cyrilzakka/clinical-trials huggingface dataset:
Pneumatic Dilatation or Surgical Myotomy for Achalasia

Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

During follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures.

Health Related Quality of Life (HRQL) has been regularly checked.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed achalasia
* Age 18-80 years
* Informed consent

Exclusion Criteria:

* Previous treatment for achalasia.
* Stage IV achalasia.
* Unwillingness to participate.
Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions

Advancements in imaging capacities and the development of a precise puncture-guiding transducer have made transthoracic ultrasonography a useful diagnostic tool for evaluating peripheral subpleural lung tumours. Different human tissues have varying levels of elasticity because of the properties of the extracellular matrix.

Pleural two-dimensional (2D) shear-wave elastography (SWE) can be used to differentiate between malignant pleural effusion and benign pleural disease.

Transthoracic 2D-SWE uses acoustic radiation force and assesses the velocity of tissue displacement propagation in multiple focal zones. The shear waves are monitored in 2D by creating a near-cylindrical shear-wave cone, enabling measurement of the shear-wave speed or Young's modulus (E) on a colour quantitative elastogram. Based on the hypothesis that transthoracic 2D-SWE could add accurate tissue stiffness information to B-mode grayscale ultrasound images and help in differentiating lung malignancy from benign lung lesions.

B-mode grayscale images will be used by ultrasound to assess peripheral lung lesions. Information including size, location, and intercostal chest wall thickness will be collected. Then, Investigators will use transthoracic 2D-SWE to assess those lesions.

Investigators intend to use regions of interest (ROIs) with 3-mm diameter, and select up to four ROIs with the highest mean elasticity values. the average as the final value will be calculated. If patients had multiple sub-pleural lung lesions, the largest and the most approachable one will be chosen to perform 2D-SWE. Final diagnosis will be made via appropriate diagnostic modalities including computed tomography of chest, microbiological results and guided biopsies if indicated.

Eligibility Criteria:
Inclusion Criteria:

* Radiographic evidence of pulmonary lesions

Exclusion Criteria:

* Patients less than 18 years.
* Patients refusing to participate in the study.
* Inability to hold breath for at least 5 s.
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)

This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other corticosteroids. During the study, patients had their corticosteroid dose gradually reduced if they responded to treatment. The anticipated time on study treatment was 12 months, and the target sample size was \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 to 70 years of age
* Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids

Exclusion Criteria:

* Female patients who are pregnant, breastfeeding, or lactating
* Regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 8 weeks prior to randomization
* CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks total duration and within 8 weeks prior to randomization
* Use of PV therapies other than those noted above, within 4 weeks prior to randomization
* Use of topical corticosteroids within 2 weeks prior to randomization
Changing Diabetes in Children

This study is conducted in Asia. The primary objective of the CDiC programme is to improve access to comprehensive diabetes care among the children with diabetes from the economically underprivileged section of the population and to establish a registry for this group of children with type 1 diabetes in India.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with type 1 diabetes
* Parents/caretakers agree to participate in the study
* Child belongs to the below poverty line economic strata (Centre Director certifies economic status for inclusion in to the study)

Exclusion Criteria:

* Children with type 2 diabetes
* Children from higher economic status
* Those getting coverage under other government / private schemes
Survey of Postoperative Pain and Pain Management in Norwegian Hospitals

The study is a national survey of pain and pain management to surgical patients in Norwegian Hospitals. Data on pain management are gathered from patient records and data on pain and patient satisfaction are gathered as patients' self report.


Eligibility Criteria:
Inclusion Criteria:

* Surgery previous day

Exclusion Criteria:

* Declined participation
* Unable to communicate (delirious, sedated, intubated)
* Does not read and speak Norwegian
* Patient not available (for instance having physiotherapy og examinations during data collection)
A Trial Comparing Docetaxel Plus Fulvestrant With Docetaxel in Metastatic Breast Cancer

Comparing Docetaxel Plus Fulvestrant With Docetaxel in Patients With Metastatic Breast Cancer

Comparing Docetaxel Plus Fulvestrant With Docetaxel in Postmenopausal, Hormone-receptor Positive and HER2-negative Metastatic Breast Cancer

