cyrilzakka/clinical-trials huggingface dataset:
Validation of a Mental Health Scale for Young People With Chronic Stomach Symptoms

This study aims to validate the Alimetry® Gut-Brain Wellbeing Survey- Youth Version (AGBW-Y), a mental health scale developed for patients aged 12-17 years with chronic stomach symptoms.

There is currently a lack of validated questionnaires developed to assess mental health within patients with chronic stomach symptoms. Our team has therefore developed and validated a new mental health scale for patients with gastroduodenal symptoms, the Alimetry® Gut-Brain Wellbeing (AGBW) Survey.

However, the AGBW Survey was developed and validated for patients aged 18 years and over. Therefore, the Alimetry® Gut-Brain Wellbeing Survey- Youth Version (AGBW- Y) was developed for use in patients with chronic gastroduodenal symptoms aged 12-17 years. This scale is adapted from the adult AGBW Survey, with more appropriate wording for this age group.

This study will distribute an anonymous, online survey to adolescent patients with chronic gastroduodenal symptoms aged 12-17 years. This survey will ask questions about a patient's general demographics, gastrointestinal symptoms, and mental health in order to assess the validity and reliability of the AGBW-Y.

Eligibility Criteria:
Inclusion Criteria:

* Aged 12-17 years
* Able to read and write fluently in English
* Meet the Rome IV criteria and/or have a self-reported previous clinical diagnosis for at least one of the following childhood gastroduodenal DGBIs: gastroparesis, cyclic vomiting syndrome, functional nausea, functional vomiting, rumination syndrome, aerophagia, or functional dyspepsia

Exclusion Criteria:

* Patients with self-induced vomiting
* Patients with an eating disorder
Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients

80% of patients with alcohol use disorders (AUD) present cognitive impairments, such as memory and executive functions. These disorders may have repercussions in addiction treatment by altering the patient's adherence to care. The level of impairment is dependent on the onset of addiction, and also the duration of abstinence.

A complete neuropsychological evaluation is necessary to highlight cognitive impairments. In practice, the evaluation of these disorders by practitioners, is done with the help of tools of screening like the MoCa (Montreal cognitive assesment) and the BEARNI (Brief evaluation of alcohol related neuropsychological impairment).

However, none of these tools have been evaluated in patients with alcoholic cirrhosis. Indeed, some studies have suggested that liver disorders including cirrhosis may be a factor aggravating cognitive disorders.

The purpose of this study is to evaluate the ability of the BEARNI tool to detect alcohol-related cognitive problems in patients with alcohol-related cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with cirrhosis
* patients with cirrhosis diagnosed by clinical examination
* patients with cirrhosis diagnosed by biological and / or morphological and / or noninvasive tests and / or liver biopsy
* CHILD A, B or C

Exclusion Criteria:

* hepatitis encephalopathy less than 6 months old
* complicated cirrhosis with hepatocellular carcinoma
* Acute alcoholic hepatitis
* viral cirrhosis
Study of Accurate Diagnosis and Treatment of Peutz-Jeghers Syndrome

The mutation of STK11 has been regcognized to be the major cause of Peutz-Jeghers syndrome (PJS).The aim of this study was to confirm the mutation rate of gene associated with gastrointestinal malignancies,including STK11, APC,PMS1,et al. Furtherly, the investigators analyze the association of STK11 with gut microbiota.

All patients diagnosed as PJS were enrolled and accepted second generation gene sequencing with their blood specimens. Then all patients allocated into gene mutation group and no gene mutation group according to if the cases accompany with gene mutation of STK11.Also, health persons were enrolled and a case controlled study will be carried out.All patients and health persons accepted 16s rRNA sequencing with their feces specimens.

Eligibility Criteria:
Inclusion Criteria:

1. Subject with ages from 18-70 years old.
2. Subject diagnosed with Peutz-Jeughers syndrome.
3. Subject without hypertension, diabetes and other gastrointestinal diseases.
4. The consent form has been signed.

Exclusion Criteria:

1. Subject is younger than 18 years or older than 70 years.
2. Subject with hypertension,diabetes and other gastrointestinal diseases.
3. Subject taken or adminstered medicine associated with digestive function during latest 1 month.
4. Pregnant women.
PD-L1 Expression in Japanese Renal Cell Carcinoma Patients

This is a multicenter retrospective study designed to compare overall survival (OS) by PD-L1 expression status in patients with RCC who have received systemic chemotherapy for recurrent or metastatic RCC, to determine whether the prognosis is worse in PD-L1-positive than in PD-L1-negative RCC.

