cyrilzakka/clinical-trials huggingface dataset:
Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease

Nitric oxide (NO) is an essential molecule in the body that is decreased in patients with chronic kidney disease (CKD), leading to reductions in vascular, movement ("motor") and cognitive functions. This study will determine if daily oral supplementation (3 months) with a supplement that increases NO in the body, i.e., nitrate-rich beetroot juice, improves vascular, motor and cognitive function in patients with CKD; this study will also provide insight into the biological reasons (mechanisms) by which supplementation with nitrate-rich beetroot juice improves vascular function in these patients. Overall, this research will provide scientific evidence supporting the use of nitrate-rich beetroot juice for preserving physiological function and preventing co-morbid clinical conditions and disability in CKD.


Eligibility Criteria:
Inclusion Criteria:

* CKD stage II-IV (eGFR using the Modification of Diet in Renal Disease (MDRD) prediction equation 20-90 mL/min/1.73m2; stable renal function in the past 3 months)
* Ability to give informed consent
* Albumin \> 3.0 g/dL
* Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 6 min, climb 10 stairs)
* Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
* Mini-mental state examination score \>21 (rationale: to screen for subjects with major cognitive impairment)
* Blood pressure (BP) \>100/60 mmHg for past 3 months (rationale: blood pressure below 100/60 mmHg may elevate the normally small risk of hypotension with nitrate supplementation)
* Not taking medications that will interfere with administered medications (e.g., sildenafil interacts with nitroglycerin)
* Body mass index (BMI) \<40 kg/m2 (vascular function measurements can be inaccurate in severely obese patients)

Exclusion Criteria:

* Life expectancy \<1 year
* Uncontrolled hypertension, defined as blood pressure \> 160/100 mmHg in the past 3 months
* History of severe liver disease
* History of severe congestive heart failure (i.e., ejection fraction \< 35%)
* History of hospitalizations within the last 3 months
* Active infection or antibiotic therapy
* Warfarin use
* Vasculitis requiring immunosuppressive therapy within the last year
* High dietary nitrate intake or current nitrate/nitrite supplementation; hypersensitivity to nitrates or nitrites
* Glucose-6-phosphate dehydrogenase deficiency or blood methemoglobin \>2%
* Unwilling to abstain from use of mouthwash or other oral hygiene practices (e.g., tongue scraping) outside of teeth brushing that disrupt the oral microbiome and would interfere with nitrate conversion to nitrite
* Blood donation within 8 weeks prior to enrolling in the study; unwilling to abstain from donating blood for 8 weeks after completing the study
The Impact of Culture in Cognitive Behavior Therapy (CBT) for Patients With Inflammatory Bowel Disease

Introduction Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, is a chronic condition that affects the gastrointestinal tract and has a significant impact on patients' quality of life (QoL) and mental health(Barberio, Zamani et al. 2021). Cognitive behavioral therapy (CBT) has been recognized as a potential therapeutic approach to address the psychological comorbidities associated with IBD(Seaton, Hudson et al. 2024). However, the effectiveness of CBT in IBD is not solely a clinical issue but is also intertwined with cultural factors that can influence treatment outcomes(Naeem 2019).

The effectiveness of CBT in IBD is not solely a clinical issue but is also intertwined with cultural factors that can influence treatment outcomes . This has implications for the delivery of CBT in IBD care, as cultural beliefs and values can affect help-seeking behaviors and responses to treatment. Cultural factors are integral to the successful implementation of CBT in IBD care(Hinton and Patel 2017, Naeem, Sajid et al. 2023). Further research is needed to understand how cultural adaptations can enhance the efficacy of CBT for IBD patients from diverse backgrounds. It is essential to consider cultural nuances in the development and delivery of CBT to ensure that it is both effective and acceptable to patients with IBD across different cultures.

Objective: To identify gaps in the current understanding of the role of culture in CBT for IBD, including the variety of cultural contexts and IBD populations studied . To provide insights that can guide clinical practice in offering culturally competent CBT to IBD patients and inform policy decisions regarding mental health services for diverse populations with IBD .


