cyrilzakka/clinical-trials huggingface dataset:
Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity

The initial symptoms described in the first cases of COVID-19 were mainly fever and respiratory signs. Recently, there has been an increase in cases of hyposmia without associated nasal obstruction or rhinorrhea. Although we do not yet know the long-term consequences of COVID-19 on olfaction, there is evidence in the literature demonstrating that post-viral hyposmias are an important source of long-term olfactory disorders, impacting quality of life.

Usually, the treatment of viral hyposmias is based on local and/or general corticosteroid treatment combined with saline nasal irrigation at the onset of signs. Because of the possible development of severe forms of the SARS-Cov-2 infection, the French Society of Otorhinolaryngology has advised against treatment by corticosteroid therapy and nasal irrigation. However, as the virus is present in the nasal fossae on average for 20 days, persistent hyposmia at 30 days would probably result from an inflammatory or neurological damage to the nasal slits or olfactory bulb. Local treatment with corticosteroids could then be instituted from 30 days after the onset of symptoms of COVID-19 without risk of dissemination.

In persistent hyposmia other than chronic rhinosinusitis, the only treatment that has proven its efficacy is nasal irrigation associated with budesonide and olfactory rehabilitation. However, this drug does not have marketing authorisation in France for this indication.

This is a multicenter randomized trial to evaluate the efficacy of local budesonide (nasal irrigation) in the management of persistent hyposmia in COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age;
* Patient with a suspected SARS-CoV-2 infection in a epidemic context, whether or not confirmed by PCR, or contact close to a PCR-confirmed case, typical chest CT scan (unsystematized frosted glass areas predominantly sub-pleural, and at a later stage of alveolar condensation with no excavations neither nodules nor masses) or positive serology ;
* Patient with isolated acute hyposmia persisting at D30. of the onset of signs of CA-MRSA-CoV-2 infection;
* Absence of PCR-confirmed SARS-CoV-2 portage at the time of inclusion

Exclusion Criteria:

* Known hypersensitivity to budesonide or to any of the excipients of the medicine;
* Hemostasis disorder, or epistaxis;
* Oromo-oral-nasal and ophthalmic herpes virus infection;
* Long-term corticosteroid treatment;
* Treatment with potent CYP3A4 inhibitors (e.g., CYP3A4 inhibitors); ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV proteases) ;
* Forms of CoV-2-SARS with respiratory signs or other than anosmia persisting at 30 days from the onset of symptoms;
* Hyposmia persisting for more than 90 days after onset of symptoms;
* Other causes of hyposmia revealed on interrogation or an MRI;
Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

This study examines the role of osmotic agents in controlling brain swelling in brain injured individuals. Two osmotic agents -- mannitol and hypertonic saline -- are in common use, and they will be compared in the context of a randomized clinical trial. The goal is to determine if these agent differ in their ability to control episodes of brain swelling.

This single-center, randomized, open label trial will compare (i) 0.9% normal saline infusion and boluses of mannitol (control group) with (ii) 3% hypertonic saline, with intermittent boluses as needed, to treat elevated intracranial pressure (ICP) following severe traumatic brain injury.

Patients will be randomized to one of the two study arms following placement of an ICP monitor. Raised ICP will be defined as an ICP greater than 20 mmHG for 20 minutes or longer. In the event of such an event, the appropriate treatment will be administered.

The primary endpoint will be success in ICP control, operationalized as the proportion of time during which ICP is less than or equal to 20 mmHg during the first 120 hours following initiation of monitoring. Secondary endpoints include therapy intensity level, incidence of pre-determined severe adverse events, and long-term outcomes measured at 3 and 6 months post-injury.

Eligibility Criteria:
Inclusion Criteria:

* closed traumatic brain injury
* either (i) GCS score 3-8 (inclusive), or (ii) GCS motor score of 5 or less AND abnormal admission CT scan showing intracranial pathology
* hemodynamically stable with systolic blood pressure greater than 90 mmHg
* at least 1 reactive pupil
* age between 18y and 70y (inclusive)
* INR less than 1.5

Exclusion Criteria:

* actively on hypertonic saline or mannitol
* hypernatremia (\>145 meq/L)
* anuric or with creatinine greater than or equal to 2.5
* known seizure disorder
* penetrating head trauma
* suspected anoxic events
* history of, or CT confirmation of, previous brain injury
* any injury that, in the opinion of the Principal Investigator, has a high likelihood of death with the first 72 hours post-injury
* any treatment, condition, or injury that contraindicates treatment with hypertonic saline
Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma

The objectives of this clinical study are threefold:

1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.

