cyrilzakka/clinical-trials huggingface dataset:
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study

This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment
* Scheduled to receive first RoActemra/Actemra infusion in this study between 4 and 6 weeks after the last IV infusion in the core study
* Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

* Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977
* Treatment with any investigational agent since the last administration of study drug in the core study WA19977 or current participation in another clinical trial except WA19977
* Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA
* Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
* Any significant concomitant disease or medical or surgical condition
* History of significant allergic or infusion reactions to prior biologic therapy
* Known current active acute, subacute, chronic or history of recurrent infection; patients suffering from ongoing active infections with Epstein Barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided
* Positive for latent tuberculosis (TB)
* Currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for \>/= 2 weeks within 6 months prior to entering the study
* Inadequate hepatic, renal or bone marrow function
The Impact of Doulas in Early Pregnancy Management

The purpose of the study is to examine the impact of doula support for women undergoing a manual vacuum aspiration (MVA) for an early pregnancy failure or undesired pregnancy.

As a means of providing emotional support and physical comfort for all pregnant women, doulas have emerged in recent years in the world of clinical abortion care. Traditionally, doulas are non-medical individuals trained to provide emotional support, pain management strategies, relaxation techniques, and information to pregnant women during labor. The positive impact of doulas on obstetrical health outcomes and patient satisfaction is well accepted.

Women with the support of a doula have been shown to have shorter labor, and rate birth as less difficult and more satisfying, than do mothers without doula support. They also report a greater ability to cope with labor and require less epidural and IV pain medication. In recent years, the term full spectrum doula has emerged to describe doulas who extend their supportive services to women at any stage of a pregnancy, including the management of a miscarriage or undesired pregnancy ending in abortion. The Doula Project, created in 2007 in New York City, and the Bay Area Doula Project, founded in 2011in San Francisco, were two of the first organized efforts to train doulas to provide abortion care and are now the largest in the United States. Scientific research on the impact of doulas during abortion and miscarriage management has been limited, but anecdotal reports from patients and providers suggest a positive impact on patient satisfaction. In this study we aim to test the impact of doulas on the physical, emotional, and overall experience among women undergoing a MVA for an early pregnancy failure or undesired pregnancy at the Penn Family Planning and Pregnancy Loss Center. We also aim to assess the impact of doula support from the medical assistants perception.

Eligibility Criteria:
Inclusion Criteria:

* Female 18 years or older who is choosing to have a surgical procedure for the management of early pregnancy failure or undesired pregnancy.
* Pregnancy is not because of an incident of sexual assault or rape.

Exclusion Criteria:

* Pregnancy is due to an incident of sexual assault or rape.
Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

The aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd chemotherapy and to assess the treatment of toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic or non-resectable soft tissue sarcoma
* Evidence of progression or relapse after an anthracycline-based and/ or ifosfamide-based chemotherapy
* At least 1 bidimensionally measurable tumor lesion according to RECIST criteria
* No previous radiation therapy on the only measurable lesion
* Willingness to receive regular follow-up
* Life expectancy more than 3 months
* ECOG status \>= 2
* Patients aged 18 years and beyond
* leucocytes \> 2500/µl, thrombocytes \> 75000/µl)
* Serum creatine \< 1,5 times the upper limit of normal value, GFR \> 60/ml
* Written patient informed consent
* Ability to give informed consent

Exclusion Criteria:

* Previous or concurrent radiation of the index lesion (radiation of single lesion is allowed if not the index lesion)
* Insufficient liver function (bilirubin \> 1.5 the upper limit of normal, prolongation of PT and aPTT \> 1.5 the upper limit of normal; ASAT and ALAT \> 3 the upper limit of normal (patients with liver metastases ASAT and ALAT \> 5 the upper limit of normal)
* Active infection
* Prior therapy with Bendamustin hydrochloride
* Prior malignancies (other than adequately treated carcinoma in situ (CIS) of the cervix, bladder urothelium, basal cell carcinoma or adenoma of the colon including pTIS,pTIN), unless treated with curative intent and without evidence of disease \> 5 years
* Symptomatic cardio- and/or cerebrovascular disease (NYHA-Scale III°)
* Interval since last chemotherapy \< 4 weeks
* Evidence of CNS-metastases
* Evidence of pregnancy or lactation
* Woman of child-bearing potential without reliable methods of birth control
A Safety Extension Study of DR-OXY-301

This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.


