cyrilzakka/clinical-trials huggingface dataset:
B-amyloid as a Marker for GBM Bioimaging

This project is aimed at improvement of glioblastoma (GBM) diagnostic strategies for discrimination of tumor progression and chemo- and radiotherapeutic treatment-related changes in brain tissue. The study will elucidate the diagnostic value of PET imaging with use of amyloid-β radioisotope tracer Amyvid (Florbetapir F18) for GBM. The results of the study will provide data for development of new approach for GBM diagnostics.

Glioblastoma (GBM) is one of the most malignant forms of brain cancer. Majority of GBMs relapse shortly after tumor resection, and the timely follow-up diagnosis and treatment is vital for patient's survival. However, chemo- and radiotherapeutic treatment of GBM patients cause metabolic and structural changes in brain parenchyma, manifested as metabolic and matrix remodeling modifications, and mimic tumor progression in magnetic resonance imaging (MRI) images. This creates difficulties in discrimination of real tumor progression and post-treatment modifications. No current imaging techniques, including MRI, magnetic resonance spectroscopy (MRS) or perfusion MR (MRP) can provide effective determination of tumor progression and treatment-related changes of brain tissue, that represents current unmet clinical need. The goal of the study is to identify specific biomarker for GBM, that can be used for precise imaging and diagnostics.

The accumulation of amyloid-β in human GBM specimens and in mouse glioma implantation model was previously demonstrated. Intravenous administration of amyloid-β marker thioflavin T resulted in accumulation of fluorescence in brain tumors in mouse GBM model 15 minutes after administration and allowed detailed visualization of tumor structure with use of confocal microscopy. The hypothesis of the study is that Amyvid (Florbetapir F18), a radioisotope tracer, that binds amyloid aggregates and is currently used for brain PET diagnostics of Alzheimer disease, can be used as a safe and effective marker for PET diagnostics of recurrent GBM.

The central study question: if Amyvid-PET provides visualization of GBM tumors and discriminate recurrent tumor and post-treatment tissue modifications in human brain, and thus presents the potential for amyloid-binding radioisotope tracers as GBM diagnostic tool. The purpose of the study is to characterize and describe the ability of Amyvid to reach GBM tumor in humans and to bind specific tumor structures as necrotic, middle and invasion areas of tumor, as well as blood vessel structures and extracellular matrix in tumor. The study is designed as human clinical trials phase 2A.

Eligibility Criteria:
Inclusion Criteria:

* GBM diagnose confirmed by MRI and histopathology
* Had undergone gross total or subtotal resection of their tumor and developed enlarging and/or new enhancing lesion(s), recommended for second resection
* Had or had not received radiation therapy with concomitant and adjuvant TMZ chemotherapy
* Had pre-operative and follow up conventional MRI, MRS and/or Perfusion MR scans, available for analysis

Exclusion Criteria:

• Previous allergic reaction to radioisotope tracers
Short and Long Time Effects of IASTM and Myofascial Release Techniques in Chronic Neck Pain

The aim of this study is to determine whether EYYDM and myofascial applications have short and long-term effects on pain and disability in individuals diagnosed with chronic neck pain.

Participants will be randomly assigned to IASTM, myofascial release and control groups. In addition to conventional treatment, IASTM and myofascial release groups will be treated twice a week for 4 weeks. Conventional treatment will be applied to the control group for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* having a diagnosis of chronic neck pain,
* To have given at least 3 values to the pain with the Numerical Pain Scale
* having bilateral muscle spasms in the cervical region

Exclusion Criteria:

* those who are taking any analgesic medication,
* those with acute injury or infection,
* those with open wounds,
* osteoporosis,
* fracture,
* hematoma,
* those with acute cardiac, liver and kidney problems,
* those with connective tissue disease,
* rheumatoid arthritis, osteoarthritis,
* cancer,
* those with circulation problems,
* those with peripheral vascular disease,
* epilepsy,
* history of surgery in the cervical region
Feasibility and Safety in the Management of Fluid Overload in Peritoneal Dialysis Patients Through Sweat Stimulation With the Use of Portable Sauna Bath, Pilot Study

