cyrilzakka/clinical-trials huggingface dataset:
Prospective National Survey of the Palliative Situation Among Inmates in French Prisons

PARME study had 3 objectives:

* To identify the specific number of incarcerated individuals with terminal illness in need of palliative care.
* To describe the health and penal situation of these prisoners.
* To analyse the situation of these ill prisoners especially in the context of suspended sentence for medical ground

In order to answer these questions, the investigators used a mixed method research.

First, in order to establish a baseline, the investigators contacted the medical units in all French prisons, which means 178 care units and 8 secures inpatient care units. The investigators census every patient with terminal illness, which was defined in this study as an evolutive pathology with a life prognosis less than a year.

A questionnaire was completed by these physicians for every situation. The census was conducted for three months across France.

For the qualitative study, the investigators selected 14 specific situations chosen into these which had been identified by the physicians.

The investigators wanted to get 3 types of patients :

1. patient who had obtained a compassionate release
2. patient whose demand has been refused
3. patient who did not demand any release. The four interviews (patients, physisians, judges, probation workers) for each situation has explained the global situation.

Each interviewee spoke about the situation with his/her perspective and sense that they attributed to the actions of others.

This research analyzes the particularity of each of these end of life situations in prison.

Eligibility Criteria:
Inclusion Criteria:

* prisonners
* serious and evolving pathology
* vital prognosis less than a year

Exclusion Criteria:

* less than 18 year
* person under tutelage
* patient who refuse to participate
Gated Radiotherapy in Left Sided Breast Cancer Patients

To assess the need of respiratory gated radiotherapy in left sided breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* left sided breast cancer patients treated with breast conserving surgery

Exclusion Criteria:

* patients treated with mastectomy
* patients with positive lymph nodes
Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

At present, there is still no effective treatment for liver cirrhosis, and the use of stem cells for the treatment of cirrhosis has caused great concern.Stem cells from human exfoliated deciduous teeth (SHED) has been shown to be safe and effective for liver diseases. Randomization controlled studies are needed to confirm the long term effect of SHED treatment for liver cirrhosis. The present study aimed to investigate the safety and efficacy of SHED in hepatitis B related liver cirrhosis patients.

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). SHED infusion (1x10E6 cells/kg body weight) via peripheral vein will be given at week 0,4,8,12.The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70 years
2. HBV-related liver cirrhosis with presentations of decompensation
3. Antiviral treatment with nucleotide drugs for more than half a year and HBV DNA is less than the minimum detection limit;
4. Child-Pugh score B and MELD-Na score≤25
5. Written consent

Exclusion Criteria:

1. Hepatic encephalopathy, hepatorenal syndrome, acute phase of severe hepatitis
2. Child-Pugh score A or C
3. Hepatocellular carcinoma or other malignancies
4. Cirrhosis or liver failure caused by non-Hepatitis B
5. Pregnancy or breastfeeding
6. Severe bacteria infection,coinfection with HIV or other viral hepatitis.
7. History of severe allergy to biological products or history of immunization within half a year
8. Patients or family members refused to participate in the study
9. Drug abuse or alcohol abuse
10. Other candidates who are judged to be not applicable to this study by doctors.
Does Minimally Invasive Surgery Reduce Anxiety?

The purpose of this study was to identify factors that may contribute to anxiety of patients undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before and after the operation. Thus, we aimed to learn whether anxiety levels change according to the type of hysterectomy.

Hysterectomy is the most common gynecological procedure worldwide. . There has been a increasing interest towards to more minimally invasive procedures in the past decade. Hysterectomy operation anxiety is a complex phenomenon affected by various parameters. Patients' anxiety may be affected by their age, gender, educational status,type of operation and personality. Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.

Eligibility Criteria:
Inclusion Criteria:

undergone hysterectomies for benign reasons.

Exclusion Criteria:

malignancy, additional operation beside hysterectomy( such as salpingo-oophorectomy), history of two or more previous caesarean sections, history of previous abdominal surgery, autoimmune disease, coagulation disorders, with known systemic or psychiatric disease, those receiving any regular sedative medication at the time of the procedure
Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years

Acute upper respiratory tract infections are the most commmon infections in children and are associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea is widely used for treatment of upper respiratoty tract infections. The aim of this study is to evaluate its efficacy as prophilaxis in children 1-5 years old.


