cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract

Given the high recurrence of urolithiasis in patients, the search for less aggressive and preventive treatments is increasingly necessary. Renalof® is presented as an alternative to herbal medicine being a product that, due to its diuretic and demineralization properties of kidney stones, has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite stones in a painless in the genitourinary system.

With the objective of determining the efficacy of this therapy, an observational, prospective, randomized, single-blind, two-arm study was carried out: treatment group with Renalof® and control group, placebo.

Given the high recurrence of urolithiasis in patients, the search for less aggressive and preventive treatments is increasingly necessary. Renalof® is presented as an alternative to herbal medicine being a product that, due to its diuretic and demineralization properties of kidney stones, has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite stones in a painless in the genitourinary system.

With the objective of determining the efficacy of this therapy, an observational, prospective, randomized, single-blind, two-arm study was carried out: treatment group with Renalof® and control group, placebo.

The treatment group consists of 120 patients over 18 years of age, of both sexes, with a diagnosis of urolithiasis less than 10 mm in diameter, present throughout the entire reno-uretero-bladder path, diagnosed by ultrasound, renal CT and urography . The Renalof® product was administered at a dose of 650 mg daily for 3 months and the presence of stones in any location of the reno-ureteral tract was evaluated using one of the diagnostic means mentioned in monthly consultations. The second group, treated with placebo corresponding to 35 people constituting 30% of the universe. The study period was from August 2019 to July 2020 at the Hospital Escuela Antonio Lenin Fonseca and the Seniors clinic, in the city of Managua, Nicaragua.

Eligibility Criteria:
Inclusion Criteria:

1. Patient over 18 years of age, in all their mental and physical capacities to decide to be part of this study.
2. There are no comorbidities or associated diseases that put the stability of the patient at risk.
3. Not be diagnosed as Chronic Kidney Disease, in any stage.
4. Existence of non-obstructive stones smaller than 10 mm located in the renoureteral path.
5. No compromise of renal viability.

Exclusion Criteria:

1. Patients under 18 years of age.
2. Existence of comorbidities or associated diseases that put the stability of the patient at risk.
3. Existence of a diagnosis of Chronic Kidney Disease, at any stage.
4. Presence of non-obstructive or obstructive stones greater than 10 mm located in the renoureteral path.
5. Renal viability compromise.
A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients at least 18 years of age with active RA for at least 3 months;
* patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

* major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
* treatment with methotrexate (MTX) within 6 months of entering study;
* patients who have stopped previous MTX treatment due to toxicity or lack of response;
* women who are pregnant or breast-feeding.
Effects Of of Pursed Lip Breathing and Coordinated Breathing in Adult Patients With COPD

COPD is the chronic lung condition characterized by the damage and enlargement of the air sacs in the lungs, leading to breathing difficulties. A blockage may develop, which traps air inside your lungs. The patient shows clinical manifestation of cough, wheezing, chest tightness, shortness of breath. This research of randomized clinical trial will check the combined effects of pursed lip breathing and coordinated breathing techniques to improve aerobic capacity and dyspnea in patients with COPD by taking sample of 54 patients through convenience sampling and randomly allocating them to two groups A and B out of which A will receive pursed lip breathing with aerobic exercise for 4 times per week for 4 week and duration will be 45-60 min, B will receive coordinated breathing with aerobic exercise for 4 times per week for 4 weeks. And duration will be 45-60 min.Pre and post training outcomes of aerobic capacity and dyspnea will be measured through Six minute walk test and dyspnea Borg scale, and Saint George respiratory questionnaire. The data will be analyzed through SPSS 21.


Eligibility Criteria:
Inclusion Criteria:

* Age range 25 -45 years(5)
* Adult patient diagnosed with (chronic obstructive pulmonary disease) based on clinical and diagnostic criteria.
* Patient willing and able to participate in an pursed lip breathing and coordinated breathing exercise program
* Gender both male and female

Exclusion Criteria:

* Those who cognitive impairment that might affect their ability to comprehend and follow instructions
* Any contraindication to the use of pursed lip breathing or coordinated breathing exercise as determined by the health care provider.
* Individual with severe musculoskeletal limitations or other physical condition that may hinder the ability to perform exercise
* Individual who have experienced the recent exacerbation of COPD symptoms within past three month
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Subjects will have been recently diagnosed with untreated melanoma. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female \> 18 years of age.
2. Subject has an untreated primary melanoma.

