cyrilzakka/clinical-trials huggingface dataset:
Impact of the COVID-19 Pandemic on the Organization of Healthcare in France

The 2020 COVID-19 pandemic, which began spreading on January 24, 2020 in France, has required a profound and rapid reorganization of the health system, based in particular on internal hospital reorganizations of front-line establishments, deprogramming of non-urgent activities, and transfers of non-covid19 patients to 2nd line facilities. Beyond the immediate impact on the management of patients infected with COVID-19, this reorganization may have reduced the capacity of management for patients requiring urgent or semi-urgent intervention, or may have postponed some necessary care. The isolation of patients at home may also have resulted in lower compliance to therapy and medical treatments and may have contributed to decompensation.

At the end of this crisis, the different organizational responses in France should be evaluated to identify the consequences and the areas for improvement in order to be prepared for future exceptional health situations. This investigation on healthcare systems confronted to an exceptional health situation thus seeks to determine if the profound reorganizations implemented during this health crisis have indirect effects on the performance of care, in particular if there is a destabilization of the care systems (emergency, semi-emergency and chronic), a loss of chance for the patients and if innovative care paths have emerged.


Eligibility Criteria:
Inclusion Criteria:

* Patients with one of these three types of chronic diseases (Prevention Quality Indicators of the Agency for Healthcare Research and Quality): heart failure, diabetes, chronic obstructive pulmonary disease.
* All French adult patients suffering from the studied chronic diseases, covered by the Health Insurance and living in metropolitan France are included.

Exclusion Criteria:

* Patients under 18 years of age or with incomplete or inconsistent data on the "Système National des Données de Santé", or with a symptomatic COVID-19 diagnosis.
A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs

This study will determine the effectiveness of a peer outreach intervention in preventing HIV infection in adults at high risk for contracting HIV and other sexually transmitted diseases (STDs).

The persistence of HIV and STD epidemics indicates that more effective, sustainable preventive interventions are needed, particularly for low-income, inner-city populations. This study will determine the effectiveness of a theoretically based peer outreach program in preventing HIV and STD transmission among adults in the Baltimore, Maryland area.

Participants will be randomly assigned to receive either a network-oriented peer program emphasizing one's social identity and the goals of protecting one's family and community or group cognitive behavioral therapy (CBT). The peer program will also train participants to provide HIV/STD education to their peers. Participants will be assessed at study entry and during several subsequent follow-up visits. At these study visits, participants will complete questionnaires about their sexual health knowledge and sexual behaviors. Participants and members of their peer network will have follow-up visits at Months 6, 12, and 18.

Eligibility Criteria:
Inclusion Criteria for CBT or Peer Intervention Participants:

1. Female
2. Age 18-55
3. Did not inject drugs in the past 6 months
4. Self-reported sex with at least 1 male partner in the past 6 months
5. Had at least 1 of the following sexual risk factors:

   1. More than 2 sex partners in the past 6 months
   2. STI diagnosis in the past 6 months
   3. Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was HIV+, or MSM)

Inclusion Criteria for Peer Network Participants:

1. 18 years old or older
2. One of the following:

   1. Injected drugs
   2. Sex partner of index
   3. Social network member that the index felt comfortable talking to about HIV/STIs

Exclusion Criteria for All Participants:

* Currently enrolled in another HIV prevention intervention
MOReS Freestyle Libre Validation Study

To measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on physical and cognitive performance, health and wellbeing in young people.

Cross over randomised exposure response experimental study in 10 healthy children and adolescents, to measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on their physical and cognitive performance, mobility, health and wellbeing. The study will assess the extent of the immediate and short-term effects of interrupting sitting with brief moderate-vigorous physical activity (MVPA) breaks compared to a sitting only condition.

Dietary analysis and metabolic and cognitive tests after acute exercise will be performed on the participants to compare the FreeStyle Libre responses between those with and without disabilities.

