cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors

The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.


Eligibility Criteria:
Inclusion criteria:

1. Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET
2. Measurable disease by radiologic assessment
3. Adequate blood work
4. Performance Status 0-2 : Ability to be out of bed most of the time
5. Adult male or female patients ≥ 18 years of age
6. Women of childbearing potential must have a negative serum pregnancy test
7. Written informed consent from patients must be obtained in accordance to local guidelines

Exclusion criteria:

1. Patients with severe kind of (poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma) cancer are not eligible
2. Other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting this trial
3. Hepatic artery procedure called embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment
4. Prior therapy with the same kind of medication (mTOR inhibitors: sirolimus, temsirolimus, everolimus).
5. Uncontrolled diabetes mellitus Patients who have any severe and/or uncontrolled medical conditions such as:
6. Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
7. Patients with a known history of HIV seropositivity
8. No other prior or concurrent cancer at the time enrolling to this trial

Other protocol defined inclusion/ exclusion criteria applied
Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.

Cardiogenic shock (CC) is one of the major challenges of current cardiology. Despite the difficulty of establishing a strict and consensual definition, it is accepted that the CC clinically corresponds to persistent hypotension (systolic blood pressure 90 mmHg for at least 30 minutes or need for vasopressor support) associated with signs of visceral hypoperfusion (confusion, mottling, oliguria, hyperlactatemia), and hemodynamic with a lowered heart index ( 1.8 L/min/m2) despite appropriate or high filling pressures. This definition of the European Society of Cardiology (ESC) masks however the great variability of hemodynamic tables grouped under the term of CC and severity levels, also variable.However, it was suggested that the etiology of CC influenced both its hemodynamic profile and therefore its therapeutic management but also its prognosis in the medium and long term.

CC diagnosis remains difficult to carry on admission and is sometimes delayed. Therefore, we would like to compare hemodynamic data from patients with CC status to those admitted for acute heart failure (ICA) to determine if a hemodynamic variable at entry would facilitate the diagnosis of CC.

Eligibility Criteria:
Inclusion Criteria:

* Patients in Cardiac Shock :
* 90 mmHg hypotension or requiring inotropic or vasopressor support,
* owered cardiac output ( 1.8 L/min/m2) to trans-thoracic cardiac ultrasound with high or normal filling pressures
* peripheral hypoperfusion. patients admitted for acute heart failure (ICA) (Acute pulmonary edema chart or left congestive heart failure without CC sign and with ultrasound FEVG at entry 40%.)

Exclusion Criteria:

* Pregnant or nursing women
* Age 18 years
* Person of full age under guardianship
* Staying in a health or social facility
* Person not covered by a social security scheme
* Person deprived of liberty
* Shocks from other etiologies
* Patient with initial cardiac arrest
* Patient with cardiogenic shock due to right ventricular dysfunction
* Patient with pulmonary embolism
* Patient with tamponade
* Refusal to participate
A Pilot Study on Training Simulator Efficacy

The purpose of this study is to plan an effective learning path in minimally invasive thoracic and general surgery with a virtual training simulator for trainees and to assess the improvement of residents' surgical skills by the introduction of this virtual training program.

All thoracic and general surgery trainees at the first and second year of residency will be randomized in two groups: A) trainees undergoing an intensive (twice a week) virtual training program and B) those undergoing a non-intensive virtual training program (once a week).

The virtual training program will be organized in 4 modules, each of 12 weeks and, according to the training simulator instructions, for each surgical skill there are predetermined goals to be achieved by the trainee. Data about duration of surgical maneuvers and type and number of mistakes made by the trainee at each training session will be collected and compared with those of the same trainee at the previous session; this will assess the number of training sessions required to achieve the training simulator predetermined goals. Moreover, the same data will be registered at the beginning and at the end of each courses to compare the two groups of trainees (intensive vs non-intensive program).

