cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma

This study is a Phase II study to determine the preliminary safety and efficacy of salvage radiation treatment after BCMA CAR-T therapy in subjects with RRMM.

The study population will consist of subjects with RRMM previously treated with SOC BCMA CAR-T cell therapy with active disease on the D30+ PET or other imaging scan after CAR-T infusion. Patients who are planned for salvage chemotherapy less than 14 days after completion of radiation treatment will be excluded.

Radiation treatment will be to bony or soft tissue plasmacytomas in up to five radiation treatment fields to 10-20Gy (or equivalent dose in 2Gy fractions of 10-21Gy). Final dose, target, and technique are per treating radiation physician discretion within these guidelines.

Thirty patients will be enrolled. The co-primary endpoints are objective response rate (ORR) at 6 months and duration of response (DOR) among responders.

Objectives

Primary Objective:

• The primary objective of the study is to evaluate the preliminary efficacy of salvage radiation therapy after BCMA CAR-T cell therapy in subjects with RRMM.

Secondary Objectives:

• Evaluate the safety of and other efficacy parameters of radiation treatment after BCMA CAR-T cell therapy in subjects with RRMM

Exploratory Objectives:

* Evaluate the immunophenotype and/or expression profile, and perform functional bulk and single cell analysis of CAR T cells, endogenous T cells as well as other immune cells in the blood, bone marrow and/or tumor tissue with BCMA CAR-T therapy and RT
* Evaluate changes in the levels of cytokines, chemokines, and soluble factors in the blood with BCMA CAR-T therapy and RT
* Evaluate changes in T cell receptor repertoire with BCMA CAR-T therapy and RT
* Evaluate gut microbiome of patients treated with BCMA CAR-T therapy and RT

Eligibility Criteria:
Inclusion criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
2. Subject is diagnosed with multiple myeloma
3. Subject previously received treatment with standard of care BCMA CAR-T cell therapy
4. Day 30 or later PET scan or other imaging scan after CAR-T infusion shows active disease
5. Subject has at least one myeloma lesion (plasmacytoma either in bone or soft tissue) that can be treated with radiation
6. Able to provide informed consent

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subjects in whom salvage chemotherapy is planned less than 14 days after the completion of radiation treatment
2. Subject is undergoing active treatment for another malignancy other than multiple myeloma
3. Pregnant women will be excluded from this study.
A Study of Varenicline in the Treatment of Visceral Sensation

The purpose of this study is to evaluate the effect of varenicline on rectal sensation, based on ascending method of limits and on graded rapid phasic distensions in participants with non-constipation IBS and chronic abdominal pain.


Eligibility Criteria:
Inclusion Criteria:

1. Participants will be 18-70 years of age
2. Irritable bowel syndrome with pain, but no constipation \[that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)\]

Exclusion Criteria:

1. Diagnosis of moderate-severe depression as per HADS\&gt;8
2. Alcohol or illicit substance dependence or abuse in the past 12 months
3. Dementia, unprovoked seizure history, seizure disorder
4. Pregnancy (all women of childbearing potential will be required to have a negative pregnancy test prior to initiation, and will be on a highly effective method of contraception, as detailed in the consent form)
5. Significant change or increase in antidepressant or pain medications within the last four weeks; significant change in primary treatment interventions for pain in the past four weeks
6. Medically unstable
7. Severe hepatic or renal impairment, such as baseline AST or ALT \&gt;2.5 X upper normal limit or end-stage renal disease with estimated glomerular filtration rate or creatinine clearance \&lt;15 mL/min
8. Concomitant use of strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/27/2024. Questions regarding updates should be directed to the study team contact.
Minimally Invasive Techniques in Ventral Hernioplasty

1. Review the surgical outcome of different techniques using extraperitoneal ventral hernia repair regarding postoperative pain. wound infection ,hospital stay , recurrence ,mesh migration and mesh induced visceral complications.
2. Reviewing advantages and drawbacks of each surgical technique regarding feasibility ,cost effectiveness and technical difficulties

