cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases

A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.

This is a Phase 1 open-label, multi-center safety and dose-escalation study of anito-cel\* in adult subjects with GMG (MGFA Grade 2 to 4a), in whom immunosuppressive therapy is clinically indicated in the judgement of the treating neurologist. The primary objective of this study is to assess the safety profile, including any DLT and identification of a MTD (if applicable), to support selection of the RP2D of anito-cel when administered to subjects with GMG.

The study will have the following sequential phases: screening, enrollment (leukapheresis), pretreatment with lymphodepletion (LD) chemotherapy, treatment with anito-cel and follow-up. Optional bridging therapy is allowed at investigator discretion while anito-cel is being manufactured.

Following a single infusion of anito-cel both safety and efficacy data will be assessed. The DLTs will be assessed in the first 28 days following anito-cel administration, and safety data will be collected throughout the study.

\*Anitocabtagene autoleucel (anito-cel) drug product consists of autologous T cells that have been genetically modified ex vivo to express a D-domain Chimeric Antigen Receptor (CAR), followed by a cluster of differentiation 8 (CD8) hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB and CD3ξ, that specifically recognizes B-cell maturation antigen (BCMA). The active substance of anitocabtagene autoleucel is CAR+ CD3+ T cells that have undergone ex vivo T-cell activation, gene transfer by replication-deficient lentiviral vector, and expansion.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older
* Must have MGFA clinical classification Grades 2-4A at time of screening
* Subject must have clinically active disease and requiring ongoing therapy for GMG
* MG-ADL score 6 and QMG score \>10 at screening
* GMG specific autoantibodies must be above the reference laboratory ULN

Exclusion Criteria:

* Subject is pregnant or breastfeeding
* Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide within the specified time frame prior to leukapheresis or prior to anito-cel infusion
* Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager
* Previous thymectomy within 6 months of screening
* Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator
Effects of Post-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals

The purpose of this study is to determine whether knowledge of post-session hydromorphone (HYD) availability reduces drug seeking behavior in heroin dependent individuals.

Drug dependence is often characterized by severe drug seeking behavior. Learning to understand, predict, and control this maladaptive choice behavior may lead to improved prevention and treatment strategies. HYD is a drug that is currently used as a cough suppressant and to relieve pain. The purpose of this study is to determine the extent to which opioid drug seeking behavior by heroin dependent individuals can be reduced by environmental factors, including supplemental opioid drug availability, drug price, and alternative non-drug reinforcers. Specifically, this study will determine whether knowledge of post-session HYD availability influences drug seeking behavior in heroin dependent individuals, who are maintained on buprenorphine during their participation.

Participants in this observational study will take part in multiple trials in which they have the opportunity to choose either HYD or money. On the first two experimental days, prior to choice sessions, participants will receive a sample of the drug doses that can be chosen. During test sessions, participants will have 12 opportunities to choose either drug or money. Participants will use a computer to earn choices. Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored throughout choice trials. Supplemental HYD will be made available following some choice sessions. Self-report questionnaires will be completed at different times during the study. Participants will be maintained on buprenorphine throughout the study, with a minimum 2-week lead before the experiment, and a fixed 3-week detoxification after study completion.

Eligibility Criteria:
Inclusion Criteria:

* Opioid dependent, as determined by the structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
* Positive urine test for opiates
* Willing to use an adequate form of contraception for the duration of the study
* Reads and writes English

Exclusion Criteria:

* Psychiatric illness, as determined by the DSM-IV criteria
* History of or current neurological disease, including structural abnormalities, seizures, infection, peripheral neuropathy, and head traumas
* History of cardiovascular disease, myocardial infarction, chest pain, or edema
* Systolic blood pressure greater than 160 mm Hg or less than 95 mm Hg; PR diastolic blood pressure greater than 95 mm Hg
* Pulmonary disease, including obstructive pulmonary disease, cor pulmonale, tuberculosis, and asthma
* Systemic disease (e.g., endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, Addison's disease, autoimmune disease)
* Current alcohol or sedative drug dependence
* Pregnant or breastfeeding
* Currently receiving treatment for opioid dependence
* Known phobia of injections
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.

The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions. The objectives of this study aim to investigate the use of Fluorescein in assisting with evaluating complete tumor removal and thorough treatment of intracranial vascular lesions as well as tumor biopsy procedures. The hypothesis is that Fluorescein Sodium will help surgeons better identify residual tumor and vascular lesions and its use will allow surgeons to obtain better surgical results and prognostic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Diagnosed by preoperative imaging modalities to have a brain tumor or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.
* The patient is determined by a board certified Neurosurgeon (above mentioned neurosurgeons) to benefit from the application of Fluorescein Sodium intraoperatively
* Patient or legally authorized representative provides written informed consent to enroll in this study.

