cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Standardised Orientation and Mobility Training in Older Adults With Low Vision

The purpose of this study is:

1. to develop a standardised orientation and mobility training (O\&M-training) in the use of an identification/symbol cane by older adults with low vision, and;
2. to evaluate this newly developed standardised O\&M-training with respect to effectiveness and feasibility in a randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Aged 55 years or over
* Low vision
* Living independently in the community or in a home for older people
* Able to see large obstacles and to go outside for a short walk or doing groceries
* One of the following:

  1. experiencing difficulties with safely crossing a street
  2. experiencing difficulties with recognising acquaintances outdoors
  3. willing to become recognisable as being partially sighted by using the identification cane
* Written informed consent
* Orientation and Mobility training (O\&M-training) in the use of an identification cane

Exclusion Criteria:

* Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
* Language or hearing problems that impede completing an interview by telephone
* Confinement to bed or possible nursing home admission that impede completion of the O\&M-training
* Permanent use of a walking aid incompatible with the use of an identification cane
* Having recently received an O\&M-training in the use of an identification cane and permanent use of this cane
Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract

The rationale of this study is to compare repeatability, reproducibility and agreement of three different AS-OCT devices and Pentacam.

The investigational devices are approved biometry and keratometry devices to perform biometric/keratometric measurements preoperatively before cataract surgery. The measurements are used to calculate the needed IOL power.

Measurements with all four devices will be performed 3 times consecutively by two trained observer. The order of the observer, the order of devices as well as the eye (left/right) is randomized.

Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry/keratometry with four different devices

The rationale of this study is to compare repeatability, reproducibility and agreement of both, AS-OCT(s) and Pentacam. In our department three different AS-OCT devices and a HR Scheimpflug imaging device are currently in use for clinical routine to measure the cornea. Among refractive and anterior segment surgeons, there is no preferred and accepted method for accurate measurements of the corneal curvature. The four diagnostic tools are based on different technical and physical imaging principles and to date only limited information on their comparability exist. One advantage of ASOCT represents faster imaging speed when compared to Scheimpflug imaging. Thus, imaging misalignment, segmentation errors and defocus aberration can most likely be avoided by AS-OCT. Chen et al demonstrated that HR Scheimpflug imaging measurements of CCT were systematically higher than the measurements provided by FD AS-OCT. Further, repeatability, reproducibility and agreement of AS-OCT and Scheimpflug imaging device will be assessed during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract
* Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

Exclusion Criteria:

* Contact lens wear within 5 days
* Pathologic changes of the cornea, eye lid or conjunctiva on slit- lamp examination
* History of corneal ocular surgery
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology
* Blind fellow eye
* Uncontrolled systemic or ocular disease
Interest of MRI in Preoperative Staging for the Laryngeal and Hypopharyngeal Cancer

To determine if MRI can detect preoperative invasion of cartilage by laryngeal and hypopharyngeal carcinoma, and to compare it to CT imaging and histopathology in excised larynges and/or hypopharynges.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years old
* Patient with a laryngeal or hypopharyngeal cancer at any stage
* Patient eligible for a surgical treatment in multidisciplinary consultation
* Patient who did not oppose its participation to the study
* Indication for performing an MRI in addition to CT at the discretion of the investigator

Exclusion Criteria:

* Patient with an ASA ("American Society of Anesthesiologists", international anesthesia classification) score ≥ 3,
* Patient with a chirurgical contraindication
* Patient with a MRI contraindication
* Pregnant or nursing woman
* Adult requiring protection (guardianship, supervision)
* Patient participating in interventional research (Excluding physiological studies and interventional research involving only minimal risks and constraints that do not interfere with the analysis of the primary outcome).
Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)

Despite its known prevalence, a recent study conducted with Prof. Cacoub (unpublished) on the national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. In patients with Chronic Kidney Disease but Non-Dialysis, the determination of Ferritinemia and Transferrin Saturation Factoris performed in only 30% and 10% of cases whereas they should be performed routinely in inflammatory situations and in case of anemia (HAS 2011, KDIGO 2012). The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients with CKD-ND, applying the international recommendations and those of the French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor).


