cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension

Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. However this single non-randomized study requires confirmation.

The investigators propose a prospective multi-center, randomized, single-blinded trial. Its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment following a simulated (sham) procedure.

The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right heart catheterization.

The study will run for 18 months and it will be necessary to recruit 50 patients.

All adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria.

The investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary artery hypertension (group 1 of the Nice classification of pulmonary hypertension)

  * Aged over 18 years old
  * NYHA class III or IV
  * Not controlled by optimal medical management as defined by:

    * dual therapy including a prostacyclin.
    * or dual therapy including an endothelin receptor antagonist and a
  * 5-phosphodiesterase inhibitors, in patients with contra-indication of prostacyclin, poor tolerance to this treatment, prostacyclin derivative treatment failure or patient refusal.
  * Valid status in the social security system
  * Signed informed consent

Exclusion Criteria:

* Patient eligible for pulmonary transplantation
* Pregnancy or breastfeeding
* Adults of the age of majority subject to guardianship court order or deprived of liberty
* Patient with history of radio frequency procedure
* Known heparin allergy
Non Surgical Treatment (Microwave Ablation) of Breast Cancer

In the Netherlands approximately one out of seven women will develop breast cancer during her life. Most of these breast cancers are early stage, 40% of the women have stage 1. Stage 1 breast cancer means that the cancer is small (size \<2cm) and only in the breast tissue or it might be found in lymph nodes close to the breast. The standard treatment for stage 1 breast cancer is breast conserving surgery (BCS), sentinel lymph node procedure (SLNP) and additional radiotherapy. This standard treatment protocol results in a10 years survival rate of 95% for stage 1 disease. However, nowadays there is a discussion whether these early stage breast cancer could be treated less invasively. To reduce the invasiveness of breast cancer treatment, without compromising breast cancer specific survival, minimally invasive ablation procedure of the breast tumor can be an option for small breast lesions.

Patients with a tumor size\<2 cm will undergo ultra guided microwave ablation (MWA) with local anesthesia. After a small incision 2-3 millimeters, an MWA electrode is placed at the end of the tumor with ultrasound guidance. The microwaves in MWA create heat around the needle and destroy the cancer cells. There are several advantages of ablation procedures: it is a minimal invasive technique, with a small or absent cutaneous scar and thereby potentially improving patient quality of life. Furthermore, ablative treatment can be done under local anesthesia and/or conscious sedation instead of general anesthesia and in daycare setting, which can reduce treatment cost. A post procedural MRI (after ablation) can determine whether the ablation procedure of the tumor volume is complete. The purpose of this study is to assess whether minimally invasive microwave ablation (MWA) followed by postprocedural MRI scan can be an alternative treatment for breast surgery in early stage breast cancer. Is the quality of life, the cosmetic outcome, fear of breast cancer recurrence, and costs in patient treated with MWA comparable or better compared to patients treated with breast surgery?


Eligibility Criteria:
Inclusion Criteria:

* age should be 18 years and older
* a solid non-lobular invasive breast tumor with a size \<2cm based upon ultrasound and MRI measurements
* without mammographic or MRI evidence of extensive disease
* no involved lymph nodes on ultrasound and MRI scan.

Exclusion Criteria:

* more than one breast tumor,
* (lymph node) metastases
* breast implants
* indication for neoadjuvant chemotherapy.
* pacemaker,
* pregnant
* breastfeeding
THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS

Head and neck cancer corresponds to tumors located in the upper aerodigestive tract, such as the oral cavity, pharynx and larynx. The most effective treatment consists of high dose of cisplatin chemotherapy and radiotherapy, however, their use is limited due to toxicities caused mainly by oxidative stress. The objective of this study will be evaluate the use of n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and neck cancer patients. This is a randomized double-blind placebo-controlled clinical trial with consecutive sampling that will be conducted at Oncology Department of Clinic Hospital / University of Campinas (UNICAMP). Head and neck cancer patients who will begin cisplatin antineoplastic treatment (80-100mg/m2 on days 1, 22 and 43) and concurrent radiotherapy will be included in this research. They will be studied in 2 groups (n-acetylcysteine and placebo). All patients will be evaluated in relation to cisplatin induced hematologic and gastrointestinal disorders, nephrotoxicity, ototoxicity, and hepatotoxicity; plasmatic and cellular oxidative stress; quality of life; and pharmacoeconomic evaluation. Results will be statistically analysed using Chi-square, Fisher, Mann-Whitney, and ANOVA for repeated measures tests (p\<0.05.)


Eligibility Criteria:
Inclusion Criteria:

* head and neck cancer
* anticancer treatment - cisplatin (80 to 100 mg/m²) plus radiotherapy
* patients without previous treatment of head and neck cancer (surgery, chemotherapy and radiotherapy)

Exclusion Criteria:

* severe psychiatric diseases
* impossibility of verbal communication
* without caregivers or companions
A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis

This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document must be signed and dated by the subject
* Male or female, 18 to 65 years of age
* Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg;
* Presumed NASH based on clinical characteristics or prior liver biopsy
* MRI PDFF liver fat content ≥ 10 %

Exclusion Criteria:

* previous diagnosis of other forms of chronic liver disease
* Laboratory Screening Results:

  * AST \> 5 x ULN
  * ALP \> 3 x ULN
  * Total bilirubin \> 1.5 x ULN
  * Albumin \< 3.2 g/dL
  * INR \> 1.3
  * Platelet count \< 100,000 /mm3
  * creatinine clearance \<60 ml/min (based on Cockroft Gault method)
* previous exposure to OCA
* uncontrolled diabetes mellitus
* presence of cirrhosis
* patients with contraindications to MRI imaging
Tolerance and Efficacy of a Predigested, High Protein, High Omega 3 Fat Enteral Feeding Formula Versus a Standard Formula In Multiple Intensive Care Unit Settings

The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post surgical patients in the intensive care unit (ICU). If enough patients are recruited, inferences about impact on outcomes may also be drawn.


Eligibility Criteria:
Inclusion Criteria:

* Subject requires enteral tube feeding as sole source of nourishment
* Subject, or subject's legally acceptable representative (LAR), has provided voluntarily and informed consent form, as deemed appropriate and approved by the Columbia University Medical Center Institutional Review Board
* Subject is ≥ 18 years of age
* Subject is male or non-pregnant female at least six weeks postpartum and non-lactating females of childbearing potential will be required to confirm non-pregnancy status with a pregnancy test at screening
* Subject has an initial APACHE II score less than or equal to 24

Exclusion Criteria:

* Subject requires parenteral nutrition
* Subject is acutely impacted or constipated
* Subject has intestinal obstruction
* Subject is too hemodynamically unstable for enteral feeding
* Subject has an allergy or intolerance to any ingredient in the study product by documentation or verbal report by subject or subject's LAR
* Subject is participating in a non-Abbott approved concomitant trial
* Subject has gastrointestinal disease, including acute pancreatitis, active gastrointestinal bleeding, acute inflammatory bowel disease, or has undergone intestinal surgery within the past month
Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism

This study sought to evaluate an innovative post-acute continuation/transition planning treatment strategy that leveraged an in-person intensive treatment followed by online, videoconferencing-based "booster" sessions for youth with selective mutism (SM). Twenty children between the ages of 4 and 10 and their caregivers were scheduled to participate in an in-person intensive group behavioral treatment (IGBT) for SM and subsequently randomized to receive either (a) six, biweekly, hour-long, videoconferencing-delivered booster sessions or (b) no additional treatment for 12 weeks. Due to COVID-19-related physical distancing restrictions, the study team was unable to provide in-person services. Thus, the clinical trial was converted to an open-trial design focused on evaluating remote treatment options (i.e., remotely delivered caregiver training sessions and/or a remotely delivered IGBT) for these families. All families retained in the study have or will participate(d) in assessments at the following time points: Intake (i.e., 4-5 months prior to the remote IGBT); Baseline (i.e., 1 month prior to the IGBT), Post-IGBT (i.e., 2 weeks following the IGBT), and School Year Follow Up (i.e., 16 weeks following the IGBT).