Exclusion Criteria:

* Known allergic reaction to Fluorescein Sodium.
* Children.
* Prisoners.
* Students.
* Infection of the central nervous system or other sites.
* Hemodynamic instability or significant impairments in circulation.
* Concomitant treatment with other investigational drugs.
* Any uncontrolled condition unrelated to the neurosurgical disease.
* History of psychiatric, additive, or any other disorder that compromises the ability to provide informed consent or comply with study protocols.
* Participation on other clinical trials during the last thirty days.
* Pregnant patients.
* Patients unable to discontinue medications that affect Fluorescein metabolism.
GPIIbIIIa Inhibitors in the RESCUe and RESURCOR Networks at the Acute Myocardial Infarction

In patients with acute myocardial infarction who are managed in the prehospital setting, and who will treated with primary angioplasty, we evaluate the benefit of an early administration of tirofiban, a powerful GPIIbIIIa inhibitors. Patients are randomised to early administration in the ambulance or administration in the cathlab. The primary endpoint is TIMI 2-3 flow in the first coronary opacification of the culprit artery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Information given to the patient and consent obtained
* Thoracic pain or symptoms of infarction
* Symptoms \< 12 hours
* ST deviation identified by electrocardiography (ECG) in at least 2 contiguous leads
* Transfer time to angioplasty room evaluated by the coordinating doctor as less than 90 minutes (from ECG diagnosis to arrival in angioplasty room)

Exclusion criteria

* Physiological or pathological conditions not compatible with a revascularisation procedure (in the acute phase of myocardial infarction (MI)
* Administration of fibrinolytics or another antiGPIIBIIIa in the previous seven days
* Contraindications to aspirin or tirofiban or heparin
* Diagnosed severe kidney failure (dialysis, creatinin \> 350µmol/l
* Pregnancy
* Time for transfer to the angioplasty room evaluated by coordinating doctor as more than 90 minutes
* Subject participating in another trial
* Subject with high hemorrhagic risk.
Improvement Project To Optimizing Nutrition With Higher Protein and Calorie Pediatric Tube Feeding

This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients.

This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients. The primary aim of this quality improvement project is to better meet protein needs of ICU critically ill children

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-18 years old with enteral feeding access and anticipated to be fed for 5 days

Exclusion Criteria:

-
Study on Feasibility of Stimulation on the Lumbar Part of the Spinal Cord to Improve Mobility Recovery in Patients With Sub-acute Spinal Cord Injury

The STIMO-2 study aims to investigate TESS-supported rehabilitation training in sub-acute spinal cord injury (\< 6 months post-injury). The primary endpoint of this study is to assess the safety and feasibility of TESS. The preliminary effectiveness of the therapy is the secondary study endpoint. The mobility recovery status of patients, who undergo TESS-supported rehabilitation, will be assessed at 12 months post SCI, compared to their predicted recovery expectations based on standard rehabilitation program


Eligibility Criteria:
Inclusion criteria (non-exhaustive list)

* Patient enrolled in the EMSCI study
* Age 18 to 70 years old included
* Focal spinal cord injury due to trauma
* Patient with history of SCI within the past 6 months (sub-acute SCI)
* Vertebral lesion T11 or above
* Psychological condition compatible with study participation
* Able and willing to fulfil all study procedures

Exclusion criteria (non-exhaustive list)

* Severe or chronic medical disorder pre-existing SCI affecting rehabilitation
* Active implanted device such as a pacemaker, implantable cardiac defibrillator
* Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia
* Pregnant or breast feeding
* Participation in other interventional study
Novel Helmet Design in Patients With Seizures

This is a two-part study that aims to determine the reliability and safety of the use of the Hövding inflatable helmet in seizures, as evidenced by the deployment of the helmet during seizures, and qualitative patient reporting.

Part 1: 4 healthy volunteers will fall from a standing position onto a padded surface to evaluate for consistent helmet deployment from a standing position. Part 2: up to 20 patients with drug resistant epilepsy who do not use existing head-protective devices will be enrolled and assigned to first enter "helmet" or "no helmet" groups. When assigned to the "helmet" group, patients will wear the helmet until deployment during a seizure or up to 3 months. Subjects will complete questionnaires about their seizures including any injuries sustained, post concussive symptom questionnaire, and the circumstances of inflation. Patients will return to site after helmet deployment. While assigned to the "no helmet" group, patients will complete the same questionnaires, except those relating to helmet inflation. We will compare circumstances, injuries, and post concussive scales in seizures resulting in falls occurring while the helmet was worn versus seizures resulting in falls occurring while the helmet was not being worn.