Eligibility Criteria:
Inclusion Criteria:

* Young people aged 9-18 years old
* No significant current or previous medical history
* Are able to participate safely in the study's assessments and brief interrupted sitting moderate to vigorous physical activity (MVPA)

Exclusion Criteria:

* Those with uncontrolled epilepsy/seizures (stable epilepsy/on medication \> 12 weeks)
* Those who have Type 1 and Type 2 diabetes or other glucose intolerance or on medication for such conditions
* Those who experience contraindications to physical training
* Those who are on any form of steroids, anti-anxiety/depression drugs, birth control, beta-blockers, statin, adrenaline, HIV or Hepatitis C medications (these medications can affect the readings during the oral glucose tolerance test)
* Those with known allergies to plasters
High-Dose Isoniazid Adjuvant Therapy for Multidrug Resistant Tuberculosis

The need for a standardized treatment protocol for multidrug resistant tuberculosis (MDR-TB) in resource-limited countries is being increasingly recognized. This single center, double blind, randomized controlled trial was designed to compare the time required for sputum culture conversion and extent of radiological improvement in cases of MDR pulmonary tuberculosis when isoniazid was included (both at a regular dose and at a high dose) as an adjuvant to the standardized second line of treatment. The study was designed to test the hypothesis that inclusion of high-dose isoniazid will enhance the effectiveness of the second line of treatment in cases of MDR-TB without significantly increasing the toxicity.

Tuberculosis was declared a global emergency by the World Health Organization (WHO) in 1993. The global problem of tuberculosis is further complicated by a substantial increase in drug resistant tuberculosis. Available data suggest that drug resistant TB especially multi drug resistant may represent a public health threat in areas with a high prevalence of tuberculosis, suboptimal TB control programmes and/ or HIV. The cure rate of these cases has been reported to be lower than for non-drug resistant TB with a failure rate of 44%. New therapies for MDR-TB have not been introduced since the fluoroquinolones in the 1970s. Strains of Mycobacterium Tuberculosis (M. tub.) in H resistant cases often contain mixture of susceptible \& resistant organisms. Use of high dose H (16- 20 mg/kg) can eliminate susceptible \& those with low level resistance4. This Study was done to evaluate the role of isoniazid (INH) at high \& normal dosages as an adjuvant therapy in treatment of patients with persistent culture positive pulmonary tuberculosis despite 6 months of continuous first line antitubercular treatment and on culture at least resistant to isoniazid and rifampicin.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients reporting to the study center
* Sputum-positive for acid-fast bacilli
* HIV-uninfected
* MDR-TB defined as resistance to at least the following two drugs: Isoniazid and Rifampicin.

Exclusion Criteria:

* Unwilling to give consent
* Abnormal renal or hepatic profile
* History suggestive of isoniazid hypersensitivity
* Pregnancy
* Lactating mother
* Previous history of taking any of the following: kanamycin, prothionamide, levofloxacin, cycloserine and p-aminosalicylic acid
Acceptability of Less Harmful Alternatives to Cigarettes

RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and nicotine replacement therapy may be useful in helping smokers stop smoking.

PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to cigarettes.

OBJECTIVES:

Primary

* To assess the impact of factual information (a fact sheet) about the relative harms of smokeless (SL)/nicotine replacement (NR) products on participants' beliefs about relative harmfulness.
* To assess the impact of trying samples of NR and/or SL products on intentions to use such products as alternatives to cigarettes.

Secondary

* To explore the effects of factual information in regard to smoked tobacco on smokers' intentions to use such products as alternatives to cigarettes.
* To assess potential barriers to use of both NR and SL products as substitutes for cigarettes.
* To obtain estimates of possible effect sizes for powering a proposed comprehensive test of the likely outcomes of using these products in preference to cigarettes (and other smoked products).

OUTLINE:

Participants undergo a 10-15 minute web-based survey on a computer in the Tobacco Research Laboratory to assess basic demographic information; beliefs about the relative harmfulness of nicotine replacement (NR) and smokeless (SL) products, including use of relevant questions from the International Tobacco Control (ITC) 4 country survey; past experiences with NR and SL products and perceptions about them; and willingness to try samples of NR/SL products they have not previously used, or, if not willing, reasons for refusal. Participants also receive an information sheet while simultaneously hearing an audio recording of it.

Participants complete questionnaires at 2, 3, and 4 weeks.