Total 600 RCC surgical specimens will be collected from patients who started systemic chemotherapy for recurrent or metastatic RCC between January 1, 2010 and December 31, 2015 at about 30 participating study sites in Japan.

PD-L1 expression status (IC; immune cell) on tumor-infiltrating immune cells will be evaluated by IHC, and classified by score: IC0 (PD-L1-negative) and IC1, IC2, IC3 (PD-L1-positive). Unless otherwise specified, between-group comparisons will be performed between IC0 and IC1/2/3.


Eligibility Criteria:
Inclusion Criteria:

* 1. Written informed consent for this study. In the case obtaining written informed consent is difficult due to death, change of address, and so on, the opt-out consent is accepted by giving patients or their relatives notification regarding the usage of their clinical information and surgical samples for the research.
* 2. Age at nephrectomy≧20 years
* 3.Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression

Exclusion Criteria:

* 1. Malignancies other than RCC is co-existed from the time of nephrectomy and death.
* 2. Treatment with anti-CTLA-4 antibody, anti-PD-1/PD-L1 antibodies as first-line therapy for recurrent or metastatic RCC.
Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease

This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe dry eye disease in both eyes
* Best-corrected visual acuity (BCVA) of 20/100 or better in each eye

Exclusion Criteria:

* Use of any cyclosporine preparations within 3 months
* Use of topical medications, other than artificial tears, in the eyes within 1 month
* Use of contact lenses in either eye within 1 month
* Stage 2 only: Participation in Stage 1 of this study
RAYALDEE Non Interventional Study (NIS) on Effectiveness in ND-CKD SHPT Patients

The overall study objective is to collect real-world data on the safety and effectiveness of ERC to gradually increase 25D to the level required by Stage 3 and 4 CKD patients.

ERC (Rayaldee), a prolonged-release calcifediol (PRC) formulation, is an orally administered prohormone of active Vitamin D (1,25-dihydroxyvitamin D (1,25D)) designed to increase serum total 25D safely and to a high enough magnitude to reliably reduce elevated PTH in patients with non-dialysis chronic kidney disease (ND-CKD). Clinical studies show that ERC is an effective, well tolerated treatment for secondary hyperparathyroidism (SHPT) in ND-CKD patients with Vitamin D insufficiency or deficiency. ERC gradually raises serum 25D levels, resulting in physiologically regulated increases in serum 1,25D and sustained and progressive reductions in PTH levels, while avoiding clinically meaningful increases in serum phosphate and calcium.

To date, experience with the use of ERC results exclusively from patients from the US and mainly from patients who have participated in clinical trials. It is therefore of major interest to observe the value of ERC in daily use outside of the controlled trial settings in the US as well as in Europe. (Protocol v.2.0,06Dec2023).

Non-interventional, prospective, multicentre, cohort study. Approximately 100 patients diagnosed with ND-CKD with SHPT being treated with ERC according to the SmPC will be included.

The scheduled total study duration is 2.5 years, with a recruitment phase of approximately 1.5 years. The individual prospective observational period per patient is scheduled to last up to 12 months, or up to 18 months for pre-treated patients. The number of observational time points for an individual patient will be dependent on the individual observational period and is assumed to be approximately every 3 months.

A patient is eligible if ERC treatment initiation can coincide with the date of patient inclusion in the study or can happen up to 6 months before patient inclusion in the study. The observational period of ERC treatment will be retrospective if it occurs before study inclusion and prospective for the period after study inclusion. The decision to initiate treatment remains with the treating physician, in line with their normal standard of care, in accordance with the SMPC.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent

  * Age ≥18 years
  * Indication for ERC treatment in accordance with the currently approved SmPC.
  * Starting ERC treatment or being on ERC treatment for a maximum of 6 months before inclusion in the study.
  * Stable kidney function in the medical judgment of the investigator

Exclusion Criteria:

Parallel participation in an interventional study

• Enrolment in a prior clinical trial with ERC
Home-based Pulmonary Rehabilitation for COPD Patients

Objectives The objective of this project is to motivate patients with COPD to incorporate the habit of doing daily mindful physical activity by using the proposed home-based pulmonary rehabilitation program that integrates video guided exercises, activity monitoring daily steps and health coaching. This program will allow patients to complete Pulmonary Rehabilitation (PR) at home and promote behavior change and lead to a more active lifestyle for patients with COPD who have been prescribed PR.

