cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma Who Have Not Responded to Anthracycline-Containing Combination Chemotherapy

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide, etoposide, and cisplatin in treating patients with intermediate or high-grade non-Hodgkin's lymphoma who have relapsed following or are resistant to anthracycline-containing primary combination chemotherapy.

OBJECTIVES: I. Determine the efficacy of high-dose cyclophosphamide/etoposide/cisplatin in patients with intermediate- or high-grade non-Hodgkin's lymphoma who have failed primary combination chemotherapy but still respond to conventional-dose DHAP (dexamethasone/cytarabine/cisplatin) and are not candidates for bone marrow transplantation. II. Determine the toxicity of the intensification chemotherapy regimen in this group of patients.

OUTLINE: Nonrandomized study. 3-Drug Combination Chemotherapy. CVP: Cyclophosphamide, CTX, NSC-26271; Etoposide, VP-16, NSC-141540; Cisplatin, CDDP, NSC-119875.

PROJECTED ACCRUAL: If at least 1 CR is seen in the first 6 patients, an estimated maximum of 20 patients will be enrolled. If 3 or more of the first 10 patients (or 25% of the study population thereafter) die within the first 35 days of treatment from causes unrelated to tumor progression, the study will be terminated.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed intermediate- or high-grade non- Hodgkin's lymphoma of the following histologies: Follicular, predominantly large cell Diffuse small cleaved cell Diffuse mixed, small and large cell Diffuse large cell Large cell, immunoblastic Lymphoblastic Small noncleaved cell Disease has relapsed following or is resistant to primary anthracycline-containing combination chemotherapy Objective response to salvage DHAP chemotherapy required Ineligible for bone marrow transplantation

PATIENT CHARACTERISTICS: Age: 18 to 64 Performance status: Zubrod 0 or 1 Hematopoietic: ANC at least 1,500 Platelets at least 140,000 Hb at least 10 g/dl Hepatic: Bilirubin less than 1.5 mg/dl (26 micromoles/liter) SGOT less than 4 x normal Renal: Creatinine less than 1.5 mg/dl (133 micromoles/liter) Cardiovascular: LVEF greater than 50% No life-threatening arrhythmia by EKG No uncontrolled hypertension Pulmonary: FEV, FVC, and DLCO greater than 50% of predicted Other: No uncontrolled diabetes No other uncontrolled medical condition No history of second malignancy except: Nonmelanomatous skin cancer Carcinoma in situ Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior anthracycline-containing combination chemotherapy required Prior salvage DHAP chemotherapy required Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Rectal Reconstruction in Treating Patients Who Are Undergoing Surgery for Rectal Cancer

RATIONALE: Rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. It is not yet known which method of rectal reconstruction is most effective after surgery.

PURPOSE: This randomized phase III trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.

This is a randomized, multicenter study. Patients are stratified according to participating center, gender, distance of the distal tumor margin from the dentate line (\> 5 cm vs ≤ 5 cm), age (\< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis (M0 vs M1). Patients are randomized to 1 of 3 treatment arms.

Eligibility Criteria:
* Histologically proven rectal adenocarcinoma or rectal adenoma with/without neoadjuvant radiochemotherapy
* Total mesorectal excision needed
* Age ≥ 18 years
* Clinically normal function of the sphincter muscles (no history of frequent fecal incontinence for liquid or solid stools)
* Any T, any N, any M or adenoma
* An R0-resection is expected (liver metastases planned to be simultaneously
* Written informed consent, signed and dated by the patient and the investigator
* Completed baseline quality of life questionnaire

Exclusion criteria:

* Rectal tumor other than adenocarcinoma or adenoma
* Previous rectal cancer surgery, other than local excision within the last 2 months
* Histologically proven chronic inflammatory bowel disease
* Contraindications to any of the 3 surgical techniques
* BMI \> 35
* Patients with psychiatric, addictive or any disorder that would prohibit the understanding and giving of informed consent, completing the QL questionnaires and/or following the structured interview
* Inability to read and understand any of the languages available on the QL questionnaires,and spoken during the interview (German, French, Italian)
PARADISE: Predicting AF After Cardiac Surgery

The PARADISE study aims to develop and validate prediction tools to identify patients at risk of Atrial Fibrillation (AF) after cardiac surgery.

Atrial Fibrillation (AF) is a common abnormal heart rhythm. AF causes the heart to beat irregularly and sometimes very rapidly. About 30-50% of patients develop AF after heart surgery. These patients stay longer on the Intensive Care Unit (ICU) after surgery, are more likely to develop complications and have a higher risk of dying. Avoiding AF is important.