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age with diagnosed IBD.
2. Age: 18 years and older.
3. residing in China, able to verbally communicate and read in Chinese, with access to the internet to ensure participation in the online intervention.
4. Able to commit to attend the 6weekly sessions of 1 hours' duration.
5. No change in antidepressant medication (dose or type) within 3 months of trial onset.

Exclusion Criteria:

1. Individuals scheduled for major surgery in the next 3 months.
2. Current psychological treatment.
3. Individuals with severe schizophrenia/psychotic disorder.
Molecular Profiling to Improve Outcome of Patients in Cancer. A Pilot Study

Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.

The first France disease genomic medicine program in the field of cancer has been retained by the 2025 Genomic Medicine France Plan. This program, called MULTIPLI encompasses two innovative personalized medicine clinical trials in soft-tissue sarcoma and colorectal carcinoma involving targeted molecules according to the tumor profile of each patient.

This 1st clinical research program aims implementing exome sequencing and RNA sequencing to determine the genomic profile and to provide a therapeutic decision for each patient. Genomic analyzes will be performed on different technical platforms: samples will be collected in each investigating center, nucleic acids extraction will be performed on two genetic platforms, Inca labeled and identified for the purpose of this study: Institut Bergonié and Hôpital Européen Georges Pompidou. CNRGH (Centre National de Recherche en Génomique Humaine) was retained for operational platform genomics and Institut Bergonie for bioinformatics data processing. Each genomic profile will be discussed within a multidisciplinary tumor board which aims at providing a therapeutic decision for each patient and to propose a targeted treatment in case of actionable molecular alteration.

The purpose of this program is to perform analysis on a set of gene, in order to provide results no more than after 6 weeks after the sample arrival on the biopathological platform. This gene panel analysis is based on the predefined list of genes that are direct targets of the drugs available in the MULTIPLI program.

Before implanting this program in a large-scale launch, it was essential to set up a pilot study in order to evaluate both sample's management between several platforms, and the time to report the results, and to verify that it was in line with the objectives set.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Disease: Advanced and/or metastatic soft-tissue sarcoma OR metastatic carcinoma
* Patient consenting to tumor sequencing, secondary reuse of their data
* Patient informed about this study

Exclusion Criteria:

* N/A
The Effect of Autologous Hematopoietic Stem Cell Transplantation on the Lower Urinary Tract Function Related to QoL in MS Patients

Academic research project monitoring the effect of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) on multiple sclerosis-associated lower urinary tract symptoms.

An observational study (academic research project) monitoring the effect of autologous hematopoietic stem cell transplantation (AHSCT) in patients with multiple sclerosis (MS) on lower urinary tract symptoms occurrence. The main goal is to observe the influence of this treatment modality on changes in the quality of life. Secondary endpoints are the changes in the urodynamic parameters and lower urinary tract occurrence. The investigators assume the inclusion of a minimum of 20 patients with AHSCT and 20 patients in the control group with other disease-modifying therapy (DMT).

Eligibility Criteria:
Inclusion Criteria:

* Subjects (male and female) aged 18 and over
* Subjects with signed informed consent
* Subjects able to undergo examination according to the protocol
* Patients indicated by neurologists to perform AHSCT or treated with the closest similar disease-modifying therapy (control group)

Exclusion Criteria:

* Subjects with a history of bladder cancer
* Subjects after previous pelvic radiotherapy
* Subjects with evidence of microscopic or macroscopic hematuria
* Subjects with a history of bladder reconstruction (augmentation cystoplasty, catheterizable stoma), subjects after cystectomy
* Treatment with botulinum toxin injection into the bladder wall in the last 12 months
* Patients in whom the pharmacological treatment of the lower urinary tract has not been stable in the last 3 months and is being adjusted
* Patients whose lower urinary tract symptoms are not stable for at least 3 months
* Patients with a permanent catheter
* Patients with recurrent symptomatic lower urinary tract infections - 3 or more episodes of infection in the last 12 months
* Subjects with tubal urine screening-proven bacteriuria
* Patients with acute lower urinary tract inflammation at baseline
* Subjects with painful bladder syndrome
* Patients after sacral neuromodulation
* Patients with severe pelvic organ prolapse
* Patients after radical pelvic surgery
* Patients with a life expectancy of less than 5 years at the time of inclusion in the study
* Lactating women, pregnant women, women trying to get pregnant, or sexually active women without a tendency to use safe contraception (hormonal-based oral contraceptives, injectable contraception, hormonally active implants, sexual abstinence, vasectomy in a partner)
* Subjects who participated in another study in the previous 90 days
Use of the Mask and Current Pandemic

