cyrilzakka/clinical-trials huggingface dataset:
Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness

Maintenance of employment is dependent upon being able to successfully integrate into one's work setting. This can present a significant challenge to individuals with serious mental illness, as they typically exhibit impairment in their ability to accurately perceive and understand social exchanges. Presently the most established intervention is Social Cognition and Interaction Training (SCIT), a 12-week group intervention in which participants learn strategies to enhance emotion recognition and to assess the accuracy of their interpretation of social interactions. To enhance transfer of training gains to functional outcomes, participants will be paired with a social mentor to facilitate completion of homework and to ensure that skills are practiced outside of treatment (supported SCIT). The study will examine the impact of supported SCIT on social and work role functioning.

The specific aims are:

1. To assess the feasibility of providing supported SCIT to individuals with serious mental illness who are engaged in compensated work activity.
2. To assess the impact of supported SCIT on social cognitive skills as well as work and social performance.
3. To assess durability of intervention-induced change 3 months after the end of intervention.

A single blind study will be conducted in which participants between 18-70 with serious mental illness (schizophrenia, schizoaffective disorder, and bipolar disorder) are assigned to 12 weeks of supported SCIT. Intervention will consist of one 2-hour small group training sessions and 30 minutes of individualized supported practice of skills with a treatment facilitator weekly. Feasibility will be assessed with attendance at group and individual sessions. Baseline, post-intervention (3-month), and follow-up (6-month) assessments will measure social cognitive abilities and functional outcomes. Potentially confounding variables such as symptom severity and outside treatment hours will also be assessed. It is hypothesized that supported SCIT will be completed by at least 75% of veterans. The intervention is predicted to improve social cognitive skills and social and work performance. Training gains are expected to be sustained 3 months after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
* Veteran
* Engaged in compensated work activity, volunteer work, school
* Age 18 to 70

Exclusion Criteria:

* Currently meet criteria for substance abuse or have met criteria for substance dependence in that previous 6 months
* Have an estimated premorbid IQ below 70,
* Have a history of a clinically significant head injury or neurological disease
* Do not speak English well enough to comprehend testing procedures
* Do not demonstrate adequate understanding of study procedures to give informed consent
Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have ovarian epithelial cancer that has not responded to previous chemotherapy.

OBJECTIVES:

* Evaluate the antitumor activity and toxicity of bryostatin 1 in patients with platinum resistant ovarian epithelial cancer.
* Determine the response rate in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bryostatin 1 IV over 24 hours. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or regressive disease may receive additional treatment.

Patients are followed for at least 4 weeks after treatment, then every 3 months.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven ovarian epithelial cancer

  * Progressive disease during or after completion of at least one platinum based chemotherapy regimen
* Bidimensionally measurable disease

  * At least 2 cm by x-ray, CT scan, or ultrasound
* No active, symptomatic brain metastases (e.g., cerebral edema and/or progressive tumor growth)

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Hemoglobin at least 10 g/dL
* WBC at least 4,000/mm3
* Platelet count at least 100,000/mm3

Hepatic:

* Bilirubin no greater than 1.7 mg/dL
* AST/ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)

Renal:

* Creatinine no greater than 1.4 mg/dL

Other:

* No active, uncontrolled infection
* No nonmalignant systemic disease which would increase risk to patient
* No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered
* No more than 2 prior multidrug chemotherapy regimens
* No more than 1 prior single agent chemotherapy regimen

Endocrine therapy:

* At least 4 weeks since prior endocrine therapy and recovered
* No concurrent steroids
* Concurrent hormone replacement therapy allowed

Radiotherapy:

* At least 4 weeks since prior radiotherapy (excluding palliative therapy) and recovered
* No concurrent radiotherapy

Surgery:

* At least 4 weeks since prior major thoracic or abdominal surgery

Other:

* No other concurrent anticancer therapy or investigational drugs
Radiotherapy of Tongue Cancer Using an Intraoral Stent

Radiotherapy of tongue cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The aim of the present study is to confirm that an intraoral stent will give lower dose to the palate throughout the treatment period.

Radiotherapy of tongue cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The main objective of the present study is to confirm that the use of an intraoral stent will result in lower dose to the palate throughout the treatment period. A secondary objective is to measure the reduction in acute mucositis in the palate.

