cyrilzakka/clinical-trials huggingface dataset:
Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients 12 years old or above with moderate to severe allergic asthma
* Body weight greater than 30kg and less than 150 kg and total serum IgE level greater than 30 to less than 700 IU/ml
* Diagnosis of allergic asthma greater than 1 year duration, according to the American Thoracic Society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
* Positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
* No clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (Visit 1) and during screening period (between Visit 1 and 2)
* Demonstrated evidence of inadequate asthma symptom control, despite treatment with ICS according to clinical features of moderate to severe persistent asthma.

Exclusion Criteria:

* Previous exposure to omalizumab
* Previous exposure to other humanized proteins or monoclonal antibodies
* Known HAHA to other monoclonal antibodies
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
* Known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
* Active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)
* Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis)
Meal Stimulating After Roux-en Y Gastric Bypass

In many studies, gastric bypass surgery led to total remission of type 2 diabetes (T2DM) as early as 1 - 2 days after surgery before any real weight loss has occurred. This suggests that the remission of the T2DM is due to the direct effect of the operation, more than the secondary effect of the weight loss. The reasons for the major effect on the glucose metabolism after gastric bypass surgery are still unaccounted for.

The aim of this project will be to unveil some of the mechanisms that explain the effect of gastric bypass surgery on the glucose metabolism. Further more to find a better way of testing patients that have just undergone gastric bypass surgery. It is not possible to test patients who have just undergone gastric bypass surgery with normal oral glucose tolerance test (OGTT) and a normal meal, because patients can only take in fluid and a normal OGTT will often lead to dumping. Instead we will try to modify these tests - OGTT with lower glucose level and meal-testing with a protein drink.

The hypothesis of the study is that the investigators can see changes in different hormones and adipokines before and after surgery, even with modified OGTT and meal testing. The project will consist of clinical trials on patients without T2DM that will undergo gastric bypass surgery. The studies will take place before and within the first week after surgery. The investigators will measure different hormones and adipokines after OGTT and a meal with a protein drink. The investigators expect to see significant changes in some of the analyses after the operation in patients undergoing gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* Obese with BMI\> 40 undergoing gastric bypass surgery OR
* Obese with BMI \> 35 with complications of their obesity in form of high blood pressure or other related complications undergoing gastric bypass surgery
* Age between 20-60 years

Exclusion Criteria:

* Age \> 60
* Diabetes
* Psychiatric illness
* Mentally challenged
* Addiction
* Serious cardiac or lung diseases
* Diseases in the abdomen
* Other serious illness
Pulsed Electromagnetic Field Therapy for TMJ Dysfunction After Facial Penetrating Injury

This study is aiming to investigate the effect of magnetic therapy in combination with traditional physical therapy on the pain and mouth opening, after facial penetrating wound injury with no facial fractures, that treated conservatively


Eligibility Criteria:
Inclusion Criteria:

* TMJ pain and mouth opening limitation after 1 month of facial penetrating wound injury as the wound is fully healed.
* TMJ pain (in 1 or both joints) after facial penetrating wound injury.

Exclusion Criteria:

* Patient excluded from the study if they had one of the following:
* TMJ fracture or dislocation
* Previous TMJ surgeries
* Dental diseases
* Infectious or systemic diseases
* Pregnancy
* Malignancy
* Pacemaker or metal implants
* Systemic diseases that affect joint function such as rheumatoid arthritis.
Balance Control and Recovery in Diabetes Peripheral Neuropathy

In this study the effects of diabetic peripheral neuropathy will be assessed on balance control, balance recovery, and muscle electrical activity in adults over 50 years.

Aim 1: Determine muscle activity and balance control during a sit-to-stand in adults age above 50 with and without diabetic peripheral neuropathy.

Aim 2: Assess local balance recovery and latency responses to lateral surface perturbation during quiet standing.

Diabetic peripheral neuropathy (DPN) is a common condition affecting patients with diabetes. The prevalence of DPN increases with age and the duration of having diabetes. Approximately 30% of patients with diabetes have peripheral neuropathy globally, and 4.5 million Americans have DPN.

