cyrilzakka/clinical-trials huggingface dataset:
Activated Allogeneic Lymphocytes for Induction Graft Versus Tumor Effect in Metastatic Solid Tumors

The present protocol is a phase 2 study designed to investigate the potential application of allogeneic cell-mediated immunotherapy in metastatic solid tumors, similarly to the well established graft versus leukemia (GVL) effects, in patients with metastatic solid tumors resistant to conventional treatment modalities. Patients will be eligible to participate in a treatment program based on systemic administration of mismatched lymphocytes activated in vitro with rIL-2 (LAK) followed by rIL-2 inoculation in vivo. This treatment is aiming to induce an anti-tumor effect mediated by the efficient killing activity of the rIL-2 activated cells. Prior to cell infusion patients will receive the conditioning treatment with low dose Cyclophosphamide (Cyc) or Fludarabine with 2 injections of low dose alpha interferon. Cell therapy will be combined with specific anti-tumor monoclonal antibodies if available for the specific disease. Further activation of the anti-tumor activity of alloreactive donor T cells and natural killer (NK) cells will be accomplished by in vivo inoculation of rIL-2, aiming for enhancing the anti-cancer potential of donor-derived effectors cells. Patients will receive one - three cycles of cell therapy, as long as there are no signs of Graft- versus - Host - disease (GVHD) and the malignant disease is controlled.


Eligibility Criteria:
Inclusion Criteria:

Consenting patients (age 12-70) will be eligible for participation in the study involving anti-tumor immunotherapy provided the following criteria are met:

1. Evidence of cancer not expected to be cured with conventional modalities:

   Pediatric patients: Chemotherapy-resistant neuroblastoma stage 4 \& sarcomas. Adult patients: Metastatic breast cancer, malignant melanoma, renal cell cancer and selected cases of ovary cancer, gastrointestinal cancer, small-cell and non-small cell lung cancer with non-bulky metastatic disease, metastatic prostate cancer.
2. Patients with measurable disease evaluable for response with anticipated life expectancy \>3 months.
3. Patients must be \>2 weeks off anti-cancer or potentially immunosuppressive treatment.
4. Adequate ambulatory performance status (Karnofsky \>80%; ECOG 0-1) to enable outpatient treatment (see Appendix 1).
5. Compliant and cooperative patients anticipated to be evaluable for response according to investigator's assessment.
6. HLA-noncompatible (partial matched or mismatched) donor available.

Exclusion Criteria:

Patients will be excluded from participation in the study if any of the following criteria are met:

1. Any of the above criteria are not met.
2. Patients with a significant history or current evidence of potentially severe cardiovascular disease.
3. Hepatic and/or renal failure.
4. Abnormal PT and PTT.
5. Patients with abnormal hemogram (PMN\<1.0x109/L; HB\<10; Plts\<50x109/L)
6. Evidence of serious active infection requiring antibiotic therapy.
7. Evidence of active disease requiring steroid or cytotoxic therapy.
8. Pregnancy.
9. Contraindication for donation due to donor disease: HIV-1; HBsAg positivity.
The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR

The involvement of eukaryotic translation initiation factor 4E (eIF4E) in human placental implantation and in the pathological pregnancies: preeclampsia and IUGR.

4 groups

Eligibility Criteria:
Inclusion Criteria:

* post TOP or DELIVERY

Exclusion Criteria:

-
BRCA1-associated DNA Repair Dysfunction in Patients With Early Triple Negative Breast Cancer Treated With Neoadjuvant Platinum-based Chemotherapy

The purpose of this study is to assess efficacy of platinum-based neoadjuvant chemotherapy in correlation with BRCA1-associated DNA repair dysfunction in patients with early triple negative breast cancer.

Recent gene expression profiling of breast cancer has identified specific subtypes with clinical, biologic, and therapeutic implications. The basal-like group of tumors is associated with aggressive behavior and poor prognosis, and typically do not express hormone receptors or HER-2 ("triple-negative" phenotype). Therefore, patients with basal-like cancers do not benefit from currently available targeted systemic therapy.

There is a lot of evidence about a link between basal-like breast cancer and BRCA1 deficiency. Many clinical characteristics and molecular features are shared by basal-like breast cancers and tumors that arise in carriers of BRCA1 germline mutations.