Eligibility Criteria:
Inclusion Criteria:

* Completed the 12 weeks of treatment in the DR-OXY-301 study
* Willing to limit medications for overactive bladder to investigational product only
* Able to understand and complete all study procedures including the required diary
Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

TolaSure is a topical gel for the promotion of accelerated wound healing. This phase II study will primarily assess the efficacy of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. Safety, cutaneous tolerability, wound pain control, and quality of healing will also be assessed. A total of 80 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will be monitored for safety and efficacy until wound closure (estimation about 8 weeks) following topical administration of TolaSure.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Males and Females \> 18 years of age
* Health history review
* Physical exam
* Blood and urine clinical chemistries
* Negative pregnancy test

Exclusion Criteria:

* Acute or chronic skin disorders (e.g. psoriasis);
* Acne or dermatitis at the test site;
* Prone to keloids or hypertrophic scarring;
* Topical or systemic antibiotics within 4 weeks of study enrollment;
* Subjects with known severe mental illness which, in the investigator's opinion, may prevent informed consent or interfere with the subject's ability to comply with study protocol procedures;
* Diagnosed with Diabetes Type I/II or glucose results indicative of prediabetic condition;
* Morbidly obese with a Body Mass Index (BMI) ≥ 40;
* Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
* History of severe vitamin or mineral deficiency;
* History of drug or alcohol abuse (as defined by the Investigator);
* Smoking/Vaping;
* HIV/AIDS;
* Consistently taking steroids and/or non-steroidal anti-inflammatory drugs. Subjects may use NSAIDs on an as needed basis with no more than 7 days of consecutive use;
* Cancer diagnosis in the last 5 years;
* Currently receiving chemotherapy or radiation;
* Women who are pregnant, nursing, or planning a pregnancy;
* Hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields;
* Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study;
* Treatment with any investigational agent within one month before treatment application for this trial;
* Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule;
* Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
Experience of Parents/Carers of Children With Severe Motor Disabilities Suffering From Spinal Pain?

Parents of disabled children suffer from back pain more frequently than the general population. At present, the literature does not identify any specific factors responsible for this suffering.

For patients suffering from chronic back pain, there are specific treatment programmes in the Physical Medicine and Rehabilitation Department, with a focus on pain management.

The investigators would like to develop specific programmes for parents/carers of children/adolescents with severe motor disabilities.

To achieve this, it is important to gain a better understanding of the factors that contribute to the onset of pain.

With this in mind, the investigators are conducting a qualitative study to gain a better understanding of the day-to-day lives of these parents.


Eligibility Criteria:
Inclusion Criteria:

* Parents or carers of children with severe motor disabilities complaining of spinal pain

Exclusion Criteria:

* Parent/carer refusing to participate
Effect of Rehabilitation of Patients With a Central Nervous System Lesion

The purpose of the study is to analyse the prehensions deficits and the effect of prehension rehabilitation in central nervous system lesioned people


Eligibility Criteria:
Inclusion Criteria:

* Adult minimum 6mounth after first stroke
* Minimal prehension of both hands

Exclusion Criteria:

* Diabetuss
* Other Upper Limb pathologies
* MMSE \< 26
Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in Pakistan

The purpose of this study was to provide stronger evidence for extended-dose chloroquine treatment of falciparum-positive Afghan refugees in Northwest Frontier Province (NWFP), Pakistan or justification for discontinuation of the policy.

To determine whether extended-dose chloroquine provided better cure rates and fewer recrudescences than standard chloroquine treatment among Afghan refugees, 163 falciparum patients from three Afghan refugee camps were recruited into 3-day (CQ 25mg/kg) or 5-day (CQ 40mg/kg) treatment arms and followed for up to 60 days.