Eligibility Criteria:
Inclusion Criteria:

* Childrens 1-5 years old

Exclusion Criteria:

* Wheezing in previous 3 months requiring bronchodilatator
* History of hyperactive reactive airway
* using steroid or Echinacea
* chronic pulmonary of cardiac disease
* Acute respiratory disease within one week before study
* Allergic rhinitis
* Allergy to Echinacea
* avoiding to participate in the study
Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study

This is a single-site, randomized, controlled trial. Investigators will evaluate feasibility of the Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) intervention among adolescents age 14-19 years receiving care in the Children's Mercy emergency department.

This study is a mixed methods feasibility evaluation that will use a randomized controlled trial to assess feasibility of Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm: ED-HEART + teen resource list; control arm: enhanced standard care \[standard care + teen resource list\]). Adolescents age 14-19 years will be recruited and enrolled during an emergency department visit. Investigators will evaluate feasibility using the eight Bowen model feasibility constructs: acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing. Investigators will also examine theory of planned behavior constructs (attitudes, beliefs, perceived behavioral control, intention) to facilitate exploratory analysis of factors that may contribute to differential outcomes.

Eligibility Criteria:
Inclusion Criteria:

* emergency department (ED) patient 14-19 years of age.

Exclusion Criteria:

* Developmental delay, severe illness, or cognitive impairment precluding informed consent/assent or completion of study activities, as determined by ED team or study team.
* Current ED evaluation for acute sexual assault/abuse.
* Current mental or behavioral health symptoms precluding completion of study activities, as determined by ED team or study team.
* Caregiver declines to step out to allow assent/consent in private or adolescent declines for caregiver to step out to allow assent/consent or participation in private.
* Adolescent is non-English speaking.
* Parent is non-English or non-Spanish speaking.
Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration

The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

Patients with age greater than or equal to 50 years with at least one subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography.
Effect of Melatonin on Sleep Quality in Patients Dementia

Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in dementia.

Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep quality.

Design: A single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations.

Participants: The investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).

Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks.

Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality Index (PSQI).

This is a single-center study. The study protocol, informed consents, and amendments were approved in writing by the appropriate local site Independent Ethics Committee (IEC)/Institutional Review Boards (IRB) (Ethics Committee of the Universidad Autónoma de Nuevo León, School of Medicine).

The patients were recruited as outpatients from the Geriatrics Clinic. A total of 67 patients were screened out of which 40 male and female patients diagnosed with mild to moderate dementia were recruited to the study. Following inclusion, all patients underwent randomization to treatment with melatonin (5 mg orally) or placebo for 8 weeks. To prevent bias, matching placebo tablets, which were identical in appearance, taste, and odor, were used. The treatment was double-blinded, with two parallel treatment groups. Selection for a treatment group was determined by a computer-generated randomization list, in a 1:1 ratio using the randomized permuted blocks method.

Eligibility Criteria:
Inclusion Criteria:

* Older than 60 years;
* Circadian cycle sleep disorder with insomnia (according to Diagnostic and Statistical Manual of Mental Disorders- V criteria);
* Mild or moderate dementia (clinical dementia rating 1 and 2);
* Medications such as anti-depressants, acetylcholinesterase inhibitors, antipsychotics or memantine were allowed as long as they were initiated for over 8 weeks.

Exclusion Criteria:

* They had other diagnoses of sleep disorders, known hypersensitivity to melatonin, use of stimulants or hypnotics, recent diagnosis (within 8 weeks) of mood disorders or neuropsychiatric symptoms.
Laryngeal Mask Airway Versus Air Q Laryngeal Airway

Nowadays, supraglottic airway devices are simple and effective alternatives to endotracheal intubation. Both laryngeal mask airway LMA and air-Q airway are supraglottic airway devices that can be used to maintain and protect airways from aspiration of secretions and blood during DCR surgery. The present study was designed to compare standard LMA versus air Q as regards the sealing effect and aspiration of blood in DCR surgery.

