cyrilzakka/clinical-trials huggingface dataset:
Divided Drug Delivery

This study will evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 65 years.
* Hospitalized after a voluntary drug intoxication.
* History of two voluntary drug intoxications at least.
* Person registered for social security.
* Signed free consent.

Exclusion Criteria:

* Patients under treatment for opiate split
* Acute or chronicgoing wild.
* Cognitive problems hindering understanding of questionnaires
* Persons targeted by articles L1121-5 to L1121-8 of CSP
Physical Training Program in Ankylosing Spondylitis

Purpose: to assess the efficacy of a physical training program in patients with ankylosing spondylitis (AS) in a randomized controlled study

AS is a chronic inflammatory rheumatic disorder affecting spine, peripheral joints and entheses. Patients undergo pain, stiffness and reduced mobility of spine and joints. Patients experience limitations in physical activities and reduced quality of life. Some uncontrolled studies reported benefits of physical activity in patients with AS.

The aim of the present study is to assess the efficacy of a physical training program in patients with AS.

Patients will be randomized in two parallel arms: program of personalized physical training (intervention group \[PEPc\]) or program of information about physical activity (control group \[PIAP\]).

Patients will be evaluated at 12 and 24 weeks on activity, functional and metrological scores (ASAS 20, ASAS 5/6, ASDAS, BASDAI, BASFI, BASMI); biological inflammation (CRP); NSAID use and pain VAS.

Primary outcome: percentage of patients reaching an ASAS 20 response at 12 weeks.

Secondary outcomes: ASAS 20 at 24 weeks, ASAS5/6, ASDAS, BASDAI, BASFI, BASMI, CRP, NSAID use and pain VAS at 12 and 24 weeks.

Statistical analysis: comparison of the percentage of patients reaching an ASAS 20 response at 12 weeks in each arm using a Fisher's exact test (main outcome).

Eligibility Criteria:
Inclusion Criteria:

* Patients with AS according to ASAS criteria,
* treated or not with NSAID,
* synthetic DMARD or anti-TNF agent.

Exclusion Criteria:

* Contraindications to physical training program (e.g. cardiac failure, pregnancy, painful arthroplasty or lower limbs damaged joint).
Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)

A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C) during 24 hours ± 1h versus normothermia (36°C≤ T°C ≤37°C), comparative open trial will be conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO.

The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between 33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality in comparison with the normothermia group (36°C≤ T°C ≤37°C).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Intubated patients with cardiogenic shock treated with VA-ECMO
* Patient affiliated to social security plan

Exclusion Criteria:

* VA-ECMO after cardiac surgery for heart transplantation or lung transplantation or left or biventricular assist device implantation
* VA-ECMO for acute poisoning with cardio-toxic drugs
* Pregnancy
* Uncontrolled bleeding (bleeding despite medical intervention (surgery or drugs))
* Implantation of VA ECMO under cardiac massage with a duration of cardiac massage \>45minutes
* Out of hospital refractory cardiac arrest
* Cerebral deficit with fixed dilated pupils
* Participation in another interventional research involving therapeutic modifications
* Patient moribund on the day of randomization
* Irreversible neurological pathology
* Minor patients
* Patients under tutelage
Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the GOLD Guidelines, 2006) and:

  * Smoking history of at least 20 pack years
  * Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) \<80% and ≥30% of the predicted normal value.
  * Post-bronchodilator FEV1/Forced Vital Capacity (FVC) \< 70%, where FVC is forced vital capacity ('Post-' refers to 15-30 minutes after inhalation of 400 μg of salbutamol at Visit 2)

Exclusion Criteria:

* Pregnant / nursing women or women of child-bearing potential
* Long term oxygen therapy (more than 15 hours per day) on a daily basis for chronic hypoxemia
* Patients hospitalized for COPD exacerbation in 6 weeks prior to Visit 2 and up to Visit 3
* Respiratory tract infection within 6 weeks prior to Visit 2 and up to Visit 3
* Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
* Any history of asthma, including: blood eosinophil count \>400/mm3; onset of asthma symptoms prior to age 40 years
* History of long QT syndrome or whose QTc (Bazett's) measured at Visit 2 or Visit 3 is prolonged (\>450ms for males or \>470ms for females)
* Clinically relevant lab abnormalities / conditions such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator's opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
* Uncontrolled Type I / Type II Diabetes or blood glucose outside normal or HbA1c \>8.0% of total hemoglobin measured at Visit 2
* Any patient with lung cancer or any active cancer or a history of cancer with less than 5 years disease-free survival time
* History of hypersensitivity to any of the study drugs
* Irregular day/night, waking/sleeping cycles e.g. shift workers
* Live attenuated vaccinations within 30 days prior to Visit 2
* Investigational drug within 30 days prior to Visit 2
* Known history of non-compliance or not able to use devices or perform spirometry