DPN typically affects more distal peripheral nerve branches, resulting in sensory loss. DPN causes axonal damage and leads to a loss of muscle strength. These degenerative effects significantly contribute to fall risks and feelings of instability.

Falls most commonly occur during transitional tasks such as the sit-to-stand (STS) and stand-to-sit (StandTS). The overall objective of this study to assess the effects of DPN on balance control and muscle activity during transitional tasks (STS and StandTS) and during lateral perturbation while standing.

Study procedures:

1. Measures of body weight, height, and limb diameter and measuring including leg length, knee width, elbow width, wrist width, and hand thickness.
2. Measures of sensation of the big toe and heel area for both legs.
3. Surface sensors will be placed on the leg muscles using non-allergic double adhesive tape.
4. Participants will sit down and stand up on a chair with adjustable height.
5. Then, participants will be asked to stand on a treadmill holding a ruler. The treadmill will slightly move left and right, and the muscle activity and balance control will be evaluated.
6. Finally, muscle strength of the legs' muscles will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes with peripheral neuropathy

Exclusion Criteria:

* Foot ulcer
* Partial amputation
* Have experience of Stroke
* Painful neuropathy
* Inability to stand or walk independently
ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of metastatic or locally advanced cancer
* Prior chemotherapy is allowed
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Prior treatment with ALIMTA
* Brain metastasis
* Pregnancy or breast feeding
Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life

This study will investigate the impact of post-surgical pain (PSP) on health related quality of life (HRQoL) within the first six months following surgery using patient-reported outcome (PRO) measures, and to investigate medical recovery measures such as ambulation and oral feeding time as secondary outcomes.

Pain and recovery after surgery are extremely concerned by patients undergoing surgery. Though it is important to understand the recovery course of postsurgical pain and recovery, most previous studies just focused on one specific time point, and the results were inconsistent.

To investigate the impact of PSP on HRQoL within the first six months following surgery using PRO measures, patients undergoing several specific surgeries will be interviewed. Patients' medical charts will be reviewed by investigators to record sociodemographic and clinical data.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Undergoing general or regional anesthesia
* Hospitalized for at least 24 hours after surgery

Exclusion Criteria:

* Existing diagnoses of psychiatric pathology
* Surgery cancellation
* Unable to give informed consent
* Unable to read and write
Changes in Resting Metabolic Rate Following Orthopedic Surgery

This project is intended to determine the magnitude and duration of RMR changes in patients receiving orthopedic surgery. The result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery.

Surgery produces a catabolic response in the body that shifts metabolism from glucose to fat and protein. Despite no studies examining ACLR, studies of other orthopedic surgeries demonstrate increased postoperative energy expenditure, as well as a shift to beta-oxidation. Additionally, in most patients, these changes reverted to baseline within six weeks, although a subset of patients did not return to baseline until beyond 12 weeks.

This project will improve our understanding of magnitude and duration of RMR changes following orthopedic surgery, and the subsequent perioperative dietary suggestions that should be made to improve patient outcomes. Currently, postoperative dietary suggestions are not surgery nor patient specific. Determining how orthopedic surgery effects RMR will help to personalize perioperative treatment, rehabilitation, and recovery.

Better understanding the change in RMR following orthopedic surgery and implementing more accurate dietary modifications will help to ensure positive outcomes and control of infection following orthopedic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Any individual over 15 undergoing an orthopedic surgery.

Exclusion Criteria:

* Pregnant female
* \< 15 years old
Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures

This study aims to characterize Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen, assess adherence to Swiss label indications, and describe treatment outcomes in this large, multicentre, heterogeneous, high-income setting. Moreover, the study aims to assess virological, immunological, demographic, clinical, and behavioural factors associated with viral failure under CAB+RPV LA regimen.


