cyrilzakka/clinical-trials huggingface dataset:
Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas

The purpose of this study is to assess the feasibility of analyzing circulating tumor DNA (ctDNA) as a biomarker using the shallow whole genome sequencing (lpWGS) technique coupled with deep sequencing of a targeted panel of genes (NGS), in a population of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma (PTCL).

Peripheral T-cell lymphomas (PTCL) are a rare and heterogeneous group of diseases resulting from the clonal proliferation of mature post-thymic lymphocytes. These T-cell neoplasms account for approximately 10-15% of all lymphomas and patients with these lymphomas have among the worst 5-year relative survivals (36%-56%, depending on prognostic factors). There are no biomarkers validated in PTCL.

Low pass whole genome sequencing (lpWGS) is an innovative molecular biology technique capable of detecting variations in the number of gene copies in patients' blood, which is a reflection of the quantity of tumor cells in the patient, lymphoma cells carrying numerous gains and deletions of certain genes at the somatic level. lpWGS is inexpensive, requires small quantities of DNA, targets the entire genome, is less time-consuming than other techniques for studying ctDNA and preliminary data in lymphomas have shown the interest of this technique. The investigators hypothesize that this study of ctDNA in PTCL will be relevant, sensitive and very informative for monitoring patients with the lpWGS technique combined with a panel of genes targeted in depth by NGS that the investigators propose to implement. This is a multicenter, prospective study, based on biological samples and clinical and imaging data to be collected.

This study will be offered to each patient suffering from PTCL, including T/NK lymphomas (NKTL) with systemic involvement (excluding cutaneous T-cell lymphomas) having an indication for systemic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Newly diagnosed or relapsed/refractory peripheral T-cell lymphoma (PTCL), including T/NK lymphoma (NKTL)
* Pre-therapeutic FDG PET-CT already performed
* Signed informed consent
* Patients affiliated with or beneficiaries of a health insurance plan

Exclusion Criteria:

* Cutaneous T-cell lymphomas without systemic involvement
* Pregnant or breastfeeding women
* For newly diagnosed patients: patient who has already started the first systemic treatment for their lymphoma (apart from pre-phase corticosteroid therapy which is authorized)
* For patients in a relapsed/refractory situation: Patient who has already started the new specific line of lymphoma treatment planned for the current relapsed/refractory situation (apart from pre-phase corticosteroid therapy which is authorized)
* Lack of patient consent
* Patient whose weight is less than 30 kg
* Protected adult or deprived of freedoms (under guardianship or curatorship)
* Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographic problem, etc.).
An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta

The investigators have currently finished conducting an international multi-center trial that compares the efficacy and safety of pamidronate and zoledronate in the treatment of moderate to severe forms of Osteogenesis Imperfecta (OI). This trial has included only children above one year of age. The aim of the current study is to extend the observations of that currently finished study to infants below 1 year of age. Moreover, it is possible to administer zoledronate in a single short infusion instead of the three-day cycles with Pamidronate, therefore decreasing patient and family burdens with shorter stays in the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Children, male or female 2 weeks to \< 12 months of age, at least at 38 weeks gestational age.
* Any child with phenotypic OI type II, III or IV.
* Any child classified as OI type I, V-VIII that has had at least two or more previous fractures of long bone, or vertebral compression fractures, and a low bone mineral density.
* No previous treatment with bisphosphonates.
* Negative urine protein as measured by dipstick. One repeat assessment of the urine protein will be allowed.

Exclusion Criteria:

* Blood oxygen saturation of less than 90% in room air.
* Serum creatinine level greater than 56 µmol/L.
* Any clinically significant clinical laboratory abnormalities at screening.
* Treatment with any investigational drug within the past 30 days.
* Patients who are unlikely to be able to complete the study or comply with the visit schedule.
* Any disease or planned therapy which will interfere with the procedures or data collection of this trial.
Impact of Dance Therapy on Parkinson's Disease

Parkinson's disease (PD) affects ability of individuals to perform unconscious learned motor tasks, affects quality of life and has been associated with depression. The purpose of this study is to investigate the effect of dance therapy on motor performance, quality of life and depression in PD patients, by comparing certain symptoms between a group of subjects with PD who undergo ballroom dancing classes and a control group of subjects with PD. The investigators will assess mental status, severity of PD, quality of life and depression using rating scales. Subjects will be randomized to intervention and control group. Intervention group will participate in dance therapy for 12 weeks and will be examined at 12 and 20 weeks. Control group will be examined at same time intervals. Classes will follow a curriculum designed by Arthur Murray Dance Studio Staff. The investigators do not anticipate significant risk for participants.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older, both males and females, all races and all ethnicities
* Idiopathic Parkinson's disease diagnosed using United Kingdom Parkinson's Disease Society brain bank diagnostic criteria
* Mild to moderate disease severity (Stage 2 to 3 on the Modified Hoehn and Yahr scale)
* Stable medication regimen for a minimum of 1 month before testing
* Ability to ambulate independently without using a walking aid
* Ability to give informed consent