72 patients were divided into two groups, 36 patients each, named LMA group, and air Q group according to supraglottic devices used. The following parameters were recorded in both studied groups, continuous Electrocardiography (ECG), heart rate (HR), means arterial pressure (MAP), arterial oxygen saturation (SpO2), end tidal carbon di-oxide (PCO2)..Oro pharyngeal leak pressure in (cmH2O), exhaled tidal volume in (ml), leak volume in (ml), leak fraction in (%) number of shifting from LMA to air Q or ETT and shifting from air Q to LMA or ETT was recorded with absence or presence of surgical blood on The undersurface of the device used.

Eligibility Criteria:
Inclusion Criteria:

* Both sex
* Age: 18-60 years
* ASA I-II
* Patients scheduled for dacryocystorhinostomy surgery

Exclusion Criteria:

* Any pathology of the neck, upper respiratory tract, upper alimentary tract
* Patients with a history of gastric regurgitation, heartburn
* Morbid obese,
* Patients with esophageal reflux (hiatus hernia)
* Anticipating difficult airway management
* Patients with coagulation disorders
Safety and Efficacy Real-world Data of Trastuzumab Deruxtecan and Sacituzumab Govitecan

The study aims to evaluate real-world efficacy and toxicity data of treatment with Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC in pretreated patients with advanced breast cancer.

Antibody-drug conjugates (ADCs) have significantly changed the therapeutic landscape of advanced breast cancer. Trastuzumab deruxtecan (T-DXd), a HER2-targeting ADC and sacituzumab govitecan (SG), a TROP-2-targeting ADC, recently demonstrated superior efficacy over standard of care treatments depending on breast cancer subtype. The study aims to evaluate real-world efficacy and toxicity data of treatment with T-DXd and SG in pretreated patients with advanced breast cancer.

This study includes a retrospective/prospective multicenter review of medical records of patients with advanced breast cancer who received treatment with T-DXd and SG at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic/recurrent breast cancer
* 18 years of age
* Triple-negative (TNBC), HER2-positive and/or hormone receptor positive advanced breast cancer
* Treatment with an ADC at any of line of treatment
* Treatment with at least one cycle of T-DXd and/or SG

Exclusion Criteria:

* NA
Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)

This study is a non interventional study where no investigational medicine is provided. Procedures and examination will follow the institution standard of care practice. The therapeutic approach will not be decided in advance by the protocol or influenced in any way by the protocol.

After standard evaluation the investigator will decide the treatment strategy and upon eligibility criteria met will propose subject to participate to the study. Informed consent will be collected for all subjects.

The study will consist of 3 possible observational visits; V1 (enrolment), V2 and V3 (follow up).

During all observational visits (V1, V2 and V3) the patient will complete the I-PSS (International Prostate Symptom Score) questionnaire including Quality Of Life (QOL) questionnaire and a Patient assessment of treatment benefit and satisfaction using a Visual Analogue Scale (VAS).

The patient will be asked to complete a voiding diary the first 3 days after Visit 1 (Baseline diary), 3 days before Visit 2 and again 3 days before Visit 3.

Prostate Specific Antigen (PSA) measurement- Uroflowmetry - Post Voiding Residual volume and Trans Rectal Ultra Sound data will be collected only if available.

During all observational visits (V1, V2 and V3) the investigator will complete the assessment of treatment benefit and satisfaction using a VAS.


Eligibility Criteria:
Inclusion Criteria:

The following subjects can be included in this study if they answer the following criteria:

* they have been prescribed solifenacin 5-10mg according to Summary of Product Characteristics (SmPC).
* Subjects with diagnosed Lower Urinary Tract Symptoms (LUTS) with substantial storage disorder defined as urgency, and/or frequency and/or Urge Urinary Incontinence (UUI) at the discretion of the investigator.
* IPSS storage sub-score \> 8
* Subject expected to require at least 3 months treatment with solifenacin.

Exclusion Criteria:

* Any reason which following current medical knowledge, physical condition of the patient and in the opinion of the investigator contraindicates administration of solifenacin to the subject, such as- signs and symptoms suggestive of urinary tract infection (confirmed by positive urine analysis).
* History of bladder obstruction not being adequately corrected.
* Anticipate or plan to participate in another study during study period of 12 weeks from study entry.
Study of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma

This study will aims to determine the maximum tolerated dose of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated until the maximum tolerated dose is established.