Eligibility Criteria:
Inclusion Criteria:

* Participant in the SHCS
* All SHCS participants initiating the CAB+RPV LA regimen
* All SHCS participants on SOC oral regimen

Exclusion Criteria:

* Not participating in the SHCS
Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder

Symptomatic urinary tract infections (UTIs) are one of the main causes of morbidity and the main cause of re-hospitalization in subjects with neurogenic bladder. Long-term antibiotic therapy increases the risk of multi-resistant bacterial infections, without reducing the rate of symptomatic UTIs. Our non-comparative preliminary study has shown that Weekly Oral Cyclic Antibiotic Programme (single, weekly dose of antibiotic X on even weeks, and antibiotic Y on odd weeks) seem to drastically reduce both the number of symptomatic UTIs and the number of hospitalizations in patients with neurogenic bladder, without affecting bacterial ecology.

The objective of this study is to validate this preliminary work with a large-scale randomized, parallel-group, multicenter study.


Eligibility Criteria:
Inclusion Criteria:

* subject over 18 years of age
* having a neurogenic bladder with automatic catheter and pharmacologic disconnection of the detrusor muscle
* having at least 4 symptomatic UTIs per year with bacterial sensitivity to the chosen antibiotics
* having given full consent to participate in the study
* being the recipient of social security benefits

Exclusion Criteria:

* known allergy or hypersensitivity to useful antibiotics (to which the bacterium or bacteria are sensitive) or to one of their components
* other contraindication in the administering of useful antibiotics
* urinary volume flow \>500 ml during automatic catheter
* different urinary drainage method than automatic catheter
* occurrence of stones in the urinary tract
* infection due to endo urinary material (urinary prosthesis, ureteral stent)
* creatinine clearance \<60 ml/min
* patient under guardianship
* women who are pregnant, nursing, or who may become pregnant
Mobile Enhancement of Motivation in Schizophrenia

Motivation deficits are a strong determinant of poor functional outcomes in people with schizophrenia. Mobile interventions are a promising approach to improving these deficits, as they can provide frequent cues and reinforcements that support goal-directed behavior. The primary aims of this study are to conduct a pilot study using a randomized design to 1) Test the feasibility and acceptability of a personalized mobile text message intervention, Mobile Enhancement of Motivation in Schizophrenia (MEMS) and to 2) Test the preliminary effectiveness of MEMS compared to a control condition.

Objectives: Motivation deficits are one of the strongest determinants of poor functional outcomes in people with schizophrenia. Mobile interventions are a promising approach to improving these deficits, as they can provide frequent cues and reinforcements that support goal-directed behavior. The objective of this study is to conduct a pilot study using a randomized design to 1) Test the feasibility and acceptability of a personalized mobile text message intervention, Mobile Enhancement of Motivation in Schizophrenia (MEMS) and to 2) Test the preliminary effectiveness of MEMS compared to a control condition. Methods: Up to forty outpatients with a schizophrenia-spectrum disorder will be recruited. All participants will set individualized recovery goals to complete over an eight-week period; those randomized to receive MEMS will also receive three sets of personalized, interactive text messages each weekday to reinforce and cue goal completion. Before and after the eight-week period, participants in both groups will complete validated measures of motivation. Both groups will also report their goal attainment after eight weeks. Results: It is anticipated that those in the MEMS group will demonstrate greater goal attainment and improvements in motivation compared to the control group. Discussion: This project will test the initial feasibility, acceptability, and effectiveness of a novel intervention for improving one of the most debilitating aspects of schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia-spectrum diagnosis
* Have a text-message enabled cell-phone
* Are a current client at a participating community mental health center
* Are in a non-acute phase of illness or have no medication changes or hospitalizations in the prior 30 days
* Demonstrate a minimum of moderate motivation impairments according to the Clinical Assessment Interview for Negative Symptoms (CAINS; Kring et al., 2013)
* Have an English reading level at or above the fourth grade according to the Graded Word List (Pray \& Ross, 1969)
Writing About Experiences With Ovarian Cancer

This online study aims to understand whether writing about one's experiences with ovarian cancer may be beneficial for psychological and physical wellbeing in women with a history of ovarian cancer. Investigators are also interested in studying how certain individual characteristics may impact the effectiveness of writing. Participants will be asked to complete an initial survey (15 min), followed by writing about their experiences with ovarian cancer on four occasions (20 - 25 min each), over the course of two weeks. A final survey (10 min) will be completed one month afterwards.

