cyrilzakka/clinical-trials huggingface dataset:
Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers

RATIONALE: Learning about quality of life, symptoms, and health behaviors in colorectal cancer survivors may help to determine the long-term effects of colon and rectal cancer treatments and may help to improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial is looking at patient-reported outcomes in long-term survivors of colon and rectal cancers.

OBJECTIVES:

* Characterize 3 separate types of patient-reported outcomes (quality of life \[e.g., generic and disease-specific\], functional outcomes \[e.g., bowel and sexual function and activities of daily living\], and clinical symptoms \[e.g., pain, fatigue\]) in long-term (5+ years) survivors of colon and rectal cancers in a large national sample recruited from five National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment trials.
* Explore the degree to which patient-reported outcomes are impacted by individual characteristics (e.g., specific predisposing factors, enabling resources, and need), by health behaviors (e.g., use of services for cancer-related and non-cancer-related issues), and, when appropriate, by the specific treatments that were received.
* Examine patient-reported outcomes prior to randomization and treatment, 1 year after treatment, and in long-term follow up \> 5 years after diagnosis in patients with colon cancer treated with adjuvant chemotherapy on protocols NSABP C-06 or NSABP C-07.

OUTLINE: This is a cohort, single-group, multicenter study.

Patients complete a one-time, computer-assisted telephone interview assessing their overall quality of life (QOL), disease-specific QOL, function and symptoms (including pain and fatigue), use of healthcare services, prevalence and severity of comorbidity, and demographics.

PROJECTED ACCRUAL: A total of 1,167 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Prior diagnosis of colon or rectal cancer
* At least 5 years since participated in 1 of the following clinical trials:

  * NSABP-R-02
  * NSABP-R-03
  * NSABP-C-05
  * NSABP-C-06
  * NSABP-C-07

PATIENT CHARACTERISTICS:

* Able to speak English

PRIOR CONCURRENT THERAPY:

* As per participation requirements of previous NSABP treatment trials
An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D

This is an open-label, multicenter, Phase 1/2 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D

VCTX211 combination product (unit) compromises 2 components: (1) allogeneic pancreatic endoderm cells (PEC211) genetically modified using Cluster Regularly Interspaced Short Palindromic Repeats/ CRISPR-associated protein 9 (CRISPR/Cas9) to promote immune evasiveness and survival, and (2) a durable, removable, perforated device designed to deliver and retain PEC211 cells.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T1D for a minimum of 5 years
* Stable diabetes regimen for at least 3 months prior to enrollment.

Exclusion Criteria:

* Medical history of islet cell, kidney, and/or pancreas transplant
* Occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment
* Known causes of diabetes other than T1D
* Immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study
* Prior treatment with gene therapy or edited product
Total IgE (Immunoglobulin E) and Der p 1 (d1) Specific IgE in Induced Sputum in Patients With Allergic and Non-allergic Asthma

Asthma is a heterogeneous disease, and specifically the phenotype of non-allergic asthma is not yet well defined. Several studies describe this group of patients as having severe asthma, persistent eosinophilia and poor therapeutic response. Among the theories being considered is the role of local IgE. Objectives: 1) To perform a pilot test to validate the measurement technique and standardize the levels of total IgE and IgE specific to Dermatophagoides pteronyssinus (d1) in the induced sputum of asthmatic patients and healthy volunteers. 2) Correlate local total IgE and specific IgE levels to d1 (sputum and peripheral blood) in patients with allergic and non-allergic asthma. 3) Describe the clinical and inflammatory characteristics of patients with allergic and non-allergic asthma.

Comparative cross-sectional study. It will include 32 allergic and non-allergic asthma patients and 10 healthy volunteers. All patients will have an induced sputum, pulmonary function studies, FENO (exhaled fraction of nitric oxide), total and specific IgE measurement at d1 (the most common perennial pneumoallergen) in blood and induced sputum, as well as a prick skin test with standardized allergen extracts. Measurement of total IgE and IgE for d1 in induced sputum will be performed in the supernatant and by the ImmunoCAP (Phadia ThermoFisher Scientific) immunofluoroassay technique.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70
* Asthma according to GEMA (spanish asthma guideline)

Exclusion Criteria:

* Pregnancy
* Active smoking
* Moderate alcohol consumption
* Atopic dermatitis
* Other respiratory disease different than asthma (COPD, bronchiectasis, cystic fibrosis, pleural disease, interstitial disease)
* Treatment with steroids or inmunodepressants
* Active malignancy.
An Intervention Study to Evaluate a Website Tailored to New Dads to Promote Mental Health

The purpose of this study is to develop and pilot test HealthyDads.ca, a website for expectant first-time fathers who have known risk factors for depression.