1. primary objectives include

   1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
   2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
   3. comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.
2. secondary objectives include

   1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
   2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
* non-keratinizing or undifferentiated type
* stage III-IVB (by AJCC/UICC 6th edition)
* ECOG Performance status less or equal to 2
* Marrow: WBC \>= 4 and platelet \>=100
* Renal: creatinine clearance \>=60
* Informed consent

Exclusion Criteria:

* Primary treatment with palliative intent
* WHO type I squamous cell carcinoma or adenocarcinoma
* Evidence of distant metastases
* Patient is pregnant or lactating
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
Effect of S-ketamine in Cesarean Section Combined Anesthesia

To compare the anti-hyperalgesia effect between S-ketamine with placebo for Maternal receiving elective Cesarean Section under Combined spinal and epidural analgesia.

Based on this study the investigators intend to verify the role and potential mechanism of S-ketamine combined anesthesia in alleviating hyperalgesia after cesarean section, prove that it can reduce hyperalgesia and postoperative pain. explore the role of S-ketamine in alleviating postoperative hyperalgesia in different PCA ways and explore the safety of S-ketamine in the perilactation


Eligibility Criteria:
Inclusion Criteria:

* ASA status I-III
* Age 20 to 45
* 37-42 weeks gestation
* undergo elective cesarean section with subarachnoid anesthesia
* participate in this study and sign informed consent

Exclusion Criteria:

* Patients with contraindications for cesarean section
* Patients with contraindications of combined spinal and epidural anesthesia
* Patients with severe systemic disease
* Alcoholism and long-term use of anti-inflammatory and analgesic drugs
* Patients who were unable to cooperate or refused to participate in the trial
* Patients with contraindications to esketamine and hydromorphone
Autonomic Imbalance and 24-h Blood Pressure Change in Patients With Chronic Renal Disease

Many patients with chronic renal disease show a loss of the nocturnal decline of blood pressure (non-dipper). However, the mechanism is not yet fully understood. We evaluate 24-hour blood pressure in patients with chronic renal disease using an ambulatory blood pressure monitoring device (A \& D TM2425). We also analyze the power spectrum of heart rate variability as an index of autonomic cardiovascular modulation using the same device.

The ratio of lower frequency (LF) and higher frequency (HF) heart rate rhythmic oscillations is expressed as an index of sympathovagal balance. Patients with chronic renal disease participate in the study. Blood pressure and power spectrum of heart rate variability for 24 hours are measured when they receive no medication for at least 1 week. The mean waking and sleeping time systolic and diastolic blood pressure are calculated. LF/HF ratios in the chronic renal disease are evaluated to calculate the waking/sleeping ratio for LF/HF.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients with diabetes mellitus
* Hypertensive patients
* Hypertensive patients with renal disease
* Patients with chronic renal disease

Exclusion Criteria:

* Cardiac, hematologic or hepatic disease
* Cerebral infarction or hemorrhage
* Other major diseases.
Chronotropic Incompetence During Exercise Testing in Obese Adolescents

In adolescents with obesity cardiopulmonary exercise testing (CPET) has become an important clinical examination providing valuable information with regard to the integrative exercise responses, including the pulmonary, cardiovascular and muscular systems.

During CPET, mechanical constraints in ventilation, an elevated risk for hypoxia and chronotropic incompetence (CI) (defined as the inability of the heart to increase its rate with increased activity), or compromised cardiac function (e.g. lowered heart rate (HR) recovery, chronotropic index and stroke volume) are often observed in obese adults. Moreover, several studies regarding exercise capacity and cardiopulmonary responses to maximal endurance exercise testing have been performed in obese adolescents. Despite these previous investigations in obese adolescents it remains controversial whether cardiopulmonary disturbances can be observed consistently during CPET. However, a number of studies have reported a suboptimal response to exercise, in particular a reduced peak heart rate (HRpeak) and peak cycling power output (Wpeak). Adult obesity modifies cardiac behavior, including resting HR and CI, which has a marked effect on exercise capacity. Therefore, chronotropic variables are the most important factors that affect exercise performance. It has been shown that both peak and resting HR account for over forty percent of variability of exercise capacity. Interestingly, resting HR and HR response to exercise, including a blunted HR increase, low chronotropic index and HR recovery, are important predictors of all-cause mortality and cardiovascular death, at least in adults. These changes in HR during and recovery from CPET are mediated by the balance between sympathetic and vagal activity of the autonomic nervous system. Adverse cardiovascular outcomes associated with the metabolic syndrome may be mediated by autonomic dysfunction, whereby obesity is characterized by sympathetic predominance and a decrease in vagal activity in the basal state, where reduced sympathetic responsiveness has been observed during exercise. Therefore, these multiple exercise risk markers could provide valuable clinical information regarding cardiometabolic health. Nonetheless HR behavior during CPET has not been described in obese adolescents. The goal of this study is to examine the HR behavior of obese adolescents during CPET to clarify whether this population suffer from CI.