The laparoscopic ventral hernia repair was first introduced by LeBlanc and Booth in the early 1990s . Since its introduction, it has continued to evolve and has become an important option in the hernia surgeon's armamentarium. However, only 27.4% of ventral hernia repairs are performed laparoscopically, likely because of the relatively advanced nature of this procedure and because all hernias may not be suitable for a laparoscopic approach. Using current techniques, numerous studies have documented the safety and efficacy of this approach. Some data suggest that the laparoscopic approach results in a shorter hospital stay and lower recurrence rates compared with open approaches. However, pain may still be significant after laparoscopic repairs and there are not significant advantages from this standpoint. Nonetheless, it is well accepted that the primary advantage of the laparoscopic approach is that wound infections are less frequent compared with open approaches .LeBlanc and Booth in 1993 first reported application of intra-peritoneal onlay mesh (IPOM) for ventral and incisional hernia, However the technique requires expensive fixation devices which may cause acute and chronic pain .The laparoscopic groin hernia repair using synthetic mesh in TEP or TAPP are acceptable surgical techniques today These techniques are rarely associated with mesh induced complications, the reason being extraperitoneal placement of synthetic mesh. It is apparent that despite great progress in mesh technology, nearly all types of meshes have been found to produce a varying level of adhesion or tissue reaction, regardless of the material and coating used. Preoperatively unpredictable, a mesh-induced visceral complication may occur in some patients to produce severe reaction or major mesh-related adverse events.The incitation to develop certain novel minimally invasive techniques that enables researchers to bring the mesh out of abdominal cavity has been an exciting trend in laparoscopic hernia repair.

Eligibility Criteria:
Inclusion Criteria:

* • Able to give informed consent for inclusion in the study

  * Age of the patient : above 18 years
  * Any type of ventral hernia including umbilical,paraumbilical,epigastric,spigelian and incisional hernias

Exclusion Criteria:

* • Patients with inguinal hernia.

  * Strangulated or obstructed hernia.
  * Previous mesh hernia repair.
  * Loss of abdominal domain.
  * Infected or contaminated field.
  * Defect size more than 10cm.
Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced epithelial, tubal, or primary peritoneal cancer
* Cancer cells in paracentesis, thoracentesis, or laparoscopic surgery
* Less probability of complete cytoreduction
* Age: 20-80 years
* GOG performance status: 0-3
* Adequate organ function Bone marrow: ANC ≥ 1,500mm3, Platelet ≥ 100,000/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine ≤ 1.25 × UNL Liver: AST, ALT ≤ × 2.5 UNL (in case of liver metastasis, AST, ALT ≤ × 5 UNL), alkaline phosphatase ≤ 5 x UNL, bilirubin ≤ 1.5 mg/ mm3

Exclusion Criteria:

* Previous chemotherapy or pelvic radiation therapy
* Final diagnosis is other malignancies
* Coincidental Other malignancies within 5 years except carcinoma in situ of uterine cervix
* History of severe allergy
* Pregnancy, lactating woman
* Uncontrolled medial disease
* Bowel obstruction requiring immediate surgery
* Etc.
Web-based Guided Self-Determination Intervention for Adults With Type 2 Diabetes in General Practice

The overall aim of this study is to assess the effectiveness of a web-based Guided Self-Determination program among adults with type 2 diabetes in general practice in order to improve diabetes self-management behaviours and HbA1c through enhanced patient activation, self-care competence, and autonomy.

Web-based self-management programs have the potential to support adults with type 2 diabetes in managing their disease condition. However, improving health care outcomes through self-management interventions have shown somewhat ambiguous results. Therefore, it is suggested that interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. To meet these challenges, the overall aim of this study is to assess the effectiveness of a theory-driven web-based Guided Self-Determination intervention among adults with type 2 diabetes in general practice in order to enable adults with diabetes to use their individual resources to self-manage their condition and reach treatment goals.

A complex intervention design based on the framework of UK Medical Research Council is employed as a guide for developing and evaluating the intervention.

This study consists of three phases:

1. the modelling phase adapting the original Guided Self-Determination program to adults with type 2 diabetes, using a qualitative design
2. feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and
3. evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design.

The two first phases will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effect on health care outcomes of this systematically developed intervention.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes of duration ≥ 3 months
* Ability to communicate in Norwegian
* Access to the internet and bank ID

Exclusion Criteria:

* Patients with cognitive impairment
* Patients with severe co-morbidity
PLUS PINK: HHRP+ Adaptation for Women With HIV Under Community Supervision

After enrollment, participants will be randomized to either receive the intervention (treatment) from trained health educators or undergo observation as usual (control group). Randomization will be stratified by HIV serostatus. A control group is appropriate because participants will still receive services offered through probation and will be offered the intervention after completion of the trial. Subjects will be paid, not for participating in the intervention, but for providing research assessments. The newly adapted intervention will be delivered over no more than a 3-month period (it will be shorter if the adaptation process is supportive). Baseline assessments will assess the pre-intervention period. The 3-month assessment will be the end-of-intervention effects and the post-intervention assessments will be at 6, 9 and 12 months. HIV prevention knowledge will be assessed based on quizzes used previously for HHRP+; though final quiz content will depend on final selected materials for the intervention. Subjects will be followed for 12 months with assessments by trained research assistants.