   OR

   Subject has high suspicion of primary malignancy of melanoma based on skin exam or imaging.
3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
3. Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
5. Less than 5 days between biopsy (other than FNA) of target pathology and blood collection.
6. IV contrast (e.g. CT and MRI) within 1 day \[or 24 hours\] of blood collection.
7. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Ultrasound Liver Intraoperative Imaging With SonoVue®

Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.

This study is a two-stage phase II multicenter study (Simon's two-stage).

Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.

This study is a two-stage phase II multicenter study (Simon's two-stage).

Eligibility Criteria:
Inclusion Criteria:

1. Patient with histological proven colorectal cancer.
2. Operable liver metastases according to preoperative imagery. Operability is the possibility of treatment by resection and/or local destruction (radiofrequency, cryotherapy...).
3. Patient treated or not with preoperative chemotherapy.
4. With or without extra-hepatic metastases
5. Age ≥ 18 years.
6. Radiological assessment by CT and MRI liver and positron emission tomography scan (PETscan) within six weeks before surgery.
7. Patient affiliated to the Social Security system.
8. Signed informed consent.

Exclusion Criteria:

1. Known hypersensitivity to sulfur hexafluoride or another component of SonoVue®.
2. Patients with recent acute coronary syndrome or suffering from unstable ischemic heart disease, especially: evolving myocardial infarction, unstable angina during the last 7 days, recent coronary intervention or another factor suggesting clinical instability, acute heart failure, class III or IV heart failure, severe arrhythmias.
3. Patients with right-to-left shunt, severe pulmonary arterial hypertension, uncontrolled systemic hypertension, as patients suffering from respiratory distress syndrome.
4. Pregnant and lactating women.
5. Patients with contraindication for a CT scan, a MRI or a positron emission tomography (PET) with contrast.
6. Patients with indication of two step liver surgery.
7. Patients already included in the study.
8. Patient who couldn't be treated or followed up according to study criteria for psychological, social, family or geographical reasons. Patient deprived of liberty or under guardianship.
A Deep Learning-based System for the Bowel Preparation Evaluation Before Colonoscopy

Educational interventions provided to patients may improve colon cleansing. The aims of this study were to develop an AI platform which can help patients evaluate the adequacy of bowel cleansing without the aid of caregivers and to investigate whether there was a statistically positive correlation between the Image rating and the BBPS score.

Inadequate bowel preparation can have multiple negative effects on colonoscopy. It has been associated with significantly lower rates of detection of adenomas and advanced adenomas in two meta-analyses. An observational study revealed a threefold higher miss rate for adenomas ≥ 5 mm in size when bowel cleansing was inadequate. Early colorectal cancers might appear as very subtle mucosal lesions. To ensure detection, these lesions require careful and complete mucosal inspection and optimal bowel preparation. Studies in various international populations have found that inadequate cleansing is a factor in approximately 20%-70% of incomplete colonoscopies. A ≥ 90 % minimum standard for adequate bowel preparation has been recommended by the Quality Committee of the European Society of Gastrointestinal Endoscopy (ESGE).

The Boston Bowel Preparation Scale (BBPS) is a rating scale used to evaluate the adequacy of bowel preparation. However ，the adequacy of bowel preparation before colonoscopy has the same significance. In clinical practice, the evaluation of bowel preparation before colonoscopy is mostly performed by the patients themselves. During bowel preparation, patients typically cannot accurately judge bowel readiness after taking laxatives. Many studies showed that educational interventions provided to patients and health care personnel may improve colon cleansing. However, patients often prepare their bowel during non-business hours such as the evening or early morning. Manual guidance during the patient's bowel preparation is not available. The aims of this study were to develop an AI platform which can help patients evaluate the adequacy of bowel cleansing without the aid of caregivers and to investigate whether there was a statistically positive correlation between the Image rating and the BBPS score.