Beginning 2 weeks after study intervention, some participants receive a day's supply of ≤ 4 smokeless tobacco or nicotine products and periodically undergo a breath CO and saliva and buccal cell sample collection. Surveys are completed and samples collected at 3 and 4 weeks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Currently smokes ≥ 10 cigarettes per day
* Not planning to quit smoking in the next 30 days and has not tried to quit in the past 30 days
* Medically eligible to receive nicotine-replacement products, based on the NYS Smokers Quitline eligibility criteria

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Able to read and speak English
* In good general health
* No history of heart attack or stroke in the past 2 weeks
* No history of chest pains in the past month
* No report of physician-diagnosed arrhythmia/irregular heartbeat or use of pacemaker
* No report of physician-diagnosed heart disease/coronary artery disease, uncontrolled hypertension, stomach ulcer, diabetes, depression, or asthma

PRIOR CONCURRENT THERAPY:

* No other concurrent tobacco products or nicotine medications
* No concurrent Zyban, Bupropion, Wellbutrin, Chantix, or other smoking cessation medication
Severity Over Time of Early Forms of Spondyloarthritis

Spondyloarthritis (SpA) is a group of chronic inflammatory pathologies whose progression over time is poorly defined, and in particular the clinical and instrumental elements that can predispose to a condition of disease severity are not completely known. It would be important to have an idea of what the predisposing factors are, possibly already at baseline, and possibly also at follow up, of severe disease, so as to be able to act early with more aggressive and targeted therapies on these patients, so as to achieve remission.


Eligibility Criteria:
Inclusion Criteria:

* age \&gt;18 years;
* Diagnosis of SpA confirmed by the rheumatologist with duration of symptoms \&lt;
* 2 years;
* Signature of the written informed consent to the study

Exclusion Criteria:

* Age \&lt; 18 years;
* Patients suffering from other rheumatic pathologies (even in overlap), or genetic diseases such as Marfan syndrome, Ehlers Danlos syndrome
* Any medical or psychiatric condition that in the judgment of the investigator would prevent the participant from complying with the protocol or completing the study according to the protocol.
* Refusal to sign the informed consent to the study.
Phase II Iressa & Carbo/Gem in NSCLC

The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* Advanced Non Small cell Lung Cell Lung cancer
* Never received chemotherapy
* Up and about 50% of waking hours

Exclusion Criteria:

* Spread of lung cancer to the brain
* Low level of white blood cells
* Radiotherapy within 4 weeks

Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.
Implementability and Effectiveness of the Safety Planning Intervention for Suicidal Behavior

The Safety Plan Intervention (SPI) has demonstrated to reduce suicide reattempts and to increase the ambulatory follow-up in american war veterans. This study evaluates the implementability and effectiveness in a significantly different population in a real world setting.

We will perform a Effectiveness-implementation Hybrid Design (Curran et al. 2012) to study firstly the feasibility of implementing the SPI in our clinical setting and secondly its effectiveness. The experimental arm will consist in a group of patients who visit the ED for a suicide-related concern in which the SPI is performed. This will be in the Emergency Department , unless for clinical reasons, the ED psychiatrist decide to postpone it to the first psychiatric appointment (which will be before one week of the ED visit as part of the treatment as usual).

Right after the SPI is performed, both the patient and the clinician will complete questionnaire with satisfaction and acceptability measures. Subjects will be followed for 6 months. At this time medical records will be consulted to obtain suicide reattempts rates and follow-up adherence.

At all times, the anonymity of the participants will be preserved and will require heading of informed consent, as well as other ethical aspects indicated by the Ethics Committee.

Eligibility Criteria:
Inclusion criteria:

1. Suicide attempt or presence of severe suicidal ideation
2. Signed Informed Consent Form

Exclusion criteria:

1. Less than 18 years old
2. Hospitalization in the Psychiatry Department
3. Inability to understand the Safety Planning Intervention

Withdrawal criteria:

1) Participant's decision to withdraw from the trial
LMWH Infusion as Anticoagulation for Home HD

There is a lack of data in the literature about the use of low-molecular weight heparin (LMWH) as anticoagulation for nocturnal home hemodialysis (NHHD). This study aims to evaluate the efficacy and safety of LMWH, administered by infusion method, as compared to unfractionated heparin as anticoagulation for NHHD treatment.

