cyrilzakka/clinical-trials huggingface dataset:
Web-based Application to Test for Long-term Cognitive Deficits in BioCog Patients

In the present study, a long-term cognitive follow-up of participants of the BioCog cohort (data collection period 2014 - 2019, Ethical vote No: EA2/092/14) from the Berlin study center is to be will be performed in order to record long-term cognitive sequelae (7 to 10 years after study inclusion). In addition to a medical telephone/video visit, the follow-up includes the collection of cognitive tests via web applications and questionnaires of acceptance and usability in the home environment. The study data are analysed in cooperation with the University of Bonn, University Medical Center Schleswig-Holstein and the University of Essen.

The primary research objective is the exploratory investigation of changes in cognitive test performance as well as cognitive self-care and functionality in former BioCog patients and BioCog subjects in the non-surgical comparison cohort in the long-term follow-up (7 - 10 years) compared to the baseline survey (from the BioCog main study).The primary question is operationalized in several ways:

* according to the International Statistical Classification of Diseases and Related Health Problems(ICD-10) classification system
* according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) classification system
* computer-based, online and independently conducted cognitive testing using Cantab Web based testing from Cambridge Cognition
* Cognitive self-care using Geriatric depression Scale item 10
* Cognitive self-care with Multifactorial Memory Questionnaire
* Cognitive other-care with The Informant Questionnaire on Cognitive Decline in the Elderly questionnaire
* Functionality with Activities of Daily Living (ADLs) \& Instrumental Activities of Daily Living (IADLs) questionnaire
* Additionally: Quality of life with 5-level EQ-5D version (EQ-5D-5L)

Evaluation by Mild Cognitive Impairment Algorithm of the University Clinic Bonn (research group Prof. Wagner).

Evaluation by mild/major Neurocognitive Disorder (NCD) algorithm of Charité - University Medicine Berlin (research group Prof. Spies)

Eligibility Criteria:
Patients

Inclusion Criteria:

* Patients of Berliner BioCog cohort with cognitive Testing (CANTAB Research Suite) at Baseline and with plasma samples for baseline that can be contacted.
* Written informed consent for participation in the BioCog-Web study.
* Data and reserve samples from patients in the Berlin BioCog cohort who can no longer be contacted.

Exclusion Criteria:

* None

Subjects

Inclusion Criterion:

-BioCog subjects of the non-operated comparison cohort from Berlin with cognitive testing (CANTAB Research Suite) at baseline who are contactable

Exclusion criteria:

-None
Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia

The purpose of this study is to validate the effectiveness of food supplement Limicol on reducing LDL-cholesterol in moderate hypercholesterolemic volunteers.

Cardiovascular disease (CVD), foremost among which ischemic heart disease and stroke, are the leading cause of mortality and morbidity in France. These diseases are multifactorial origin and even if it is not possible to act on risk markers such as age, sex, or heredity, risk factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical inactivity, are the main target of prevention strategies.The dydlipidémies have a role in the formation of CVD in participating in the genesis of atherosclerosis. The cholesterol and LDL-cholesterol in particular is subject to oxidation process in plasma. The molecules of oxidized LDL-cholesterol, small and dense, easily penetrate the arterial endothelial wall and are greeted by macrophages. Following a succession of different processes including inflammation, atherosclerotic plaque is formed. The result is either an arteriopathy when the arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. Given this pathophysiology, reduce blood lipids, including LDL-cholesterol and reducing oxidation and inflammation are interesting strategies in the context of cardiovascular prevention. Several scientific study showed that nutritional supplementation with some plant extracts such as artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several cardiovascular risk factors including regulate concentrations of circulating lipids.

The objective of this study is to validate the effectiveness of Limicol, formulated with proven scientific data on the reduction of LDL-cholesterol in volunteers with moderate hypercholesterolaemia (LDL-cholesterol).

Eligibility Criteria:
Inclusion Criteria:

* About 18 to 65 years (inclusive).
* Subject has a stable weight for at least three months before the start of the study.
* Subject able and willing to comply with the protocol and agreeing to give their consent in writing.
* Subject affiliated with a social security scheme.
* Subject willing to be included in the national register of volunteers who lend themselves to biomedical research.
Effect of a Personalized Sound Intervention During Autogenous Gingival Grafts in Adults

Anxiety feeds the avoidance of dental treatments, leading to the neglect of general oral health. This avoidance is often amplified by the fear of potential pain and dissatisfaction after a dental appointment. A music listening intervention could be beneficial to reduce anxiety, pain and dissatisfaction. This intervention has the advantage to be non-invasive, cheap, and easy to implement in clinical settings. The objective of this study is to explore the effects of a personalised musical intervention on anxiety, pain and dissatisfaction associated with an autogenous gingival graft in comparison to the use of an audiobook (control). In this regard, three groups of patients will receive the gingival graft along with the personalized music intervention (n=20), an audiobook (n=20) or standard care (n=20). Participants will be distributed randomly between conditions in a single blind design (surgeons will be unaware of the condition). However, since the third standard care control group was added as of 07-01-2023, all recruited participants will be enrolled in the standard care control group (non-randomized). Self-reported measures of anxiety, pain, and dissatisfaction will be taken at different times (baseline, preoperative, postoperative, and follow-up).


