cyrilzakka/clinical-trials huggingface dataset:
BEL114333, a Continuation Study of BEL113750 in Subjects With Systemic Lupus Erythematosus (SLE) in Northeast Asia, and in Japan Subjects Completing the Open-label Extension of HGS1006-C1115

This study provides subjects who complete the BEL113750 study and subjects who complete the open-label extension of HGS1006-C1115 (referred to as C1115) Study in Japan the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their standard of care SLE therapy.

This is a multicentre, continuation study of belimumab plus standard of care (SOC) in SLE subjects who completed the Phase III BEL113750 protocol in Northeast Asia or who completed the open-label extension of the HGS1006-C1115 protocol in Japan. This study provides subjects who complete the BEL113750 study the option of continuing treatment with belimumab (10 mg/kg intravenously every 4 weeks) for those randomized to belimumab, or the option to begin treatment with belimumab for those randomized to placebo, as an add-on to their SOC SLE therapy. Subjects participating in this continuation protocol will continue to be monitored for safety and efficacy, as measured by the SLE responder index. Subjects who complete 48 weeks of treatment on the BEL113750 study and who meet inclusion/exclusion criteria, and provide informed consent, will be given the option to enter the continuation study. All subjects will receive belimumab 10 mg/kg IV infused over 1 hour every 4 weeks. Subjects recruited into this study will continue to receive treatment with belimumab until such time as belimumab becomes commercially available in a subject's country of participation, or the subject elects to participate in another belimumab continuation study for SLE, or until either the subject's physician withdraws the subject from the study, or upon the decision by the sponsor to discontinue further development of belimumab for SLE.

Eligibility Criteria:
Inclusion Criteria:

* Have completed the BEL113750 Protocol in Northeast Asia through Week 48 OR have completed the open-label extension of C1115 in Japan.
* Be able to receive the first dose of belimumab for BEL114333 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in BEL113750 OR be able to receive the first dose of IV belimumab 1 week (plus a 1 week visit window) after the last dose of open-label SC belimumab in C1115..

Exclusion Criteria:

* Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk.
* Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that in the opinion of the principal investigator, makes the subject unstable for the study.
Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Lecithin in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.

The main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Age between 38 and 70 years,
* OA diagnosed by the American College of Rheumatology (ACR) criteria,
* OA diagnosed by radiographic imaging (grade II - III according to the Kellgren-Lawrence scale),
* Pain in the knee joint for at least 3 months,
* Screening pain intensity in the target knee measured on VAS scale was required to be 4 for symptomatic knee and 2 for the contralateral knee.

Exclusion Criteria:

* Previous injections of hyaluronic acid or platelet-rich plasma within 6 months or corticosteroid injections within 3 months before the enrollment,
* Present joint infection,
* Previous knee arthroscopy up to 1 year prior to examination,
* Peripheral inflammatory and autoimmune diseases that progress with joint involvement (rheumatoid arthritis, spondyloarthropathies, systemic lupus erythematosus etc.),
* Total arthroplasty and osteotomy,
* Ankylosis of the study joint,
* Dermatitis or dermatological disease at the intended injection site,
* Known hypersensitivity to the components of the preparation,
* Coexistence of the degenerative changes in other limb joints (hip, foot),
* Cancer,
* Oral corticosteroid therapy,
* Use of medicines that affect blood clotting (heparins, oral anticoagulants, thrombolytic drugs),
* Pregnancy or breast-feeding.
* History of injury to the knee, a broken bone or dislocation of a joint, other musculoskeletal diseases that affect the study joint, neoplastic disease.
* Participation in other clinical trials.
Is Screening for Esophageal Pathology in Asymptomatic Patients Post-Treatment for Head and Neck Cancer Beneficial?

The purpose of this study is to evaluate the prevalence of esophageal pathology in asymptomatic patients with a history of head and neck cancer.

There are certain factors (i.e. alcohol, tobacco, decreased saliva production from radiation) that predispose patients with a history of head and neck cancer to have esophageal disease. Often, in the initial stages of the disease, patients do not have symptoms. However, the early detection of precancerous lesions or small cancers improves patients' chances of being cured. There is no direct data supporting the practice of screening patients with a history of head and neck cancer after treatment for esophageal disease if they are not experiencing symptoms. However, many argue that screening endoscopy is justified in high risk patients to detect early esophageal cancer or dysplasia at a curable state. We are, therefore, performing this study to determine the value of endoscopic screening of the esophagus after treatment for head and neck cancer in patients without symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients that are six months post treatment and asymptomatic for esophageal disease.