Other protocol-defined inclusion/exclusion criteria may apply
Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)

Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue Syndrome (CFS/ME) by Lipidomics, Metabolomics, Intestinal and Peritoneal Microbiome Analysis and Exome Analysis and Investigation of a Possible Benefit of Probiotics.

This study aims to identify the underlying pathophysiology of Cancer Related Fatigue (CRF) by screening lipidome, metabolome, exome and microbiome of affected patients with tumor disease with and without fatigue. These results will be compared to an age- and gender matched control group with a comparable tumor disease and to another age- and gender matched control group without tumor disease.

The investigators are following the same strategy for investigating an underlying pathophysiology of Chronic Fatigue Syndrome (CFS/ME) in another group of patients. The age- and gender matched control group will be established from the beforementioned control group.

The investigators will also be screening for a peritoneal microbiome (possible correlate for leaky gut) in study patients undergoing abdominal surgery.

We will also investigate changes in fatigue and in lipidome, metabolome, exome and microbiome by double-blinded, placebo-controlled administration of probiotics to the study population.

Eligibility Criteria:
Inclusion Criteria:

* histologically, cytologically or radiologically confirmed tumor disease
* indication for chemotherapy
* Written consent to participation

Exclusion Criteria:

* chronic-inflammatory bowel disease
* pregnancy
This is an Early Study to Investigate the Effect of Gimatecan® in Adults With Solid Tumor

Gimatecan® is sigma-tau Research's new, potent, oral Topoisomerase I inhibitor. Drugs in this class play a crucial role in destroying DNA replication in tumors. We are conducting this study to determine the Maximum Tolerated Dose of our compound, when given as a capsule, rather than by intravenous injection.


Eligibility Criteria:
Inclusion criteria:

* Histologically/cytologically proven advanced solid tumors
* Life expectancy of at least 3 months with normal hematological, liver and renal function

Exclusion criteria:

* Pregnant and lactating patients
* Participation in any investigating drug study within 4 weeks preceding treatment start or concurrent treatment with any other anti-cancer therapy
* Gastrointestinal dysfunction that could alter absorption or motility
Versailles Hospital Cardiac Arrest Registry

Out-of-hospital and in-hospital cardiac arrest (CA) requiring intensive care unit management.

Data collection using a standardized form : demographic data and data related to the CA according to the Utstein guidelines.. Circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures).

On-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of CA. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Cerebral Performance Category scale score at ICU and hospital discharge, day-90 and 1-year after CA and determined based on data in the ICU and/or hospital/neurologist charts and/or general practitionner phone interview.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest requiring Intensive Care Unit management
* Age \>= 18 years

Exclusion Criteria:

- Refusal to participate
TCM Differentiation and Treatment Protocol of COVID-19

Evaluation of the efficacy and safety of TCM differential treatment of COVID-19 in Jiangsu Province based on the historical prospective multicenter cohort study.

This is a multi-center cross-sectional syndrome investigation study, taking confirmed cases as the main observation object, A prospective multicenter cohort study was designed, focusing on the common type with the largest number of confirmed cases, to evaluate the intervention effect of this project in relieving the disEvaluation of the efficacy and safety of TCM differential treatment of COVID-19 inease and preventing disease progressio.

According to the actual situation of receiving treatment, if the subjects received the combination of western medicine and traditional Chinese medicine, it was the exposure group (integrated traditional Chinese and western medicine cohort), and if the subjects only received western medicine treatment, it was the control group (western medicine cohort). The choice of treatment for patients is entirely determined by clinicians according to the patient's condition, and patients are free to choose after fully understanding different schemes).The choice of control group: COVID-19 (common type) who received routine treatment + antiviral therapy；The choice of exposure group: COVID-19 (common type) who received routine treatment + TCM.The sample size is tentatively set at 340.

Eligibility Criteria:
Inclusion Criteria:

* It conforms to the diagnostic criteria of confirmed cases of COVID-19 that belongs to the common type;
* The age ranges from 18 to 80 years old, regardless gender；
* In the prospective study, the patient informed consent and sign the informed consent form (if the subject has no capacity, limited capacity and limited expression of personal will, he or she should obtain the consent of his guardian and sign the informed consent at the same time), the retrospective study is visa-free informed consent.