Eligibility Criteria:
Inclusion Criteria:

* Able to communicate in French or English
* Either married or cohabiting at the time of study entry
* First child for both partners
* Have internet access
* Score \<12 on the Edinburgh Postnatal Depression Scale (EPDS)
* Not currently receiving psychotherapy from a health professional or on medication for a mental disorder
* At least 1 risk factor for depression if they score \< 6 on the EPDS: a)history of depression, b) elevated anxiety or c) couple discord

Exclusion Criteria:

* Suicidal ideation or intent
* Physical condition precluding participation in exercise
Compliance With Antidepressant Medication in Treatment of Functional Dyspepsia

The study hypothesis is appropriate clinician-patient communication that provides explanations of the reasons for psychoactive drug prescriptions based on the generation of FD symptoms and the drugs' effects might improve compliance with psychoactive agent regimens among FD patients.

Antidepressive agents have been proved to be effective in the treatment of functional dyspepsia (FD) patients. However, one of the factors that limit therapeutic benefit is the poor compliance with prescribed drugs. The possible reasons for lack of compliance include the patient's health beliefs (e.g., that people who took such agents is possibly considered insane in China), lack of knowledge about antidepressants (that they are addictive or can be stopped on recovery), and aversion to side effects. The investigators propose to examine whether different clinician-patient communication methods could affect adherence to antidepressant drugs in functional dyspepsia patients.

Eligibility Criteria:
Inclusion Criteria:

* met the ROME III criteria for FD;
* education level no lower than high school;
* Hospital Anxiety and Depression Scale (HADS) score \> 8 respectively;
* absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months;
* absence of H. pylori infection

Exclusion Criteria:

* known allergy to omeprazole, flupenthixol or melitracen;
* any evidence of organic digestive diseases;
* reflux-related symptoms only (e.g., retrosternal pain, burning and regurgitation) or predominantly reflux-related symptoms;
* severe psychological symptoms that affected life and work;
* pregnancy or breastfeeding;
* recent myocardial infarction or cardiac arrhythmias;
* previous gastric surgery;
* use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months
Water-soluble Ubiquinol Supplementation on Blood Glucose, Lipids, Oxidative Stress, and Inflammation in Diabetes

Diabetes is considered an oxidative stress and a chronic inflammatory disease. Coenzyme Q10 (ubiquinone) is recognized as a lipid soluble antioxidant. Ubiquinol is a reduced form of coenzyme Q10 in our body after food or supplements intakes. Studies have indicated that the water-soluble ubiquinol had better antioxidant activity and absorption than lipid-soluble. The purpose of this study was to investigate the effects of a water-soluble ubiquinol supplement (100 mg/d) on antioxidation and anti-inflammation in diabetes patients.

The patients with type 2 diabetes will recruit as subjects (n = 50) and randomly assign to the placebo (n = 25) or coenzyme Q10 groups (n = 25). The intervention will administer for 12 weeks. The concentrations of coenzyme Q10, oxidative stress marker (malondialdehyde), antioxidant enzymes activities (superoxide dismutase, catalase, and glutathione peroxidase), inflammatory markers \[C-reactive protein (CRP), and interleukin-6 (IL-6)\], and biochemical parameters (fasting glucose, A1C, insulin, C-peptide, and lipid profiles), and blood pressure will measure. Hopefully, the results of this study could provide the information of water-soluble ubiquinol supplement for clinical doctors and dietitians recommend that diabetes patients deserve to know whether the use of coenzyme Q10 supplement.

Eligibility Criteria:
Inclusion Criteria:

* The diagnostic criteria for type 2 diabetes were defined as a glycohemoglobin (A1C) ≧ 6.5%, a fasting glucose ≧ 7.0 mmol/L or a 2-h plasma glucose ≧ 200 mmol/L during an oral glucose tolerance test (OGTT), as well as the use of anti-hyperglycemic drugs.