The purpose of this randomized controlled experiment is to examine the effects of writing about experiences with ovarian cancer on psychological and physical outcomes in English-speaking women with a history of ovarian cancer. It will also examine how certain individual characteristics may impact the effectiveness of the writing interventions for different women. After completing an initial survey, women will be asked to write about their experiences with ovarian cancer on 4 separate occasions of 20-25 min each in the course of 2 weeks. A final survey will be completed one month after the last writing session. The entire study will be conducted online.

Eligibility Criteria:
Inclusion Criteria:

* Women with a history of ovarian cancer (any stage)
* At least 18 years old
* English-speaking/Can comfortably read and write in English
* Able to provide informed consent
* Internet access
* Valid email address
* Any region/country

Exclusion Criteria:

* Minors (younger than 18)
* Lack of English proficiency
* Inability to provide informed consent
* Male
A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a histopathological diagnosis of HCC
* Subjects who have undergone a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only)
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* Absence of major macrovascular invasion
* No extrahepatic spread
* Full recovery from Curative resection or ablation within 4 weeks prior to randomization
* High risk for HCC recurrence after resection or ablation
* For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
* Child-Pugh Class: Grade A
* ECOG-PS score: 0 or 1
* Subjects with HCV- RNA (+) must receive antiviral therapy
* Adequate organ function

Exclusion Criteria:

* Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously
* Evidence of residual lesion, recurrence, and metastasis at randomization;
* Moderate-to-severe ascites with clinical symptoms
* History of hepatic encephalopathy
* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage
* Active or history of autoimmune disease
* Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
* Cardiac clinical symptom or cardiovascular disease that is not well controlled
* Severe infection within 4 weeks prior to the start of study treatment
* HIV infection
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Serious non-healing or dehiscing wound
* Major Curative procedure within four weeks
* Factors to affect oral administration
* Previous or current presence of metastasis to central nervous system
Rituximab in Treating Patients With Multiple Myeloma

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them.

PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab in treating patients with multiple myeloma that is newly diagnosed.

OBJECTIVES: I. Evaluate the role of rituximab in inducing apoptosis of malignant plasma cells in patients with multiple myeloma. II. Evaluate the role of this regimen in improving the response rate to melphalan and prednisone in these patients. III. Determine whether the regimen decreases residual disease in these patients. IV. Evaluate the toxic effects of this regimen in these patients.

OUTLINE: Patients receive rituximab IV every week for 4 weeks. Treatment is repeated every 6 months for six courses. Treatment may be discontinued after four courses if uncontrolled infection occurs. Patients also receive oral melphalan and prednisone for 4 days which begin after the first course of rituximab. Treatment is repeated every 4-6 weeks for at least nine courses.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 12-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven, newly diagnosed multiple myeloma Eligible if pancytopenia related to multiple myeloma At least 50% plasma cells in the bone marrow OR Splenomegaly OR Plasma cell leukemia No solitary extramedullary plasmacytoma or plasma cell dyscrasia

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: If less than 50% plasma cells in bone marrow: WBC at least 2,500/mm3 OR Absolute neutrophil count at least 1,000/mm3 (greater than 500/mm3 if platelet count at least 75,000/mm3) Platelet count greater than 45,000/mm3 (thrombocytopenia related to idiopathic thrombocytopenic purpura or vitamin B12 or folate deficiency allowed) Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) ALT or AST less than 2 times ULN (if greater than one third of liver involved, then no greater than 5 times ULN) No severe hepatic disease Renal: Creatinine no greater than 2.0 mg/dL Other: No severe infection requiring intravenous antibiotics Not pregnant or nursing Fertile patients must use effective contraception No prior malignancy within 5 years except for treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix No Type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of rituximab

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation Concurrent sargramostim (GM-CSF) allowed for severe, symptomatic neutropenia Chemotherapy: At least 4 weeks since investigational drugs Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent use of investigational drugs or devices Concurrent epoetin alfa allowed for anemia Plasmapheresis allowed at study onset to treat renal failure