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over 18 years of age;
* Patient present at the hospital on the day of the study (traditional hospitalization, week hospital, day hospital, or in consultation with CKD-ND);
* Diagnosis of CKD-ND (glomerular filtration rate (GFR) \> 15 mL/min/1.73 m²)
* Patient with signed consent

Exclusion Criteria:

* Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision;
* Pregnant or breastfeeding woman;
* Patient with dialysis
Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes

This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants.

This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants. Retrospective and prospective data will be collected on all subjects before and after pharmacogenetic recommendations have been made. Retrospective data will be collected for the previous 12 months before pharmacogenetic recommendations are made and prospective data will be collected for 12 months after pharmacogenomic recommendations have been made.

Eligibility Criteria:
Inclusion Criteria:

* Must be taking either an anti-depressant or an anti-psychotic medication
* Must provide informed consent
* Must have Avera Health Plans insurance coverage
* Must have three months of participation in the Avera Care Coordination Program

Exclusion Criteria:

* Must not be pregnant or breastfeeding
* Must not have an active and/or unstable diagnosis of substance abuse
* Must not have a primary diagnosis of dementia, bulimia, or anorexia nervosa disorder
* Must not have had a previous pharmacogenetic evaluation
Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Detrusitol® Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered Detrusitol® Capsule in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Detrusitol® Capsule.
Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally invasive surgery has been progressively developed, first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues are currently being debated, including the superiority between total laparoscopic pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing these two surgery techniques are merging and randomized controlled trials (RCT) are lacking but clearly required.

Methods/design: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery (ERAS) pattern. The trial's aim is to exploring the overall survival (OS), disease free survival (DFS) and quality of life. The duration of the entire trial is seven years including prearrangement, a presumably five-year follow-up and analyses.

Discussion: Despite the fact there are several RCTs comparing minimally invasive pancreaticoduodenectomy (MIPD) and Open approach or LPD versus OPD. This trial will be the first comparing TLPD and OPD in a large multicenter setting. TJDBPS01 trial is hypothesized to assess whether TLPD has superiority over OPD in recovery and other aspects.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 years and 75 years.
2. Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
3. Patients feasible to undergo both LPD and OPD according to MDT evaluations.
4. Patients understanding and willing to comply with this trial.
5. Provision of written informed consent before patient registration.
6. Patients meeting the curative treatment intent in accordance with clinical guidelines.

Exclusion Criteria:

1. Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
2. Patients requiring left, central or total pancreatectomy or other palliative surgery.
3. Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.
4. History of other malignant disease.
5. Pregnant or breast-feeding women.
6. Patients with serious mental disorders.
7. Patients treated with neoadjuvant therapy.
8. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
9. Body mass index \> 35 kg/m2.
10. Patients participating in any other clinical trials within 3 months.
Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery

The objective of this study is to evaluate the performances of the Six-Minute Stepper Test (6MST) and Sit To Stand test (STST) to predict post-operative complications after minimally invasive lung cancer resection.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Non-small cell lung cancer stage I to II, justifying major resection by VATS or RATS (segmentectomy, lobectomy, pneumonectomy), with or without histological confirmation

Exclusion Criteria:

* Partial or total amputation localized to the lower limb;
* Weight greater than 100 kg;
* Orthopedic, vascular or neurological disorders leading to the incapacity of realize the 6MST;
* Patient under tutorship or curatorship;
* Pregnant woman.
* Surgery canceled
Side Effect Prevention Training (SEPT) for Nocebo Effects in Breast Cancer Patients

The purpose of this study is to evaluate a side effect prevention training (SEPT) that optimizes patients' response expectations before the start of adjuvant endocrine treatment (AET) to prevent nocebo side effects and enhance quality of life during longer term drug intake.