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female between 18 and 70 years old
* ECOG performance status of ≤ 1
* Life expectancy more than 3 months
* Histologically confirmed metastatic breast cancer
* ER and\&or PR pqositive, HER2-negative
* Disease progression during adjuvant or first-line endocrine therapy, or endocrine naive but unsuitable for endocrine therapy alone
* No pretreated chemotherapy for metastatic disease
* Have at least one target lesion according to RECIST 1.1
* No therapy (chemotherapy, endocrine therapy, target therapy and operation) within 4 weeks before enrollment
* Hemoglobin ≥ 90 g/L, Absolute Neutrophil Count ≥ 1.5×10\^9/L, Platelet Count ≥ 75×10\^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 1.5×ULN, Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance\>50ml/min

Exclusion Criteria:

* Pregnant or lactating women
* Evidence of CNS metastasis
* Seriously uncontrolled infection
* History of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pretreated with Fulvestrant
* Pretreated with two or more lines of endocrine therapy
Institutional Registry of Liver Transplantation

The Institutional Registry of Liver Transplantation is a system for data collection related to patients with liver disease who are possible candidates for liver transplantion. This tool was designed by a multidisciplinary team that includes hepatologists, surgeons, informatics and biostatisticians. It intends to collect the information from the clinical evaluation, physical examination, complementary diagnostic methods and laboratory data. The information is captured sistematically, following structured, standardized and monitored processess to ensure the quality of the data obtained.

The aim is to use the available technology to generate a complete database that can be used to answer research questions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for liver transplantation
* Patients who are followed by the Liver Transplantation Unit of Hospital El Cruce

Exclusion Criteria:

* Patients who deny to participate after the informed consent process.
InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention

Inadequate medication adherence (MA) in chronic conditions, including cardiovascular prevention, represents an important risk factor. The use of new IT technologies in this setting is supposed to be useful to improve patients' adherence, but currently available solutions have significant limitations, including lack of personalization and reliance on expensive ad hoc systems.

This interdisciplinary project aims to verify the hypothesis that in patients on chronic antihypertensive treatment MA can be improved through the implementation of a novel digital health solution for MA monitoring and support, based on inexpensive and user-friendly, commercially available technology (voice assistant), connected with web interface for the physician. The intervention will be personalized based on the creation of Personas, intended as multidisciplinary-based representations of different user types. This approach will be tested in a randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years old) patients
* History of essential hypertension
* Treatment with at least one antihypertensive drug for which dedicated plasma essay is available
* wireless internet connection available at patients' home
* stable clinical conditions
* written informed consent

Exclusion Criteria:

* insufficient technological literacy to manage vocal assistant
* dementia or significant psychiatric disorders
* conditions significantly limiting vocal communication (deafness, significant speech disorders, poor knowledge of Italian language)
* pregnancy or breastfeeding
* active cancer (except basal cell skin carcinoma)
* upper limb amputation
Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease

This study is to evaluate the safety and efficacy of radiofrequency energy procedure for Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis grade, esophageal acid exposure and lower esophageal sphincter pressure. Symptom assessment was performed at baseline and 3, 6, 12 months after treatment.

Gastroesophageal reflux disease (GERD) is a chronic disease characterized by symptoms of heartburn and acid regurgitation. Uncontrolled GERD can significantly impact quality of life. The use of proton pump inhibitors (PPI) remains the mainstay therapy. However, the efficacy of this intervention is often hampered by adherence, costs, and the risks of long-term PPI use. Anti-reflux surgery is an option for patients with refractory symptoms or in those in whom medical therapy is contraindicated or not desirable, but the incidence of dysphagia, abdominal distension associated wth the surgery is high. Radiofrequency ablation, minimally invasive, less complications, has become alternative treatments options. But the current research on radiofrequency treatment of the data is limited in China. Therefore, the investigators conduct this multi-center clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* diagnosis of GERD established by either

  * 24-h oesophageal pH monitoring (performed off medications) showing an abnormal OAE (pH \< 4 at least 4% of time) and/or
  * an upper gastrointestinal (GI) endoscopy showing oesophagitis grade A or B in Los Angeles (LA) classification
* presence of typical symptoms of GERD (heartburn and ⁄or regurgitation with at least three episodes of typical symptoms per week in the absence of PPI therapy),
* adequate symptom relief obtained with PPIs,but needing maintenance with at least standard dose.

Exclusion Criteria:

* presence of Barrett's oesophagus \>3 cm and ⁄or with dysplasia and ⁄or previously treated,
* presence of hiatus hernia \>3 cm,
* presence of oesophagitis grade C or D in LA classification,
* presence of oesophageal stricture or achalasia,
* history of oesophageal or gastric surgery,
* presence of gastric or oesophageal varices,
* impossibility to stop an anticoagulant therapy or severe coagulopathy,
* any contraindication to general anaesthesia.
Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment

Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a night cream

Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the activity of a "revitalizing" face treatment consisting of a day and a night cream, applied for an uninterrupted period of 3 months, by female volunteers, aged 35-60 years, with aging/photo aging of moderate grade.