The objective of this pilot study is to evaluate the feasibility and safety of the use of diaphoresis achieved through the use of portable sauna baths in peritoneal dialysis patients with fluid overload

Fluid overload is a common problem in peritoneal dialysis (PD) patients and it is associated with left ventricular hypertrophy and other adverse cardiac consequences. Fluid management is therefore an important aspect in the management of dialysis patient. Despite improvements in dialysis methods and other techniques in these patients, fluid overload persists due to the great limitations of the affected population: physiopathological, economic, educational, social and psychological. The above creates the need for other therapies that lead to the reduction of overload and thus avoid the comorbidity that this entails. The objective of this study is to evaluate the feasibility and safety of the use of diaphoresis achieved through the use of portable sauna baths in peritoneal dialysis patients with fluid overload. The patients are subjected to a period of data collection for 3 days and then use the portable sauna bath 30 minutes a day supervised by the research team during the 6 following days, without interrupting their peritoneal dialysis therapy. We plan to recruit at least 9 patients with PD with fluid overload. Changes in the degree of overhydration are determined by bioimpedance spectroscopy and patient weight at the beginning and end after treatment. Changes in body weight, blood pressure, potassium, urea and creatinine levels, the degree of edema, as well as knowledge about the salt and liquid line were also evaluated. Adverse events will be reported.

Eligibility Criteria:
Inclusion Criteria:

Being on chronic peritoneal dialysis every day since at least 3 months Diagnostic of Fluid overload Stable clinical condition Written informed consent

Exclusion Criteria:

Any cardiovascular event in the last 12 months (acute myocardial infarction, NYHA Heart Failure III-IV, Cardiac Arrhythmia, Cerebral Vascular Event, Unstable-Stable Angina) Peritonitis Pregnancy
Dialogue to Empower Traditional and Faith Healers to Deliver mhGAP-IG Adapted Psychosocial Interventions in Kenya

The project aimed to create a dialogue between the informal sector (traditional and faith healers) and the formal sector (trained health care workers) in order to increase synergy and communication between the two systems, by minimizing any harmful practices and enhancing complementary practices. The informal sector will also be trained on how to use WHO mhGAP-IG component on depression for routine screening in order to ameliorate functional and social outcomes and refer complicated cases to the formal sector for biological interventions

This study seeks to empower, supervise, support and include the informal traditional and faith healers to deliver evidence-based mhGAP-IG adapted psychosocial interventions to reduce mental health treatment gap in Kenya. This will be achieved through establishing a dialogue and collaboration between the formal and the informal sector and training the informal sector on the use of mental health Gap Action Programme Intervention Guideline (mhGAP-IG) to identify and manage depression. It will take place in Makueni County among 100 randomly selected TH/FH. A descriptive (prospective cohort) study will be used to determine the impact of training TH/FH on the use of mhGAP-IG in the identification and management of depression. A mental health specialist will also determine the accuracy of diagnosis made by the informal sector using randomly selected patients (true positives and true negatives for depression) by an independent person. Moreover, patients identified to have depression will be followed up at 6 and 12 weeks to assess their health outcomes using BECKs Depression Inventory Scale, Suicidality Scale and WHO quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Traditional and faith healers residing in Kibwezi West constituency
2. Traditional and faith healers who are willing to participate in the study.
3. Traditional and faith healers' patients' above 18 years who agree to participate in the study

Exclusion Criteria:

1. Traditional and faith healers not residing in Kibwezi West constituency
2. Traditional and faith healers who are not willing to participate in the study.
3. Traditional and faith healers' patients' above 18 years who do not agree to sign an informed consent
Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies

This research was conducted to identify the effect of the practice of Guided Imagery on the perceived stress level in high-risk pregnancies.

Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).

Eligibility Criteria:
Inclusion Criteria:• Having a high-risk pregnancy

* Being aged 18 years or above
* Agreeing to participate in the study
* Being literate in Turkish

Exclusion Criteria:

* The pregnant women who voluntarily wanted to leave the research at any stage after being included in the study, could not communicate verbally, had a visual or hearing disorder, and were previously diagnosed with a psychiatric disease were excluded from the research
Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer

Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung cancer. Relatives with family history of lung cancer are at increased risk of lung cancer compared to those without a family history in pooled analysis. A prospective trial using LDCT of lung to screen the relatives with family history of lung cancer is needed.

Investigators invited participants with family history to join in this study under the criteria of (1) relatives of the lung cancer patients; (2) age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old; (3) compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation. The participants with (1) proved lung cancer either with or without treatment, (2) presence of hemoptysis or history of remarkable lung fibrosis, (3) any other cancer history or (4) chest CT examination within one year would be excluded from the study.

The study was planned to enroll 1000 participants from simplex families and 500 participants from multiplex families for lung LDCT screening. Multiplex family was defined as two or more family members with lung cancers, and simplex family as one family member with lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. relatives of the lung cancer patients;
2. age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old;
3. compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation.

Exclusion Criteria:

1. proved lung cancer either with or without treatment,
2. presence of hemoptysis or history of remarkable lung fibrosis,
3. any other cancer history or
4. chest CT examination within one year
Exploring the Psychophysics of Keratoconus Using the Moorfields Acuity Chart

The measurement of visual acuity is made using black letters of varying size superimposed on a uniform white background. The objective is to determine the smallest letter, or optotype, that can be correctly identified. One limitation of current tests is the variability of measurements, this making it difficult for clinicians to determine if changes in visual acuity are related to ocular disease. This variability has been attributed to the design of current optotypes, in particular their differing legibilities. Our group has recently demonstrated that a new type of letter chart (Moorfields Acuity Chart), containing letters with a black core and a white border presented on a grey background, reduces the variability of visual acuity measurements. In this study the investigators wish to determine if changes in vision owing to keratoconus, a disease that causes the cornea to adopt an irregular shape, may be detected more easily using the Moorfields Acuity Chart compared with conventional letter charts.


Eligibility Criteria:
Keratoconic subjects (50):

* Age 18-40 years.
* The presence of keratoconus in at least one eye.
* The absence of significant media opacities (e.g. cataract, corneal scarring).
* The absence of any other ocular pathology (e.g. glaucoma, diabetic retinopathy, uveitis).
* The absence of amblyopia in the test eye.
* No previous ocular surgery (e.g. corneal crosslinking, cataract surgery, etc.)
* Best corrected visual acuity better than or equal to 6/60 (1.0 logMAR).
* Pupil diameter ≥3 mm and ≤7 mm in normal room illumination.

Healthy subjects (30):

* Age 18-35 years.
* The absence of clinically significant keratoconus.
* The absence of significant media opacities. (e.g. cataract, corneal scarring).
* The absence of any other ocular pathology (e.g. glaucoma, diabetic retinopathy, uveitis).
* The absence of amblyopia in the test eye.
* No previous ocular surgery (e.g. corneal crosslinking, cataract surgery, etc.)
* Best corrected visual acuity better than or equal to 6/9 (0.1 logMAR).
* Pupil diameter ≥3 mm and ≤7 mm in normal room illumination.
Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India

The purpose of the India iPro2 study is to demonstrate that iPro2 Continuous Glucose Monitoring System (CGMS) evaluation enables Health Care Professional (HCP)s treating patients in India with type 2 diabetes to get a better understanding of their patient's metabolic fluctuations, and support appropriate therapeutic intervention.

The study will be designed to demonstrate the value of iPro2 in real-world diabetes management in type 2 patients in India. It will be an interventional post-market, prospective, multi-center study with a data review performed after 30 subjects have completed the trial.