Due to the continued use of the mask in order to prevent the spread of COVID-19, an impact on people is observed in different areas. The objective of our study was to collect impact aspects related to the continued use of the mask that may affect the quality of life of the population. For this, an observational study has been carried out that includes an interview with aspects related to headaches, problems in the temporomandibular joint, headache impact and quality of life.

Introduction

Due to the continued use of the mask in order to prevent the spread of COVID-19, an impact on people is observed in different areas. The objective of our study was to collect impact aspects related to the continued use of the mask that may affect the quality of life of the population.

Material and methods

Diseny. For this, an observational study has been carried out that includes an interview with aspects related to headaches, problems in the temporomandibular joint, headache impact and quality of life.

Participants. Subjects of all ages from 18 years old will be recruited who use a mask daily for the avoidance of COVID-19 and with the ability to answer the questions and complete the questionnaires. The study will be carried out at the Faculty of Physiotherapy of the University of Valencia. The participants will sign an informed consent guaranteeing the confidentiality of the data. The study is approved by the ethics committee of our institution.

Outcomes. The sociodemographic characteristics and the use of the mask will be collected. Subsequently, the evaluation instruments without the use of a mask and with the use of the same in: Headache and the impact on headaches, pain related to temporomandibular joint and quality of life.

All data will be coded in a database and analyzed later.

Eligibility Criteria:
Inclusion Criteria:

* from 18 years old will be recruited who use a mask daily for the avoidance of COVID-19.
* that they use the face mask at least 2 hours a day
* with the ability to answer the questions and complete the questionnaires.

Exclusion Criteria:

* I do not use the mask
* institutionalized subjects
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin

This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered:

* Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
* Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive placebo.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18 to ≤32 kg/m2, both inclusive.
* Stable health based on a medical history without any major pathology/surgery in the 6 months before Screening and no clinically significant physical examination findings or clinical laboratory test results
* Resting supine blood pressure of 90 to 139 mmHg (systolic) and 60 to 89 mmHg (diastolic) and a resting heart rate of 50 to 100 beats per minute at Screening and Check-in (Day -1).
* Calculated creatinine clearance ≥80 mL/min (Cockroft-Gault method) at Screening.
* Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the investigator

Exclusion Criteria:

* Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before study drug administration in this study.
* History/evidence of clinically relevant pathology
* History of clinically significant food or drug allergy
* Positive alcohol or urine drug screen
Effects of Free Weight and Machine Training With and Without Aerobic Training Among Body Builders

Effects of free weight and machine training with and without aerobic training among body builders.

Effects of free weight and machine training with and without aerobic training on strength, endurance and muscle mass of lower limb among body builders.

Eligibility Criteria:
Inclusion Criteria:

* Age: - 17-35 years(16)
* Body builders(16)
* Physically fit Athletes (17)
* Male athletes
* Benchmarks for body builders

  1. Minimum 60 kg leg press
  2. Minimum 15 kg hams curl
  3. Minimum 10 kg weighted squats

Exclusion Criteria:

* Participants who will be unable to complete the training
* No musculoskeletal disorder
* No cardiorespiratory disorder
* Jumper's knee
* Any respiratory issue
* Foot and ankle injuries
* Patellar tendinopathy
* Pulmonary disorder
* Ligamentous and meniscal injury
* Bone deformity
* Fractures of lower limb
Stratification Protocols and Clinical, Physical and Biochemical Parameters to Forecast Cardiovascular Intercurrences.