Exclusion Criteria:

* pregnant or lactation women.
* patients with liver or renal disease
* Antioxidant dietary supplements user.
* patients under warfarin therapy.
* patients with hypoglycemia (fasting glucose \< 60 mg/dL) or hyperlipidemia (fasting triglyceride ≧ 500 mg/dL)
Clinical Performance Assessment of Two Silicone Hydrogel Daily Disposable Contact Lenses

The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

The expected duration of subject participation in the study is approximately 4 days with 2 scheduled visits.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
* Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Habitual monovision or multifocal contact lens wearers.
* Other protocol-specified exclusion criteria may apply.
Validity of Using Connected Soles In Measuring Steps Number In the Older Subject, Hospitalized in Follow-up and Rehabilitative Care and Achieve Its Rehabilitation Objectives

The purpose of this study is to evaluate counting steps by connected soles worn in the shoes of subjects, having recovered the maximum walking capacities of patients . To answer the question asked in the study, it is planned to include 60 patients over 70 years of age.

The main objective of this interventional, monocentric, transverse, nonrandomized and prospective study is to assess the concordance of step counting between connected soles and video, in elderly subjects hospitalized in Follow-up and rehabilitation care, at Paul Brousse hospital, having recovered maximum walking capacities of participants, on 10 meters. After inclusion, following data will be collected : Measure blood pressure, heart rate, neurological and cardiological exam, pneumological exam, Short Physical Performance Battery Score Feetme connected soles comply with European standards (CE label no. 29762). The study will consist of 10-metre walk for patient during a rehabilitation session :

* By wearing the soles connected to patient's size (in patient's usual shoes). The recording of data will be triggered by an investigator, via an application downloaded on a smartphone. The application will trigger and stop the registration of soles.
* While being filmed by a camcorder mounted on a tripod (excluding the face) for footsteps. The test will be filmed (excluding the face) to avoid a measurement bias in counting steps. Two physician observers will view each patient's film in a second time in order to perform the step count. Before starting the walk, an on-site observer will ensure that the footings are set to 0 for counting step and that the recording is stopped after 10 metres. If this is deemed possible by the referring physiotherapist, the same protocol will then be carried out over 30 meters (new test: the patient who can do it will perform 40 meters in total (10 meters then test of 30 meters).

Eligibility Criteria:
Inclusion Criteria:

* Age \>70 years olde
* Patients able to walk 10 meters
* Patients who received physiotherapy
* Patients able to understand instructions and freely consent (mini mental state examination (MMSE) ≥ 20
* Informed consent, major unprotected
* Membership in a social security scheme

Exclusion Criteria:

* Unable to walk the required distance (severe dyspnea, post-fall syndrome, blindness)
* Foot sores (bedsores or other)
* Patients participating in another intervention study
* Major patients protected or deprived of study freedom
Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis

The purpose of this study is to establish if BMS-986202 is safe and effective at treating autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first time this drug is given to humans.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy Male and Female participants
* 18 to 50 years of age (Parts A-D)
* 18 to 70 years of age (Part E)
* Diagnosed with plaque psoriasis (Part E)

Exclusion Criteria:

* Participants that had recent infections
* Participants with Low Blood Pressure
* Participants with any heart related problems
* Participants with cancer
* Participants with any other major medical illness

Other protocol defined inclusion/exclusion criteria could apply
Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk

Congenital CMV infection is the leading cause of non-genetic deafness and neurodevelopmental disorders. Its prevalence in France is estimated between 0.3% and 1% of births depending on the study.

Congenital infection is symptomatic in 10% of cases with a large clinical spectrum with different degree of severity. These sequelae develop progressively and fluctuate, which justifies prolonged follow-up of children for several years, even if they are asymptomatic at birth.

There is yet no treatment with AMM in neonates or pregnant women. In France, screening for congenital CMV infection is widely debated. It remains oriented to certain newborns considered at risk or depending on their symptoms and varies with the practices of each Neonatology or Maternity Hospital.

In the Regional Maternity of Nancy, a new screening protocol for congenital CMV infection was implemented from early 2019.

It is based on screening by non-invasive salivary test (CMV PCR) in newborns at particular risk who are included in a registry open for this screening.

The aim of this research was to assess the relevance of the proposed criteria in the Protocol for defining a population at risk of congenital CMV infection thus qualifying for CMV screening. The secondary endpoints are the modalities of the screening test, the evaluation of each risk factor for infection, and the study of affected patients (symptoms, therapeutic intervention, neurological and auditory outcome).