Exclusion Criteria:

* None if meets the inclusion criteria.
Functional Assessment of Cancer Therapy - Bone Marrow Transplant

Functional Assessment of Cancer Therapy - Bone Marrow Transplant

Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma

Exclusion Criteria:

* Patients with diagnosis other than HD and NHL.
Physical Exercise to Reduce Anxiety in Underserved Children With ASD

Anxiety is one of the most frequent comorbidities in children with ASD leading to poor clinical outcomes. Physical exercise has been shown to be a promising and easy to implement intervention for reducing anxiety. However, little is known about the feasibility and efficacy of physical exercise to reduce anxiety in children with ASD from underserved, low-income families. Children with ASD, ages 6 - 12 years old from low-income and Latino families will be recruited for the study and assigned to an exercise intervention group and a sedentary control group. The physical exercise program is an eight-week program, administered three times per week in small groups. Compliance, parent-rated anxiety, and salivary cortisol will be measured before and after completion of the exercise and control group interventions.


Eligibility Criteria:
Inclusion Criteria:

* Autism Spectrum Disorder (ASD) Diagnosis 6-12 years old
* ≥ 93rd percentile on CBCL or total score of ≥ 25 on SCARED
* Able to attend 3x/week for 8 consecutive weeks
* Able to follow instructions
* CalOptima Insurance or Medicaid and ability to participate in moderate physical exercise

Exclusion Criteria:

* Danger to themselves or others
* Medical conditions that may pose a risk during exercise
* Unable to participate in moderate physical exercise
* Joining a regular physical exercise program in the last 4 weeks or planning to start or discontinue a regular physical exercise program in the next 8 weeks
* Unable to attend 3x/week for 8 consecutive weeks
* Visual, auditory or motor impairments, which would preclude participation in study activities
Intravenous Ibuprofen Versus Ketorolac in Bariatric Surgery

The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.

Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 5 mg dexamethasone drugs.

Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 2 mcg/kg fentanyl (lean body weight), and tracheal intubation will be facilitated by 0.6 mg/kg ideal body weight rocuronium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg rocuronium every 30 minutes. Fentanyl boluses of 1 mcg/kg will be given if heart rate or/and systolic blood pressure \>120% of baseline.

Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 4, 10, 18, and 24 h after leaving the operating room. If the VAS score is \> 3 intravenous nalbuphine 0.1-0.2 mg/kg (lean body weight) titrated to response with maximum single dose of 20 mg and maximum daily dose of 160 mg.

Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting

Eligibility Criteria:
Inclusion Criteria:

* adult (18-65 years) patients
* body mass index ≥35 kg/m2
* scheduled for laparoscopic bariatric surgery

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical class IV,
* severe cardiac comorbidity (impaired contractility with ejection fraction \< 50%, heart block, significant arrhythmias, tight valvular lesions),
* known obstructive sleep apnea or patients with STOP-bang score ≥5,
* baseline SpO2 \<95%,
* renal impairment,
* allergy to any of study's drugs,
* history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease
An Open-Labeled, Extended-Use of XERECEPT (hCRF) for Patients in Studies NTI 0302, 0303, or Other Designated Studies

The purpose of this study is to examine the long-term safety and tolerability of human corticotropin-releasing factor (hCRF), XERECEPT®, in patients requiring dexamethasone (Decadron) to treat peritumoral brain edema. This open-label, extended-use study is open to all patients who participate in either of the blinded studies, NTI 0302, NTI 0303, or other designated studies, including patients who may have discontinued blinded study medication early but completed the protocol-stipulated follow-up periods.

XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Participation in and completion of stipulated final follow-up periods for study NTI 0302, NTI 0303, or other designated studies.
* Have a Karnofsky Performance of \> 50 at Baseline
* Capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver.
* Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent.
* For women of childbearing potential: a negative serum pregnancy test at Baseline

Exclusion Criteria:

* Concurrent enrollment in any investigational drug or device study, other than NTI 0302, NTI 0303, or other designated studies.
* Systemic steroid use for any indication other than peritumoral brain edema.
* Use or intended use of dexamethasone as an anti-emetic during study.
* Clinical signs and symptoms of cerebral herniation.
* Serious concomitant cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which could put the patient at unusual risk during study participation.
* Confounding previous or concurrent neurological disorders that would interfere with adequate clinical evaluation.
* Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations.(Maintenance anticonvulsant therapy is allowed)
* Central nervous system (CNS) infection.
* Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential.
Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.