During the course of the study, patients will undergo two iPro2 evaluations:

* First iPro2 test (Visit 1 \[application\] \& 2 \[removal\])
* Second iPro2 test (Visit 3 \[application\] \& 4 \[removal\])

Patient and HCP questionnaires will be administered at Visit 1, 2, 3, 4 and 5. These questionnaires aim to assess the impact of an iPro2 evaluation on the physicians understanding of their patient's metabolic fluctuations and its support of therapeutic interventions. They will also investigate the subjects understanding (both pre \& post iPro2 evaluation) of the concept of glycemic variability and the importance of compliance to HCP recommendations.

Eligibility Criteria:
Inclusion criteria:

1. Subject is \> 18 years to ≤ 70 years of age
2. Subject has been diagnosed with type 2 diabetes mellitus for at least 1 year and is currently being treated with an oral anti-hyperglycemic medication and/or insulin
3. Subject's A1C \> 8.0% to ≤ 10% conducted in the last 4 weeks
4. Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC)
5. Subject is willing to comply with the study procedures

Exclusion criteria:

1. Subject is unable to tolerate tape adhesive in the area of sensor placement
2. Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.
3. Subject has no experience with SMBG and blood glucose meter use
4. Subject has undergone an iPro evaluation during the past 6 months
5. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
6. Subject is actively participating or planning to actively participate in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
7. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
8. Subject has unresolved alcohol or drug addiction
Comparison of Sub-maximal Voluntary Isometric Training vs Eccentric Training in Management of De Quervain Tenosynovitis

This study is a randomised control trial and the purpose of this study is to compare the effects of Sub-maximal Voluntary Isometric Training vs Eccentric Training in Management of De Quervain Tenosynovitis

Participants will be recruited into their respective groups using a coin toss method. De Quervain Tenosynovitis will be assessed using the following tests:

1. Wrist hyperflexion and abduction of thumb (WHAT) test
2. Finkelstein's / Eichhoff's test
3. De Quervain Screening Tool

Eligibility Criteria:
Inclusion Criteria:

* Patients having history of pain, tenderness in thumb region from 3 weeks or more
* Age 21-50
* Both genders
* Individuals meeting the diagnostic criteria i.e.
* A score of 3 or more out of 7 on De Quervain screening tool.
* Positive Wrist hyperflexion and abduction of thumb (WHAT) test
* Positive Finkelstein's / Eichhoff's test

Exclusion criteria:

* Diagnosed cases of Osteoarthritis of 1st CMC joint and Rheumatoid arthritis
* C6 cervical radiculopathy
* Any systemic inflammatory condition like septic arthritis
* Carpal Tunnel Syndrome
* Complex regional pain syndrome
* Previous surgery impacting the first extensor compartment of the wrist
* Corticosteroid injection in the radial wrist region within 3 months of enrolment into the study
* If patient had undergone isometric thumb exercises or any strengthening protocol lasting greater than 2 weeks for the management of their current episode of de Quervain's syndrome
Proteomic Characterization of Aggressive Oligodendrogliomas

Oligodendrogliomas represent a distinct subgroup of adult gliomas characterized by specific molecular alterations (1p/19q codeletion, mutations of IDH, TERT promoter, CIC, FUBP1). These tumors account for 5 to 10% of adult gliomas and are of special relevance in the neuro-oncology field because of their frequent chemosensitivity (Louis et al. 2016). The genetics of oligodendrogliomas is relatively well characterized but the mechanisms of oncogenesis for these tumors are poorly understood.

