* Active or former smoking
* Age \> 65 years
* World health Organisation (WHO)/Zubrodt score \> 1
* chronic kidney disease stage 2-3 (GFR 30-89 ml/min/1.73 m2)
* chronic liver disease without portal hypertension (porto-caval pressure gradient ≤5mmHg)

Exclusion Criteria:

* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia.
* Patients younger than 18 years
* Patients undergoing esophagectomy for benign disease or for malignancy other than adenocarcinoma or squamous cell carcinoma
* Patients scheduled for other technical variants of esophagectomy, such as open, hybrid, or transhiatal procedures (intraoperative conversions to open access surgery will not be excluded)
* Chronic liver disease with portal hypertension (porto-caval pressure gradient \>10mmHg)
* Distant organ metastasis (cM+)
A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery

To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman 18 years of age or older.
* Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
* Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
* Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
* Willing to adhere to the prohibitions and restrictions specified in this protocol.
* Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* Known allergy or contraindication to the test article(s) or their components.
* Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
* Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
* History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
* Use of disallowed therapies (systemic or topical):

  * Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
* Use of contact lenses for one week prior to the study and for the duration of the study.
* Received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
Barriers to Adherence to Asthma Controller Meds in Low Income Urban Minority Adolescents

Poor adherence to appropriate asthma medications is an important risk factor contributing to high asthma morbidity and mortality in urban African American adolescents. As part of the ADEPT (Adolescent Disease Empowerment and Persistency Technology) for Asthma Pilot 2 study, a focus group was developed specifically to explore existing barriers to adherence among inner city African American adolescent asthmatics.


Eligibility Criteria:
Inclusion Criteria:

* 12-18 years of age
* self identify as African American
* have persistent asthma
* read at a minimum fourth grade reading level
* be on a prescribed daily inhaled corticosteroid medication for asthma

Exclusion Criteria:

* candidate refusal or presence of other co-morbidities
Neural Mobilization on Multiple Sclerosis

Current treatments for pain in MS patients include the use of non-pharmacological interventions such as electrotherapy and exercise, as well as pharmacological treatments. Neurodynamic mobilization exercises are an intervention that aims to restore homeostasis in and around the nervous system by activating the nervous system itself or the structures surrounding the nervous system. Neurodynamic mobilization facilitates movement between neural structures and their environment through manual techniques and exercise. Human and animal studies reveal that neurodynamic mobilization reduces intraneural edema, improves intraneural fluid distribution, reduces thermal and mechanical hyperalgesia, and reverses increased immune responses following a nerve injury.

Multiple Sclerosis (MS) is a chronic neurological disease characterized by local inflammation, gliosis and demyelination in the central nervous system (CNS). It is characterized by demyelinating plaques seen in the brain and medulla spinalis. Many different symptoms can be seen depending on the affected areas in the CNS. One of the common symptoms in these patients is pain. Approximately 50% of patients complain of pain at some point in their lives, and in 20% of them, pain is one of the initial symptoms. Pain may originate from the musculoskeletal system; It may also develop due to inflammation and upper motor neuron damage and may have a neuropathic character. As a result, pain in MS negatively affects patients' physical, emotional functions and quality of life.

Current treatments for pain in MS patients include the use of non-pharmacological interventions such as electrotherapy and exercise, as well as pharmacological treatments. Neurodynamic mobilization exercises are an intervention that aims to restore homeostasis in and around the nervous system by activating the nervous system itself or the structures surrounding the nervous system. Neurodynamic mobilization facilitates movement between neural structures and their environment through manual techniques and exercise. Human and animal studies reveal that neurodynamic mobilization reduces intraneural edema, improves intraneural fluid distribution, reduces thermal and mechanical hyperalgesia, and reverses increased immune responses following a nerve injury.

As a result of this study, it is thought that the determination of effective treatment methods for pain, which is a common symptom of MS patients, will increase the patient's muscle strength and dexterity.

The aim of the study is to examine the effects of neurodynamic mobilization exercises on pain, muscle strength and dexterity in Multiple Sclerosis patients.

Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with MS according to McDonald 2010 diagnostic criteria
2. Being between the ages of 18-65
3. Volunteering to participate in the study

Exclusion Criteria:

1. Being under 18 years of age and over 65 years of age
2. Having a history of trauma within the last year
3. Having alcohol and substance addiction
4. Having diabetes mellitus
5. Having another known neurological disease
6. Being pregnant
Investigating the Protective Impact of LY-2940094 on Stress-induced Depression- and Anxiety-related Phenotypes in Humans

This project will integrate pharmacological and psychophysiological methodology to mechanistically investigate, in humans, the role of N/OFQ in laboratory phenotypes of both disorders. Specifically, a N/OFQ receptor (NOPR) antagonist will be used to test the hypothesis that NOPR blockage will have antidepressant-like effects (potentiate reward processing); in addition, this study will also evaluate a key anxiety phenotype (fear learning). Finally, the impact of recent life stress on these processes will be assessed. Results will demonstrate the specificity of NOPR blockage on depressive phenotypes or suggest a common pathway for emotional disorders and will confirm a modulatory role of life stress.