Eligibility Criteria:
Inclusion Criteria:

* female sex,
* age 35-60 years,
* Caucasian subjects,
* presence of moderate face ritidosis,
* agreeing to present at each study visit without make-up,
* accepting to follow the instructions received by the investigator,
* accepting to not change their habits regarding food, physical activity, face cleansing and make- up use,
* agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and skin qualities during the entire duration of the study,
* accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,
* no participation in a similar study currently or during the previous 3 months
* accepting to sign the Informed consent form.

Exclusion Criteria:

* Pregnancy,
* lactation,
* sensitivity to the test products or their ingredients (to be assessed by the investigator during the baseline visit),
* subjects whose insufficient adhesion to the study protocol is foreseeable.
* presence of cutaneous disease on the tested area as lesions, scars, malformations,
* recurrent facial/labial herpes,
* clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
* endocrine disease,
* hepatic disorder,
* renal disorder,
* cardiac disorder,
* pulmonary disease,
* cancer,
* neurological or psychological disease,
* inflammatory/immunosuppressive disease,
* drug allergy.
* anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago),
* using of drugs or dietary supplements able to influence the test results in the investigator opinion.
Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients

Rationale: It is well known that insulin resistance occurs after mediocre and intensive surgery, such as colon cancer surgery. Disturbances in insulin action negatively affect the postoperative recovery, either by prolonging the capacity of the body to regain normal function, or by increasing the metabolic stress and the risk for complications. Several studies have shown that focusing therapies on improving insulin resistance is successful. Experimental studies have shown that antioxidant agents, like glutamine (a precursor of glutathione), improve insulin sensitivity. The hypothesis of this study is that perioperative parenteral or enteral administration of glutamine, given as the dipeptide alanyl-glutamine, will reduce or prevent postoperative insulin resistance in colon cancer patients. The study will also be focused on the different routes of administration, because of the expected differential metabolic effects.

Objective: The investigators' primary objective is to study whether intravenous or enteral administration of the dipeptide alanyl-glutamine will reduce or prevent postoperative insulin resistance in colon cancer patients.

Study design: A double-blinded, placebo controlled randomised, pilot study at the Surgery Department of the Medical Center Alkmaar.

Study population: Thirty patients of male gender and any ethnicity, who will undergo elective open abdominal colon surgery for colon cancer, aged 18-75 years.

Intervention: Patients will receive dipeptide alanyl-glutamine intravenously or enterally, starting 24 hours prior to surgery, until 24 hours after surgery in the dosage of 0.5 g/kg/day, or saline (control group), for the same period of time.

Main study parameters/endpoints: The main study parameter is postoperative insulin resistance. Secondary study parameters are lipolysis, oxidative stress and glucoregulatory hormones. Muscle, liver and fat biopsies will be taken to study insulin sensitive as well as inflammatory pathways.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Colon cancer patients scheduled for elective open abdominal surgery
* Capable of giving informed consent

Exclusion Criteria:

* Patients who are participating in another clinical trial
* Unable to receive oral intake
* Major malabsorption disorder of the gut
* Patients with diabetes mellitus
* BMI above 30 kg/m2
* Use of certain medication: thyroid medication, corticosteroids, diuretic medication
* Known bleeding disorders or increased PTT and or APTT
* Any medical condition except for colon cancer
Assessment of Efficacy and Safety of Therapy With COVID-19 Convalescent Plasma in Subjects With Severe COVID-19 (IPCO)

This phase 2b clinical study will enroll adult subjects of both sexes with ARDS due to COVID-19 necessitating invasive mechanical ventilation.

The primary objective of the study is the assessment of impact of immune therapy with COVID-19 convalescent plasma on severity of COVID-19.

The secondary objectives is the Impact of immune therapy with COVID-19 convalescent plasma on markers for ARDS due to severe COVID-19 infection; short-term all-cause mortality; time course of ARDS due to severe COVID-19 and assessment of safety and tolerability of immune therapy with COVID-19 convalescent plasma.

As a primary endpoint/variable we will assess change in SOFA score from Baseline Visit to Day 8.