Some drugs, including beta blockers and amiodarone may help prevent AF if given after surgery. However, these may also lead to complications (such as lung damage). It is therefore important to identify which patients are most likely to benefit from these treatments (i.e., where the benefits outweigh the risks). There are existing tools designed to predict the risk of suffering AF after heart surgery. However, they are unreliable and therefore not used in clinical practice. A modern, reliable risk prediction tool is needed.

The PARADISE study will develop and test new prediction tools to identify which patients are most at risk of developing AF after heart surgery. The investigators will focus our tools on those patients who most commonly develop AF, such as those who have had surgery to repair a valve or blood vessel in their heart.

To do this the investigators will:

* Review the medical literature and assemble a panel of medical experts to create a list of known factors that affect patients' risk of AF after heart surgery
* Use a large UK general practice database (CALIBER) to see whether the investigators can find new risk factors.
* Ask the expert panel to agree a list of known and new risks factors to be included in the prediction tool.
* Develop two new prediction tools using an existing American cardiac surgery database (the Partners research Database). The first will be used before surgery, the second immediately following surgery. Two models are needed as events during surgery may alter the risk of AF.
* Test how reliably our new tools predict which patients suffer AF after surgery, with data from large UK (United Kingdom) NHS (National Health Service) heart centres, one US Hospital (Brigham) and a UK clinical trial (Tight-K).
* The investigators will work with two charities (AF Alliance and StopAfib) to share our results with patients and the wider public.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or over
* Admitted to hospital for any cardiac surgery

Exclusion Criteria:

* Patients who have requested that their data not be used for research (e.g. NHS Opt-out)
Treatment of MDEs During the Course of Psychotic Disorders With Duloxetine

We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders

Major depressive episodes (MDE) frequently occur during the course of schizophrenic psychoses, both as as "post-psychotic" depressions, and also independently from psychotic episodes. A number of clinical studies reported the application of different antidepressive substances, such as Imipramine, Reboxetine or Venlafaxine. In general, the treatment of schizophrenic patients with antidepressive drugs can be considered as necessary and save, resulting in therapeutic guidelines of different psychiatric societies. However, since 5 to 10 % of the schizophrenic patients commit suicide, there is still much effort necessary in order to improve the treatment of affective symptoms in schizophrenic psychoses.The recently introduced antidepressive substance Duloxetine selectively inhibits as a SSNRI the reuptake of serotonine and noradrenaline from the synaptic cleft. Duloxetine was proven as antidepressive, anxiolytic and analgetic in a series of multi-centre, placebo-controlled investigations. Based on these considerations and on successful experiences in single case reports we aim to investigate the therapeutic effects of duloxetine in patients with lifetime diagnoses of the schizophrenic spectrum.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive episode, Severity: CDSS at least 8 points or HAMD at least 15 points, indication for the treatment with duloxetine
* Lifetime diagnosis of a psychotic disorder (PANSS positive scale below 15 points)
* Age between 18 and 65,
* Informed consent

Exclusion Criteria:

* No informed consent,
* Contraindications with respect to duloxetine,
* Gravidity or missing anticonceptive safety
* Substance dependance (excluded nicotin)
Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation

This study concerns elderly person aged more than 65 years with autonomous mobility.

It is a multicentric randomized trial in two arms :

Arm one : remote consultation then physical consultation Arm two : physical consultation then remote consultation

Consultations consist to take a Five Times Sit To Stand test, in physical consultation with physiotherapist in the same room and in remote consultation with a physiotherapist in the next room to the patient.

This study concerns elderly person aged more than 65 years with autonomous mobility.

It is a multicentric randomized trial in two arms :

Arm one : remote consultation then physical consultation Arm two : physical consultation then remote consultation

Consultations consist to take a Five Times Sit To Stand test, in physical consultation with physiotherapist in the same room and in remote consultation with a physiotherapist in the next room to the patient.

Tests are realized at baseline after randomization. The test with best time will be considered for analysis.

Once the 2 tests have been carried out, a satisfaction survey will evaluate the preference between the two tests for each patient.

Patients will be re-contacted by telephone at 3, 6 and 12 months post-inclusion to collect the number of falls.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers over the age of 65.
* Elderly people who can walk and move around independently.
* Subjects capable of giving informed consent.
* GIR 3,4,5,6.
* Affiliated to a Social Security scheme.