Eligibility Criteria:
Inclusion Criteria:

* Need a gingival graft that will not exceed 1.5 hour of surgery
* Understand spoken and written French or English
* Has the capacity to understand procedures and follow instructions
* Consent to follow instructions
* Consent to receive either the active or control sound condition
* Being 18 years or older

Exclusion Criteria:

* Do not need a gingival graft
* Need a gingival graft that will last more than 1.5 hour of surgery
* Mental health or neurological disorders
* Auditory disorder
* Allergy or intolerance to NSAIDS
Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670

Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmacodynamic) relationship


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects
* Sterilized by tubal ligation
* Age 18-45 years
* Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m²
* At least 3 consecutive regular menstrual cycles with a cycle length of 24 - 35 days before first screening examination according to the subject's history
* Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy

Exclusion Criteria:

* Regular use of medicines (incl. anabolics)
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Amenorrhea for more than 3 months within the last 6 months before the first screening examination
* Lacking suitability for frequent transvaginal ultrasonography (TVU) examinations
* Clinically relevant findings (e.g. blood pressure, electrocardiogram \[ECG\], physical and gynecological examination, laboratory examination)
MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer

The investigators propose to evaluate the feasibility, safety, and preliminary efficacy of delivering online, adaptive magnetic resonance imaging (MRI)-guided and gated stereotactic body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel, integrated Co-60 MRI treatment machine. To best assess this technology, the investigators will focus on patients that have no more than three sites of progressive disease within the central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, MRI-guided and gated SBRT with MRI simulation. Patients will be treated in five fractions over one to two weeks. By adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care but will allow adaptation based on daily anatomic changes. The prescription dose will be determined based on hard normal tissue constraints, and capped at 10Gy per fraction. Although the long term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by the short term goal of demonstrating the feasibility of this novel treatment approach for recurrent or metastatic ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed primary disease histology of solid ovarian, fallopian tube, or primary peritoneal tumor categorization.
* Deemed medically fit for stereotactic body radiation therapy by the treating physician.
* At least 18 years old.
* Karnofsky Performance Status ≥ 70
* Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).
* Able to understand and be willing to sign an IRB approved written informed consent document (or legally authorized representative, if applicable).

Exclusion Criteria:

* Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, gated, and/or online adaptive SBRT
* Current central nervous systemic disease.
* Widespread progressive disease, i.e., more than three sites of progressive disease (note that more than three sites of disease are permitted provided there are no more than three sites of progressive disease).
* Actively receiving any investigational agents.
* Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Medical contraindication to undergoing MR imaging.
Testing a Training Program to Enhance Emotional Management Skills and Professional Resiliency in Healthcare Providers

The Behaviour Change Institute (BCI) was created in 2008 within Capital Health to provide healthcare providers with evidence-based skills in helping patients change. In addition, the BCI has also become a resource within the organization to assist with other needed changes, such as helping healthcare providers use new or different procedures to provide better patient care. Through our work at the BCI we have identified the need to help healthcare providers to better cope with change. The purpose of this project is to implement and to evaluate an evidence-based professional resiliency training program for staff to help them better cope with change. This professional resiliency training program is based on an empirically supported form of therapy called Acceptance and Commitment Therapy. The training takes the form of a hands-on, applied workshop designed to increase resiliency and flexibility in a workplace setting.

The Behaviour Change Institute (BCI) was created in 2008 within Capital Health to provide healthcare providers with behaviour change counselling skills. These skills are backed by evidence-based theory and competency training methods and are designed to be used by healthcare providers to help their patients change their behaviours. Acquiring these skills involves change for the healthcare provider. Through our work at the BCI we have come to identify the need to help healthcare providers effectively manage their emotions in such situations in order to learn behavior change counselling skills and to continue to use them effectively over time. The ability to effectively manage emotions, including discomfort and distress, may differentiate between individuals who are able to successfully adopt and maintain new behaviours over time from those who do not (Brown, Lejuez, Kahler, Strong, \& Zvolensky, 2005). That is, we have identified that there is a significant need to support healthcare providers to more effectively manage emotions in order to help them change.

The Acceptance and Commitment Therapy for the Workplace program (ACT-W) is an evidence-based program designed to help individuals manage emotions and stress by learning skills to accept negative feelings, thoughts, and sensations and to move toward valued behaviours (Flaxman, Bond, Livheim, Hayes, 2013). The ACT-W program has been shown to increase the ability to manage emotions and stress (Flaxman \& Bond, 2010) and to increase the ability to learn new behaviours (Bond \& Flaxman, 2006; Luoma et al., 2007; Varra, Hayes et al., 2008).

The purpose of this project is to evaluate the implementation of the ACT-W training program for healthcare providers through the BCI.

Eligibility Criteria:
Inclusion Criteria:

* Employees (full time or part time; administrative or clinical) within service areas with managerial approval to attend the training program.

