cyrilzakka/clinical-trials huggingface dataset:
ALLPS VERSUS PVO Randomized Controlled Trial

This randomized phase II trial compares how well associating liver partition with portal vein ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing liver cancer. ALPPS may be more effective than PVO in patients whose disease would traditionally be considered inoperable.

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria: •Patient may have primary or secondary hepatic malignancies with a FLR/TLV \< 30% or a FLR/BW ratio of \< 0.5 for patients with normal liver function (defined as normal transaminases, normal bilirubin, normal factor V, and normal PT/INR). In case of injury due to chemotherapy, known high grade steatosis, or cholestasis \> 50 mmol/L, patient may be enrolled into the trial if FLR/TLV is \< 40% or FLR/BW ratio \< 0.8.

* Patient must have extensive liver tumors that would require portal vein embolization or a two-stage hepatectomy and portal vein embolization or ligation by the judgment of surgeons in the tumor board.
* Patient may have extrahepatic disease as long as it may be addressed after liver surgery and there is a tumor board decision to proceed with liver resection (mostly applicable to CRC metastases).
* Patient may have received previous chemotherapy.
* In cases of cholestasis, preoperative drainage procedures (PTC or ERCP) are left up to judgement of physicians.
* Patient must be = 18 years of age. The patient population over 65 years old needs to be carefully included based on comorbidities.
* Patient may have undergone previous liver resection.
* Patient's location must be such that proper staging and follow-up may be performed.
* Patient's case must be presented at the Multidisciplinary Meeting attended by hepatobiliary surgeons, oncologists, hepatologists, and radiologists, or must be approved directly by Dr. Strasberg or Dr. Chapman.

Exclusion criteria: •Patient must not have any significant concomitant diseases rendering him/her unsuitable for major liver surgery by the judgment of the physicians involved, especially if the patient is \> 65 years old.

* Patient must not have enrolled into a clinical trial within 4 weeks of study entry.
* Patient must not have peritoneal carcinomatosis or other extensive extrahepatic disease.
* Patient must not have advanced stages of carcinoma of the gallbladder (T3/T4)
* Patient must not have issues such as drug and/or alcohol abuse.
* Patient must not need major extrahepatic surgery (e.g. pancreas resection, gastric resection, rectal surgery) within 3 months of study entry.
* Patient must not be a candidate for liver transplantation in case of HCC.
* Patient must not be pregnant or breastfeeding. If a female of childbearing potential, patient must have a negative pregnancy test within 14 days of enrollment.
A Study of Avastin (Bevacizumab) and Transarterial Chemoembolisation (TACE) Treatment in Patients With Liver Cancer

This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE sessions until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 18 years of age.
* Liver cancer, not suitable for resection.
* At least 1 measurable lesion, and overall tumor lesions occupying \< 50% of liver volume
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:

* Patients receiving concurrent radiotherapy or immunotherapy.
* Patients who have received previous chemotherapy, biological agents, or radiotherapy.
* Prior transarterial chemoembolisation (TACE) or transarterial embolisation (TAE).
* Prior liver transplantation or liver resection.
* Current or recent (within 10 days of study start) use of full-dose anticoagulants for therapeutic purposes.
* Patients with high risk esophageal/gastric varices.
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers

The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* The patient has participated in study DK143WS
* The patient is able to understand the treatment and is willing to comply with the treat-ment regimen.
* The patient is willing and able to give written informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Concomitant participation in other studies
A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis

This single-arm study will assess the efficacy and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Chronic renal anemia
* Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
* Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months
* Poorly controlled hypertension
* Significant acute or chronic bleeding
Treatment Intensification With Temozolomide in Adults With a Glioblastoma

Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d'Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years old
* Histological diagnosis of de novo GBM (extemporaneous diagnosis or standard pathological examination). In case of extemporaneous diagnosis, the patient can be included. If the diagnosis is not confirmed, the patient will be withdrawn from study.
* Time between initial surgery/biopsy and planned start of treatment (if allocated to the experimental arm) ≤ 15 days (ideally in the first 7 days)
* Karnofsky performance status (KPS) ≥ 60%, or KPS \<60% only related to glioma-related motor paresis.
* Adequate biological functions
* Common toxicity criteria (CTC) non hematological adverse events ≤ Grade 1 (except for alopecia, nausea, vomiting and neurological symptoms)
* Females of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 6 months after stopping the study drug.
* Standard radiation therapy deemed feasible (60 Gy, 30 fractions)
* Time interval of less than 43 days between initial surgery/biopsy and planned start of radiation therapy
* Written informed consent

Exclusion Criteria:

* Secondary or recurrent glioblastoma (GBM)
* Planned use of tumor-treating electric fields
* Planned use of Carmustine implants
* Prior malignancy in the last 5 years before inclusion or concomitant
* Severe myelosuppression
* Known hypersensitivity to any of the study drugs, study drug classes, excipients in the formulation or to dacarbazine (DTIC)
* Current or recent treatment with another experimental drug or patients included in a clinical therapeutic trial (in the 30 days prior to inclusion).
* Known current viral hepatitis, HIV infection or current active infectious disease
* Inability to swallow oral medications or any mal-absorption condition
* Pregnant or breastfeeding patients.
* Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
* Person under guardianship or curatorship
Change in Mindfulness in Borderline Personality Disorder

The current study aims to investigate the effect of dialectical behavioral therapy on mindfulness in patients with Borderline Personality Disorder. A treatment group will be compared to a waitlist control group.

Participants will be recruited from the Dialectical-Behavioral-Therapy (DBT) unit. DBT is a treatment approach that has been shown to be effective in the treatment of Borderline Personality Disorder. DBT integrates different psychotherapeutic interventions as well as Mindfulness Meditation exercises. Mindfulness is a meditation practice that can improve present moment awareness. When applied as therapeutic intervention mindfulness meditation can help patients to stay with their attention in the present moment, to be aware what is happening in the here and now, and to better identify and regulate upcoming emotions.

The current observational study investigates changes in symptom severity and mindfulness skills during DBT treatment. A treatment group will be compared to a waitlist control group. The two groups are predefined by routine medical care.

Symptom severity and mindfulness skills will be assessed at baseline (before treatment or when accepted for the waitlist) and after 12-weeks. A within and between group analyses will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Borderline Personality Disorder
* On the waitlist for DBT treatment or actually treated with DBT
* Not previously treated with DBT.

Exclusion Criteria:

* Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality
Pesticides and Parkinson´s Disease

The aim of this project is to study whether people exposed to pesticides have a higher risk of developing PD. We will perform an epidemiological study determining the presence of pesticides in urine and comparing signs traditionally associated with PD in early forms.

Within different risk factors, pesticide exposure increases the risk of developing Parkinson's disease (PD) through epigenetic mechanisms by modifying the expression of genes related to PD and secondary mitochondrial dysfunction.We will conduct a cross-sectional prevalence study with cases (exposed to pesticides) and controls (not exposed to pesticides), randomly selecting 130 individuals in each group. Pesticide exposure will be determined through questionnaires.We will study the prevalence of preclinical and prodromal PD based on pesticide exposure, stratified by age and gender in the exposed, and non-exposed groups. Preclinical and prodromal PD will be assessed using: biological biomarkers and prodromal PD signs. Multivariate analyses will be employed to determine the risk of presenting early PD, adjusting for different clinical covariates. The results of this study will allow us to understand the early mechanisms associated with neurodegeneration and pesticides exposure.

Eligibility Criteria:
Inclusion Criteria:

* Farmers exposed to pesticides for cases
* No work exposure to pesticides for controls

Exclusion Criteria:

* Subjects without signed consent form
* Neurological significant conditions
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer

This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual and psychosocial function.