Although oligodendrogliomas prognosis is usually better than that of other adult glioma subtypes, it remains heterogeneous and there is no effective treatment at recurrence after radiotherapy and chemotherapy. Our recent work conducted within the INCa-funded national POLA network has related this clinical heterogeneity to inter-tumoral heterogeneity. Based on a transcriptomic analysis of a large series of oligodendroglial gliomas we identified 3 subgroups, the most aggressive group being characterized by aggressive clinical and molecular pattern. Recent studies, however, have shown a relatively low level of concordance between mRNA and protein expression, emphasizing the need to use proteomic-based approaches to better understand tumor biology. Taking advantage of the POLA cohort, we propose to expand our previous analysis by integrating a proteomic analysis of oligodendrogliomas.

The aim of this project is to identify drivers of oligodendroglioma subgroups, among which potential druggable targets (i.e receptors, metabolism effectors). For this purpose, the proteomic profiles of 90 oligodendrogliomas will be generated and integrated with transcriptomic, genomic and methylation profiles in order to identify signaling pathways specifically associated with each subtype, especially with the most aggressive one. Associations will be explored between candidate signaling pathways expression and clinical outcomes (survival, progression-free survival, objective response). The relevance of the 2 most promising candidate signaling pathways will be assessed in vitro and in vivo using genetically relevant mouse and xenograft models.

Our project will identify targetable oncogenic pathways associated with poor prognosis that could lead to new therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* - transcriptomic (microarray) data available or possible to obtain them,
* methylation (450K) data available or possible to obtain them,
* genomic (SNP array) data available or possible to obtain them,
* sufficient material for proteomic analysis (frozen tumor samples)

Exclusion Criteria:

* opposed patients
Open Versus Laparoscopic Appendectomy

The aim of this prospective randomized trial is to compare the feasibility of open with laparoscopic appendectomy in suspected acute appendicitis. The investigators especially focused on the postoperative recovery and long-term complications.


Eligibility Criteria:
Inclusion Criteria:

* age over 15 years
* suspected acute appendicitis
* suitability for laparoscopy

Exclusion Criteria:

* patients refusal to participate
* lack of a laparoscopic surgeon
A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes

The objective of the study is to assess the effect of low-calorie diets with normal (18%) vs. high (35%) protein (mainly coming from animal source) composition on body weight and carbohydrates metabolism in overweight and obese subjects with pre-diabetes or diabetes. A dietary intervention is carried out during 6 months in 100 subjects who are individually randomized to an energy-restricted diet with two types of macronutrients composition: 1) 35% protein, 30% fat and 35% carbohydrates and 2) 18% protein, 30% fat and 52% carbohydrates. Around 80% of total protein in diet comes from animal source (of whom around 40% from lean red meat). Subjects are provided with weekly menus and different recipes to use them as part of the diet. Monitoring visits with the nutritionist will be performed every 15 days. At the beginning of the study, after 3 and 6 months, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoproteins A1 and B, iron, transferring, ferritin, uric acid, glucose, HbA1c, insulin, adiponectin and resistin). Urine samples are also collected to assess microalbuminuria and ureic nitrogen.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years old.
* Body mass index between 27.5 - 40.
* Steady weight (± 4 kg) in the last 2 months.
* Glycated hemoglobin between 6 - 7%.

Exclusion Criteria:

* Anti-diabetic drugs (oral or subcutaneous) in the last 2 months.
* Lipid-lowering drugs in the last 2 months.
* Gouty arthritis in the last 2 years or uric acid \> 735 mg/dl.
* Presence of uncontrolled endocrinological pathology (including hypothyroidism).
* Hepatic chronic disease (glomerular filtration rate \< 45 ml/min).
* Renal, inflammatory or tumoral diseases.
* Drugs which could interfere in glucose or lipid metabolism such as androgens, corticosteroids (except for those with topic administration) and estrogen replacement therapy.
* Intake of functional foods with plant sterols in the past 6 weeks.
* High alcohol intake (\> 30 g per day).
* Any serious disease which involves less than 1 year life expectancy or, in investigators judgment, limit the follow-up of an homogeneous diet throughout the study.
* Pregnancy or intention of pregnancy during the study.