Eligibility Criteria:
Inclusion Criteria:

* Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (diagnosed using the SCID-5)
* Written informed consent
* Absence of any medications for at least 3 weeks

Exclusion Criteria:

* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician
* Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception
* Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
* History of seizure disorder
* History or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, obsessive-compulsive disorder, patients with mood congruent or mood incongruent psychotic features, substance dependence, substance abuse within the last 12 months (with the exception of cocaine or stimulant abuse; which will lead to exclusion)
* History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine)
* History of use of dopaminergic drugs (including methylphenidate)
* History or current diagnosis of dementia
* Patients with mood congruent or mood incongruent psychotic features
* Current use of other psychotropic drugs
* Clinical or laboratory evidence of hypothyroidism
* Patients with a lifetime history of electroconvulsive therapy
* Abnormal ECG and lab results
* History of seizure disorder or currently on anticonvulsants
Xience or Vision Stent Management of Angina in the Elderly

The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.


Eligibility Criteria:
Inclusion Criteria:

* AGE\>80
* Stable angina or acute coronary syndrome
* Coronary narrowing suitable for stenting that is either ≥15mm long and/or ≤3mm diameter.
* Any lesion with high risk of restenosis eg chronic total occlusion, bifurcation, severe calcification
* Any left main stem lesion

Exclusion Criteria:

* Acute ST segment elevation myocardial infarction
* Cardiogenic shock
* Platelet count =50 x 109/mm3
* Patient life expectancy \< 1 year
* Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
* Recent major GI haemorrhage (within 3 months)
* Any previous cerebral bleeding episode
* Participation in another investigational drug or device study
* Patient unable to give consent
* Clinical decision precluding the use of drug eluting stent
Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer

Anetumab ravtansine is developed for the treatment of patients with recurrent platinum-resistant ovarian cancer. The purpose of the proposed trial is to identify the maximum tolerated dose of anetumab ravtansine that could be safely combined with pegylated liposomal doxorubicin in this indication.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with locally invasive or metastatic, epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Subjects must provide samples of tumor tissue
* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Subjects with low-grade ovarian, fallopian tube, or Primary peritoneal cancer
* Women who are pregnant or breast feeding
* Subjects who have an active hepatitis B virus or hepatitis C virus infection requiring treatment as defined in the protocol
Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL

Primary Objective:

To estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to other treatments

Secondary Objective(s):

To describe key efficacy outcomes, including incidence of complete response (CR) within 2 cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and 100-day mortality after alloHSCT.

Hypotheses:

A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and treatment-related adverse events will be estimated.

Study Endpoints:

* Incidence of treatment-emergent and treatment-related adverse events
* Incidence of CR within 2 cycles of blinatumomab
* MRD remission within 2 cycles of blinatumomab
* RFS
* OS
* Incidence of alloHSCT
* 100-day mortality after alloHSCT

Study Design:

Multi-center, open-label, single-arm expanded access protocol


Eligibility Criteria:
Inclusion Criteria 101 Immunophenotypic evidence of CD19 positive B-precursor ALL (pro B-, pre B-, common ALL) 102 Age \> 28 days and \< 18 years at the time of informed consent/assent 103 Morphological or molecular evidence of relapsed/refractory disease, defined as one of the following:

* Second or later bone marrow relapse (defined as M3 marrow or M2 marrow or M1 marrow but with MRD level ≥ 10E-3), or
* Any marrow relapse after alloHSCT (defined as M3 marrow or M2 marrow or M1 marrow but with and MRD level ≥ 10E-3), or
* Refractory to other treatments:

  * For patients in first relapse: failure to achieve a CR following a full standard reinduction chemotherapy regimen
  * For patients who have not achieved a first remission: failure to achieve remission following a full standard induction regimen
* Subjects previously treated with blinatumomab may be eligible, if subject ended treatment for reason(s) other than disease progression or intolerability to blinatumomab (Note: This does not include patients who have already received blinatumomab treatment on this study, but refers only to patients outside of the 20130320 study)

Other Inclusion Criteria may apply

Exclusion Criteria 201 Any active acute Graft-versus-Host Disease (GvHD) grade 2 to grade 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment 202 Immunosuppresive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment (except for topical corticosteroids) 203 Active (overt) ALL in the CNS (confirmed by cerebrospinal fluid \[CSF\] analysis) or in testes

Other Exclusion Criteria may apply
A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation

This study will evaluate the efficacy of the Rael Miracle Clear Complete Acne Serum product in improving facial acne and post-acne pigmentation. This study will last for 56 days. The study will be conducted as a single-arm trial where all participants will use the test products. Participants will be required to complete questionnaires at Baseline, Day 1, Day 3, Day 7, Day 14, Day 28, and Day 56. Photos will be taken at Baseline, Day 28, and Day 56. The photos from Baseline and Day 56 will undergo expert skin grading


Eligibility Criteria:
Inclusion Criteria:

* Female. Age 18+. Currently experiencing mild to moderate acne issues. Generally healthy -and not living with any uncontrolled chronic disease.

Exclusion Criteria:

* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.

Anyone currently using an oral and/or topical prescription acne treatment. Anyone unwilling to stop using their current acne supplements. Anyone with known severe allergic reactions. Anyone unwilling to avoid excessive sun exposure. Anyone who is breastfeeding, pregnant, or attempting to become pregnant. Anyone unwilling to follow the study protocol. Anyone who identifies as having sensitive skin.