Exclusion Criteria:

* None
Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL

First in humans, exploratory, open-label, single-arm, multicentre, non-competitive, dose escalation study to assess the safety and efficacy of CD1a-CAR T therapy in patients with relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LL)


Eligibility Criteria:
Inclusion Criteria:

1. Children older than 2 years or adults, male and female in both groups.
2. Patients CD1a antigen blast expression ≥20% at inclusion, either immunophenotypically (flow cytometry) or histologically confirmed.
3. R/R CD1a-positive T-ALL/LL patients, including morphologic or MRD-detectable (≥1x10-4) bone marrow and/or extramedullary relapses after 2 therapy lines:

   1. Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT)
   2. Primary refractoriness, defined as either morphologic persistence or detectable MRD (≥1x10-4) after two standard therapy lines, making the patient not candidate for allo-HSCT.
   3. Refractory first relapse.
   4. Second or further relapse.
4. Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.

Exclusion Criteria:

1. Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), \<45%), pulmonary, liver, renal or CNS dysfunction.
2. Allo-HSCT within a timeframe \<3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD).
3. Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease.
4. Active bacterial, fungal or viral infection not controlled by adequate treatment.
5. Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection.
6. Women who are pregnant (positive urine/blood pregnancy test) or lactating.
The "Peripheral Access Utilizing Sonographic Evaluation" Study

The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.

The purpose of this study is to reduce, by using the ultrasound guided technique, the minor surgical procedures that might be required to deliver fluids into the blood of critically ill patients simply because the patients' veins cannot be located through the manual technique.

The ultrasound assisted technique will increase accessibility to small veins that might be missed via the manual technique. The technique of using an ultrasound machine to assist the administration of fluids into a patient's veins is called ultrasound guided peripheral intravenous access (USGPIVA), while the traditional technique that uses only sight and touch to locate a patient veins without machine assistance is called the traditional landmark technique (TLT). The investigators will compare the effectiveness of USGPIVA with TLT in terms of reducing complications and costs.

Eligibility Criteria:
Inclusion Criteria:

* The patient is \>= 21 years of age
* Adult critically ill patients in CCU and MICU requiring short peripheral intravenous access
* The patient has been identified as difficult intravenous access (DIVA), defined as at least two failed blind sticks in the antecubital fossa or more distal upper arm veins
* The patient does not otherwise require a CVC

Exclusion Criteria:

* The patient has a PICC line on the same side as IV placement and has the following:

  * Has a condition poses risk for DIC, inadequate flow, or infection.
  * Has been identified as a site for "Save the Vein" protocol implementation, unless permission is otherwise obtained by the patient's physician.
  * Has a hemodialysis fistula in place on that upper arm side.
* The patient is expected to require therapeutic agent or procedure that necessitates central venous access such as:

  * central venous monitoring
  * Total Parenteral Nutrition
  * Antibiotic requiring central venous access
  * Chemotherapy
  * Vesicants
  * Medications pH less than 5 or more than 9
  * Medications of glucose concentrations above 10%
  * Solution with protein concentrations above 5% (Vascular Access Management, n.d.)
* The patient already has a central venous catheter access, for reasons other than DIVA, through which therapy can be infused
* The patient has renal disease and a "Save The Vein" order is anticipated or pending (serum creatinine \>2mg/dL and GFR \<20) for one of the patient's arms, unless permission is otherwise obtained by the patient's physician
* The patient has a bleeding disorder, unless permission is otherwise obtained by the patient's physician
* The clinician believes the patient is not a good fit for the study or that the procedure is not appropriate for patient at the given moment
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.

The study is divided into two parts: single agent FT-2102 followed by combination therapy.

Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored.

Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients must have documented IDH1-R132 gene-mutated disease as evaluated by site
* Glioma: Advanced glioma that has recurred or progressed following standard therapy, or that has not responded to standard therapy.
* Hepatobiliary cancer that is relapsed/refractory or intolerant to approved standard-of-care therapy (including: hepatocellular carcinoma, bile duct carcinoma, intrahepatic cholangiocarcinoma or other hepatobiliary carcinomas)
* Chondrosarcoma that is relapsed or refractory and either locally advanced or metastatic and not amenable to complete surgical excision
* Intrahepatic cholangiocarcinoma that is advanced nonresectable or metastatic cholangiocarcinoma not eligible for curative resection or transplantation. Phase 1b/Safety Lead-in of Phase 2: relapsed or refractory disease. Combination Phase 2 (beyond Safety Lead-in): have received no more than 1 cycle of gemcitabine/cisplatin therapy
* Other solid tumors that have relapsed or refractory to standard-of-care therapy with no other available therapeutic options
* Good performance status
* Good kidney and liver function

Key Exclusion Criteria:

* Prior solid organ or hematopoietic cell transplant
* Prior treatment with IDH1 inhibitor (single agent cohorts only)
* Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
* Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, including pneumonitis and/or interstitial lung disease, and uncontrolled diabetes)
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* PD-1 only: active autoimmune disease