The program will be able to effectively monitor daily step count. A health coach will receive more this detailed data and will guide weekly health coaching sessions designed to increase awareness of the physical activities completed and ignite inner motivation for healthy behaviors.

The proposed PR program is innovative and responds to an unmet need in chronic care for COPD patients in the context of COVID-19 pandemic and it mitigates the common accessibility barriers.

Specific aims will guide the proposed project:

* Aim 1: To determine the feasibility of the proposed home-based PR program. We will additionally address adherence and appropriateness of the program.
* Aim 2: To determine improvements in quality of life and mental health of the proposed home-based PR determined.
* Aim 3: To evaluate if the average number of daily step counts increase after the home-based PR program

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 40 years and older
* FEV1 \<80% or less (forced expiratory volume in one second) as documented by pulmonary function.
* Medical diagnosis of COPD, GOLD classification B,D, and C based on symptoms and history of exacerbations.
* The patients must be able to access a smart-phone or computer tablet with internet service.

Exclusion Criteria:

* Unable to perform low intensity exercise.
* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move, are not living in the healthcare area.
* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
Effect of Diaphragmatic Myofascial Release on Thoracic Angle and Pulmonary Functions in Hyperkyphotic Adolescents

Adolescent kyphotic girls will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. They will be assessed at baseline and after three successive months of interventions for the following outcomes: Cobb angle by x-ray and pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer

Adolescent kyphotic girls with an age range of 12-15 years old will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. Both groupss will receive intervention for three three successive months. They will be be assessed at baseline and after three three successive months of interventions for the following outcomes:

Primary outcome: Cobb angle by x-ray Secondary outcome: pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer

Eligibility Criteria:
Inclusion Criteria:

* Adolescents girls with thoracic kyphosis with cobb angle ranged from 45 to 55 degree.
* Age ranged from 12 to 15 years old.
* selected from preparatory and secondary schools.

Exclusion Criteria:

* free from any associated deformities other than the thoracic kyphotic deformity.
The Disease Severity In Patients With Psoriasis

This observational study aims to evaluate new markers to predict disease activity in psoriasis. The main question is SGOT, SGPT, GGT, hs-CRP, and apo B related to disease severity in psoriasis.

Psoriasis patients who had signed an informed consent were assessed for PASI scores and 5 cc of blood was drawn for GGT, hs-CRP, and apo B examinations. A PASI score is a tool used to measure the severity and extent of psoriasis. PASI is an acronym for Psoriasis Area and Severity Index.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Psoriasis

Exclusion Criteria:

* Heart Failure
* Diabetes Mellitus
* Kidney Disease
Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI

Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC reduces the incidence of CI-AKI measured standard way of using SCr concentration but also with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective coronary angiography (CA) followed by percutaneous coronary intervention (PCI).

Nowadays CI-AKI is defined according to serum creatinine concentration (SCr) as any of the following: (1) an absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or (2) a relative increase of 25% in serum creatinine compared to baseline within 48 to 72 hours after contrast administration. In the last decades, several novel biomarkers of AKI have been studied including neutrophil gelatinase-associated lipocalin (NGAL). Furthermore, remote ischemic preconditioning (RIPC) turned out to be one of the most promising and intriguing non-pharmacological strategy. This simple procedure consisting of brief, non-lethal episodes of ischemia and reperfusion applied in one tissue or organ protects remote tissues or organs from subsequent injury.

Eligibility Criteria:
Inclusion Criteria:

* aged over 18 years
* patients with stable angina pectoris
* patients admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz with intention of elective CA with follow-up PCI.

Exclusion Criteria:

* history of severe injuries up to 2 months before intervention
* history of surgeries up to 2 months before intervention
* history of cancer,
* acute inflammation during hospitalization
* chronic autoimmunologic diseases
* patients needing hemodialysis
* chronic kidney disease in stage 4 or 5 (eGFR\<30 ml/min/1,73m2)
* peripheral vascular disease affecting upper limbs.
Effectiveness of Laser Hair Removal in Pilonidal Disease

Pilonidal disease is a common painful condition that affects 26 per 100,000 people with an incidence of 1.1% in the young male population. Recurrence rates of pilonidal disease after initial incision and drainage and after resection have been reported to be 16% and 11% respectively. Furthermore, wound issues after resection with primary closure have been reported to be as high as 30%. In several retrospective studies and small prospective studies, laser hair removal has shown promise as an adjunct therapy to decrease recurrent infections and decrease the need for repeat surgery in adults and older adolescents. We are performing a randomized control trial of laser hair depilation plus chemical/mechanical depilation to examine outcomes related to recurrence of pilonidal disease.