Exclusion Criteria:

* Women during pregnancy or lactation;
* Allergic constitution, such as those who have a history of allergy to two or more drugs or food, or who are known to be allergic to drug ingredients observed in this study.
* Severe complications such as multiple organ failure and shock occurred.
* Complicated with severe primary diseases such as heart, brain, liver, kidney and so on.
* Patients have mental illness.
* Patients who participated in or is currently participating in other clinical trials within the first month of this study.
Correlation Tests for Patients With Benign Paroxysmal Positional Vertigo

This study aimed to investigate whether there is a relationship between nystagmus intensity and vestibular-ocular reflex gains by comparing Videonystagmography and video head impulse test in patients with posterior semicircular canal-benign paroxysmal positional vertigo.

The aim of this study is to investigate the relationship between the vestibulo-ocular reflex (VOR) gains obtained by video Head Impulse Test (vHIT) and the slow phase velocity (SPV) of nystagmus in patients with benign paroxysmal positional vertigo (BPPV) originating from the posterior semicircular canal (PSCC).

The patients were included in two groups. The study group consisted of patients with isolated PSCC BPPV (PSCC-BPPV), and the control group consisted of age and gender-matched healthy individuals. VOR gains were measured by vHIT in both the study group and the control group. The SPV values of the nystagmus observed during the Dix-Hallpike maneuver in the study group were recorded by Videonystagmography (VNG) and compared with the VOR gains.

Eligibility Criteria:
Inclusion Criteria:

* Patients with isolated benign paroxysmal positional vertigo were included in the study group.
* The patients included in the control group were composed of those who did not complain of vertigo.

Exclusion Criteria:

-Participants with a history of neuro-otologic disease, an orthopedic disease that prevents neck movements, and any disease or surgery that causes impairment in ocular movements were excluded from the study.
Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection

Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* 1. Aged between 18 and 75 years, extremes included, male or female
* 2. Laboratory (RT-PCR) and clinical symptoms confirmed case of 2019-nCoV pneumonia, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"
* 3. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)
* 4. No family planning within six months, and agree to take effective contraceptive measures throughout the study and for at least 30 days after the final study drug dose
* 5. Must agree not to enroll in another study of an investigational agent prior to completion of Day 30 of study
* 6. Informed Consent Form (ICF) signed voluntarily

Exclusion Criteria:

* 1. Severe 2019-nCoV pneumonia met one of the following criteria: respiratory distress, RR ≥ 30 times / min, or SaO2 / SpO2 ≤ 93% in resting state, or arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg (1mmHg = 0.133kpa)
* 2. Critical severe 2019-nCoV pneumonia met one of the following criteria: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required ICU monitoring treatment
* 3. Severe liver disease (e.g. Child Pugh score ≥ C, AST \> 5 times upper limit)
* 4. Known allergic reaction to any of components of ASC09 / ritonavir compound tablets
* 5. Patients with definite contraindications in the label of ritonavir
* 6. Positive serum pregnancy test result for women with childbearing potential at screening
* 7. Using HIV protease inhibitor drugs
* 8. Not suitable for the study, in the opinion of the Investigator (e.g. patient may be transferred to another hospital during the study period, patient with multiple basic diseases, etc.)
Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study

The standard treatment for Type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months.

In this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. The body produces insulin in response to eating. The participants will drink a meal replacement shake, and then test the blood for levels of insulin produced over 2 hours.

With blood tests taken five times over two hours, the investigators will measure the blood glucose (sugar), and insulin levels. This study will assess the differences in insulin produced in the participants and try to understand the reasons for these differences.

This study will measure the ability of the pancreas to produce insulin after the participant drinks a Boost Original meal replacement shake. The Boost Original meal replacement shake contains nutrients similar to a typical meal, and allows to standardize this "meal" for all participants. This is a cross-sectional study for 90 participants with type 2 diabetes mellitus who undergo a single study visit that lasts 2 hours with blood drawn at five time points. The area under the curve will be a quantitative measure of each participant's pancreatic insulin production capacity.