The study design will be prospective, open-label, randomized, controlled and parallel-grouped.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject aged ≥18 years.
2. Estimated BMI ≥19kg/m² to ≤40kg/m².
3. Florid1 SARS-CoV-2 infection confirmed by RT-PCR in tracheo-bronchial secretion sample or pharyngeal swab sample.
4. ARDS with Horovitz index \<300mmHg.
5. Necessity of invasive mechanical ventilation.
6. Written informed consent obtained from the subject's legal representative or under such arrangement as is legally acceptable in Germany (
7. Subject's assent if obtainable

Exclusion Criteria:

1. Previous exposure to COVID-19 convalescent plasma.
2. Adverse reaction to plasma proteins in medical history.
3. Interval \>72h since endotracheal intubation.
4. Current or imminent necessity of ECMO treatment.
5. Pre-existing COPD GOLD stage 4.
6. Chronic congestive heart failure NYHA ≥3.
7. Pre-existing left ventricular ejection fraction \<30%.
A Study of Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids

This is a randomized, double-blind, placebo-controlled study to evaluate the effects of lebrikizumab in patients with asthma who remain inadequately controlled while on chronic therapy with inhaled corticosteroids (ICS).


Eligibility Criteria:
Inclusion Criteria:

* Body weight 40 kg--150 kg
* Chest radiograph with no evidence of clinically significant abnormality
* Uncontrolled asthma

Exclusion Criteria:

* Asthma exacerbation during screening
* Known malignancy
* Known immunodeficiency
* Pre-existing lung disease other than asthma
* Uncontrolled clinically significant medical disease
* Current smoker
* History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator
* Prior allergic reaction to a monoclonal antibody
* Patients (men and women) of reproductive potential who are not willing to use contraception
* Pregnancy
Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

This is an open-label, mono-center phase I/II study designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer. Additionally, the study is designed to characterize the safety, the tolerability and efficacy of this study.

During the phase I part the study will include at least 3 patients at each dose-level until MTD is reached. Each cohort will consist of newly enrolled patients. Intra-patient dose escalation is not permitted. Once MTD is reached a total of 6 patients will be treated at MTD (phase I). For the phase II the minimax two-stage design will be applied. After testing the drug on 16 patients in the first stage of phase II, the trial will be terminated if 1 or fewer respond (SD, PR, CR). If the trial goes on to the second stage, a total of 34 patients will be studied during the phase II part.

Eligibility Criteria:
Inclusion Criteria:

* adult female patients
* at least two prior chemotherapies due to metastatic or inoperable breast cancer
* Karnofsky performance status of at least 60%
* pretreatment with at least one taxane and one anthracycline

Exclusion Criteria:

* previous treatment with mTOR-inhibitors, carboplatin, cisplatin or oxaliplatin
* inadequate organ function including bone marrow function
* bleeding tumours
* known uncontrolled metastases in CNS or carcinomatous meningosis
* patients who have been treated during the last five days with inhibitors or inducers of CYP3A
* serious pulmonary, neurological, endocrinological or other disorders interfering with this study medication, especially patients with known lung fibrosis, emphysema or severe COPD
Improved Diagnostics of Celiac Disease in Children

The main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. Further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large scientific database.

Prevalence of celiac disease is on a steep rise in Western countries, but due to difficult diagnosis the majority of patients remain unrecognized. Undiagnosed celiac disease causes incremental burden to the health care and predisposes to severe complications. On the other hand, increasing screening in at-risk groups of celiac disease frequently detects seropositive subjects with no obvious symptoms and/or still normal small-bowel mucosal morphology. At present the natural history and benefits of an early diagnosis in such individuals is poorly known. Further, the endoscopic demonstration of the small-intestinal damage required for the diagnosis is unpleasant, expensive and often misleading. New serology-based diagnostic criteria have been suggested but prospective data is lacking. Aims of the present study are to improve the diagnostic yield and accuracy of the current diagnostic methods and to develop novel non-invasive methods and biomarkers for early detection of celiac disease. In addition, the investigators will evaluate natural history of celiac disease in screening-detected asymptomatic children and in those with positive serology but normal histology, and form a large database for future clinical and translational studies. The study and patient collection are to be conducted at the pediatric clinics in Finland and in Romania. All children referred due to suspicion of celiac disease or gluten sensitivity will be asked to participate to the study. Patient samples and clinical information are collected during the routine visits and the study does not include any additional visits or endoscopies. The total duration of the study is 10 years but data will be analyzed on-line.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of celiac disease or gluten sensitivity
* Age below 18 years

Exclusion Criteria:

* Study refusal
* Age 18 years or more