cyrilzakka/clinical-trials huggingface dataset:
Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia

To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS and moderately severe PCP.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Empiric therapy for other opportunistic pulmonary infection (TB or fungi) for the first 72 hours of study enrollment ONLY, until presence of suspected pathogens can be confidently excluded.

Patients must have:

* AIDS.
* Confirmed diagnosis of PCP.
* Alveolar-arterial differences in dissolved oxygen \>= 35 mm Hg but \< 55 mm Hg on room air.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Severe renal or hepatic dysfunction.
* Serious or life-threatening intolerance to TMP/SMX, TMTX, or dapsone.
* Concurrent pneumothorax.
* Active pulmonary tuberculosis or other inadequately treated opportunistic pulmonary infection (e.g., Cryptococcus neoforms, CMV). NOTE:
* Identification of Mycobacterium avium or CMV in sputum or BAL fluid does not exclude, since these organisms may be present without causing disease.
* Pulmonary Kaposi's sarcoma.
* Active opportunistic infections or malignancies requiring induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).
* Unable to have arterial blood gases on room air obtained at baseline.
* Unwilling to undergo bronchoscopy, if sputum induction does not reveal Pneumocystis carinii.
* Suspected malabsorption (e.g., ileus or severe diarrhea with \> 6 stools/day).
* Known absence of G6PD activity.
* Large volume (1.0 to 1.5 liters) of intravenous fluid (5 percent in water) per 24 hours is medically inadvisable.
* Unwilling to comply with study design.

Concurrent Medication:

Excluded:

* Induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).
* AZT, ddI, ddC, d4T, or other antiretroviral therapy.

Patients with the following prior condition are excluded:

Prior history of serious or life-threatening intolerance to TMP/SMX. (NOTE:

* Patients with less severe reactions may be included at the discretion of the investigator and primary care provider.)

Prior Medication:

Excluded:

* More than 24 hours of systemic anti-PCP therapy within 2 weeks prior to study entry.
Utility of a Weaning Protocol in ICU

The purpose of this study is to evaluate the difference of the duration of weaning process from the ventilator between protocol-driven weaned patients and clinical judgment driven weaned patients.

All patients with prolonged weaning and who required tracheostomy are enrolled in the study. These patients are randomized as "Case or Control" by a computer program.

Patients can start the weaning process when the acute phase of the respiratory failure has been resolved and pressure support ventilation was setted.

For all this patients are calculated modified-BWAP(BWAP-M) and TOBIN indexes. The "Case" patients started the weaning protocol process only if BWAP-M value is more than 15 or BWAP-M 10-15 with Tobin index \< 100.

If not, the BWAP-M and Tobin will be calculated every day. The Control patients will start weaning by clinical judgement even if the BWAP-M value is less than 10.

For all patients are calculated: the duration of weaning process, the ICU length of stay and the duration of the mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

1. all patients that are clinically identified as prolonged to wean (failed 3 spontaneous breathing trials or 7 days or more of mechanical ventilation after the initial unsuccessful trial) and tracheostomized in ICU
2. improvement or resolution of the underlying causes of acute respiratory failure ratio between pressure partial artery of oxygen and fraction inspired oxygen (PaO2/FiO2) \>200 with fraction inspired oxygen (FiO2)\< 0,45.
3. pressure supported ventilation at the time of enrollment.

Exclusion Criteria:

1. patients assessed as easy weaning and not tracheostomized;
2. patients already tracheostomized on admission to ICU.
Mixed-method Evaluation of a Parental Psychoeducation Programme in a Suicide Risk Prevention Group

The number of emergency consultations for children and adolescents for suicidal ideation and suicide attempts has been rising steadily since 2010, and even more so since 2020. In addition, 30% of children and adolescents who have committed a suicidal act reoffend within the year.

Psycho-education programmes for patients have been shown to be effective in a large number of psychiatric pathologies. The programs of psychoeducation for the caregivers of these patients have them also shown their effectiveness, however to date there is no parental psychoeducation program group, for the prevention of the suicidal risk of children and adolescents, which is validated. The service of child psychiatry at the Robert Debré hospital built a program for this purpose, according to current data from the science and has been offering it for 6 months to parents of patients who consulted for suicidal ideation. Rate this program through the description of its implementation would allow it to be validated, this in a dissemination objective. This validation through a mixed method would also allow us to describe the experience participants in this program and to understand improvements Track.