PRIMARY OBJECTIVES:

I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a phase II randomized clinical trial (RCT).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic or breast cancer treatments and sexuality, and provision of a survivorship care plan (SCP) created using OncoLink over 1 hour following baseline assessment and before 6 months.

ARM II (Psychological intervention): Patients participate in individual or group therapy over 1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.

After completion of study treatment, patients are followed up at 3, 6, and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III gynecologic (any site) or breast cancer
* Able to speak/read English
* Able to give informed consent

Exclusion Criteria:

* Prior non-gynecologic/breast cancer diagnosis
* Refusal of any cancer treatment(s)
* Non-ambulatory
* Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
* Major mental illness (e.g, schizophrenia, major depressive disorder)
* Current/recent (prior 12 months) pregnancy
* Residence \> 70 miles from research site
Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable disease or a partial remission following definitive salvage therapy.

Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients who have received ASCT following salvage chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older and willing and able to provide informed consent;
* Histologically confirmed relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma (follicular or other), or primary mediastinal large B-cell lymphoma;
* Received prior treatment with a standard anthracycline and therapeutic anti-CD20 monoclonal antibody-based regimen;
* For transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment must have resulted in a PR or stable disease;
* For post autologous stem cell transplant (ASCT) patients, salvage therapy plus ASCT just prior to MDV9300 treatment must have resulted in a PR or stable disease;
* Adequate bone marrow reserve as defined per protocol;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Patients with stable ECOG scores of 2 may be allowed with medical monitor approval.

Exclusion Criteria:

* Burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma
* History of serious autoimmune disease;
* History of central nervous system involvement of lymphoma;
* Prior therapy with agents targeting immune coinhibitory receptors.
Study of BMS-986497 (ORM-6151) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).


Eligibility Criteria:
Inclusion Criteria:

* Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
* Detectable levels of cluster of differentiation 33 (CD33) expression.
* Failed alternative therapies with established benefit.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.

Exclusion Criteria:

* Acute Promyelocytic Leukemia.
* Clinically active central nervous system leukemia.
* Active malignant solid tumor.
* Pregnant or breastfeeding.
* Other protocol-defined inclusion/exclusion criteria apply.
A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia

This multicenter, open label, dose-escalating study will evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of RO5503781, administered once daily (QD) or once weekly (QW) in participants with advanced malignancies except leukemia. Participants will receive multiple escalating oral doses in two different dosing schedules (Sch) until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced malignancies, except all forms of leukemia, for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the participants
* Measurable disease (according to RECIST or Cheson criteria) or evaluable disease prior to administration of study drug
* Minimum weight of 35 kg and life expectancy of greater than or equal to (\>=) 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Acute toxicities from any prior anti-tumor therapy, surgery, or radiotherapy must have resolved to NCT-CTCAE Grade less than or equal to (\<=) 1
* Adequate renal, hepatic and bone marrow function
* Participants with stable Central Nervous System (CNS) metastasis and with chronic, stable and rate controlled atrial fibrillation
* Participants in consideration for the biomarker cohorts or apoptosis imaging cohort must consent and be able to undergo paired biopsies for tumor biomarker analyses
* Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

* History of any form of leukemia except for Stage 0 and 1 chronic lymphocytic leukemia (CLL) not requiring treatment in addition to the underlying solid tumor
* Use of hormonal therapy within 2 weeks and use of other investigational agents or having received investigational drugs \<= 4 weeks prior to study treatment start
* History of seizure disorders or unstable CNS metastases
* Severe and/or uncontrolled cardiovascular disease or disorder
* Active (acute or chronic) or uncontrolled infection
* Pregnant or breastfeeding women
* HIV-positive participants who are currently receiving anti-retroviral treatment
* Known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
* Participants receiving oral or parenteral anticoagulants/antiplatelet agents; anticoagulant flushes for maintenance of indwelling catheters are allowed
* Participants with known bone marrow disorder which may interfere with bone marrow recovery
* Participants with hypersensitivity reaction to 18Fluorothymidine (FLT or 18F) compounds
CEDM as a Screening Tool for Breast Cancer in Higher-risk Women: A Prospective Study

To evaluate the effectiveness of Contrast-enhanced digital mammography (CEDM) in detecting breast cancer in women at higher risk.