Some studies have indicated that BRCA1 mRNA expression was lower in basal-like sporadic cancers than in controls matched for age and grade. BRCA1 is rarely mutated in sporadic breast cancers and, therefore, it is believed that this may be a result of epigenetic mechanisms such as acquired methylation of the BRCA1 gene promoter or a dysfunction in the pathways that regulate BRCA1 expression, such as overexpression of ID4. The profound similarities between hereditary BRCA1-related breast tumors and basal-like tumors strongly implicate a fundamental defect in the BRCA1 or associated DNA-repair pathways (p53, PTEN) in sporadic basal-like tumors.

There is increasing evidence that the BRCA1-related DNA-repair defects, especially defective homologous recombination, determines sensitivity to certain agents, such as platinum salts-based chemotherapy. The complexity in downregulation of BRCA1 expression suggests that these approaches may only be effective in the treatment of a subset of sporadic basal-like cancers. Identification of specific markers for these cancers will be essential to translate an understanding of defective DNA repair into targeted treatments for this poor prognosis subtype.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients, age ≥18 years≤75;
2. Histologically confirmed invasive ER-, PR-, and HER2-negative (triple- negative) adenocarcinoma of the breast;
3. Clinical stage T1-2, N0-1, M0.

Exclusion Criteria:

1. Previous treatment for this breast cancer
2. History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease
3. Pregnancy or breast-feeding
Differences in Ovarian Aging Between Caucasian and Indian Women

The investigators want to carry out a prospective study of 400 infertile Caucasian and Indian women who will undergo a controlled ovarian stimulation for in vitro fertilization (IVF). The investigators will collect data about ovarian reserve markers and also the results after ovarian stimulation in both ethnic groups.The aim is to identify differences in ovarian response after IVF stimulation between both groups.

A total of 200 Caucasian patients and 200 Indian patients who will attend the first or second IVF cycle will be included.

The date we will collect in both groups include the age, the body mass index, and the ovarian reserve markers like the antral follicle count (AFC), the follicle stimulation hormone (FSH) and antimullerian hormone (AMH) serum levels.

The investigators will also determine the number of oocytes retrieved and the metaphase two oocytes in both groups after IVF stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Women aged \< 42 years old, with both ovaries present, undergoing a first or second IVF treatment due to male factor, tubal disease or previous failed intrauterine insemination (IUI).

Exclusion Criteria:

* Women diagnosed of polycystic ovary syndrome according to Rotterdam criteria, endometriosis stage III-IV, or previous pelvic inflammatory disease.
Study on Pressure Ulcers Prevention With Mepilex® Border Sacrum Dressing in Scheduled Cardiovascular Surgery

The study is a randomised controlled trial of patients admitted for a scheduled cardiac surgery at the Clermont-Ferrand hospital.

Patients meeting the study inclusion criteria will be allocated to either the control group that will receive pressure ulcer prevention standard care or the intervention group that will receive pressure ulcer prevention standard care plus have a Mepilex® Border dressing applied to their sacrum.

The main objective of this research is to evaluate the impact of Mepilex Border® dressing applied in addition to standard pressure ulcer prevention protocol, in a French hospital setting, in at-risk patients in a cardiovascular surgery unit with full hospitalisation including block operation and ICU.

Hypothesis: Patients treated with Mepilex® Border dressings will have a lower incidence rate of sacral pressure ulcer development than patients receiving standard care.

Eligibility Criteria:
Inclusion Criteria:

* Subject over 18 years of age,
* Subject programmed to benefit from cardiac surgery with sternotomy,
* Subject capable and willing to comply with the protocol and willing to give his written consent,
* Subject affiliated to a social security system

Exclusion Criteria:

* Subject with a skin lesion in the sacral area upon admission,
* Subject admitted for emergency cardiovascular surgery (unscheduled subject),
* Subject admitted for heart transplant surgery,
* Subject participating in another clinical study or in a period of exclusion from a study previous,
* Subject with a linguistic or psychological disability to sign informed consent,
* Subject refusing to give written consent,
* Subject deprived of liberty by administrative or judicial decision, under guardianship or curatorship.
Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy

The purpose of this study is to investigate the use of intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine if these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins.