Exclusion Criteria:

* GIR \< 3
* Major visual and/or hearing impairment (known pathology and not fitted with hearing aids)
* Patient deprived of liberty by judicial or administrative decision, under guardianship or curatorship
* Subject having refused to participate.
* Subject at risk of syncope on rising (cardiac pathologies, orthostatic hypotension).
* Subjects with known vestibular disorders.
Proton Magnetic Resonance Spectroscopy (1H MRS) in Evaluating the Bone Marrow, Muscle and Adipose Tissue on Normal and Human Immunodeficiency Virus Infected Subjects

Magnetic resonance spectroscopy (MRS) is commonly applied in medicine with 1H proton or 31-phosphorus spectra. The proton MRS is often used in evaluating the central nervous system and 31P MRS is used in muscular diseases or neoplasms. However, the proton MRS is also considered to be applied to the musculoskeletal system because of its profound amount of protons. Ballon used the STEAM technique, and Schick used the PRESS technique, to investigate the lipid and water spectra of the bone marrow and also correlated those with hematological diseases and post-treatment effects. Schellinger et al. used the STEAM sequence to calculate the lipid content of the vertebral bone marrow and found that it was influenced according to age and sex. The investigator had used the proton MRS to evaluate the lipid and water spectra of the femoral head and revealed its significance in predicting avascular necrosis of the femoral head. According to the above research literature, the investigators considered further investigation of the proton MRS in evaluating the musculoskeletal system.

Magnetic resonance spectroscopy (MRS) is commonly applied in medicine with 1H proton or 31-phosphorus spectra. The proton MRS is often used in evaluating the central nervous system and 31P MRS is used in muscular diseases or neoplasms. However, the proton MRS is also considered to be applied to the musculoskeletal system because of its profound amount of protons. Ballon used the STEAM technique, and Schick used the PRESS technique, to investigate the lipid and water spectra of the bone marrow and also correlated those with hematological diseases and post-treatment effects. Schellinger et al. used the STEAM sequence to calculate the lipid content of the vertebral bone marrow and found that it was influenced according to age and sex. The investigator had used the proton MRS to evaluate the lipid and water spectra of the femoral head and revealed its significance in predicting avascular necrosis of the femoral head. According to the above research literature, the investigators considered further investigation of the proton MRS in evaluating the musculoskeletal system.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of acquired immunodeficiency syndrome (AIDS)
* Normal volunteers

Exclusion Criteria:

* AIDS patients with newly developed neoplasms
Positron Emission Tomography (PET) Study With [18F]AZD4694 and [11C]AZD2184, Candidate PET Ligands for Aβ Amyloid

The study is carried out in order to investigate if \[18F\]AZD4694, compared to \[11C\]AZD2184, is a suitable PET ligand for in vivo imaging of Aβ amyloid depositions in the human brain. In the study the two PET ligands will be examined in both healthy volunteers and patients with Alzheimer's Disease. A whole body dosimetry scanning will be performed in 6 healthy volunteers to obtain human data to estimate a safe dose.


Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's Disease patients - 50-85 years, mild to moderate AD: MMSE ≥16 and ≤ 26, clinical progression of AD over 12 months.
* Healthy volunteers: - 50-75 years
* BMI 18 and 30 m2/kg
* Clinically normal physical findings including supine blood pressure and pulse rate.

Exclusion Criteria:

* Alzheimer's Disease patients - Clinically significant illness the 2 weeks prior to the administration of the PET ligand
* Significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions
* Administration of any investigational product within 3 months prior to study and/or PET measurements for scientific purposes within the last 12 months.
* Healthy volunteers - clinically significant illness within 2 weeks before administration of PET ligand, history of psychiatric or somatic disease/condition that may interfere, first degree relative with dementia. Obvious deterioration of memory functions.
Prehabilitation and Recovery After Head and Neck Cancer Surgery

Implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.

BACKGROUND: Head and neck cancer (HNC) is the 7th most common cancer worldwide, and treatment often involves surgery. HNC surgery is intensive, complications are common, and quality of life (QOL) is negatively impacted. Support must be expanded to not only help patients survive HNC but to recover faster and live well following surgery. Prehabilitation, or optimizing a patient's condition before surgery, is a key opportunity to integrate supportive care early in the clinical care pathway for this underserved patient group. RESEARCH DESIGN AND METHODS: Using a mixed-methods approach, the aims of this hybrid implementation-effectiveness study are to (i) implement a multiphasic exercise prehabilitation program for HNC patients in a real-world setting and describe factors influencing implementation across the phases; (ii) determine the safety and tolerability of a multiphasic exercise prehabilitation program for HNC patients; (iii) explore the potential benefits of a multiphasic exercise prehabilitation program for HNC patients, and (iv) build a systematic screening and referral pathway into exercise oncology resources post-operatively. Outcomes are detailed below and include patient-reported outcomes, physical function, mobility (step count) and hospital length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years;
* Histologically verified primary head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or in lymph nodes of the neck from an unknown primary tumour
* Scheduled to undergo oncologic resection or resection for benign disease with free flap reconstruction
* Approval received from a clinical exercise physiologist (CSEP-CEP) and/or clinician
* Ability to provide written informed consent and understand study information in English