This study will use a dose escalation design to determine the MTD of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated in cohorts of 3 patients and dose escalation can proceed in each treatment group independent of dose escalation in the other treatment groups. CGC-11047 will be administered IV over 60 minutes and the doses of gemcitabine, docetaxel, bevacizumab, cisplatin, 5-flurouracil or sunitinib will remain fixed according to their respective product labeling.

Eligibility Criteria:
Inclusion Criteria:

* non-hematological advanced solid tumor malignancy or lymphoma where no curative therapy exists in which monotherapy with gemcitabine or docetaxel or bevacizumab or erlotinib or cisplatin, or 5-flurouracil or sunitinib would otherwise be warranted.
* measurable disease based on radiographic evaluation or elevated tumor markers.
* ECOG - 0 or 1 (KPS \>70).
* Life expectancy \> 3 months.

Exclusion Criteria:

* chemotherapy within 21 days or radiotherapy within 4 weeks prior to entering the study
* known active brain metastases or leptomeningeal carcinomatosis.
* history of a myocardial infarction within the prior 6 months or, hospitalizations for congestive heart failure within the prior 6 months, or active treatment for uncontrolled cardiac arrhythmias
* clinically significant gastrointestinal tract hemorrhage, requiring transfusion therapy, within the prior 3 months.
Study to Determine Incidence of Hypoventilation in Patients Who Have Undergone Gastric Bypass

The purpose of this study is to determine if gastric bypass patients experience hypoventilation in the immediate postoperative period, and to what degree.

We propose to determine if patients with clinically significant obesity (body mass index, BMI, between 40 kg/m2 and 85 kg/m2), who have undergone gastric bypass procedures under general anesthesia hypoventilate during the initial twenty-four hour postoperative period, and if so, to what degree. Adequacy of ventilation will be assessed by serial arterial blood analyses. Patients will be monitored for SpO2 in the preoperative holding area, in the operating room, and the post-anesthesia care unit (PACU) by conventional and study pulse oximeters. SpO2 data will be collected continuously and recorded on the study pulse oximeter for the entire study period. Arterial blood samples will be drawn for analysis every four hours by in-dwelling arterial catheter, using standard sterile technique. Hypoventilation is defined as an increase in PaCO2 five or more mm Hg above patient's baseline.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 to 65 years of age
* Clinically significant obesity with a BMI between 40 and 85
* Candidates approved for gastric bypass surgery at Tampa General Hospital (\*Please note: authorization for gastric bypass will be completed prior to enrollment in study; this study does not pay for the cost of the operation.)
* American Society of Anesthesiologists (ASA) Physical Status Classification I-III
* Able to understand and sign informed consent

Exclusion Criteria:

* Patients not able to understand the informed consent process, or unable to understand the research protocol
* Patients in which placing an arterial catheter would pose a clinically unacceptable health risk, e.g., bleeding disorders, radial artery malformation
Renal Denervation in Patients With Heart Failure With Normal LV Ejection Fraction

It is a randomized prospective controlled study of transcatheter renal denervation in patients with Heart Failure With Normal LV Ejection Fraction. The purpose of the study is to evaluate the safety and effectiveness of renal denervation in patients with Heart Failure With Normal LV Ejection Fraction, due to reduction in renal and systemic sympathetic activity.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension treated with at least 2 antihypertensive drugs;
* Heart failure with a normal LV ejection fraction;
* Left Ventricular Hypertrophy (LV mass index \> 96 g/m2 in women and \> 116 g/m2 in men);
* ≥ 18 years of age;

Exclusion Criteria:

* Known secondary cause of hypertension
* Uncontrolled blood pressure (≥ 180x110mmHg)
* Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent
* Advanced renal insufficiency (estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73 square meters)
* Diabetes Mellitus type 1
* Acute coronary syndrome or a cerebrovascular accident in the last 6 months
* Known other cause of respiratory dysfunction
* Previous LV systolic dysfunction (LVEF \< 50%)
* Restrictive cardiomyopathy or Hypertrophic cardiomyopathy
* Significant valvar dysfunction
* Atrial flutter or atrial fibrillation
* Use of the oral anticoagulants
* Drug and Alcohol dependence