Eligibility Criteria:
Inclusion Criteria:

Part 1:

1. Age 18-60 at the time of enrollment.
2. Have neck circumference between 34 and 42 cm.
3. Can understand and provide written informed consent.
4. Must be competent to follow all study procedures.
5. Able to read, speak, and understand English.

Part 2:

1. Have at least one seizure every 6 months that might result in a fall (Generalized Tonic Clonic Seizure, Atonic Seizure, and/or Complex Partial Seizure resulting in a fall).
2. Has a seizure frequency of at least once per 2 months.
3. Be between ages 18-65 at the time of enrollment.
4. Have neck circumference between 34 and 42 cm
5. Must live in a home with electrical power supply.
6. If female and of childbearing potential, has negative pregnancy test at the beginning of the study and willing to use appropriate birth control for the duration of the study.
7. Can understand and sign written informed consent.
8. Must be competent to follow all study procedures.
9. Able to read, speak, and understand English.

Exclusion Criteria:

Part 1:

1. Subject is currently pregnant

Part 2:

1. Patient already wears a helmet for seizure safety.
2. Subject is pregnant, planning to become pregnant during the study, or is unwilling to use an appropriate form of birth control during the study.
Low Bacterial Diet in Patients With Cytopenia

The purpose of this prospective, randomized study was to determine the efficacy of low bacterial diet, in comparison to normal hospital diet, with gut colonization by aerobic Gram negative rods and yeasts as primary endpoint. In addition, the occurrence of infections and the total costs of hospital care were documented, in order to identify potential cost savings by the use of either diet.

Patients with hematological malignancies who receive intensive chemotherapy usually develop a period of cytopenia, during which there is an increased risk of infection. Mucositis can also develop in these patients, enabling micro-organisms, belonging to the endogenous intestinal flora, to translocate from the intestine to the lymphoid tissue and blood. Therefore, when mucositis and cytopenia develop simultaneously, the risk of infection increases further. In this regard bloodstream infection by Gram negative rods and yeasts are an important cause of serious infections causing considerable morbidity.

In order to reduce the risk of infection several preventive measures have been adopted. Fundamentally, all of these measures were designed to prevent either acquisition of Gram negative rods or fungal pathogens from the environment, or the translocation of these potential pathogens across the mucosal barrier of the gut. These measures include protective (or reverse) isolation, antibiotic prophylaxis with antibiotics which selectively eradicate the aerobic Gram negative rods and yeasts from the gut flora, and finally the use of low-bacterial diets.

In this prospective, randomized study on the efficacy of low bacterial diet, in comparison to normal hospital diet, gut colonization by aerobic Gram negative rods and yeasts, the occurrence of infections and the total costs of hospital care were chosen as study endpoints.

Eligibility Criteria:
Inclusion Criteria:

* acute leukemia receiving remission induction chemotherapy
* receiving antibiotic prophylaxis for cytopenia leukocytes lower than 1000/mm3 in peripheral blood)
* informed consent

Exclusion Criteria:

* none
Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora

Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora


Eligibility Criteria:
Inclusion Criteria:

* Healthy women between 18 and 45 years old
* Women without current symptoms of vaginal infection
* Negative bacteriological and clinical examination

Exclusion Criteria:

* Women with vaginal infection
* Women with undiagnosed vaginal bleeding
* Patients with endometrial hyperplasia
* Suspicion of neoplasia or active neoplasia
* Women with intolerance, allergy or hypersensitivity to the components of the probiotic
* Women with immunosuppressive disorders or with HIV
* Women who are currently using probiotics by any route of administration
* Women who are using some treatment for vaginal sepsis
* Chronic decompensated noncommunicable diseases (diabetes mellitus, heart disease ...)
* Pregnant women or those with precocious menopause
Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis

Research hypothesis:

Does delayed primary wound closure after appendectomy in adults with complicated appendicitis reduce postoperative superficial surgical site infection compare to primary wound closure.

Study design:

This study is a multicenter randomized controlled trial of delay versus primary wound closure in complicated appendicitis.

Setting:

Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira Hospital, and Pathumthani Hospital

Participants:

Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as gangrenous or ruptured appendicitis.

Outcome:

Superficial surgical site infection

Period of study:

August 2012 - August 2014


Eligibility Criteria:
Inclusion criteria

1. Adult patients age 18 years or older
2. Have been diagnosed as gangrenous or ruptured appendicitis base on clinical criteria with the following conditions

   a.Gangrenous appendicitis i.Erythematous or swelling of appendix and ii.Appearance of necrotic wall (dark, grayish color) b.Ruptured appendicitis i. Erythematous or swelling of appendix and ii.Appearance of hole in an appendix or iii.Rupture of appendix during a procedure c.Appearance of frank pus
3. Non-immunocompromised hosts which include