Exclusion Criteria:

* Prior enrollment in a dancing class during the last 6 months
* Presence of another neurological or medical disorder likely to affect gait or causing frequent falls (rheumatologic/orthopedic disease, stroke, myelopathy, severe neuropathy)
* Significant cognitive decline (MMSE ≤ 24)
* Visual deficit
* Hearing deficit that impairs music perception
* Psychotic symptoms
* Symptomatic heart disease
* Depression associated with suicidal ideation
Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation.

The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.

This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult intubation.

The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.

This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult mask ventilation of tracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg m-2
* Preoperative Polysomnography

Exclusion Criteria:

* Pregnant women
* ENT Cancer
Phase I/II Trial of PTK787 and Pemetrexed With or Without Cisplatin for Lung Cancer

This is an open-label, two-arm, multicenter Phase IA/II dose-escalation study of PTK787 in combination with Pemetrexed alone (Cohort 1) or Pemetrexed and Cisplatin (Cohort 2).

This study is designed to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin, and to characterize the safety, tolerability, biologic activity, and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas.

This is an open-label, two-arm, multicenter Phase IA/II dose-escalation study of PTK787 in combination with Pemetrexed alone (Cohort 1) or Pemetrexed and Cisplatin (Cohort 2).

This study is designed to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of PTK787 when administered in combination with Pemetrexed or Pemetrexed and Cisplatin, and to characterize the safety, tolerability, biologic activity, and PK profile of PTK787 in adult patients with advanced non-small cell lung cancers and mesotheliomas.

In cohort 1, PTK787 will be administered orally every 12 hours on days 2-42 of a 42-day cycle. In addition, Pemetrexed will be administered on days 1 and 22.

In cohort 2, PTK787 will be administered orally every 12 hours on days 2-42 of a 42 day cycle. In addition, Pemetrexed will be administered on days 1 and 22. Thirty minutes after Pemetrexed administration, Cisplatin will be infused on days 1 and 22.

In the current study, initially patients will be treated on Cohort 1 (Pemetrexed + PTK787). Once an MTD determination is made on this cohort (or PTK787 has been escalated to the maximum dose of 750 mg Q12h enrollment will begin on Cohort 2. At the MTD dose, both cohorts will be expanded to a minimum of 20 patients to determine additional safety of the combinations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced non-small cell lung cancers (non-squamous variety and advanced mesotheliomas
* Patients with advanced solid tumors who are refractory to standard treatments and/or standard treatments are not be available for the patient

Exclusion Criteria:

* Non-small cell carcinoma of squamous variety
* Patients with uncontrolled brain metastases
Ayurvedic Management of Chronic Kidney Disease

The purpose of this study is to determine the effect of multi-dimentional ayurvedic treatment in the patients of various types of chronic kidney disease.

Ayurvedic treatment includes some complex classical herbal formulations and Niruha basti (procto-colonic administration of ayurvedic medicines mainly contained decoction of punarnavadi compound, rocksalt, sesame oil and mixture of some herbal poweders) will be given to the patients of chronic kedney disease who are not on dialysis. Patients of CKD of various etiology will be grouped accordingly and will get the same treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients having a confirm diagnosis of chronic kidney disease with GFR level \< 60mL/min and persistent (present for \> 3 months) indicates substantial reduction in kidney function. Confirmation of diagnosis with ultrasound of KUB, indicating reduction of kidney size and / or cortico-medullary difference.

Exclusion Criteria:

* Female patients having pregnancy, breast feeding or post-delivery period.
* Patients who are on dialysis treatment from more than 6 months period. Patients who are already operated for renal transplantation and then having nephropathy.
* Patients with some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism, other kidney, liver or metabolic disorders etc.
Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia

Statin therapy does not fully eliminate the cardiovascular disease (CVD) risk associated with low high density lipoprotein-C (HDL-C) and high triglyceride levels. It is currently unknown what would be the best treatment option for patients with mixed hyperlipidemia who fail to meet their lipid targets with statin monotherapy at conventional does, i.e. high dose rosuvastatin or conventional statin dose plus micronized fenofibrate or conventional statin dose plus niacin/laropiprant. The aim of the present study is to compare the efficacy of high-dose rosuvastatin vs conventional statin dose plus micronized fenofibrate vs conventional statin dose plus extended-release niacin/laropiprant on lipid profile in patients with mixed hyperlipidemia. The primary efficacy endpoint will be changes in non-HDL-C levels at 6 months after treatment initiation.