Eligibility Criteria:
Inclusion Criteria:

* slide-confirmed infection with P. falciparum only
* initial parasite density of 1000-100,000 asexual parasites/μl
* absence of severe malnutrition
* ability to attend stipulated follow-up visits and easy access to facility
* informed consent provided by patient or parent/guardian
* absence of history of hypersensitivity reactions to CQ

Exclusion Criteria:

* infants under six months old
* pregnancy or lactation
* underlying chronic severe illness
* patients with other febrile illnesses
* parasitaemia outside the range of 1000-100,000 asexual parasites/µl
* severe malaria
Neuromodulation With rTMS in Dysphagic Patients With Stroke

The patients with chronic dysphagia secondary to first-ever stroke were randomly assigned to 2 groups: Group A: sham stimulation for 10 minutes , Group B: real rTMS for 10 minutes. rTMS conditioning: daily rTMS 10 min for 10 days. Assessments: 1. videofluoroscopy，2.Functional outcome swallowing scale (3 scales). 3. MEP measurements

While the reﬂex component of swallowing depends on swallowing centres in the brainstem, initiation of swallowing is a voluntary action that involves the integrity of motor areas of the cerebral cortex. Oropharyngeal dysphagia occurs in more than 50% of stroke patients. Aspiration pneumonia occurs in up to 20% of acute stroke patients and is a major cause of mortality after discharge. Oropharyngeal dysphagia is both underestimated and underdiagnosed as a cause of major nutritional and respiratory complications in stroke patients. Recently, transcranial magnetic stimulation (TMS) has been used to study the cortical input to swallowing control and has revealed that the topographic representation of esophageal motor function in the human cerebral cortex is bilateral but with consistent interhemispheric asymmetry unrelated to handedness.

In a number of recent studies, poststroke motor and dysphagia performance has been improved after daily treatment sessions with repetitive TMS (rTMS) using an excitatory frequency in patients with hemispheric ischaemic stroke due to occlusion of territories of the middle cerebral artery. Our hypothesis was that rTMS would facilitate dysphagia recovery.

Eligibility Criteria:
Inclusion Criteria:

1. a diagnosis of stroke related dysphagia
2. no concurrent neurodegenerative or dementia history
3. an absence of TMS contraindications.

Exclusion Criteria:

* arrythmia, epilepsy, infection, hyperglycemia, pacemaker or implants, external ventricular drain or ventriculoperitoneal shunt
Assessing the Impact of Mount Sinai Parenting Center's Newborn Class

This study is the first to evaluate the effectiveness of a Newborn Parenting Class designed by Mount Sinai Parenting Center. The study measures how effective the class is in improving maternal knowledge on newborn care, decreasing maternal self-perceived anxiety and increasing maternal confidence.

The important role positive parenting plays in promoting a child's developmental trajectory has led to the design and implementation of many postpartum education initiatives. With 99% of babies in the U.S. born in hospitals, there is a uniqueness of being in the hospital for an extended period of time with the opportunity to educate parents on the importance of promoting early development. Pediatricians are uniquely well-positioned to address both medical and developmental concerns parents may have during critical periods in a child's development, yet very few interventions are led by pediatricians. The Mount Sinai Parenting Center designed the Newborn Parent Education and Discharge Class (hereafter referred to as Newborn Class) to address this issue. The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai. The class aims to educate parents about medical issues, responsive parenting, and sleep. It is currently taught every Tuesdays and Thursdays. Because of the limited availability of the class, not all mothers have the opportunity to attend. This research study will survey first time mothers of newborns to explore the effectiveness of attending the class. The study team hypothesizes that attending the class would result in increased knowledge on newborn care, increased confidence levels and decreased levels of anxiety.

First time mothers who delivered a full-term singleton vaginally with no major complications were included in the study. Only mothers who attended the class (intervention) or expressed desire to attend class but were discharged before a class was offered (control) were included in analysis. Mothers were recruited between May 2018 and August 2019 at the Klingenstein Pavilion of Mount Sinai. Maternal self-perceived anxiety and confidence were measured using standardized scales, and knowledge on newborn care was assessed using an internally-developed scale.

Eligibility Criteria:
Inclusion Criteria:

* First-time mother
* Above 18 years old
* Vaginal delivery of a healthy full-term singleton
* No major perinatal complications (per self-report)
* Consent to participate.

Exclusion Criteria:

-none
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation

The goal of this clinical trial is to investigate the changes in body composition in head and neck cancer patients during treatment. The main questions it aims to answer are: What is the rate of lean body mass loss and how is it associated with changes in muscle strength and functional performance? Is the lean body mass loss impacted by adding chemotherapy to the radiation treatment? Participants will be asked to undergo five body composition scans during treatment and undergo tests for muscle strength and functional performance before and after treatment.