   1. AIDS
   2. History of end-stage renal disease (ESRD)
   3. History of autoimmune disease (SLE)
   4. Taking immunosuppressive agents (e.g, steroids, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil)
   5. Cirrhosis with ascites
   6. Morbid obesity (BMI \> 40 kg/m2)
4. Non-pregnant women
5. Willing to participate and provide written informed consent
Financial Incentives to Increase Pediatric HIV Testing Pilot Study (FIT-Pilot)

The aim of the pilot study is to evaluate the feasibility, acceptability and costs of a financial incentive intervention to motivate pediatric HIV testing in Western Kenya. The study will evaluate 3 cash incentive values and determine percent uptake of testing. A post-test questionnaire will explore parental satisfaction, mechanisms of incentive effectiveness and the impact of testing on emotional health and pediatric healthcare utilization.

The study will be a randomized trial with 3 arms (1:1:1 allocation) with small, medium, and large cash incentive. The investigators will randomize 60 parents with children of unknown status at Kisumu County Hospital in Western Kenya.

Eligibility Criteria:
Inclusion Criteria:

* Parent/caregiver receiving HIV care
* Parent/caregiver is female
* Parent/caregiver has one or more children \<13 years old
* Child is HIV exposed (parent/caregiver report or clinic confirmation)
* Caregiver reports child's HIV status is unknown

Exclusion Criteria:

-None

\*The investigators reserve the right to exclude any potential enrollee who is deemed to be a high personal risk, or whose children are at high personal risk, of interpersonal violence, by study participation.
Prospective Investigation of Robotic Single-port System

To determine the feasibility of representative urologic procedures as measured by the rate of conversions


Eligibility Criteria:
Inclusion Criteria:

* Prostatectomy:
* Patients age 18-75 years
* BMI \<=35 kg/m2
* Confirmed localized adenocarcinoma of the prostate
* Suitable for minimally invasive prostate cancer surgery

Nephrectomy:

* Patient age 18-75 years
* BMI \<=35 kg/m2
* Kidney disease amenable to nephrectomy or partial nephrectomy
* Suitable for minimally invasive kidney surgery

Exclusion Criteria:

Untreated active infection (includes local kidney infection)

* Vulnerable population (ex: prisoners, mentally disabled)
* Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (i.e., cancer)
* Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
* Patient with second primary cancer
* Extensive previous abdominal surgery
* Prior radiation treatment for prostate or kidney cancer
* Patient with distant metastasis
* Complex renal vascular anatomy
* Patient with kidney cancer - stage T3 or N+ M+ \*\*
* Horseshoe kidney\*\*
* Previous ipsilateral kidney surgery \*\*- specific to kidney surgery -
Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability

the main aim of this study is to evaluate the results of performing minimally invasive surgical management for cases with traumatic spinopelvic instability and spinopelvic dissociation. This will include using percutaneous pedicle and S2 alar iliac screws, minimally invasive transforaminal lumbar interbody fusion and transtubular posterior decompression.

Study Procedure:

1. Patient enrollment and pre-operative evaluation:

   Upon Arrival, the patient will be managed in the emergency department according to the Advanced Trauma Life Support (ATLS) protocol. After achieving the haemodynamic stability, in cases of shock, X-rays (AP and lateral view of the lumbosacral region, inlet and outlet views of the pelvis) and CT scan of the pelvis will be performed. If the fracture pattern fits the inclusion criteria, the patient will be offered to enroll in the study and the patient will be prepared for surgery.
2. Surgery:

   The surgery will be performed under general anaesthesia and fluoroscopic guidance. The patients will be positioned prone on an open top of a radiolucent table with large bumps under the thighs to accentuate an extension force on the legs which will be the main reduction maneuver in the surgical procedure.

   Bilateral percutaneous L4 and L5 pedicle screws will be placed under fluoroscopic guidance with Jamshidi needles, and these were will also be used the iliac fixation via percutaneous S2 alar iliac screws.

   Cases presenting with significant instability, minimally invasive Transforaminal lumbar interbody fusion (MIS-TLIF) will be performed. Additionally, in cases with neurological deficit, posterior decompression will be performed.
3. Follow-up The patient will have four follow up visits (one and half month, 3month, 6month and 1 year) besides the discharge visit, during which the functional outcome scores will be filled out.

AP and lateral view pelvis x-rays will be performed every visit. CT scan, AP and lateral scanograms will be only performed on the 1-year visit.

Eligibility Criteria:
Inclusion Criteria:

Skeletally mature patients presenting with sacral fractures (provided that the fracture line passes below the level of S2) associated with lumbosacral instability showing one of the following:

1. Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2)
2. Spinopelvic dissociation (AO type C3)
3. Traumatic lumbosacral dislocation

Exclusion Criteria:

1. unwillingness to participate in the study
2. pathological fractures
3. other medical comorbidities that preclude surgical intervention.