Implementation study: non-randomized, single-center, quasi-experimental study before - after for the evaluation criteria of intermediate effectiveness (effectiveness). Study mixed qualitative-quantitative method for the evaluation of several judgment criteria.

The main objectives is to Evaluate the implementation of a parental psychoeducation program in a group of suicide prevention through parental support for the entire program.

The secondary objectives are to evaluate:

* reaching the target population (Reach)
* the intermediate effectiveness of the program
* the adoption of the program by health professionals
* the implementation on other dimensions
* the sustainability of the program

Eligibility Criteria:
Inclusion Criteria:

* Parent committing to participate in the 4 sessions of the parental psychoeducation prevention program suicide risk (PEPPS program)
* Parents of children under 15 years and 6 months
* Parents fluent in French

Exclusion Criteria:

* Lack of affiliation with a social security scheme or CMU (universal health coverage)
* Parents under guardianship or curatorship
Treatment Result of KTP Laser Nasopharyngectomy in Recurrent NPC Patients

Investigate the treatment result of KTP laser nasopharyngectomy in recurrent NPC patients

Nasopharyngeal carcinomas (NPCs) are highly radiosensitive tumors, and the primary treatment of NPCs is radiotherapy.1 Because most patients who have NPC are at advanced stages when initially seen, local failures in terms of persistence or recurrence are not infrequent after primary radiotherapy.2,3 Local regional relapse without the presence of distant failure can still be salvaged and should be aggressively treated. Tumors relapsing in the nasopharynx can be salvaged using either re-irradiation or surgical techniques.1 Although re-irradiation to the recurrent tumor can extent the 5-year actuarial survival rate, it is associated with high morbidity. 4-6 Traditional nasopharyngectomy has been associated with local control rates on the order of 40%\~50%, but it has also been associated with complications such as palatal defects, trismus, facial scarring, osteomyelitis, etc.7-10 That is the reason why surgeons continue searching for new methods for performing nasopharyngectomies with lower morbidities.

Nasopharyngectomies are difficult to perform because of the inaccessibility of the nasopharynx. More difficulties are encountered in performing a nasopharyngectomy through the nose due to the restricted surgical field. With advances in techniques of endoscopy and application of the potassium-titanyl-phosphate (KTP) laser in surgery, pathologic lesions located either at the choanal margin or in the nasopharynx can easily be managed with instruments inserted via the nasal cavities. The surgical technique had been accepted by the authority journal. This time, we will review the therapeutic result of KTP-laser nasopharyngectomy in patients with recurrent NPC.

Eligibility Criteria:
Inclusion Criteria:

* recurrent NPC patients

Exclusion Criteria:

* patients with distant metastasis
A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer

The purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with locally advanced or metastatic breast cancer.
2. Participants must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an Anthracycline and a Taxane unless participants who are not suitable for these treatments.
3. Participants must have documented disease progression within or on 6 months from their last anti-cancer therapy.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2.
5. Participants must have normal organ and marrow function as defined below:

   * Absolute neutrophil count greater than (\>) 1,500 per microliter (/mcL)
   * Hemoglobin \>10.0 gram per deciliter (g/dL)
   * Platelets \>100,000/mcl
   * Serum total bilirubin less than (\<) 1.5\*upper limit of normal (ULN)
   * Serum aspartate aminotransferase (AST) (Serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase \[SGPT\]) \<3\*ULN or \<5\*ULN in the presence of liver metastases
   * Serum creatinine \<1.5 mg/dL.
6. Females in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study.

Exclusion Criteria:

1. Hypersensitivity to the active substance or any of the excipients.
2. Participants who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start.
3. Participants receiving any other investigational agents.
4. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, or other comorbid condition that investigator believes may compromise participant's condition.
5. Participants requiring concurrent anti-cancer therapy during the study period.
6. Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting study treatment.
Association of Centre of Excellence Self- Administered Questionnaire Score and Frailty Levels

This study evaluates the frailty and the health adverse events in the population of the Canadian Longitudinal Study on Aging. It will be used the Centre of Excellence Self-Administered questionnaire (CESAM) which assesses frailty of older adults by providing a score and a of frailty in 4 levels.