Eligibility Criteria:
Inclusion Criteria:

1. Consent provided
2. Age \>= 18 years.
3. Diagnosed as type 2 diabetes mellitus.
4. Not on insulin therapy.

Exclusion Criteria:

1. Diagnosed as another form of diabetes mellitus.
2. Allergic to one or more ingredients in Boost meal replacement shake.
3. Unable to fast since midnight and attend in person for the morning protocol.
A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease

The purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.


Eligibility Criteria:
Inclusion Criteria:

-General Inclusion Criteria

1. Skeletally mature adult males and females 18 years of age or older.
2. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.
3. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as:

   1. Postmenopausal for at least 1 year OR
   2. Documented oophorectomy or hysterectomy
   3. Surgically sterile OR
   4. If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
4. Able to understand and provide informed consent.
5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.

   -Impending Fracture-Specific Inclusion Criteria
6. Documented presence of solitary metastatic lesion.
7. Mirels Criteria Score ≥ 8.
8. Destruction of cortical bone at impending fracture site \> 50%.

   -Actual Fracture-Specific Inclusion Criteria
9. Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A1, 11A2 and 11B1, 11B2 and 12A1,12A2 and 12B1, 12B2 and 13A1,13A2 and 13B1, 13B2.
10. Fracture is closed, Gustilo Type I or IIA.

Exclusion Criteria:

-General Exclusion Criteria

1. Primary tumor (osteogenic origin, etc.) at site.
2. Impending fracture or actual fracture location other than humerus.
3. Current concomitant traumatic fracture of any other location.
4. Active or incompletely treated infections that could involve the device implant site.
5. Distant foci of infection that may spread to the implant site.
6. Allergy to implant materials or dental glue.
7. Vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site.
8. Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).

   -Impending Fracture-Specific Exclusion Criteria
9. Mirels Score \< 8.
10. Destruction of cortical bone at impending fracture site \< 50%.
11. Prior surgery and/or prior fracture of affected site.
12. Any articular component to impending fracture site.

    -Actual Fracture-Specific Exclusion Criteria
13. Index treatment is greater than 28 days post fracture.
14. Open fractures with severe contamination.
15. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
16. Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment
17. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)

The investigators seek to demonstrate that the combined use of cilostazol and nimodipine will significantly decrease the rate of delayed cerebral infarction and cerebral vasospasm after cerebrovascular intervention when compared to nimodipine alone.

This research study is for people who have a brain hemorrhage, due to a ruptured aneurysm. Adding the drug cilostazol to the standard care may improve outcomes after surgery. The blood within the brain following aneurysmal hemorrhage can have harmful effects on the blood vessels causing them to narrow and thus decrease blood flow; this process is called vasospasm. Decreased blood flow in the brain can lead to more damage. Delayed cerebral ischemia is a complication which is believed to be a consequence of reduced blood flow to the brain following this type of hemorrhage. Cilostazol opens blood vessels and reduces the formation of blood clots. The standard treatment of these hemorrhages currently involves the use of nimodipine which also relaxes blood vessels and allows blood to flow more freely. The combination of these two drugs cilostazol and nimodipine may improve neurologic outcomes after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Anterior circulation aneurysm
* Patients who have undergone surgical intervention
* Absence of rebleeding or new intracranial hemorrhage noted on post-intervention CT scan
* Consent for study participation

Exclusion Criteria:

* Non-aneurysmal subarachnoid hemorrhage
* Multiple ruptured aneurysms
* Patients with congestive heart failure
* Severe aneurysmal subarachnoid hemorrhage (Hunt Hess Grade V)
* Active pathological bleeding
* Allergy to cilostazol
* Positive pregnancy test
* Coagulopathy not caused by anti-coagulant use
* History of hemorrhagic complications (gastrointestinal bleeding, etc)
* Uncontrolled or severe comorbidity that would qualify as an absolute contraindication for cilostazol
* Patients requiring anticoagulant/antiplatelet treatment following intervention (e.g. stent-assisted coiling or flow-diverting stent obliteration of aneurysm)
Acute Lymphoblastic Leukaemia Related to Lenalidomide (LenALL)

Although lenalidomide (LEN) have proved effective in treating many cancers, few patients receiving LEN may experience rare but life-threatening adverse events such as Acute Lymphoblastic Leukaemia (ALL). Today, data about ALL are scarce.

The objective was to investigate reports of ALL adverse events related to LEN in patients with cancer using the World Health Organization (WHO) pharmacovigilance database.


Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO, also called VigiBase) at the time of the extraction
* Patients treated with at least LEN (L04AX04)

Exclusion Criteria:

-Chronology not compatible between LEN and ALL