The majority of breast cancer patients discontinue today's standard adjuvant treatment (endocrine therapy) due to side effects and reduced quality of life. Thereby, most side effects are unspecific, thus, not related to the specific pharmacological action of the drug, but to the individual treatment context and patients´ expectations (nocebo effects). The aim of this study is to evaluate a side effect prevention training (SEPT) that optimizes patients' response expectations before the start of pharmacotherapy to prevent nocebo side effects during longer term drug intake. Using a randomized trial, we will study the time course of response expectations and side effects in breast cancer patients receiving either SEPT, standard medical care or an attention-control intervention ("supportive therapy") before the start of adjuvant endocrine therapy. We will analyze the effects of changing pre-treatment expectations on cancer-treatment related side effects, quality of life and adherence 3 and 6 months after the start of endocrine therapy. Moderator analyses will be used to determine predictors of non-specific medication side effects and patients that are at high risk of experiencing them. Furthermore, we will explore the mediating influence of coping behaviours, thereby providing insights into pathways of clinical nocebo effects. The study findings promise significant advances in the clinical application of nocebo research with strong implications for clinical and research practice.

Eligibility Criteria:
Inclusion Criteria:

* Women with estrogen receptor positive breast cancer scheduled to start first-line adjuvant endocrine therapy with Tamoxifen (+/- GnRH) or a third generation Aromatase inhibitor at the Breast Cancer Centre
* Sufficient knowledge of German language and ability to give informed consent
* Age of 18 and more

Exclusion Criteria:

* Presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety)
* Presence of a life threatening comorbid medical condition
Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway

Hypothesis:

Prucalopride can mimic electrical stimulation of the abdominal vagus nerve and has an anti-inflammatory effect.

Aims:

In the present pilot study, the investigators want to evaluate the anti-inflammatory effect of prucalopride. The following aims are formulated:

1. to show that prucalopride has a similar inflammatory effect as abdominal vagus nerve stimulation (VNS)
2. to evaluate whether prucalopride leads to accelerated post-operative recovery


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing partial or full resection of the pancreas due to a benign or malignant tumor

Exclusion Criteria:

* adjuvant radiotherapy
* evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory results, including an abscess or cholecystitis)
* chronic pancreatitis
* pancreatic polypeptide producing endocrine tumor
* American Society of Anesthesiologists physical-health status classification (ASA-PS)\>3
* Poorly regulated diabetes (\>200 mg/dl (=11 mmol/l))
Satellite™ PEEK Nucleus Replacement Retrospective Analysis

The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.

The purpose of this study is to evaluate number of adverse device effects (ADEs), serious adverse device effects (SADEs) and serious adverse event (SAEs) and early clinical effectiveness for the Satellite™ Nucleus Replacement in a standard clinical practice. Data collection will include information on health related quality of life (QoL), physical functioning and adverse event after nucleus replacement surgery. Radiographic measures will also be assessed to evaluate changes in disc height at the operated level and changes in segmental range of motion.

All patients who were implanted with a Satellite™ Nucleus Replacement Prosthesis in the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have signed a Patient Data Release Form
* Age of at least 18 years and skeletally mature at the time of surgery

Exclusion Criterion:

* Patient has not reached the age of legal consent according to local laws
Induction of Stable Chimerism for Sickle Cell Anemia

To investigate a modified hematopoeitic cell transplantation (HCT) procedure for sickle cell disease that significantly reduces the toxicity of HCT, yet retains its therapeutic benefit.

BACKGROUND:

Hematopoietic cell transplantation (HCT) has curative potential for individuals with sickle cell disease. While the results of conventional HCT have been good, this treatment carries risks of significant short- term and longterm toxicities. For this reason, HCT has been reserved for children who have experienced severe symptoms that predict a poor outcome. Of interest, some patients developed stable donor-host hematopoietic chimerism after conventional HCT. Due to a natural enrichment of donor erythrocytes in the blood, those who developed stable chimerism had a significant clinical benefit, even when there was a minority of donor cells. These observations have paralleled efforts to develop less-toxic, non-myeloablative preparative regiments for transplantation, proved first in a canine model of transplantation, and subsequently translated successfully in a clinical trial for older adults with hematological malignancies.