Eligibility Criteria:
Inclusion Criteria:

* People sign an "informed consent form"
* People able to use smartphone to follow the WeChat public account

Exclusion Criteria:

* People who have contraindications for colonoscopy
* People who have known colorectal polyps
* People with history of surgery in any part of the large bowel
* People who refuse to join the study
Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation

The prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. Poor response to the treatments recommended for neuropathic pain, namely antidepressants and/or gabapentinoids, requires the development of new techniques to prevent this chronic pain. Certain well-tolerated techniques, such as the administration of plasma enriched with platelets and fibrin (PRF), are increasingly used in regenerative medicine for their anti-inflammatory and analgesic properties. Thus, a periradicular intraoperative application of PRF may have an analgesic effect on the intensity of residual postsurgical neuropathic pain after disc herniation surgery.

A superiority study, phase III, prospective, single-center, randomized in parallel groups and conducted in a single-blind manner, with evaluation by a blind outcome assessor. Patients will be randomized to one of two treatment groups: Experimental group (surgery and periradicular administration of PRF) or Control group (reference treatment, surgery alone).

Eligibility Criteria:
Inclusion criteria:

* Patient, male or female, \>18 years old at the time of signing informed consent;
* Patient for whom a diagnosis of radiculopathy on lumbar disc herniation has been made, and for whom surgery has been scheduled in the Neurosurgery department;
* Patient affiliated to a social security health insurance scheme;
* Patient able to understand the objectives and risks of research and to give informed, dated and signed consent;
* Patient having been informed of the results of the prior medical examination;
* Women of childbearing age provided that a negative blood pregnancy test is recorded at the inclusion visit and effective contraception used throughout the study.

Exclusion criteria:

* Patient with a history of lumbar spinal surgery (multiple herniated discs, herniated disc other than lumbar);
* Patient with HIV, active cancer, HBV, HCV (verified by interview);
* Patient on long-term systemic corticosteroid therapy;
* Patient with an ASA score \> 3 during the consultation with the anesthesiologist;
* Inability to give the patient informed information (patient in an emergency or life-threatening situation, difficulties in understanding);
* Patient in exclusion period (determined by a previous or ongoing study);
* Subject under safeguard of justice;
* Subject under curatorship;
* Pregnancy;
* Breastfeeding.
Clinical Outcome of Surgical Treatment for Osteochondral Lesions of the Talus

Assess clinical and radiological outcome of the various surgical techniques for treatment of osteochondral lesions of the talus

Osteochondritis dissecans (OCD) of the talus is a subchondral bone pathology that presents as an osteochondral lesion of the talar dome with consequent articular cartilage abnormalities. Osteochondral lesions of the talus (OLT) are frequent after acute ankle trauma. The natural history of the OLT remains unclear due to paucity of longitudinal follow-up studies. Various treatment strategies have been described for OLT, including conservative treatment and operative treatment However, the current literature does not allow firm evidence-based recommendations concerning the treatment to be established ; Microfracture is the most common reparative surgery for osteochondral lesions of the talus (OLTs). While shown to be effective in short- to midterm outcomes, the fibrocartilage that microfracture produces is both biomechanically and biologically inferior to that of native hyaline cartilage and is susceptible to possible deterioration over time following repair . Arthroscopic debridement (AD) for the osteochondral lesions of the talar dome (OLT) was widely documented in the nineties with satisfactory results. However, in modern treatment algorithms, its role is not described. A frequently used instrument for assessing outcome after ankle and hindfoot injuries is the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score .

Eligibility Criteria:
Inclusion Criteria:

* Age from 15 to 60 years old.
* Traumatic and degenerative etiology.
* without ankle deformity.
* No inflammatory arthritis.
* Absent or corrected ligamentous instability

Exclusion Criteria:

* Older than 60 years old and younger than 15 years old.
* Charcot ankle.
* Vascular injury.
Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome

This study is to analyze the indications of the two most popular techniques of distal femoral osteotomy (DFO) performed in patients with valgus malalignment and symptomatic degenerative changes in the lateral compartment of the knee and to evaluate the clinical and radiological outcome of a case series of patients who have received this operation at the Department of Orthopaedics and Traumatology and the Department of Surgery of the University Hospital Basel.