The aim of this study was to evaluate the effectiveness of different imaging techniques for detecting breast cancer in women with a higher risk due to personal or family history of the disease.

Eligibility Criteria:
Inclusion Criteria:

* women underwent CEDM screening

Exclusion Criteria:

* incomplete imaging exams
Hemodynamic Changes During Implant Surgery with Intravenous Conscious Sedation

The goal of this study is to determine whether intravenous sedation would contribute to the stabilization of hemodynamics in adult patients during periodontal/implant surgery compared to receiving local anesthesia during periodontal/implant surgery

Monitoring is the global method of observation and data recording in relation to body organ and system function that afford constant information to ensure continuous evaluation of the patient's physical condition. The aim of this study is to determine whether intravenous sedation would contribute to the stabilization of hemodynamics in adult patients during dental surgery.

Secondary, patient related outcome will be evaluated by a questionnaire to determine the patients' perception, acceptance and comfort during intravenous sedation after assessing the influence of patients' preoperative anxiety.

50 subjects who need implant/periodontal surgery at the University of Michigan School of Dentistry will be recruited for this study.

Eligibility Criteria:
Inclusion Criteria:

* Be ≥ 18 years of age
* Need dental implant/periodontal surgery with or without IV sedation (up to a maximum of 4 implants)

Exclusion Criteria:

* You have any reason you cannot comply with the study protocol
* You take any medication that may influence hemodynamic changes including anxiolytic medication (last intake \<48 hours before intervention) as well as pain medication (last intake \<48 hours before intervention)
* Pregnant or unsure of pregnancy (self-reported)
Progressive Resisted Exercise Plus Aerobic Exercise on Osteoporotic Systemic Lupus Erythmatosus

systemic lupus erythematosus (SLE) is the most common autoimmune disease in women of childbearing age. Promoting physical activity is a major national priority for the general population, including patients with chronic diseases. The aim of this study is to investigate the efficiency of combined effect of progressive resisted exercise with aerobic exercise for bone mineral density, quality of life, muscle strength and physical activity for patients with SLE.

The following factors were found to be significantly related to lower BMD by univariate analysis: Caucasian race, older age at diagnosis, higher age at the time of the first DXA, longer disease duration, higher cumulative corticosteroid dose, lower serum levels of 25(OH)D, higher SLE Damage Index score, and postmenopausal status. In the multivariate analysis only the following factors were significant: Caucasian race, increased number of pregnancies, postmenopausal status, higher SLE Damage Index, and higher cumulative corticosteroid dose.

As the quality of life among patients with SLE not fully associated with SLE disease activity, pharmacologic treatments that are effective for SLE disease activity might not be able to improve quality of life in these patients Therefore, the beneﬁt of nonpharmacological therapies on quality of life has been explored.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus by the classification criteria ACRa and the 2019 EULARb/ACR Classification Criteria for systemic lupus erythematosus
* Systemic Lupus Erythematosus Disease Activity Index ≥4
* For 30 day prior, stable immunosuppressive therapy with steroid (0-20 mg/day) or other immunosuppressive medication such as hydroxychloroquine, chloroquine, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, belimumab, rituximab

Exclusion Criteria:

* Those who are pregnant.
* Patients with active lupus nephritis, cardiovascular dysfunction, rhythm and conduction disorders.
* Patients with musculoskeletal disturbances; kidney and pulmonary involvements; peripheral neuropathy and fibromyalgia.
* Use of tobacco; treatment with lipid-lowering, chronotropic or antihypertensive drugs