The intraoral stent used in the present study is available in two sizes, 10 and 20mm thickness. The intervention group and control group will consist of approximately five patients each. Target coverage will be measured by the minimum dose covering 98% of the clinical target volume (D98CTV). Dose to the organs at risk (hard and soft palate) will be measured by the mean dose. Data will be collected from the planning computed tomography (CT) and daily cone-beam CT (CBCT). Acute mucositis will be scored by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Eligibility Criteria:
Inclusion Criteria:

* Patients with tongue cancer
* Curatively intended radiotherapy requiring a total dose of 50-70 Gy
* Age \>18 years
* Performance status, Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

None
CER-1236 in Patients With Acute Myeloid Leukemia (AML)

This is a ﬁrst in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efﬁcacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.

CER-1236 is a first in class chimeric engulfment receptor T-cell therapy candidate that targets the Tim4 ligand.

This is a ﬁrst in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efﬁcacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.

The study is divided into Part 1 (escalation phase) and Part 2 (expansion phase).

Part 1 (Escalation Phase): The primary objectives of Part 1 are to deﬁne the safety of different doses of CER-1236 and to deﬁne the recommended dose for Part 2 (RP2D) of CER-1236.

Part 2 (Expansion Phase): The objective of the Part 2 expansion cohort is to evaluate the safety and efﬁcacy of CER-1236 in patients with acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to have a confirmed diagnosis of de novo or secondary AML, or myelodysplastic syndrome (MDS)/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.
* Absolute lymphocyte count \>0.3 x 109/L prior to apheresis.
* Eastern cooperative oncology group (ECOG) performance status 0 to 1.

Exclusion Criteria:

* Prior therapy with a permanently integrated, genetically modified cell product.
* No measurable leukemia on the screening bone marrow evaluation prior to any bridging therapy.
* Active autoimmune disease or history of autoimmune disease requiring treatment within the prior 2 years. Patients with history of autoimmune thyroiditis or type 1 diabetes well controlled on replacement regimen are eligible.
* A known hypersensitivity or severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents.
* Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the physician.
* Primary immunodeficiency disorder.
Prognosis of Coronary Stenosis Based on Intracoronary Imaging; A Multicenter, Prospective Observational Study

The purpose of this study is to evaluate the prognosis of coronary stenosis based on intracoronary Imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients with intracoronary imaging
* Written consent

Exclusion Criteria:

* Severe calcification and/or severe tortuosity
* Lesion with previous bypass graft surgery (CABG)
* Left ventricular ejection fraction less than 30 %
* Coronary spasm
* Life expectancy less than 2 years
* Pregnancy or breast-feeding
Oculomotor and Vestibular Ocular Reflex Exercises in Patients With Benign Paroxysmal Positional Vertigo

The aim of this research is to assess effects of Oculomotor and VOR exercises on vertigo, dizziness and balance in patients with BPPV. Randomized controlled trial was conducted at Hameed Latif Hospital, Lahore. The sample size 32 participants which were divided into two groups, 16 participants in traditional physical therapy group and 16 in oculomotor and vestibular ocular reflex exercises group. Study duration was of 6 months. Sampling technique applied was non-probability consecutive sampling technique. Only 30-70 years individuals with Benign Paroxysmal Positional Vertigo (BPPV) were included. Tools used in the study are vertigo handicap questionnaire, visual vertigo analogue scale, dizziness handicap inventory, berg balance scale and dynamic gait index. The data was analyzed using SPSS.

Randomized controlled trial was conducted at Hameed Latif Hospital, Lahore. The sample size 32 participants which were divided into two groups, 16 participants in traditional physical therapy group and 16 in oculomotor and vestibular ocular reflex exercises group. Study duration was of 6 months. Sampling technique applied was non-probability consecutive sampling technique. Only 30-70 years individuals with Benign Paroxysmal Positional Vertigo (BPPV) were included. Tools used in the study are vertigo handicap questionnaire, visual vertigo analogue scale, dizziness handicap inventory, berg balance scale and dynamic gait index. The data was analyzed using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have vertigo with posterior canal involvement during Dix-Hallpike test with or without accompanying nystagmus (objective or subjective BPPV).
* Ability to walk at least 3 meters by itself with or without assistive device
* Normal vision with or without correction by spectacles or contact lenses

Exclusion Criteria:

* Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases to eliminate confounding factors affecting balance performance
* Unable to understand and answer a simple verbal command.
* Previously underwent oculomotor and vestibular ocular exercises.
* Other vestibular disorders like Meniere disease
* Long-term use of benzodiazepines (more than 20 years).
* Patients who are already performing structured physical activities such as muscle strengthening exercises, Pilates, yoga or high intensity aerobic exercises
Adenomyosis and Ulipristal Acetate

Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.