The primary aim of the present study is to investigate the rate of decline in body composition (LBM, body weight and fat mass) as well as changes in maximal muscle strength and functional performance during radiation treatment in HNSCC patients and to investigate the association between the loss of LBM and impairments in maximal muscle strength and functional performance. Secondly, the study investigates whether adding cisplatin during chemoradiation induces exacerbated LBM loss compared to radiation alone.

50 patients are expected to be included in the study. Inclusion criteria are: (1) histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity, (2) prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy. Exclusion criteria were palliative radiation or participation in competing research protocols.

Five times during treatment (biweekly), patients will be asked to undergo a Dual Energy X-ray Absorptiometry scan to evaluate changes in lean body mass and fat mass. Before and after treatment patients are asked to perform three test for maximal muscle strength (one repetition maximum knee extension, chest press and leg press) as well as three functional performance test (30 s arm curl, 30 s chair rise and stair climb).

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity
* Prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy

Exclusion Criteria:

* Palliative radiation or participation in competing research protocols
Weight Loss and Appetite Reduction After Percutaneous Electrical Stimulation Dermatome T6

The patients are randomized into 4 groups : Patients undergoing PENS of dermatome T6 in and a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and a 2000 Kcal/day, Patients undergoing transcutaneous electrical neurostimulation (TENS) of Dermatomes T11-T12 and following a 1200 Kcal diet and those patients following only a 1200 Kcal diet (Group 4). Weight loss, appetite and ghrelin levels at baseline and after treatment are investigated.

The patients were randomized into 4 groups using an Internet randomization module: Patients undergoing PENS of dermatome T6 in conjunction with the implementation of a 1200 Kcal diet (Group 1), Patients undergoing PENS T6 and following a normocaloric diet (2000 Kcal/day) (Group 2), Patients undergoing transcutaneous electrical neurostimulation (TENS) of dermatomes in right iliac fossa (Dermatomes T11-T12) and following a hypocaloric diet (1200 Kcal/day) (Group 3) and those patients following only a 1200 Kcal diet (Group 4).

Weight loss, appetite and ghrelin levels, at baseline and after treatment, are investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with obesity (BMI\>30 Kg/m2) or overweight (BMI 25-30 Kg/m2)

Exclusion Criteria:

* Untreated endocrine disease causing obesity
* Serious psychiatric illness.
PGx Study to Develop and Validate the Predictive Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy

To develop and validate the predictive warfarin dosing algorithm.

This study aims to develop and validate the predictive warfarin dosing algorithm for personalized warfarin pharmacotherapy in Korean patients.

Eligibility Criteria:
Inclusion Criteria:

* the patients taking warfarin

Exclusion Criteria:

* noncompliance
Janus II Feasibility

The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.


Eligibility Criteria:
Inclusion Criteria:

* Severe sleep disordered breathing
* Expected to tolerate study procedures
* No heart failure or medically stable heart failure

Exclusion Criteria:

* Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval
* History of severe COPD or pulmonary arterial hypertension
* Current or previous history of nerve injury or palsy
* Prior cervical surgeries or radiation treatment to head region
* Known need for an MRI
* History of psychosis or severe bipolar disorder
* Active Infection or sepsis within 30 days of enrollment
* Currently on kidney dialysis or significantly reduced kidney function
* Hemoglobin less than 8g/dl
* Pacemaker dependance
* New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months
* Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures
* Allergy to contrast dye unless can be prophylactically treated
* Known pregnancy or planning to become pregnant
Teriflunomide's Therapeutic Mechanisms of Action in Patients With Relapsing Remitting Multiple Sclerosis.

The purpose of this research is to characterize the effect of teriflunomide on the activation of B-cells, as well as its capacity to modify B-cell cytokine secretion. The in-vitro identified effects of teriflunomide on the expression of B-cell activation markers, costimulatory and antigen presenting molecules, as well as on cytokine secretion, will then be confirmed in a cohort of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with this medication.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of RRMS according to McDonald's diagnostic criteria,
* age 18-55,
* an extended disability status score (EDSS) of 1.5-5.5.

Exclusion Criteria:

- Previous treatment with DMT.