This research study is a Phase II clinical trial investigating the use of intra-operative MRI and MS in breast cancer surgery. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

Prior research has shown that intraoperative MRI and MS are two types of tests that are feasible to use during cancer surgery and may be able to guide therapy. In this study, we are evaluating the accuracy of intra-operative MRI and MS in determining whether or not all cancer tissue was removed during breast surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be female
* Participants must have a pre-operative standard mammogram with or without ultrasound. These may be performed at outside institutions.
* Participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at BWH/DFCI.
* Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for BCS, and the ability to undergo standard radiation therapy post-operatively).
* Patient must meet standard MRI guidelines and be able and willing to undergo MRI
* Age ≥18 years and \< 75.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants with a known BRCA 1 or 2 mutation.
* Participants with known Li-Fraumeni or Cowden's Disease.
* Participants with prior mantle radiation.
* Participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin.
* Participants who are pregnant.
* Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy.
* Participants with known active collagen vascular disease.
* Participants with prior history of ipsilateral breast carcinoma.
* Patients who have biopsy confirmed multi-centric disease.
* Participants who have documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure.
* Participants who exceed the weight limit for the surgical table at AMIGO, 350 lbs or who will not fit into the 70 cm diameter bore of the MRI scanner at AMIGO or the 60 cm diameter bore of the pre-procedure imaging MRI scanner.
Mindfulness and Student Health

In recent years, there has been growing interest in the well-being and mental health of college students, driven by a significant increase in mental health problems within this population. Several mindfulness interventions, a technique to improve present moment awareness and emotional acceptance, have shown positive results in improving mental health and developing healthy lifestyle habits in this group.

A recent systematic review with meta-analysis (González et al. 2023) indicates that not only the complete standardized 8-week Mindfulness-Based Stress Reduction (MBSR) program but also other Mindfulness-Based Interventions (MBI) are effective. Compared to MBSR, other MBIs require less time commitment, making them more accessible to a larger population and potentially improving program adherence.

In this study, the researchers compare the results of two interventions, one with MBSR (both in-person and virtual) and another with a shorter MBI (in-person) in a sample of 100 university students. Using four different tools as pre- and post-test measures (Healthy Lifestyle Questionnaire \[CEVS-2\], Mental Health Continuous Form \[MHC-SF\], Perceived Stress Scale \[PSS\], and Mood Regulation Skills Questionnaire). emotions \[ERSQ\] \]), researchers aim to establish the potential degree of health improvement that different mindfulness interventions can have on the health of university students.


Eligibility Criteria:
Inclusion Criteria:

* Individuals enrolled in university education programs.
* Specific age range that fits the typical characteristics of college students (e.g., 18-25 years old).
* Participants who have given informed consent to participate in the study.
* Students who can commit to participating in the intervention sessions and completing the evaluation questionnaires.

Exclusion Criteria:

* Individuals with medical conditions that could interfere with safe participation in mindfulness sessions (e.g., serious cardiovascular conditions, respiratory disorders).
* Students who have significant difficulties in language comprehension or communication that may affect participation and evaluation.
* Students who are currently actively participating in other similar mindfulness programs could be excluded to avoid bias in the results.
* Individuals with diagnoses of unstabilized serious mental disorders who may require more intensive clinical management.
* Students who are unable to commit to scheduled dates and times for interventions and assessments.
Outcome of Crisis Intervention for Subjects With Borderline Personality Disorder or Post-Traumatic Stress Disorder

Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in patients with borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD). The term "behavioral crisis" is used strictly for periods of uncontrollable urges to repeat mental or outward activity, e.g., flashbacks, cutting, binging on food, drugs or sex, with no intervals to rethink one's priorities or to consider others' direction.

The clinical hypothesis states, in two steps, that:

1. the perception of a life crisis precedes and then underlies every behavioral crisis;
2. the behavioral crisis resolves promptly and all symptoms end if the clinicians engage the patient about his management of the life crisis that underlies the symptoms.

Subjects in the experimental group will be treated by Dr. Laddis after their admission to a crisis stabilization unit (CSU) or to an inpatient unit (IPU) for a behavioral crisis. Subjects will be included at random, as assigned to Dr. Laddis according to his routine duties at those units.

Subjects in the control group will receive treatment for behavioral crisis according to the preference of the clinical staff at other comparable units. That treatment will constitute "treatment as usual". Clinicians in the control settings will not be informed about the experimental hypothesis, the clinical intervention and the contingent outcomes.