After inclusion according to criteria, 2 arms : placebo and Ulipristal acetate (UA) 10mg with randomisation, 1 patient with placebo for 3 patients with UA.

48 patients will be included in this trial. The end point will be the bleeding evaluated by Pictorial Blood-loss Assessment Chart (PBAC) score, the amenorrhea rate and the pain evaluated with visual analogic scale.

Eligibility Criteria:
Inclusion Criteria:

* Not postmenopausal women aged 30 to 50,
* Accepting to give consent informed in writing,
* Suffering from a symptomatic pelvic endometriosis (menorrhagia isolated or associated with pain)
* Diagnosis information, confirmed the adenomyosis (T2-weighted) MRI and/or transvaginal ultrasonography, in the 6 months preceding the inclusion-having a score of bleeding (PBAC) \> 100 from J1 to J8 of the menstruation before the visit of inclusion,
* With an index of body mass (IMC) ≥18 and \< 40,
* Using a reliable method of non-hormonal contraception (non-hormonal intrauterine device (IUDs), sexual abstinence, diaphragm, condoms or vasectomy by the partner, or having undergone a surgical sterilization),
* Willing and able to complete auto-questionnaires in french
* Had no difficulties to understand and communicate with the investigator and his representatives
* Affiliation to a social security or assign.

Exclusion Criteria:

* Patient with a hormonal oral contraceptive or with a hormonal intrauterine Device (IUD) contraceptive
* Patient with a history of surgery (other than a caesarean or a cervical conization) uterus, ablation endometrial or uterine artery embolization,
* With other than the endometriosis endometrial pathology,
* Suffering of myoma of type 0, 1, 2 or 3,
* Requiring a transfusion or having a ≤6g/dL hemoglobin
* Existence of systemic coagulation,
* History of thromboembolism
* Progestagen taking severe disorders in the month preceding the tour selection, and corticosteroids and aspirin in the previous week,
* Existence of Pathology renal, respiratory or cardiac severe or progressive,
* Having a disturbed liver function (defined by the aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT), γGlutamylTranspeptidase, alkaline phosphatase or total bilirubin above 2 times the upper limit of normal),
* Existence or suspicion of malignancy,
* Considering pregnancy in the coming year,
* Pregnant patient or nursing
* Any clinical condition that the investigator considers incompatible with the conduct of the study in terms of acceptable security,
* Participation in courses at another clinical study
* Patient whose accession to the test procedures may be insufficient or for which a long term follow-up seems difficult to achieve
* Person under authorship or curators under safeguard of justice
* History of hypersensitivity to the ulipristal or any of the excipients of ESMYA ® 5 mg tablet.
Prospective Assessment of Quality of Life in Patients With Locally Recurrent Breast Cancer and Hyperthermic Radiotherapy

Prospective assessment of Quality of Life in patients with locally recurrent breast cancer after close R0, R1 or R2 resection or local inoperability and hyperthermic radiotherapy.

This prospective monocentric trial evaluates the health-related Quality of Life in patients with local recurrence of Breast cancer after close R0, R1 or R2 resection or local inoperability during and after radiotherapy in combination with hyperthermia of the chest wall. The Health-related Quality of Life and the intensity of fatigue will be documented by the EORTC QLQ-C30, EORTC QLQ - BR 23, FACT - B + 4 and FACIT - Fatigue Questionnaires at the end of the hypertermic radiotherapy and during follow-up after 3 and 12 month and then annually up to year 5.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed local recurrence of breast cancer after close resection (≤1mm Resection margin), R1 or R2 resection respectively inoperable recurrence of the chest wall
* age ≥18 Jahre
* ECOG PS 0-2
* Estimated life expectancy more than 2 years
* Informed consent

Exclusion Criteria:

* Extensive distant metastases that have an estimated life expectancy of \<2a
* Heart disease: severe heart failure (NHYA III / IV), coronary heart disease, state after Myocardial infarction within the last 6 months), AV block III °
* Cardiac pacemaker
* Second malignancy (except cervical carcinomas in situ, local controlled basaliomas, superficial bladder carcinomas (Ta, Tis, T1) or other carcinomas that have lasted more than 5 years behind and have been treated curatively)
* Pregnancy or breastfeeding
* Implanted port on the side to be treated in the Hyperthermia field (located contralateral is not an exclusion criteria)
* Subclavian vein thrombosis less than \<6 months behind
* Other circumstances that preclude hyperthermia
* Circumstances that conflict with regular follow-up care
* Transplanted organs
* Other implants of the ipsilateral chest wall
Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology

This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.