Low-molecular weight heparin (LMWH) and unfractionated heparin (UFH) are established systemic anticoagulants for the patients who receive conventional thrice-weekly hemodialysis in absence of significant bleeding risk. For the patients who undergo nocturnal home hemodialysis (NHHD), LMWH is seldom utilized because of the need of an additional bolus injection during a long dialysis treatment, which is impractical as the patients are sleeping during hemodialysis. Moreover, there is a potential risk of LMWH accumulation due to its longer half-life. As there is a paucity of data in the literature on the use of LMWH for NHHD treatment, this trial is conducted to assess the safety and efficacy of LMWH, administered by infusion method, in this particular group of dialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Prevalent NHHD patients who have received \>1 year dialysis with unfractionated heparin as anticoagulant
* Age \>= 18
* Informed consent available

Exclusion Criteria:

* History of intolerance to LMWHs during HD
* Receiving warfarin or other oral anticoagulant
* Pregnant patients
Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)

This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects
* BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
* Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress

Exclusion Criteria:

* Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease
Two Step Versus the Standard Three Step Approach of the WHO Analgesic Ladder for Cancer Pain Relief.

The World Health Organization analgesic ladder for cancer pain relief is an internationally used approach to managing cancer pain. Patients generally start on Step 1 of the ladder (paracetamol). As pain increases or is not well controlled on this, they progress to Step 2 which involves a stronger pain killer (weak opioid such as codeine). If pain is still not controlled they progress to Step 3 of the ladder which is a strong opioid (such as morphine). Work to date has suggested that Step 2 may be unnecessary and most patients usually require Step 3 analgesia. The TVT trial aims to examine the standard approach (Step 1-Step2-Step-3) versus a two step approach (Step 1-Step 3).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and over.
* Patient has a cancer diagnosis (based on radiological, histological, cytological, or operative evidence). Those with haematological malignancies are eligible.
* Cancer related pain - which in the opinion of the clinician is caused by the presence of tumour or metastases.
* Average pain score \> 4, on a numerical rating scale from 0-10, requiring step 2 analgesia (weak opioid).
* Patient is able to comply with trial procedures.

Exclusion Criteria:

* Patients who have received radiotherapy in the previous 6 weeks or are planned to receive radiotherapy during the trial period where in either case, it is expected to affect pain during the trial period.
* Pain due to surgery in the preceding 4 weeks.
* Life expectancy less than two months (based on clinical impression).
* Patients with psychotic disorders or cognitive impairment.
* Patients who have received regular doses (scheduled doses - NOT as required dosing) of weak or strong opioids in the preceding two weeks.
* Patients using immediate release opioids \> 2 doses/24 hours, in the previous 24 hours.
Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer

This phase Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck cancer. Near-infrared image guided surgical resection with indocyanine green may make it easier to find and remove tumors.

PRIMARY OBJECTIVES:

I. To determine the safety profile of high-dose optical dye, indocyanine green, in head and neck cancer surgical patients.

SECONDARY OBJECTIVES:

I. Determine the efficacy of high-dose indocyanine green to identify cancer compared to surrounding normal tissue (tumor to background ratio; TBR) in head and neck cancer resections.

OUTLINE:

Patients receive indocyanine green intravenously (IV) on day 0 and undergo near-infrared image guided surgical resection on day 1.

After completion of study treatment, patients are followed up for 14-30 days.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of a head and neck cancer diagnosis as evidenced by tissue biopsy.
* Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
* Planned standard of care surgery with curative intent for squamous cell carcinoma.
* Have life expectancy of more than 12 weeks.
* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1.
* Hemoglobin \>= 9 gm/dL.
* White blood cell count \> 3000/mm\^3.
* Platelet count \>= 100,000/mm\^3.
* Serum creatinine =\< 1.5 mg/dL.
* Liver enzymes (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and total bilirubin) =\< 1.5 times the upper reference range.
* Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study.
* Agree to not have radioactive iodine uptake studies done within 1 week of indocyanine green.

Exclusion Criteria:

* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Allergy to iodine or iodinated materials.
* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study

This is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. It is possible that placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron stores during early infancy.


Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women
* 37 - 42 weeks of gestation
* vaginal delivery
* prenatal care initiated prior to 20 weeks of gestation

Exclusion Criteria:

* maternal diabetes
* intrauterine growth restriction
* hypertensive disorders of pregnancy
* chronic hypertension requiring medical therapy
* Apgar score less than 7 at 5 minutes
* unusual bleeding prior to delivery
* alloimmunization
* maternal hemoglobinopathy
* need for immediate infant resuscitation preventing adherence to protocol