Exclusion Criteria:

* Neurological or musculoskeletal co-morbidity inhibiting exercise
* Diagnosed psychotic, addictive, or major cognitive disorders
* Severe coronary artery disease (Canadian Cardiovascular Society class III or greater)
* Significant congestive heart failure (New York Heart Association class III or greater)
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

The duration of treatment is 1 day.

Eligibility Criteria:
Inclusion Criteria:

* Impaction of a molar tooth requiring removal

Exclusion Criteria:

* Any known allergy to the study drugs
Impact of LDL-cholesterol Lowering on Platelet Activation

The primary goal is to assess the impact of Evolocumab therapy on platelet function of familial hypercholesterolemia (FH) patients in a randomized, double blind study. Evolocumab is a humanized monoclonal antibody that targets circulating PCSK9, increases hepatic LDL receptor, decreases plasma LDL cholesterol and reduces risk of cardiovascular events. Evolocumab (brand name Rapatha) has been approved by FDA along with diet and maximally tolerated statin therapy in adults with FH or atherosclerotic heart or blood vessel problems, who need additional lowering of LDL cholesterol.

The secondary goal is to determine if platelet activation or the response to Evolocumab therapy is modified by rs3184504 polymorphism. The investigators believe that these investigations will complement ongoing studies to demonstrate that Evolocumab reduces athero-thrombotic risk and aid the decision-making as to whether Evolocumab can reduce the atherothrombotic risk in acute coronary syndrome (ACS) patients.

Hyperlipidemia as exemplified by familial hypercholesterolemia is associated with increased platelet activation and an underlying pro-coagulant state. Hyperlipidemia primes platelets and increases platelet activation in response to various agonists. Plasma cholesterol levels appear to have a critical role in modulating platelet activity as hypercholesterolemia increases platelet activation more potently than hypertriglyceridemia. Increased platelet reactivity may contribute to the increased risk of atherothrombosis associated with hypercholesterolemia. Plasma levels of platelet activation markers such as thrombin-antithrombin complex (TAT), soluble P-selectin (sP-selectin), soluble CD40L (sCD40L) or P-selectin exposure at surface of platelets are increased in hypercholesterolemic patients. Increased levels of the platelet activation markers are associated with increased platelet membrane cholesterol content in hypercholesterolemia.Statins may show antithrombotic properties.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a clinical diagnosis of familial hypercholesterolemia (FH)
* Subjects who are referred to Dr. Ginsberg's Lipid Practice for treatment with PCSK9 inhibitor
* Subjects with LDL cholesterol levels \>100 mg/dl on baseline treatment with statins and/or ezetimibe

Exclusion Criteria:

* Children under 18 years of age
Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI

Endolymphatic hydrops is well known of the lay public in its primary form that is Ménière disease. Nowadays, the best w ay to approach it in vivo, is to use magnetic resonance imaging (MRI).

However, endolymphatic hydrops don't limit itself to its primary form but cover a whole range of pathologies.

The hypothesis is that patients with vestibular schwannomas are more likely to develop secondary saccular hydrops.

The aim is to compare high-resolution T2-weighted images of the saccule in patients followed up for vestibular schwannomas with healthy volunteers and histological sections from cadavers in order to identify its changes.

The secondary purpose of The protocol is to determine if vestibular and audiometric abnormalities could be related to this secondary hydrops more specifically than to the tumor size and localisation.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18,
* Subject having benefited from an MRI with T2 high-resolution 3D sequence (FIESA) in the context of the diagnosis of vestibular schwannoma between 2008 and 2017 at the University Hospitals of Strasbourg,
* Subject who has agreed to the use of medical data for the purposes of this research.

Exclusion Criteria:

* Refusal of the patient to participate in the study
* Insufficient imaging data,
* Tumors already treated,
* Atypical tumors with uncertain diagnosis, intra-labrinthic or intra-labyrinthine schwannomas, concomitant infectious or inflammatory pathology in the middle or inner ear.
* Impossibility of giving the subject informed information (difficulty understanding the subject,)
* Subject under the protection of justice
* Subject under guardianship or curatorship