The aim of this study is to adapt and pilot test the Holistic Health Recovery Program for women with and at risk for HIV (HHRP+), a CDC evidence-based secondary HIV prevention intervention, that will serve as a framework to optimize HIV treatment outcomes and reduce HIV-associated risk for women under correctional community supervision.

Hypotheses

1. It will be feasible to recruit and retain HIV+ and at-risk women under community correctional supervision in the pilot study.
2. Using the ADAPT-ITT methods, we will be able to adequately adapt HHRP+ for HIV-infected and at-risk women under community supervision.
3. The adapted intervention will be feasible to implement and acceptable to participants.
4. The adapted intervention will produce higher measureable preliminary effects on HIV-focused treatment outcomes in the intervention group compared with the control group.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years old
* female
* have laboratory confirmed HIV OR are at-risk for HIV (ever injected drugs, ever engaged in commercial sex work, were incarcerated in prison or jail within the past 2 years, had condomless sex with an HIV+ partner or partner whose HIV status is unknown in the past 90 days, or had a diagnosed sexually transmitted infection in the past 90 days),
* and are under or anticipating transfer to probation.are either a) sentenced to probation or on intensive pretrial supervision by a probation officer; b) sentenced to parole; or c) incarcerated in jail or prison in the prior 60 days.

Potential participants will be excluded

Exclusion Criteria:

* unable or unwilling to provide informed consent,
* have \<3 months of remaining scheduled supervision term,
* or are threatening to staff
Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors

The primary purpose of this study is to estimate the maximum tolerated dose of irinotecan with the use of cefpodoxime for pediatric solid tumor patients.

This is a phase I study with the exploratory investigation of at least four dosage levels (20, 30, 45, 60) to define the tolerable dose for phase II studies. Primary consideration will be given to determinations of the qualitative and quantitative toxicity of the administration of irinotecan with cefpodoxime, and pharmacokinetics of irinotecan when given with cefpodoxime.

Standard phase I escalation study in cohorts of 3-6 patients. Starting level is 20 mg/m2/d, and subsequent levels will be 30 mg/m2/d, 45 mg/m2/d and 60 mg/m2/d. An amendment to the study has included an intermediate level at 40 mg/m2/d.

Irinotecan will be administered as a 60-minute intravenous infusion daily for 5 consecutive days, followed by a 2 day rest, and followed by an additional 5 consecutive days course \[(qd x 5) x 2\]. Twenty-one days from the first dose will be considered one cycle of therapy. Cefpodoxime will be given orally at 10 mg/kg/day divided BID, starting 2 days prior to the beginning of the first course of irinotecan, and will be continued for the duration of study participation.

Additional objectives include:

* To describe the pharmacokinetics of intravenous irinotecan when given with oral cefpodoxime.
* To describe the dose-limiting toxicity/ies of irinotecan given on the \[(qd x 5) x 2\] with oral cefpodoxime.
* To evaluate the effect of the administration of oral cefpodoxime on the amount of intestinal beta-glucuronidase.
* To correlate the incidence and severity of diarrhea with the amount of intestinal beta-glucuronidase.
* To describe the toxicities of irinotecan given at doses above 20 mg/m2/d
* To note tumor responses within the confines of a phase I trial

Eligibility Criteria:
Inclusion Criteria:

* Subjects under 21 years of age at the time of initial diagnosis
* Recurrent solid tumors that have shown to be unresponsive to conventional treatment for their disease, or subjects with newly diagnosed tumors for whom no conventional treatment is available
* Histologic verification of solid tumor malignancy at original diagnosis
* Adequate performance status
* Neurologic deficits in subjects with central nervous system (CNS) tumors must have been relatively stable for a minimum of 2 weeks prior to study entry
* Subjects must have recovered from the toxic effects of all prior chemotherapy before entering the study
* Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* No active infection at time of protocol entry, and should not be receiving antibiotics other than P. carinii pneumonia prophylaxis.
* Patients must not be pregnant or lactating.
* Patients must not be taking an enzyme-inducing anticonvulsant (e.g., phenobarbital, phenytoin, or carbamazepine), rifampin, or St. John's Wort. Dexamethasone is not to be used as an antiemetic.
* Patients must not have had any previous allergic reactions to penicillin or cephalosporins.
Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies

The different reconstructive methods (V-Y flap, lotus flap, gracilis muscle flap, TRAM flap) will be compared with the complications that occurred following the surgery, so as to define which reconstructive methods have led to fewer complications and in which categories of patients.

he study is of a non-interventional observational nature. It involves the collection of patient data in pseudonymous form from preoperative and postoperative assessments in accordance with daily clinical practice and normally performed for proper patient management.