The goals of this project include evaluating the feasibility, acceptability, and helpfulness of the real-time smoking intervention and to assess the preliminary efficacy of the real-time intervention as an adjunct to standard tobacco treatment. Rates of adherence, participant satisfaction, and perceived usefulness will be evaluated through post-treatment interviews and ratings. Biochemically confirmed 7-day point prevalence abstinence will be compared between the experimental and control groups at the end of treatment (week 8).

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Able to read English
* Cigarette smoker
* Seeking smoking cessation treatment

Exclusion Criteria:

* Serious psychiatric or medical condition
* Unable or unwilling to complete study protocol
Molecular Markers in Treatment in Endometrial Cancer

The purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment.

This is a prospective multicenter study to investigate the predictive value of molecular markers in endometrial cancer for lymph node metastasis, prognosis and treatment. For the previously studied tumor markers p53, p16, ER, PR and HER2neu, we want to investigate the expression in curettage material in relation to lymph node metastasis and prognosis among endometrial carcinoma patients. We also want to investigate the distribution of genetic alterations in fresh frozen tumor tissue in order to design prospective randomized treatment trials of metastatic endometrial cancer based on molecular profile. There will be a special emphasis on disturbances in the pathways influenced by new targeted therapy, such as inhibitors of Her2/NEU, EGFR, receptor tyrosine kinase, mTOR, PTEN and hormone receptor pathways.

Eligibility Criteria:
Inclusion Criteria:

* Women with endometrial carcinoma
* Available endometrial biopsy
* Informed consent

Exclusion Criteria:

* No informed consent
Laparoscopic Splenectomy in Children

Laparoscopic splenectomy (LS) gained popularity since it has been described for the first-time during nineties of past century. It has become "golden method" for splenectomy in all ages including children

Background: laparoscopic splenectomy (LS) gained popularity during the last years in pediatric age group. Benign hematological diseases represent the main indications of that procedure. There are some score systems of difficulty of the technique but they are for adult patients. The aim is to develop a prognostic score system of LS in children with benign hematological diseases.

Methods: LS was performed in all children with benign hematological diseases. LS was done by the same team. They operated children in lateral decubitus position. The control of pedicle was achieved using bipolar sealing devices, polymer clips or endoscopic linear staplers. Preoperative, operative, and postoperative data were recorded and analyzed. Children were divided into two groups A and B according to the development of complications.

Eligibility Criteria:
Inclusion Criteria:

* children with benign hematological diseases

Exclusion Criteria:

* malignant hematological diseases
Using a Motivational Interviewing (MI) Informed Text Messaging Program to Lower Blood Sugar in Diabetic Patients.

Despite advances in medical therapy for diabetes, significant numbers of patients fail to achieve adequate blood glucose control. Diabetic patients who engage in more self-care behaviors have better glycemic control, as measured by HbA1C. Patient "activation", defined as the knowledge, skills, beliefs, and behaviors to manage a chronic disease, is key to the performance of these self-care behaviors.

There is a growing literature on diabetes behavioral change interventions; however interventions are often developed and implemented without consideration of patients readiness to engage in lifestyle changes. Additionally, patient-tailored interventions require intensive clinical and financial resources, making them difficult to integrate into clinical practice. Mobile text messaging (SMS) programs have been successfully used to promote smoking cessation, alcohol cessation, and weight loss in diverse patient populations. SMS interventions for diabetes have also been developed, but they have been designed primarily to provide feedback on blood glucose management, rather than to motivate behavioral change. The few studies that included motivational content as a primary feature, did not tailor their intervention to a patient's readiness for change or rigorously describe their motivational intervention, and show limited efficacy.

To address these concerns, we will perform a three-month randomized controlled pilot study to develop and test a Motivational Interviewing (MI)-informed SMS intervention tailored to patient level of activation for patients with poorly controlled type II diabetes.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* type II diabetes
* poorly controlled diabetes (HbA1C \>8 x 2 measurements, with goal \< 8)

Exclusion Criteria:

* pregnancy
* non-English speaking or reading