Eligibility Criteria:
Inclusion Criteria:

* Child between the ages of 4-10 years, and his or her caregiver(s)
* Child meets DSM-5 criteria for selective mutism diagnosis
* Child speaks English fluently

Exclusion Criteria:

* Child is identified as having any psychiatric condition significantly more impairing than selective mutism that requires alternate treatment
* The child is nonverbal with all caregivers
Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure

The hypothesis is that Nasal High Flow therapy for patients with Hypercapnic Acute Respiratory Failure without acidosis, in addition to standard treatment would improve the care.

The aim of the PIRAHNA study is to compare patients treated with Nasal High Flow in association with conventional standard treatment versus patients treated only with conventional standard treatment.

Primary objective : To demonstrate the therapeutic superiority of Nasal High Flow in hypercapnic Acute Respiratory Failure without acidosis, in combination with conventional standard treatment

Secondary objectives :

1. Identify the characteristics (etiologies) of responder patients (defined by a decrease in capnia and a failure to develop acidosis within two weeks of hospitalization)
2. Identify the etiology (trigger) of the Acute Respiratory Failure of responder patients
3. Compare the evolution of respiratory rate between the two treatment groups
4. Compare the evolution of dyspnea between the two treatment groups
5. Compare the evolution of gas exchanges between the two treatment groups
6. Compare the length of stay between the two groups
7. Compare the evolution of patients comfort state in the two treatment groups

Eligibility Criteria:
Inclusion Criteria:

* Major patient ≥ 18 years old
* Medical diagnosis of Acute Respiratory Failure less than 48 hours
* With partial pressure of carbon dioxide (PaCO2) \> 45 and pH \> 7.35 for less than 48 hours, with no indication of Non-Invasive Ventilation (NIV) placement
* Underlying terrain of known or unknown chronic respiratory pathology (may be unknown at time of diagnosis) Examples : COPD, Bronchiectasis, Pulmonary fibrosis, asthma, sequelae pathologies ...
* All etiologies (infectious, cardiac decompensation, trauma, etc.)
* Having given informed consent
* Patient under a social security scheme
* Possibility to include a patient having already been included in the study but suffering from a new episode of hypercapnic non acidic Acute Respiratory Failure

Exclusion Criteria:

* Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies
* Drug-induced Acute respiratory failure
* Pneumothorax (X-ray pulmonary detachment)
* Oxygen poisoning
* Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COVII) Pneumonia
* Tracheostomy
* Prior treatment with chronic or initiated NIV just prior to treatment (e.g. Intensive Care Unit)
* Respiratory Severity Criteria for Resuscitation Management
* Agitation or non-cooperation
* Pregnancy or breastfeeding
* Person participating in other biomedical research
* Any other reason that the investigator believes may interfere with the evaluation of the study objectives
* Person under judicial protection (guardianship, curatorship)
* Person deprived of liberty by a judicial or administrative decision
Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these treatments before surgery may kill more tumor cells in patients with non-small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or stage IIIA non-small cell lung cancer.