The data recorded in the study are obtained from the medical records of patients who are normally accessed by the doctors of the operating unit during daily practice.

After having performed a meticulous collection of the basic data of the patients (gender, age, remote pathological history, recent pathological history, type of demolitive and reconstructive surgery performed), the different reconstructive methods (V-Y flap, lotus flap, gracilis muscle flap, TRAM flap) will be compared with the complications that occurred following the surgery, so as to define which reconstructive methods have led to fewer complications and in which categories of patients.

The complications are assessed through the retrospective analysis of the outpatient reports that are normally drawn up during the usual follow-up outpatient visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pelvic-perineal amputations for oncological disease or chronic inflammatory diseases whose surgical treatment required the collaboration of the plastic surgeon
* Patients with complications in the abdominal or pelvic-perineal region of surgical relevance and requiring reconstruction (enteric fistulas, abdominal wall defects)
* Age greater than or equal to 18 years
* Acquisition of written informed consent

Exclusion Criteria:

* Incomplete or missing data.
Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts

PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog tracers has the potential to provide an imaging technique targeting subclinical granulomatous disease in those with latent tuberculosis (TB), allowing identification of individuals who may be at risk of progression to active TB.

Granulomas, the hallmark of TB infection, have an increased density of somatostatin receptors. Somatostatin analog PET tracers, such as 68Ga-DOTANOC, bind to somatostatin receptors and are able to detect pulmonary TB lesions using PET/MRI. This study aims to better understand the pathology of the spectrum of latent TB using 68Ga-DOTANOC PET/MRI imaging, identifying individuals with subclinical pulmonary TB who may be at risk of progressing to active TB.

Currently, biomarkers to identify those who are at risk of developing active TB are limited. Non-invasive biomarkers for pulmonary lesions are sorely needed and imaging with 68Ga-DOTANOC PET/MRI provides an opportunity to detect subclinical pulmonary disease in those who have been in close contact with smear-positive pulmonary TB.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21 years or over
2. Close household contact of any patient with newly-diagnosed (within last 2 months) smear positive pulmonary TB (close contact defined as sleeping in the same house for at least one month with a TB patient prior to start of treatment).
3. Interferon Gamma Release Assay (IGRA) positive
4. Willing to comply with the study visits and procedures
5. Willing and able to provide written informed consent

Exclusion Criteria:

1. Previous treatment for TB disease
2. Diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate PET scanning
3. Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI
4. Occupation involving substantial exposure to radiation
5. Malignancy requiring chemotherapy or radiation
6. Known lung disease which may affect interpretation of the scan
7. Known chronic kidney disease
8. Symptoms, signs and/or previous investigations suggestive of active TB in the opinion of the investigator (cough for \>1 month, cough productive of sputum or blood, shortness of breath, weight loss, night sweats, fever, abnormal examination, chest X-ray findings)
9. Women who are currently pregnant or breastfeeding
Metabolomic Profiling of in Patients With type2 Diabetes

To exam the metabolomic profiling of CSF and plasma in diabetes and establish the human CSF Metabolome Database of Type 2 DM.

Human cerebral spinal fluid (CSF) is known to be a rich source of small molecule biomarkers for central neurological and neurodegenerative diseases. However, the metaboloic bases of CSF in diabetes patient have not been studied. In this plan, the investigators will use analytical platforms, including nuclear magnetic resonance (NMR), liquid chromatography-mass spectrometry (LC-MS), to perform quantitative metabolomics on human CSF and blood samples and further establish the human CSF Metabolome Database of DM. This work will can supply important CSF metabolic profit information and help to facilitate a wide range of metabolomic studies on central nervous system diseases and their associations disease.

Eligibility Criteria:
Inclusion Criteria:

Diabetes group

1. .20-75 years of age
2. .Type 2 diabetes patient by clinical diagnosis
3. .American Association of Anesthesiologists (ASA)≦III

Control group (non-diabetic group):

1. .20-75 years of age
2. .No history of DM and other systemic illness
3. .American Association of Anesthesiologists (ASA)≦ II

Exclusion Criteria:

1. patient refuses to sign informed consent
2. patients with coagulopathy, systemic infective disease and severe liver and renal function impairment.
3. patients with spine or brain tumor and severe CNS disease.
4. the presence of severe and/or uncontrolled and/or unstable medical disease within 12 months prior to study other than DM which could compromise participation in the study (e.g. acute pancreatitis, stroke, liver cirrhosis, congestive heart failure, and systemic immune disorder etc.
5. Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

   -