Eligibility Criteria:
Inclusion Criteria:

* Newborn born between Bebruary 2019 and December 2021 in the Regional Maternity Hospital of Nancy
* Patients who were screened for congenital CMV infection by salivary PCR

Exclusion Criteria:

* No one
Population Pharmacokinetics of L-AmB in Chinese Patients Assisted by Extracorporeal Membrane Pulmonary Oxygenation (ECMO)

The goal of this study is to investigate the effects of ECMO-assisted therapy on L-AmB PK parameters in patients with critically ill patients of invasive fungal infections, and to determine the in vivo pharmacokinetic changes of L-AmB in the ECMO population. To establish and validate a population pharmacokinetic model for liposomal amphotericin B in patients with critically ill patients of invasive fungal infections treated with ECMO adjuvant therapy, and to explore the pharmacokinetics/pharmacodynamics of the drug with different dosing regimens.

The information of patient characteristics, physiological parameters, ECMO related parameters, administration and sampling information of L-AmB were collected.Patients were intravenously titrated after 3 doses of maintenance dose titration. The sampling window was from 0 to 24 h. The time points were 0.5 h before and 1, 2, 3, 6, 9, 12, 16, 20 and 24 h after administration. NONMEM software was applied to establish the PPK model of L-AmB.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria for invasive fungal infections presenting to the intensive care unit (ICU) with probable or proved patients According to the 2021 EORTC/MSGERC guideline.
* Requiring ECOM assistance.
* Age 18 years.

Exclusion Criteria:

* Intolerance of L-AmB therapy.
* Pregnancy.
* Expected survival time \<24 hours.
* Lack of necessary data on patient demographics physiopathology, and clinical status.
Vestibular Function After Chemoradiotherapy for Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is usually treated with chemoradiotherapy. While the effects of this treatment on cochlear function is well characterized, its effect on vestibular function is not well studied.

In this study the investigators will study the vestibular function of 50 patients undergoing chemoradiotherapy for NPC both before and after treatment in order to better define its effects. All patients will undergo a validated questionnaire (dizziness handicap index), posturography, audiometry and vestibular-evoked myogenic potentials.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Biopsy-proven NPC.
* About to undergo chemoradiotherapy with intensity-modulated radiotherapy (IMRT).

Exclusion Criteria:

* Pregnancy.
* Prior vestibular dysfunction.
Botulinum Toxin in Peripheral Neuropathic Pain

Pain due to peripheral nerve lesion remains extremely difficult to treat and current treatments have onl moderate efficacy and/or side effects. The investigators have previously demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second injection is associated with a therapeutic gain. This will be a randomized placebo controlled study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous injection in the painful area) or placebo. Each injection will be repeated within at least 3 months depending on the duration of efficacy. Skin punch biopsies will be performed before and 1 month after BTX-A administration. The investigators postulate that this study will confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the treatment of peripheral neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

Men or women aged 18 to 85 years Spontaneous pain with a minimal intensity of 4/10 on numerical scle Pain present for at least 6 months Pain related to painful mononeuropathy or sensory polyneuropathy Able to understand the protocol and comply to the requirements of the study Written informed consent Painful area limited to a maximum of 240 cm2

Exclusion Criteria:

Facial pain Litigation (pending) Unstable condition responsible for neuropathic pain (ie, unstable immunological disease...) HIV or chemotherapy induced neuropathy Contraindications to BTX-A (neuromuscular disease, hypersensitivity, infection, coagulation disorder, pregnancy) Other pain more severe than neuropathic pain No compliance with the self diary Drug abuse or alcoholism Severe major depression Cognitive impairment Other research protocol within the last 30 days
A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy

Clinical trial for the safety and efficacy of CS1-targeted CAR-T Cells therapy for relapsed multiple myeloma after BCMA CAR-T cells therapy

This is a single arm, open-label, single-center study. This study is indicated for relapsed CS1+ multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 50 patients will be enrolled for this trial. Primary objective is to explore the safety, main consideration is dose-related safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of CS1+ multiple myeloma (MM)：

   1. Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA expression;
   2. Relapsed after hematopoietic stem cell transplantation;
   3. Cases with recurrent positive minimal residual disease;
   4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
2. Anticipated survival time more than 12 weeks;
3. Male or female aged 30-75 years;
4. Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

Subjects with any of the following exclusion criteria were not eligible for this trial:

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagicdiseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infectionand bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.