OBJECTIVES:

* Determine the response rate, duration of response, and survival in patients with bulky stage IIB or stage IIIA non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection.
* Assess the toxicity of this regimen in this patient population.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 5 weeks. Patients also undergo concurrent radiotherapy daily 5 days a week for 5 weeks in the absence of unacceptable toxicity. At approximately 4 weeks after completion of chemoradiotherapy, patients with stable or regressive disease undergo surgical resection. If disease is unresectable, patients receive an additional 2 weeks of radiotherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 29-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed bulky stage IIB or stage IIIA non-small cell lung cancer

  * Ipsilateral mediastinal node involvement by mediastinoscopy
* No contralateral lymph node involvement
* No malignant pleural effusion
* No distant metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic:

* ALT/AST less than 2 times upper limit of normal
* Bilirubin no greater than 1.5 mg/dL

Renal:

* Creatinine no greater than 2.0 mg/dL

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy

Surgery:

* See Disease Characteristics
Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke

The aim of this study is to investigate the most effective stimulation site in transcranial direct current stimulation for gait recovery after stroke. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) bihemispheric stimulation - anodal stimulation on both ipsilesional and contralesional leg area of primary motor cortex and supplementary motor area. 2) ipsilesional stimulation - anodal stimulation on ipsilesional leg area of primary motor cortex and supplementary motor area. 3) contralesional stimulation - anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area. 4) sham stimulation. Subjects will walk on treadmill for 10 minutes during transcranial direct current stimulation. Motor evoked potential and functional evaluations will be done before and after stimulation to measure the changes.


Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke patients with 6 months after onset.
* Functional ambulation category ≥ 3

Exclusion Criteria:

* patients who needs assist in surface level walking
* patients with mini mental status exam score under 9
* patients with implantable electronic device
* metal device inside skull
* history of epilepsy
* pregnancy
Reliability of a Food Frequency Questionnaire in the Assessment of Dietary Intake Including FODMAPs in Different Populations, and Relationship with IBS Symptoms and the Degree of Self-assessed Physical Activity

During an online assessment participants will fill in questionnaires evaluating demographic data, psychological variables, the degree of self-assessed physical activity and symptoms of irritable bowel. Dietary intake will be assessed by a newly developed food frequency questionnaire (FFQ) and a 4 days food diary. In order to validate the FFQ in different populations, participants will be recruited from university students, staff of UZ Brussel and VUB, and from the community by advertisement (including social media). IBS patients will be recruited from the gastro-enterology outpatient clinic.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years;
* Provide written informed consent;
* Living in Belgium

Exclusion Criteria:

* Diet \< 8 weeks prior to participation;
* Known or suspected eating disorder;
* Major psychiatric disorder;
* Known gastro-intestinal disease (IBS is allowed);
* Any malignancy in the past 3 years (basocellular carcinoma is allowed);
* Chemotherapy in the past 6 months;
* Infectious gastro-enteritis in the past 6 months (infectious gastro-enteritis defined as the concurrent presence of one of the following signs during 2 or more consecutive days: fever, vomiting, sudden onset of diarrhea, hospitalization because of these symptoms);
* Previous abdominal surgery (appendectomy and cholecystectomy are allowed);
* Alcohol abuse defined as \> 14 U per week;
* Use of illicit drugs;
* Intake of drugs with known major gastro-intestinal side effects.
* Initiation of neuromodulators less than 3 months before participation. Neuromodulators are allowed when taken at a stable dose for at least 3 months;
* Pregnancy.
Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR Methods

Experimental study without drug and device, on pseudo-anonymized samples archived at the Tropica Biobank.

The objective is to evaluate the performance for the identification of microorganisms in blood samples and rectal swabs of real time PCR assays for the targets: KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR.

The evaluations will be carried out taking into consideration the data obtained from the diagnostic routine at the DITM.


Eligibility Criteria:
Inclusion criteria:

* Samples of patients for whom blood culture and Multi Drug Resistant (MDR) surveillance tests were carried out in rectal swabs at the IRCCS Sacro Cuore Don Calabria Hospital
* Samples for which the Information and consent to the conservation of biological samples for research purposes at the Tropica Biobank has been signed

Exclusion criteria:

* Absence of data relating to positivity or negativity to the germs of interest
* Absence of stored residual material
* Absence of information and consent to the conservation of biological samples for signed research purposes