Eligibility Criteria:
Inclusion Criteria:

* Non-HDL-C above target goal according to NCEP-ATP III after 3 months of treatment with conventional statin doses, e.g. simvastatin 10-40 mg, atorvastatin 10-40 mg or rosuvastatin 5-20 mg

Exclusion Criteria:

* Known CVD, triglycerides \> 500 mg/dL, renal disease (serum creatinine levels \> 1.6 mg/dL), hypothyroidism \[thyroid stimulating hormone (TSH) \> 5 IU/mL\], liver disease (ALT and/or AST levels \> 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption \> 3 drinks/day for men and \> 2 drinks/day for women, and current or previous gout.
* Patients with diabetes will be included in the study if they are adequately controlled (HbA1c \<7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period).
* Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period).
* Patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 4 weeks before study entry will be excluded.
High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma

The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.

This is a phase I/II study of high dose irinotecan in patients with recurrent unresectable malignant glioma on steroids/anti-epileptics. The purpose is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.

Eligibility Criteria:
Inclusion Criteria:

* recurrent, unresectable primary CNS neoplasm per MRI
* ECOG status of 2 or less
* no prior therapy with camptothecans
* on an enzyme-inducing antiepileptic
The Development Path

The aim of this project is a research-based evaluation of a multidisciplinary program focusing on moving citizens from unemployment and social security benefits to employment and education in Sonderborg Municipality. The citizens who are assigned cannot readily enter the labor market or can get education through employment initiatives in the Job Centre in Sonderborg Municipality because of complex health-related troubles.

The project is designed to include a prospective observational study and a qualitative study using questionnaires, observations, interviews and informations about employment from the Sonderborg Municipality.


Eligibility Criteria:
Inclusion Criteria:

* Assigned to a multidisciplinary program in Sonderborg Municipality (the Law on Active Employment §68 https://www.retsinformation.dk/forms/r0710.aspx?id=164698#Kap2 )

Exclusion Criteria:

* Not able to communicate in Danish
The Effect of Foot Care Training Given to Diabetic Hemodialysis Patients on Foot Care Behavior

Diabetic foot causes hospitalization, amputation and serious health problems in individuals. This situation also leads to loss of productivity of the individual, negatively. diabetic foot can be reduced by 85% with good foot care, education and a multidisciplinary team approach. Diabetes is observed in the majority of hemodialysis patients. Foot care becomes even more important if you have more than one chronic disease. The aim of this study is; To determine the effect of "Diabetic foot care training" given to diabetic hemodialysis patients on foot care behavior. The study was planned as a randomized controlled experimental study. It was planned for diabetic hemodialysis patients who were treated in a dialysis center with a study permit.

Diabetic foot causes hospitalization, amputation and serious health problems in individuals. This situation also leads to loss of productivity of the individual, negatively affecting mental health and quality of life; It creates a serious economic burden on the family and healthcare system. However, it is stated that the development of diabetic foot can be reduced by 85% with good foot care, education and a multidisciplinary team approach. Diabetes is observed in the majority of hemodialysis patients. Foot care becomes even more important if you have more than one chronic disease. The aim of this study is; To determine the effect of "Diabetic foot care training" given to diabetic hemodialysis patients on foot care behavior. The study was planned as a randomized controlled experimental study. It was planned for diabetic hemodialysis patients who were treated in a dialysis center with a study permit. The population of the research consists of 64 diabetic hemodialysis patients. The sample consists of individuals who agreed to participate in the study. Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. A normal distribution test will be applied to determine whether the research variables have a normal distribution. In case the research variables do not show normal distribution (p\<0.05). In the analysis of variables for which the normality assumption is not met, non-parametric analysis methods Mann Whitney U (for comparisons of two groups) and Kruskal Wallis (for comparisons of three or more groups) will be used. Spearman correlation analysis will be performed to determine the relationship between the continuous variables of the research.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Having a diagnosis of diabetes
* Volunteering to participate in the study
* Good communication skills and the patient's ability to receive training himself

Exclusion Criteria:

* Not willing to participate in conflict
Functional Imaging and Reading Deficit in Children With NF1

A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.

The principal aim of the study is to highlight the activation of brain area involved phonological and visuo-spatial processing in children with NF1 with or without reading disabilities.