DESIGN NARRATIVE:

Multicenter open-label phase I-II study in 30 children with sickle cell disease that combines a non-myeloablative pre-transplant hematopoietic cell transplantation (HCT) therapy with modulated post-grafting immunosuppression to control host-versus-graft and graft-versus-host reactions. The approach relies on the ability to establish and maintain donor-host chimerism. The primary study endpoint is stable donor cell engraftment; secondary endpoints measure the impact of therapy on sickle cell-related symptoms and end-organ damage (disease-free survival, patient survival, graft-versus-host disease, complications etc). The trial will be conducted within the existing network of Comprehensive Sickle Cell Centers, and will be centrally coordinated by the Sickle Cell Coordinating Center.

Eligibility Criteria:
No eligibility criteria
Structured Patient Education and Quality of Life of Elderly Patients With Diabetes Mellitus- a Prospective Study

The improvement of the quality of life (QoL) is one of the key treatment goals in patients with diabetes mellitus. Objective: Prospective study to evaluate the impact of structured diabetes education on the QoL in insulin-treated, elderly patients with type 2 diabetes mellitus. Inpatients with insulin treated type 2 diabetes or failure of oral antidiabetic therapy were successively recruited and participated in the structured inpatient diabetes treatment and teaching program (DTTP) for insulin therapy QoL was assessed before and six months after participation in the DTTP with the standardised questionnaire of Lohr analysing the subscales: social relations, physical complaints, worries about the future, diet restrictions, fear of hypoglycemia, and daily struggles.

All patients with type 2 diabetes mellitus, who were older than 54 years and admitted by general practitioner to the inpatient unit of the university hospital of Jena, Germany, for participation in a structured DTTP for insulin therapy because of hyperglycemia, were candidates for successive inclusion in the study. All patients participated in a five day inpatient structured DTTP for single or split dose administration of intermediate-acting insulin which included instruction in insulin injection, self- monitoring, hypoglycemia, acute/late complications, nutrition and foot care. Quality of life was assessed by using a validated instrument, the standardised QoL- questionnaire of Lohr et al. (21) both before and six months after participation in the DTTP. This questionnaire consists of 58 Likert- scaled items comprising the subscales: social relations, physical complaints, worries about the future, diet restrictions, fear of hypoglycemia, and daily struggles. Higher scores reflect higher quality of life with 100% as an optimum quality of life. The primary outcome measure regarding patients metabolic control was the improvement of quality of life six months after DTTP.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus, insulin therapy, age \>54 years, hyperglycemia

Exclusion Criteria:

* dementia, severe neurological deficits, polioencephalitis, rejection of informed consent
A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To determine the immunogenicity of gp160.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV.

Healthy volunteers are injected on days 0, 30, and 180 with one of four preparations: gp160 vaccine (40 mcg), gp160 vaccine (80 mcg), hepatitis B vaccine, and placebo. The hepatitis B vaccine group will serve as an additional control for immunological evaluations. An optional fourth injection may be given 15-21 months following the initial inoculation.

Eligibility Criteria:
Inclusion Criteria

Subjects must have:

* Normal history and physical exam.
* Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
* T4 count \>= 800 cells/mm3.
* Normal chest x-ray and urinalysis.
* Negative surface antibody and core antibody for hepatitis B.
* Negative hepatitis B surface antigen.
* Negative HIV p24 antigen test.
* Normal skin reactivity by Merieux test.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

* Positive PPD.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).

Subjects with the following prior conditions are excluded:

* History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
* Prior hepatitis B vaccination.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.

Prior Medication:

Excluded:

* Prior hepatitis B vaccine.

Prior Treatment:

Excluded:

* Prior blood transfusions or cryoprecipitates within the past 6 months.

Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:

* Any history of IV drug use.
* Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
* More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.