The subjects will be tested for the results of treatment 12-24 hours after composition of a treatment plan. The testing will be done with the Brief Psychiatric Rating Scale (BPRS), as well as with a set of criteria devised by Dr. Laddis to measure the outward behavior and the mental events during behavioral crisis. The patients and the attending frontline staff will be interviewed also about their beliefs in regard to what, among the clinicians' interventions, made a difference for the course of the behavioral crisis, for better or for worse. The raters will be trained for interrater reliability and they will not be informed about the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with BPD or PTSD, with a structured interview according to the current diagnostic manual
* In behavioral crisis

Exclusion Criteria:

* Brain damage
* Currently intoxicated with alcohol or drugs or in withdrawal
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients

The purpose of this study is to investigate the pharmacokinetics of rectal and sublingual administration of tacrolimus and to compare with pharmacokinetics after oral administration of tacrolimus in renal transplant patients before transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients that will have a kidney transplant patient and will be treated with tacrolimus. As well as hemodialysis patients as well as peritoneal dialysis patients are included.
* Age: 18 - 65 years
* Patient's informed consent

Exclusion Criteria:

* Patients that use drugs that interact with tacrolimus
* Patients that participate in other studies
* Patients that are treated with tacrolimus
Taiwan Cancer Moonshot Project

The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform.

Multiomic integrative analysis is an effective strategy to facilitate the investigation of molecular mechanism, cause, and early intervention of specific diseases. Gastric cancer is specifically chosen for our research target to decrease its incidence and improve survival. To increase precision diagnosis, prognosis and precision therapy, patients from Taiwan are selected as cohort subjects. The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform. Genome, transcriptome, genomic methylation, proteomics, and post-translational modification will be used to construct a map for determine the in-depth carcinogenesis of gastric cancer and strategies for cancer early diagnosis, prevention, and targeted treatments.

Eligibility Criteria:
Inclusion Criteria:

* lung cancer, breast cancer, gastric cancer, pancreatic cancer, ovarian cancer

Exclusion Criteria:

* other cancer types
Facial Expression Recognition and Mirror Neurons in Parkinson's Disease

After few years of evolution, patients with Parkinson's disease may develop apathy, with different degrees of severity. Apathy is characterized by a loss of interest for the others and for activities. The lack of social interactions in these patients may be due to an impairment in decoding emotional facial expression. Indeed, facial expression recognition, which is necessary to understand other's emotional state, requires a subclinical facial mimicking of the expression observed. Yet, one of the clinical signs of PD is amimia.

This study aims to determinate if there is a facial mimicry disorder in PD ( Parkinson's disease )patients with emotional facial expression (EFE) recognition impairment, compared to healthy control subjects. We also want to know if this facial mimicry disorder is primary (subtended by facial mobility impairment, that is to say amimia) or secondary (related to the mirror neuron systems that allows us to activate similar neural networks when observing and feeling a specific emotion)

20 patients with an Idiopathic Parkinson's disease

+ 20 paired healthy volunteers (on sex, age, and education)

After inclusion, patients are evaluated two times: they are studied without medication (MED OFF) and with medication (STIM ON) in a randomized order. The 2 evaluations should be spaced out 15 days to one month (J0 and J+15d)

Healthy subjects have only one visit J0 (inclusion and emotional facial expression recognition tests are made at the same time)

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic Parkinson's disease according to UKPDSBB criteria - Men or women aged between 18 to 75 years
* Free from any visio-perceptive disorder (visual acuity and Vitec)
* Affiliated to National Health system
* Having given their informed consent

  --Healthy controls
* Men or women aged between 18 to 75 years
* Free from any visio-perceptive disorder (visual acuity and Vitec)
* Affiliated to National Health system
* Having given their informed consent

Exclusion Criteria:

* With dementia or with significant dysexecutive disorder (MMS \<24, MATTIS\< 130)
* With fluctuations (\<5 Levodopa intakes / day)
* With severe depression (BDI \> 27)
* With psychiatric comorbidities (hallucinations, psychos) evaluated with l'Unified Parkinson's disease Rating Scale part I (UPDRS part I =0)
* With faces processing disorder (Benton \< 39)
* Pregnant
* Treatment with deep brain stimulation
* Under guardianship
* In excluding period for another study

  --Healthy controls
* Suffering of neurological or psychiatric evolutive condition
* With severe depression (BDI \> 27)
* With faces processing disorder (Benton \< 39)
* Pregnant
* In excluding period for another study
Effects of Open-label vs Double-blind Treatment in IBS

The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Meet Rome IV diagnostic criteria for IBS