Eligibility Criteria:
Inclusion Criteria:

* All Fitzpatrick skin types
* 11-21 years of age
* Diagnosis of pilonidal disease

Exclusion Criteria:

* History of photosensitivity
* Actively inflamed pilonidal sinus. These patients are invited to participate upon resolution of their inflamed sinus.
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections

The objectives are to evaluate whether variations in vaginal and/or urinary and/or fecal microbiome predispose postmenopausal women to recurrent cystitis. This will be explored using comparison of microbiome profiles between those with recurrent UTI compared to age-matched women without recurrent UTI.

Patients and age-matched control subjects will be recruited from the Urogynecology clinic in Hadassah Mt Scopus and the gynecology clinic, respectively.

After assessment of inclusion and exclusion criteria and patient's consent to participate, a history intake (detailing demographics, medical history, risk factors for rUTI etc.) and gynecological examination will be conducted as part of the usual assessment in the clinic.

Vaginal, urine and fecal samples for microbiome molecular analysis will be collected during clinic visits, given at least one month without antibiotics before samples collection, using agreed protocols and will be kept for future evaluation. Urine will be collected for urinalysis and for a urine culture.

In addition, urine cultures, as well as vaginal, urine and fecal samples for molecular analysis will be collected during an acute UTI episode from the same patients.

Healthy patients (the control group) will be examined only once.

Eligibility Criteria:
Patients' inclusion criteria:

* Menopausal status
* Two or more documented, culture-positive infections in the last six months or ≥3 infections in the last year Patients' exclusion criteria
* Neurogenic bladder condition
* Known immunodeficiencies
* Usage of antibiotics or probiotics within the previous month
* Known renal calculi or anatomic malformations

Control subjects- Inclusion criteria:

* Menopausal status
* Sterile urine cultures, normal urinalysis, and negative sexually-transmitted PCR urine assay

Control subjects- Exclusion criteria:

- A prior history of UTIs or other urologic abnormalities.
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.

There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. This trial aims to compare personalized PRRT to non-personalized PRRT in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Written informed consent
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Presence of histologically confirmed, advanced, well-differentiated, inoperable neuroendocrine tumors (NET) of any primary tumor origin and any grade, except for pheochromocytoma and paraganglioma.
* Somatostatine receptor (SSTR)-expression in tumor lesions \> basal liver uptake on 68Ga-DOTA-PET
* Radiologically progressive disease within the last 1-24 months according to common clinical criteria and confirmed by the institutional multidisciplinary conference for the treatment of NETs. The CT/MRI that shows tumor progression compared to screening/baseline must have been performed 1-24 months earlier.
* All previous anti-tumor treatment except SSA must be terminated at least 4 weeks before start of treatment within the trial.
* Measurable disease according to RECIST v 1.1
* Given the available, approved anti-tumor treatments and the specific characteristics of the patient and the tumor, the investigator judges peptide receptor radionuclide therapy (PRRT) to be the treatment of choice
* GFR \> 50 ml/min/1.73 m2 as determined by iohexol- or 51Cr-EDTA clearance, calculated according to a combination of LMR18 and CAPA formulas, or equally accurate method
* Hemoglobin \> 90 g/L, platelets \>100 x109/L, leukocytes \> 3.0x109/L, neutrophils \> 1.5 x109/L, aspartate transaminase (ASAT)/alanine aminotransferase (ALAT) \< 3 x ULN, bilirubin \< 2 x upper limit of normal (ULN), albumin \> 25 g/L
* For women of child-bearing potential, highly effective contraception should be used from the time of inclusion up to at least six months after the end of treatment (EOT) visit.

Exclusion Criteria:

* Pregnancy or lactation
* Previous treatment with PRRT
* Concomitant systemic anti-tumor therapy other than somatostatin analogue (SSA)
* Contraindications for treatment with capecitabine according to the approved label.
* Discordance between CT/MRI/18F-FDG-PET and 68Ga-DOTA-PET, with evidence of tumor lesions without uptake on 68Ga-DOTATOC.
* Any other serious, uncontrolled medical or psychiatric condition that, in the opinion of the investigator, precludes the patient from participation in the trial
* Unwillingness, or inability, to participate in any part of the trial procedures or treatments.