Eligibility Criteria:
Inclusion Criteria:

* obese or lean (based on extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity)
* Parental permission

Exclusion Criteria:

* Chronic cardiovascular, renal, pulmonary or orthopaedic disease
* Medication use that could possibly influence the heart rate
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus

The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310
* Had an intact uterus
* Met the inclusion and exclusion criteria for Protocol 15-50310
* Had completed Protocol 15-50310

Exclusion Criteria:

* Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310
* Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures
Exposure to Neurotoxins as Risk Factors for Amyotrophic Lateral Sclerosis

This study is a follow-up to an earlier study that examined the relationship of This study will examine whether exposure to neurotoxins, such as lead, mercury, solvents, and pesticides, can contribute to amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The cause of this degenerative disease of the brain and spinal cord is not well understood. Some studies suggest that exposure to environmental neurotoxins may increase its risk. This follow-up study will examine the relationship of neurotoxin exposure to the interval between the diagnosis of ALS and death. It will also examine the possible roles of genetics, lifestyle and dietary factors in the disease. Information on ALS patients previously enrolled in the study will be used to examine this relationship. No new individuals will be enrolled in the study.

Objective: The objective of this proposal is linkage with the National Death Index (NDI) for cases from a study that was conducted in the early 1990's. The purpose of the initial study was to examine the role that lead and other exposures, including mercury and solvents, play in the etiology of amyotrophic lateral sclerosis (ALS).

Study population: The study involved 110 ALS cases and 256 population based controls, recruited in New England between 1993 and 1996. Data collection involved an interview, blood collection, and measurement of bone lead using x-ray fluorescence.

Design and outcome parameters: The results of this study suggested that lead exposure was a risk factor for ALS. Compared to controls, cases were more likely to have occupational lead exposure, and both blood and bone lead levels were higher in cases. We are presently analyzing data on other neurotoxic exposures including mercury, solvents, and pesticides. In order to investigate prognosis, we would like to determine the date of death by searching the National Death Index. This information will enable us to evaluate the relationship of neurotoxic exposures to ALS prognosis.

Eligibility Criteria:
* INCLUSION CRITERIA:

The purpose of the NDI search will be to verify death and obtain date and cause of death information for the study participants.
The Impact of Reformulated Foods on Cardiovascular Risk Factors

Specific policies on obesity reduction often include a recommendation to reduce sugar consumption as a means of lowering overall caloric intake. Reformulating processed foods (e.g. sugary products) is considered one of the key options for improving population diet. The implications of regular consumption of reformulated products are not fully understood. Previous studies have demonstrated that dietary compensation is common, although the extent is not fully elucidated. In addition to the perceived impact of sugar consumption on weight control, high sugar intake, specifically sucrose and fructose, has been implicated in the increase of plasma lipids and markers of insulin resistance. However to date no randomised controlled study has investigated whether the consumption of reformulated low sugar products as components of a habitual diet have a significant impact on plasma lipid, insulin or glucose concentrations within a free-living, non-diseased population. It is hypothesised that exchange of reformulated, low sugar food products for habitually consumed foods will result in dietary compensation and minimal weight change compared with unmodified products and will have little impact on plasma glucose, insulin and lipid levels.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20 - 49 years
* BMI 18.5 - 30 kg/m2
* Plasma glucose \<7 mmol/l (Not diagnosed with diabetes)
* Plasma cholesterol \<7 mmol/l
* Plasma TAG \<2.3 mmol/l
* Normal liver and kidney function
* Haemoglobin (\>110 g/l women; 140g/dl men)

Exclusion Criteria:

* Having suffered a myocardial infarction/stroke in the past 12 months
* diabetic (diagnosed or fasting glucose \> 7 mmol/l)
* Smoking
* On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
* Suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
* Excessive alcohol consumption
* History of alcohol abuse
* Following a reducing diet or vegan diet
* Taking any fish oil, fatty acid or vitamin and mineral supplements
* Participating in intensive aerobic activity for \> 20 minutes 3 times per week
* Food allergies
* Anti-inflammatory usage
Feasibility Study of a Dose Increase by a Boost of Curietherapy in Pulse Dose Rate (PDR) Associated With the Extern Radiotherapy in Prostate Cancer