Age is broadly recognized to confer a risk for health adverse outcomes, but it is an insensitive and non-specific measure for use in individual decision-making. Frailty has been emerging to take its rightful place as a better measure for over past decades. Despite general consensus that the concept of frailty is clinically useful, the lack of agreement on its definition and the challenge of its measurement by front-line health providers mean that frailty remains only 'their apparent' to chronological age as a criterion to select older persons at risk.

Eligibility Criteria:
Inclusion Criteria:

* Being 65 years and over
* Being enrolled in the Canadian Longitudinal Study on Aging

Exclusion Criteria:

* Never being enrolled in the Canadian Longitudinal Study on Aging
* Undisclosed health adverse events
Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab

Currently, no study has addressed real-life data describing changes in health resource consumption and related costs attributable to mepolizumab treatment. The aim of the current study is to fill this knowledge gap by performing an exhaustive extraction of data for patients receiving mepolizumab in the French single-payer health care system. The change in real-life health-resource usage and costs observed for these patients would provide the first evidence that mepolizumab is changing the care landscape for eligible severe asthma patients.

The overall objectives of this study are: (i) using the SNDS French national database, to identify a representative, nation-wide population of patients treated with mepolizumab with a follow-up period of at least 12 months, (ii) to describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment and (iii) to estimate the change in associated costs for the first year of treatment. These initial data will additionally serve as a basis for the design of longer-term studies.

Primary objective: To estimate the change in associated costs for the first year of treatment

Secondary objectives:

* To describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment
* To further characterize rates of change in health resource usage and/or costs in subpopulations of interest (sex, age groups, severe asthma, uncontrolled asthma, COPD, diabetes)

This retrospective, non-interventional (not involving human subjects) database study will compare real-life patient health resource consumption before versus after a first injection of mepolizumab. Data concerning patients receiving mepolizumab will be collated for a 12-month period (the "baseline period") preceding a first index treatment (at "T0") and compared to a 12-month period occurring after the index treatment (the "exposure period").

Eligibility Criteria:
Inclusion Criteria:

* Beneficiary in the anonymous French national SNDS database
* The beneficiary received mepolizumab

Exclusion Criteria:

* Health resource use data covering the 12 months preceding the first filled prescription for mepolizumab are not available
* Health resource use data covering the time period starting at the first filled prescription for mepolizumab and ending at subsequent death or at 12 months later are not available
Ultrasound Guided Hematoma Block in Distal Forearm Fractures

This is a randomized control trial comparing the efficacy of ultrasound (US) guided vs landmark-guided hematoma blocks on distal forearm fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patients greater than and equal to seven years of age
* Patients with traumatic acute distal radius/ulnar fractures with displacement that require reduction and immobilization with splinting
* Patients that receive distal radius hematoma blocks, including those who require additional pain control adjuncts if pain control is not adequate

Exclusion Criteria:

* Prisoners
* Pregnant women
* Patients with altered mental status/have impaired decision-making capacity.
* Patients with allergies to amide anesthetics
PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease
* Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
* Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Men or women 18 years of age or older
* Adequate hematologic, renal, hepatic, metabolic, and coagulation function

Exclusion Criteria:

* History of prior or concurrent central nervous system (CNS) metastases
* Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
* Clinically significant cardiac disease
* Clinically significant peripheral sensory neuropathy
* Active inflammatory bowel disease
* Recent gastroduodenal ulcer to be active or uncontrolled
* History of interstitial lung disease
* Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
* Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
* Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.
Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)

This study will evaluate the efficacy and Safety of QiShen YiQi Dripping Pills in the treatment of Diabetic Kidney Disease (syndrome of Qi deficiency with blood stasis)


Eligibility Criteria:
Inclusion Criteria:

* Man or woman between 18-75 years-old
* Subjects with type 2 diabetes mellitus
* Subjects with a clinical diagnosis of diabetic kidney disease
* eGFR≥ 45 mL/min/1.73 m2
* UACR ≥ 30 mg/g but ≤ 300 mg/g
* Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis
* Received Steady dose of ACEI or ARB therapy for chronic heart failure at least 2 weeks before receiving investigational drug
* Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment

Exclusion Criteria:

* Subjects with type 1 diabetes mellitus or other specific types of diabetes
* Acute complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemia occurred in the past 3 months
* HbA1c ≥8.5% or fasting blood glucose \>11 mmol/L
* Urinary sediment indicates "active" glomerulogenic hematuria
* Subjects have been clinically confirmed cases of primary glomerular disease, secondary glomerular disease other than DKD or other systemic diseases
* The presence of uncontrolled hypertension, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg or Hypotension with a systolic blood pressure \<90mmHg and/or a diastolic blood pressure \<60mmHg
* ALT or AST\> 2 times the upper limit of normal
* Serum potassium\> the upper limit of normal
* Patients with unstable basic treatment for lowering blood glucose and blood lipids within the past 3 months, and patients with unstable basic treatment for lowering blood pressure within the past 1 month (changing the type of drugs, such as changing the β-receptor blockers to calcium ion antagonists, etc.)
* Take the following medications within the last 2 weeks：a. Other drugs for the treatment of DKD (Finerenone, Keluoxin capsule, Qizhi Yishen capsule, SGLT2i drugs, GLP-1 drugs, etc.), b. Calcium oxybenzenesulfonate for the treatment of diabetic retinopathy, c. Chinese patent medicine, Chinese medicine decoction, formula granule and other Chinese medicine preparations with the same composition or function indications, d. Tripterygium wilfordii related preparations, Huangkui capsule
* Patients who need to take antiplatelet drugs, the dose was stable for less than 1 month
* Serious diseases of other systemic systems that may affect the judgment of efficacy and safety
* A history of alcohol or drug abuse with a combination of mental illness and poor control
* Allergic to the experimental drug or its ingredients
* Women who are pregnant or breastfeeding, or who have a need to have children during the trial
* Participating in other clinical studies and taking investigational drugs from other studies within 3 months prior to screening
* The investigator deems that the patient is not suitable to participate in the study
Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy

This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.


Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosis of acute peanut allergy as manifested by urticaria, angioedema, gastro-intestinal or respiratory tract symptoms, with acute onset of symptoms after ingestion (up to 2 hours).
* Positive peanut food challenge at baseline, i.e., have objective allergic events at a level of 300mg (not cumulative) or below of peanut protein but not to the placebo test.

Main Exclusion Criteria:

* Prior exposure to any monoclonal antibody treatment
* Asthma patients on maintenance long acting beta-agonists
* Use of systemic corticosteroids
* Concomitant use of beta blockers, ACE inhibitors, tiotropium or ipratropium, antidepressants, oral beta-agonists
* Use of immunosuppressants within 6 months of visit 1 Other protocol-defined inclusion/exclusion criteria may appy
Risk Factors for Progressive Supranuclear Palsy (PSP)

Progressive supranuclear palsy (PSP) is the most common atypical parkinsonian movement disorder. This study will determine the role of specific genetic, occupational and environmental components in the development of PSP by evaluating patients with this disorder and age and gender matched controls.

This proposal will determine: (1) if there is an association between PSP and specific genes of interest; (2) if there is an association between PSP and occupational and/or environmental chemical exposures functionally or structurally similar to known parkinsonian toxicants; and (3) if hypertension or traumatic brain injury prior to symptom-onset is associated with PSP. To disentangle the complex etiology of PSP, this case-control multicenter study involves 500 PSP cases, 500 age/gender matched primary controls, and 500 secondary controls for genetic confirmation. Understanding the etiology of PSP may also help explain the causes of other related diseases such as Alzheimer's disease. This multidisciplinary team of movement disorder specialists, epidemiologists, geneticists, biostatisticians, industrial hygienist and toxicologist is well suited to unravel the etiology of PSP.

Eligibility Criteria:
Inclusion Criteria:

* PSP patients able to visit one of the screening sites for diagnostic confirmation and able to participate in a one hour telephone interview

Exclusion Criteria:

* No other major neurological disorders
* Unable to communicate by telephone