Eligibility Criteria:
Inclusion Criteria:

* Age included between 8 and 12 years
* Child presenting a type 1 neurofibromatosis according to 2 criteria in the following criteria list :

  * At least 6 café au lait spots
  * 2 or more neurofibromas or 1 plexiform neurofibroma
  * axillary or inguinal freckling
  * 1 optic nerf glioma
  * 2 or more Lisch nodules
  * 1 osseous lesion as sphenoid dysplasia or thinning of the long bone cortex with or without pseudarthrosis
  * 1 A first degree relative (parent, sibling, or offspring) with NF1 by the above criteria
* Membership in a national insurance
* Consent of the child and the parents

Exclusion Criteria:

* Mental retardation (QI T \< 70)
* Treated or untreated epilepsy
* Visual deficit (visual Acuteness \< 4/10
* Presence of a symptomatic optic glioma
* Presence of a brain tumor.
Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis

This is a randomised study that compares different diagnostic approaches for diagnosing pulmonary tuberculosis in patients suspected of pulmonary tuberculosis in whom the three classic (non-induced) sputum samples didn't show tuberculous bacillus on direct examination.

The investigators compare the sensibility of induced sputum technique with an endoscopic approach (CT-scan followed by BAL and fluoroscopy-guided transbronchial biopsies and eventually sputum collection immediately after the bronchoscopy).

People in high risk population for tuberculosis undergoing screening by chest X-ray or symptomatic patients will be admitted to the hospital if their chest X-ray shows a suspicion of active tuberculosis.

According good clinical practice: (non-induced) sputum samples will be taken at admission and every following morning. If direct examination and PCR of the first three classic sputum samples are negative: patients will be randomised in two groups with a different diagnostic approach (induced sputum versus endoscopic approach) The aim of our study is to proof that a thoroughgoing endoscopic approach has a higher sensibility than an induced sputum in the diagnosis of pulmonary tuberculosis in patients with a high suspicion of active tuberculosis on the chest X-ray but with a negative direct examination and/or PCR on three consecutive normal sputum samples.

The investigators will include 154 patients (based on a statistical analysis for a hypothesis that the endoscopic approach has a sensibility that's twice the sensibility of the induced sputum).

* first arm: 2 consecutive induced sputum using an ultrasonic nebulizer.
* second arm: CT thorax to evaluate the exact anatomic localisation of the disease followed by fluoroscopy-guided bronchoscopy for BAL (bronchoalveolar lavage) and transbronchial biopsies. A sputum sample immediately after the endoscopy will be collected if possible.


Eligibility Criteria:
Inclusion Criteria:

* Patient suspected of pulmonary tuberculosis with 3 consecutive (non-induced) sputum samples negative on direct exam and PCR.

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Actual asthma exacerbation
* Participation to study refused by patient
Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery

A laparotomy is a surgical technique, the increasing rate of this surgical interventions and the subsequent need to evaluate the post-surgical recovery and rehabilitation process comprehensively. This study aims to provide essential insights into the reliability, validity, and responsiveness of such tests, enabling healthcare professionals to make informed decisions about patient recovery progress and the optimization of rehabilitation protocols.

The significance of this research lies in its potential to enhance the quality of care and patient outcomes, reduce healthcare costs, and contribute to evidence-based decision-making in postsurgical rehabilitation, ultimately improving the overall well-being of surgical patients. This study is to evaluate the clinimetric properties of four distinct tools designed for assessing performance-based functional outcomes following open abdominal surgery. 6 Minute Walk Test (6MWT), 5 Times Sit to Stand test (5T STS), 2 minute Walk test (2MWT), and Timed Up and GO (TUG)will be assessed to determine any changes in their functionality and overall well-being on day 2 and on day of discharge.

Eligibility Criteria:
Inclusion Criteria:

* Post-laparotomy patients
* Hemodynamically stable
* Age between 30 to 60 years
* Ambulatory patients
* Patients score 1

Exclusion Criteria:

* Incidence of adverse events through hemodynamic and medication data.
* Diagnosed cognitive dysfunction.
* Diagnosed neurologic or musculoskeletal disease (excluding osteoarthritis) adversely affecting gait or weight-bearing.
* History of Orthostatic intolerance.
* History of recent fractures, blunt trauma emergency laparotomy, carcinoma.
Potential Nosocomial Infection Prevention Via Modification of Anesthesia Intraoperative Aseptic Practice

We hypothesized that by improving hand hygiene compliance in the operative environment, we would reduce horizontal transmission of pathogenic bacteria to surgical patients.

We performed an observational study evaluating provider adherence to these techniques. We then sought to increase hand hygiene compliance through the use of a point of care alcohol based hand hygiene device. We hypothesized that increased hand hygiene compliance would reduce bacterial contamination of the anesthesia workspace and peripheral intravenous tubing, and ultimately reducing overall morbidity and mortality secondary to a reduction in nosocomial infection rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients present in operating rooms randomized to study.

Exclusion Criteria:

* Patients that were already enrolled in study and return to the operating room.