The objective of the trial is to evaluating the feasibility of dose increase by a boost of curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in intermediate risk in prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years and ≤ 75 years
* Life expectancy \>10 years
* Localized prostatic adenocarcinoma and histologically proven
* Intermediate risk cancer(T2b or PSA between 10 and 20 or Gleason = 7(3+4) according to Amico criteria
* Metastasis or pelvic pathologic ganglion (≥ 10 mm) absence
* OMS \< 2
* No previous treatment by radiotherapy and/or curietherapy
* Hormonotherapy authorized before and during the study
* Rectal or uretero-vesical pathology
* Signed informed consent
* Social security system affiliation
* Individual deprived of liberty or placed under the authority of a tutor.
* No anesthesia contraindication

Exclusion Criteria:

* Adenocarcinoma not histologically proven
* Metastases presence
* Pathological nodes presence(≥ 10 mm)
* Prior prostate endoscopic resection
* history of other malignancy except for appropriately treated superficial basal cell skin cancer
* Medical contraindications to anesthesia
* Patients with uncontrolled psychiatric disease or medical disease incompatible with the protocol
* Impossibility to respect the medical follow-up of the protocol for geographical, social or psychic reasons
Clinical Evaluation of the Scopio Cell Morphology Technology

Digital morphology is currently expanding and developing new applications based on artificial intelligence software. We recently published a study comparing screen validation and microscopic reading of bone marrow aspirates. The aim of the current research will be the comparison between optical microscope reading and automatic pre-classification (AI based)


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from hemopathies with bone marrow aspirate assessable under the optical microscope

Exclusion Criteria:

* Patients not affected by blood disorders
* Patients suffering from hemopathies with bone marrow aspirate that cannot be assessed under the optical microscope
Orthomolecular Therapy and Asthma in Children

The purpose of this study is

1. To pilot the research methodology for a randomized trial on an orthomolecular treatment regime versus placebo as add-on therapy for children with asthma;
2. To obtain a preliminary estimate of the effectiveness of an orthomolecular treatment regime for allowing tapering of inhaled corticosteroids in clinically stable asthmatic children. The obtained estimate will allow sample size calculations for a full-scale randomized trial; and
3. To obtain preliminary information about the safety and tolerability of an orthomolecular treatment regime.

An orthomolecular treatment approach that combines supplements has, to date, not been tested, although it is commonly used by naturopathic practitioners to treat respiratory problems in individual children. A well-designed controlled trial is needed to determine if this approach is effective. This smaller study should establish guidelines for a large trial to follow. This proposed research is particularly important, as the trend to use natural treatments may encourage non-compliance with conventional medical treatments, leading to poor asthma control.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 7 to 18 years
* Mild to moderate asthma diagnosed by a respirologist
* Use of budesonide at a dose of 200-800 µg/d (or equivalent corticosteroid therapy) for ≥3 months
* Stable asthma, defined as no significant change in the regular asthma medication and no acute asthma exacerbation requiring corticosteroid rescue for at least 3 months before enrollment in the run-in phase. Asthma symptoms must be under good control
* Baseline forced expiratory volume at 1 second (FEV-1) \>= 70% of the predicted normal value.
* Possible participants treated with orthomolecular therapies within the previous year will require a wash out period of 7 days prior to enrolment in the trial. (Vitamin C \> 200mg, Vitamin E \>50IU, Vitamin B12 \> 100µg, Magnesium \> 200mg, Selenium \> 50µg, Omega-3 \> 300mg, Quercetin \> 3mg, Vitamin B6 \> 75mg will all be considered orthomolecular doses).

Exclusion Criteria:

* Known hypersensitivity to any component of the orthomolecular therapy or placebo.
* Acute infectious sinusitis or respiratory tract infection or active lung disease other than allergic asthma within 1 month or any other significant systemic disease within 3 months of the study entry visit.
Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

This study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT)

This is a multi-center, double-blind, randomized, active-controlled study.

Eligibility Criteria:
Inclusion Criteria:

patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection

Exclusion Criteria:

1. patients who have H.pylori eradication history
2. patients with history of gastric cancer surgery
3. patients who have taken antibiotics within 4 weeks prior to trial
4. a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine
5. pregnant or breastfeeding women