The purpose of this study is to determine if naso-jejunal feeding (feeding beyond the stomach) improves the efficacy of enteral feeding (feeding into the gut) in critically ill patients.

The study hypothesis is that in patients who fail to establish enteral feeding via the nasogastric route, introduction of nasojejunal feeding will lead to more effective enteral feeding than the current regime involving staged introduction of promotility agents.

The study examines the area of enteral feeding in critically ill patients. Current standard enteral feeding practice is via a nasogastric with the addition of promotility agents for patients who fail to absorb their enteral nutrition.

This study compares the efficacy of nasojejunal feeding feeding with nasogastric enteral feeding with the addition of promotility agents.

The duration of feeding will be determined by the patients nutritional requirements and their general condition. However the data will be collected for duration of enteral feeding, 28 days or ICU discharge whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (18years or over) admitted to the ICU with an expected stay of more than 48 hours.
2. Patients commenced on enteral feeding via a nasogastric tube who fail to tolerate gastric feeding due to excessive gastric aspirate volumes.
3. Patients who consent or if the patient is incompetent, the next of kin, who consent, to inclusion in the study.

   -

Exclusion Criteria:

1. patients less than 18 years of age.
2. Patients with known allergy to promotility agents, metoclopramide or erythromycin.
3. Patients with a contra indication to nasojejunal feeding. -
Evaluation of the Effectiveness of a Product Containing Topical Hydrocortisone in the Treatment of Seborrheic Dermatitis of the Face

Clinical single-blind randomized comparison with the overall objective of evaluating the clinical efficacy of the products Nutracort lotion and Nutracort cream in the treatment of seborrheic dermatitis on the face.

Will be held clinical and perceived efficacy assessment and instrumental measurements. Each product will be applied at half face for 7 consecutive days and all applications will be monitored in the research site. 60 volunteers will be recruited.

Evaluations will be held at the following times: T0 - before the initial application of the product; T1 - 24 hours after starting treatment, T2 - 48 hours after starting treatment, T3 - 72 hours after initiation of treatment, T4 - 96 hours after the start treatment, T7 - 7 days after initiation of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Subjects with seborrheic dermatitis on both sides of the face
* both sexes
* aged 18 to 60 years
* skin types I through IV.

Exclusion Criteria:

* pregnancy / lactation
* skin condition in the area of application of the product
* diabetes
* immune insufficiency
* subjects that are using systemic corticoids
* subjects that are using immunosuppressors
* skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis
* history of reaction to the product category
* other diseases or medications that might interfere directly in the study or endanger the health of the subject
Improving Sexually Transmitted Infection (STI) Results Notification and Partner Services

The primary goal of this project is to improve the process for contacting patients that test positive for a sexually transmitted infection (STI) in the emergency department by using text messaging. We believe patients that are contacted by both a phone call and a text message will be reached more often and they will be reached sooner than those that only receive a phone call or only a text message. In addition, patients will be given reminder cards at the time of testing to remind them that they will be contacted within 7 days if they test positive. Half of the reminder cards will have a number to call for test results. We believe patients that receive a card with a number are more likely to be contacted within 7 days.

Aim 1: To improve the results notification system among all female adolescents who test positive for STIs in the ED using mobile phone texting technology.

Hypothesis 1: We will increase our contact rate for STI positive adolescents in the ED from 65-82%.

Hypothesis 2: We will decrease the time interval between testing and appropriate STI treatment by the ED.

Hypothesis 3: We will decrease the recidivism rates for STI positive patients diagnosed in the ED.

Aim 2: To explore qualitatively the barriers to and preferences for partner notification and treatment among 14-21 year-old females and males being tested for STIs in the ED.

Aim 3: To determine baseline rates of partner notification and preferences around partner notification among STI-positive females in the ED, and to explore the feasibility of ED personnel notifying their sexual partners.