Eligibility Criteria:
Inclusion Criteria:

* Trainees at the first and second year of residency in thoracic or general surgery

Exclusion Criteria:

* Fully trained surgeons
* Persons who are not trainees at year of specialization higher than the second
Quality of Life in Adult Neurological Patients

The purposes of this study were to evaluate the influence of an interdisciplinary rehabilitation program in the improvement of the health-related quality of life among adult neurological patients and to identify the sociodemographic and clinical associated characteristics. Subjects with spinal cord injury, acquired brain injury and poliomyelitis survivors participated in the study. All participants underwent a rehabilitation program (RP) from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2 days a week. The WHOQOL-BREF was applied at the initial and discharge assessments.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with spinal cord injury, acquired brain injury and poliomyelitis survivors
* at least 18 years old
* consented to participate in the study

Exclusion Criteria:

* cognitive problems to understand and to respond the assessment instrument, according to medical files description and interviewer previous judgment
Clinical Translation of a Novel FAPI Dimer [68Ga]Ga-LNC1013

Fibroblast activation protein (FAP) emerges as a highly promising target for cancer diagnostic imaging and targeted radionuclide therapy. To exploit the therapeutic potential of current FAP inhibitors (FAPIs), this study presented the design and synthesis of a series of FAPI dimers to increase tumor uptake and retention. Preclinical evaluation and a pilot clinical PET imaging study were conducted to screen the lead compound with the potential for radionuclide therapy.

Three new FAPI dimers were synthesized by linking two quinoline-based FAPIs with different spacers. The in vitro binding affinity and preclinical small animal PET imaging of the compounds were compared with their monomeric counterparts, FAPI-04 and FAPI-46. The lead compound, 68Ga-LNC1013, was then evaluated in a pilot clinical PET imaging study involving seven patients with gastrointestinal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically and/or clinically confirmed and/or suspicious of gastrointestinal cancer.
2. Signed informed consent.

Exclusion Criteria:

1. pregnancy;
2. breastfeeding;
3. any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation

The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine Spray compared with placebo in patients with premature ejaculation.

Promescent Lidocaine Spray is a non-prescription drug that is marketed under an over-the-counter drug monograph (21 CFR Section 348.10 Subpart B (a)(2)) for male genital desensitizing drug products. In addition the evaluating the efficacy of treatment with Promescent, this study will evaluate patients' subjective distress, perception of improvement and optimal dose, and safety and tolerability of Promescent for patients with premature ejaculation and their respective partners.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent before screening.
* Subject is a male, 18 years of age or older.
* Subject meets the diagnostic criteria for premature ejaculation as defined by the DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision; 2000).
* Subject has a stable, monogamous, heterosexual relationship and sexually active for at least the last 6 months.
* Subject and partner are willing and able to engage in sexual intercourse.

Exclusion Criteria:

* Subject has never achieved an intravaginal ejaculation during the past 6 months (i.e., always ejaculates prior to penetration).
* Subject has other forms of ejaculatory dysfunction (e.g., retrograde ejaculation, anejaculation, painful ejaculation).
* In the opinion of the investigator, the subject has a condition or is in a situation that may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's ability to participate in the study.
Novel Approach to Radiotherapy in Locally Advanced Lung Cancer Concomitant Navelbine®

To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET positive areas compared to a standard homogeneous dose spread

To investigate the effect of escalation of radiation dose to tumor and lymph nodes based on an inhomogeneous dose distribution controlled by FDG-PET-positive areas compared to a standard homogeneous dose spread.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically proven locally advanced NSCLC stage IIB to IIIB
* Performance status 0-1
* Able to comply with treatment and follow study and follow-up procedures
* Women must have negative pregnancy test
* Signed, informed consent
* Plan for radiotherapy with conventional 66 Gy/ 33 F, which meets all dosing limits two normal tissue must be available

Exclusion Criteria:

* Any unstable systemic disorder (including infection , unstable angina, congestive heart failure , severe liver , kidney or metabolic disease)
* Need for nasal oxygen
* Former thoracic radiotherapy, unless there is no significant overlap with previous fields
* Any other active malignant disease
* Unable to take oral medications or needing intravenous nutrition
* Ulcer
* Nursing women
Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan

The purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome. The results will be compared to the study with conventional treatment without sivelestat.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with systemic inflammatory response syndrome (SIRS)
2. Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference
3. Within 72 hours of onset of lung injury
4. Other inclusion criteria as specified in the protocol

Exclusion Criteria:

1. Already administrated Sivelestat before enrollment in the study
2. Neuromuscular disease that impairs spontaneous ventilation
3. Severe central nervous system disease
4. Bone marrow transplant
5. Lung transplant
6. Severe chronic liver disease
7. Neutropenia (neutrophil count: below 1000/mm3)
8. Other exclusion criteria as specified in the protocol
Appendicitis Choice of Treatment Study

A longitudinal observational/survey study evaluating patient centered decision making in the choice of treatment for acute appendicitis. Survey evaluates patients experience with decision making and the types of decision support they receive.


Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* Diagnosed with acute appendicitis
* Considered by the treating clinical team to be eligible for treatment with surgery or with non operative treatment (antibiotics)
* Access to an internet connected device capable of taking the survey

Exclusion Criteria:

* Patients who do not make their own medical decisions
* Patients who are not felt to be candidates for a decision between operative and nonoperative treatment by the treating clinical team
* Under 18 years of age
An Extension Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection

This is an extension study of HCV-05-002. The objective of this study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed HCV-05-002 only
* 18-65 years of age, inclusive
* Primary diagnosis of chronic HCV infection
* Non-responders to previous pegylated interferon-based therapy

Exclusion Criteria:

* Patients naive to interferon-based therapy for chronic HCV infection
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 \[NCT03945188\] or APD334-302 \[NCT03996369\] or APD334-210 \[NCT04607837\]).


Eligibility Criteria:
Inclusion Criteria:

* Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:

  1. Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
  2. Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit

Exclusion Criteria:

* If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
* Experienced an adverse event that led to discontinuation from parent study
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal

This is a prospective, randomized, multi-center pilot study of isolated, displaced neck fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with antegrade intramedullary splinting or conservative treatment.

The aim of this study is to provide criteria for treatment decisions in patients with isolated, displaced neck fractures of the fifth metacarpal. The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters.

Eligibility Criteria:
Inclusion Criteria:

* displaced neck fracture of the fifth metacarpal (at least 30° angulation)
* isolated injury
* age between 18 and 75 years
* informed consent

Exclusion Criteria:

* rotational displacement
* open fracture
* injury older than one week
* treatment other than within this study
* other relevant injuries of the upper extremities
* other injury or disease of the hand
* pregnancy
* missing informed consent
* incompliance
* coagulopathy
* allergy to metallic implants
* Patients who have participated in any other device or drug clinical trial within the previous month
Treatment Efficacy for Developmental Motor Speech Disorders

The purpose of this study is to carry out a high-level treatment efficacy study on children with speech sound disorders with motor speech involvement (SSD-MSI) using a well-controlled Randomized Controlled Trial design.

The intervention of choice is the Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) approach, which has been effective in treating motor speech disorders in adults and in children with autism and cerebral palsy.

The results of this study will allow us to determine if there is a causal relationship between PROMPT treatment and outcome measures and predict how much improvement can be expected from this therapy. This study is being conducted as a part of a multicenter clinical trial in the province of Ontario, Canada with three sites: The John McGivney Children's Centre in Windsor, The ErinoakKids Centre for Treatment and Development in Mississauga, and The Speech and Stuttering Institute in Toronto.

The study integrity will be monitored by an arms-length, external agency, The Applied Health Research Centre (AHRC) at St. Michael's Hospital in Toronto. The study is coordinated by the Department of Speech-Language Pathology at the University of Toronto and funded by the PROMPT Institute in Santa Fe, New Mexico.

Eligibility Criteria:
Inclusion Criteria:

* The child is between 3 and 10 Years.
* English is the primary language spoken by the primary caregiver at home.
* Hearing/Vision (corrected is acceptable- e.g., spectacles) is within normal limits.
* Readiness for direct speech therapy.
* Age appropriate social interaction and play skills.
* Age appropriate or mildly delayed receptive language skills.
* Normal to any amount of delay in expressive language development.
* Moderate to severe speech sound disorder.
* Age appropriate or slight delay non-verbal intelligence.
* 4 red flags for motor speech involvement.