Introduction: Despite the various beneficial effects, cardiovascular rehabilitation programs (CVRP) have been associated with the appearance of signs and symptoms. Risk stratification protocols are used to stratify into risk trials for an occurrence of events during physical exercise, although studies investigating their efficacy in predicting signs and symptoms during VCTV are inconclusive. In addition, several clinical, physical and biochemical parameters have been used in the literature as risk markers for the appearance of adverse events, and to investigate whether these parameters are capable of predicting a possibility of intercurrences during PRCV sessions.Objectives: 1) to evaluate the efficacy of risk stratification protocols in predicting signs and symptoms during the performance of a PRCV; 2) to analyze the correlation between clinical, physical and biochemical parameters measured at rest with the presence of signs / symptoms in participants of a PRCV; 3) to evaluate whether changes in clinical, physical or biochemical parameters induced by PRCV influence the appearance of signs and symptoms during PRCV. Materials and Methods: To perform this study, data from 70 patients inserted in a PRCV will be evaluated. The study will be divided into three subprojects that can be divided into three stages: 1) risk stratification of patients who will participate in the study by two independent evaluators (Study 1) and evaluation of clinical parameters (cardiorespiratory parameters and autonomic modulation evaluation); (maximal isometric resistance, maximal isometric contraction, functional capacity and level of physical activity) and biochemical (IL-6, TNF-alpha and IL-10) (Studies 2 and 3). Patients will then be followed up by 24 sessions during the PRCV routines to evaluate signs and symptoms, for posterior correlation with the risk stratification obtained in each protocol (Study 1), and with resting values of clinical, physical and biochemical studies (Studies 2 and 3); 2) Patients perform the normal routines of their PRCV for a period of 6 months (Study 3); 3) The patients will again have their clinical, physical and biochemical parameters evaluated and then will be followed up for another 2 months (24 sessions) during the routines of the PRCV sessions to evaluate signs and symptoms, which will allow to evaluate if gains / losses in these parameters exert influence on the appearance of signs and symptoms during PRCV sessions.


Eligibility Criteria:
Inclusion Criteria:

* To present clinical diagnosis of cardiovascular disease and/or cardiovascular risk factors;
* Be able to perform all the proposed evaluations;
* Agree to participate in the studies.

Exclusion Criteria:

* Patients who miss more than six consecutive sessions of the program or those who total more than 12 absences during the two months that total the period of analysis of the signs and symptoms will be excluded from the analyzes.
Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program

This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).

The participation to the national screening program for colorectal cancer in France is low. In order to improve the performances of its organized program, the National Cancer Institute is planning to modify the invitation procedure. This is a pilot project and if an improvement in the program performances is reported, the invitation procedure may be scaled up.

Eligible individuals for colorectal cancer screening will be identified by the Regional Cancer Screening Coordinating Centre and randomized into the intervention or control arms. They will be followed for FIT test submission to the central laboratory (participation to screening). Those who did not send their test will receive reminder letters. Those who had a positive FIT test will be followed up for coloscopy referral, and result of the coloscopy. Comparison of the participation rates to screening program and to coloscopy among those with a positive FIT test will be compared between the two study arms.

Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 50 to 74 years old
* Living in the study area (Departments of Ardennes, Meurthe-et-Moselle, and Moselle, France)
* At moderate risk of colorectal cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)

Exclusion Criteria:

* Outside the target age (less than 50 years old, or 75 years and more)
* Receiving the reminder letter
* At high or very high risk of colorectal cancer
Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.

Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded.

Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.

Prior to initiation of root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes before treatment).

Root canal treatment will then be carried out in a single visit.

Each patient will receive a 7-day diary to record postoperative pain and swelling. In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement.
* Mandibular posterior teeth.
* Patients with non-contributory systemic condition.
* Patients who can understand pain scales and able to sign informed consent.

Exclusion Criteria:

* Patients allergic to penicillin.
* Patients who have a draining sinus tract.
* Retreatment cases.
Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of advanced or metastatic solid tumor.
* Measurable disease per Response Criteria in Solid Tumors (RECIST criteria).
* Incurable cancer, with disease progression following at least 1 conventional or standard therapy for locally advanced or metastatic disease.
* Negative pregnancy test for women of child bearing potential.

Exclusion Criteria:

* Chronic treatment with corticosteroids.
* Primary central nervous system (CNS) tumors and active metastases.
* Presence of clinically significant or uncontrolled cardiac disease.
* Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
* Symptomatic or prior history of non-infectious interstitial pneumonitis.