Eligibility Criteria:
Inclusion Criteria:

* patients who received a distal femoral osteotomy (DFO) for valgus knee osteoarthritis between 1.1.2013 and 31.12.2017

Exclusion Criteria:

* Absence of informed consent
* Absence of X-Rays documenting the preoperative deformity or postoperative result
Clinical and Electrophysiological Patterns of Chronic Dysimmune Polyneuropathy

Chronic dysimmune neuropathies (CDN) are a heterogenous group of acquired inflammatory demyelinating neuropathies including chronic inflammatory demyelinating polyneuropathies (CIDP), Lewis-Sumner Syndrome (LSS), multifocal motor neuropathy (MMN) and other rare entities.

Despite their relatively low prevalence, CDN lead to substantial costs for patients and society. CDN are usually misdiagnosed due to progressive nature of the disease with little known data regarding disease activity and treatment response

CIDP is the most common treatable CDN worldwide. Its prevalence is ranging between approximately 1 to 8.9 cases per 100.000 . In addition, there is often the tendency to diagnose CIDP in order to attempt a treatment option. This ultimately leads to overdiagnosis and overtreatment in some patients

Although the different CDN have varying underlying pathophysiology and clinical characteristics, they are all potentially treatable with immunomodulatory drugs.

To date, diagnostic criteria, measurement of disease activity and treatment response of CDN are mainly based on clinical, electrophysiological, and patient related outcome parameters. The commonly used EFNS/PNS diagnostic criteria for CIDP seems to have the best sensitivity among different sets of diagnostic criteria

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, both sexes, history of sensory and/or motor complaint with progressive course over more 2 months

Exclusion Criteria:

* \*Patients with systemic diseases (DM, chronic kidney or liver disease, thyroid disease, vitamin B12 deficiency)

  * Family history of peripheral neuropathy or neurological symptoms suggestive for heredo-familial neurological disorders
  * Patients with infective cause as (HBV, HCV, HIV, leprosy)
  * Toxic and drug induced polyneuropathy (chemotherapeutics, antimicrobial ..
Budesonide Inhalation Suspension for Acute Asthma in Children

The purpose of this study is to determine whether the addition of budesonide inhalation suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone.

Context: Acute asthma is a leading cause of emergency department (ED) visits and hospitalizations. Although standard therapy for acute asthma includes systemic corticosteroids (SCS), these drugs take many hours to have an effect. Recent studies demonstrate that inhaled corticosteroids (ICS) may improve patients' asthma severity more rapidly than SCS and may decrease hospitalizations. Only a few small studies have evaluated ICS added to standard therapy for acute asthma in children.

Objective: To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients' asthma severity faster than standard therapy alone and leads to fewer hospitalizations.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of budesonide inhalation suspension (BIS) versus placebo for children 2 to 18 years of age who present to a tertiary care, urban pediatric ED with a moderate to severe asthma flare.

Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.

Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Chief complaint of "respiratory distress", "asthma", "trouble breathing", or "reactive airway disease"
* Males or females age 2 to 18 years
* Weight greater than or equal to 10 kilograms
* Two or more prior Emergency Department or primary care visits for asthma or reactive airway disease
* Identified in triage as either "acute" or "critical"
* Asthma score of 8 or greater
* Systemic corticosteroid prescribed in the Emergency Department
* English-speaking parent/guardian present
* Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

* Systemic corticosteroid use in the last 30 days
* Chronic lung diseases including cystic fibrosis
* Sickle cell anemia
* Immunodeficiency
* Cardiac disease requiring surgery or medications
* Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
* Known renal or hepatic dysfunction
* Exposure to varicella in the last 21 days
* Impending respiratory failure requiring positive pressure ventilation
* Altered level of consciousness
* Suspected foreign body aspiration or croup
* Prior enrollment in the study