Exclusion Criteria:

* Signs and symptoms suggesting global motor involvement (Cerebral Palsy).
* Signs and symptoms suggesting Autism Spectrum Disorders.
* Oral structural deficits.
* Feeding impairments.
* Signs of Dysarthric speech or significant drooling.
* Prosodic and / or resonance disorders.
* Diagnosis of Childhood Apraxia of Speech features
Evaluation of Galantamine in the Treatment of Alzheimer's Disease

Galantamine is an experimental drug being evaluated in the United States for the treatment of Alzheimer's disease. Results from previous clinical trials suggest that galantamine may improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function communicate using a chemical called acetylcholine. Research has shown that deterioration of cells that produce acetylcholine in the brain affects thought processes. Galantamine is thought to work in two ways to increase the amount of acetylcholine available in the brain. It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic receptors in the brain to release more acetylcholine.

After a 1-month single-blind run in phase, 910 subjects will be titrated, over a period of up to 8 weeks, to target doses of either: 0 (placebo); 24 mg/day galantamine; 16 mg/day galantamine; or 8 mg/day galantamine, in a 2:2:2:1 randomization ratio. Double-blind treatment will continue for a total of 5 months. The change from baseline in ADAS-cog and CIVIC-plus scores at Month 5 will be the primary efficacy endpoints. Tolerability will be evaluated based on adverse event reports, laboratory values, ECG, and vital signs with particular focus on the adverse event rates in the slower titration schedule for 24 mg/day. Efficacy of 24 mg/day and 16 mg/day galantamine will be compared with that of placebo. Information on the dose response relationship of galantamine will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Probable Alzheimer's disease
* Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18
* Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least 18
* Opportunity for Activities of Daily Living
* Caregiver
* Subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). This includes a friend or relative or paid personnel. The caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject.

Exclusion Criteria:

* Conditions that could confound diagnosis
* Neurodegenerative disorders
* Acute cerebral trauma
* Psychiatric disease
* More than one infarct on CT/MRI scans
* History of alcohol or drug abuse
* Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV block.
Prediction of PaO2 Values Using the PRoPERLy II Database

Four prospective observational studies of ventilation in critically ill patients were harmonized and pooled.

The individual data from four observational studies ('Epidemiology of Respiratory Insufficiency in Critical Care study' \[ERICC\], the 'Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure' \[LUNG SAFE\], 'PRactice of VENTilation in critically ill patients without ARDS' \[PRoVENT\], 'PRactice of VENTilation in critically ill patients in Middle-income Countries' \[PRoVENT-iMiC\]) were harmonized and pooled into a database named 'PRoPERLy II'. This database will be used to address various issues in diverse patient categories.

Eligibility Criteria:
ERICC included patients aged 18 years or older that received ventilatory support for at least 24 hours during the first 48 hours of ICU admission at the participating ICUs. ERICC excluded patients with a tracheostomy, patients admitted for routine uncomplicated postoperative care, readmissions and patients with a terminal condition. ERICC enrolled patients during 2-months period.

LUNG SAFE included patients aged 16 years or older that received invasive or noninvasive ventilation. LUNG SAFE excluded patients without informed consent. LUNG SAFE enrolled patients during a 4-week period in the winter months.

PRoVENT included patients aged 18 years or older that received invasive ventilation. PRoVENT excluded patients in whom ventilation was started before the study recruitment week, patients receiving only noninvasive ventilation, and patients that were transferred to the ICU from another hospital under ventilation. PRoVENT enrolled patients during 4-week period.

PRoVENT-iMiC included patients aged 18 years or older that started with invasive ventilation. They excluded patients that received only noninvasive ventilation, patients whose invasive ventilation started before the inclusion phase of the study, and patients transferred from another hospital while under ventilation. PRoVENT-iMiC enrolled patients during 4-week period.