Eligibility Criteria:
Inclusion Criteria:

* 14 to 21 years old
* Seen in the emergency department at Cincinnati Children's Hospital Medical Center
* Test positive for an STI

Exclusion Criteria:

* Seen for a psychiatric evaluation
* Seen for sexual assault or abuse
China Early Esophageal Cancer Cohort

With the development of endoscopy, more and more patients with superficial esophageal squamous cell carcinoma (ESCC) receive endoscopic resection rather than traditional surgery. However, there is still no complete consensus on the risk factors for lymph node metastasis (LNM) and recurrence of ESCC after endoscopic resection. The existing curative resection criteria are strict to a certain extent, and a considerable number of patients are overtreated according to the current standard of additional treatment. Thus, we aim to conduct a multi-center retrospective and prospective study to construct a large cohort of ESCC based on the previously established multi-center collaborative research network and clinical big data, analyze the risk factors of LNM and recurrence in patients with early esophageal squamous cell carcinoma after ESD, establish an accurate and simple risk prediction model, and evaluate the discrimination efficiency of this model.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18-85.
2. ESD was performed for early (superficial) esophageal squamous cell carcinoma, and the indication was in line with domestic and foreign guidelines.
3. The pathological stage after ESD was pT1a/pT1b.
4. The effective follow-up time after ESD was ≥3 years, or recurrence or LNM occurred during the follow-up period.

Exclusion Criteria:

1. Esophageal chemoradiotherapy or esophageal surgery were performed before ESD.
2. There is a history of carcinoma, early carcinoma, adenoma and other benign and malignant tumors of stomach and duodenum.
3. Pathological data after ESD were incomplete.
4. Combined with malignant tumors of other organs.
5. Fragmented endoscopic mucosal resection (EMR), multi-loop mucosal resection (MBM) and other endoscopic non-monolithic resection techniques were used.
6. New squamous cell carcinoma in other parts of esophagus during follow-up (metachronous carcinoma).
Pupil Dilation for Treatment of IFIS

A novel intervention for targeting the treatment of Intraoperative Floppy Iris Syndrome.

This study explores the effects that medication can have on increasing pupil dilation. Pupil dilation size is important for operative eye procedures. Decreased pupil size is related to increased complication risks in eye surgery. By exploring novel pupil dilation techniques, there is a potential to counteract the effects of poor pupil dilation that is caused by medications such as alpha-blockers. Intraoperative floppy iris syndrome is a syndrome characterized by a floppy iris (IFIS) and poor pupil dilation during surgery that is caused by BPH medications. This study evaluates treatment methods targeting IFIS.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 years old or greater) 3. History of having taken, or currently taking any systemic alpha blocker 2. Ability to consent themselves 3. Ability to apply eye drops themselves TID for 7 days

Exclusion Criteria:

1. Subjects with untreated hypertension or baseline BP \>160
2. Subjects with Thyrotoxicosis
3. Pregnant women or women trying to conceive
4. Prisoners
5. Inability consent
6. Subjects with anatomical narrow angles or who have never had a dilated eye exam
7. Subjects currently prescribed brimonidine tartrate for glaucoma
8. Subjects who take topical or systemic alpha agonists
9. Patients who take monoamine oxidase (MAO) inhibitors
10. Patients with known severe cardiovascular disease
Evaluation of Consuming Olive Extract on Total Cholesterol Levels

The main objective of this nutritional intervention is to assess the efficacy of polyphenol-rich capsules on reducing metabolic syndrome traits, mainly cholesterol levels. For this purpose, a double blind, placebo controlled study of 12 weeks will be carried out.

The target population is women and men with overweight or obesity. Researchers will compare the experimental capsules with placebo capsules, but will be blinded during the intervention and results analyses. Only after analysing the parameters, the groups will be revealed.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 35 Kg/m2
* Total Cholesterol levels in peripheral blood above or equal to 200 mg/dL or LDL-cholesterol levels above or equal to 160 mg/dL.
* Weight stability during the three months prior the start of the study (±5% of variation).
* To be able to attend the visits and accomplish with all the indications of the research staff.
* To have signed the written informed consent.

Exclusion Criteria:

* Any alteration of the Gastrointestinal system, functional or structural (gastric ulcer, chronic inflammatory diseases, hernia, etc.)
* Subjects having undergone any surgical operation in th egastrointestinal tract with permanent consequences (i.e. gastroduodenectomy).
* Subjects following any pharmacological treatment affecting gastric homeostasis.
* Suffer from any metabolic disease or cancer process.
* Being allergic to any of the compounds contained in the study capsules.
* Excessive alcohol ingestion (14 units/day for women, or 20 units/day for men).
* Women lactating or during pregnancy.
* Following any cholesterol-lowering treatment.
* People with any mental impairment or whose compliance with the study protocol is at risk.