cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction

Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)

Completer from parent study(DA8159_EDD_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 20 years or more diagnosed with erectile dysfunction(ED)

Exclusion Criteria:

* Had uncontrolled blood pressure
* Had hepatic or renal dysfunction
* Had significant psychiatric disorders or drug abuses
* Was currently under anticancer chemotherapy
* Had a treatments for ED using other phosphodiesterase type 5(PDE-5) inhibitors
Multimodal Long Covid19

Due to the COVID-19 pandemic, the world has seen the need to identify groups of patients who experience various effects in the medium and long term after recovering from the initial illness. These medium- and long-term effects are collectively known as the post-COVID-19 condition, Long-COVID, or prolonged COVID. Current evidence indicates, with conservative estimates, that between 10% and 20% of the population could be affected. Its nature is varied and ranges from physical conditions such as chronic fatigue, dyspnea and muscle weakness, to neurocognitive (compromised memory, decreased concentration) and psychological (anxiety, depression, anguish, stress). Early recognition and treatment of this symptom burden is essential for physical recovery and mental health. Due to its multivariate nature, it has been suggested that optimal recovery of patients' quality of life would only be achieved to the extent that their main symptoms are addressed from an interdisciplinary perspective.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria will be: Adults between 40 and 80 years of age. Individuals will be included if they have had a positive polymerase chain reaction (PCR) test diagnosis of SARS-CoV-2 virus, presence of dyspnea and/or fatigue greater than 3 months after COVID-19 diagnosis, at least 1 point higher on the modified Medical Research Council Scale (mMRC) compared to the period before infection. All participants must have no contraindications to perform the exercise and training tests and must be able to read, understand and sign the information and consent form.

Exclusion Criteria:

Individuals with one of the exclusion criteria will not be eligible for our research project these are: pulmonary embolism; absolute and relative contraindication to cardiopulmonary stress testing or physical training; severe exercise intolerance, significant cardiac arrhythmias or ischemia during low intensity exercise, severe pulmonary hypertension; severe pulmonary disease (e.g.: chronic obstructive pulmonary disease, severe COVID-19 related symptoms, severe asthma); recent cardiovascular event (cardiac decompensation, angioplasty or cardiac surgery less than 4 weeks old, valvular heart disease requiring surgical correction, pericarditis, ventricular rhythm disturbances and unstable despite treatment); renal failure requiring dialysis; Heart failure (NYHA III or IV).
Ultrathin Bronchoscopy for Solitary Pulmonary Nodules

The evaluation of solitary pulmonary nodules (SPN) requires a balance between procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis is endemic. Data on ultrathin bronchoscopy (UB) for this purpose is limited. In this prospective randomised trial we compared diagnostic yield and adverse events of UB with standard-size bronchoscopy (SB) in a cohort of patients with SPN located beyond the visible range of SB.

The present prospective single-centre randomised pilot study was performed at Tygerberg Academic Hospital, a tertiary university hospital in Cape Town, South Africa, with a referral drainage area of 1.5 million people and tuberculosis notification rate of up to 1'000/100'000 persons per year when the study was performed. Between November 2000 and November 2003 all patients referred to the lung unit with single pulmonary lesion ≤ 6 cm in diameter on chest computed tomography (CT) were included. SPN was defined as a single and circumscribed pulmonary lesion with a diameter ≤ 6.0 cm, surrounded by aerated lung tissue, and without evidence of atelectasis, pneumonitis, or cavity on CT scan. Location and maximal diameter of all SPNs were recorded from the chest CT prior to enrolment of patients. Inclusion criteria were a previous cytological and microbiological negative sputum examination, absence of enlarged mediastinal or hilar lymph nodes on chest CT scan, and informed consent obtained before start of the procedure. Exclusion criteria were SPN with lesion size unchanged over two years, inability to undergo bronchoscopy or thoracotomy, and pregnancy. Participants with consent for participation in the study in whom the lesion was found to be visible on SB were then not randomised and not considered part of the study population. Written informed consent was obtained from all patients before inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary nodule on a recent CT
* non-visible on standard-size bronchoscopy

Exclusion Criteria:

* missing informed consent
Effect of Modified Kinesio Taping Technique on Morbidity After Impacted Third Molar

Removal of impacted lower third molar is considered as the most common surgical procedure carried out in the oral and maxillofacial Clinics. The surgical removal of the impacted mandibular third molar is usually associated with pain, swelling and inability to open the mouth. Those symptoms reach the maximum intensity between the third to fifth hours postoperatively for the pain and 24 to 48 hours postoperatively for the swelling and then, they gradually diminished until the 7th day postoperatively

Removal of impacted lower third molar is considered as the most common surgical procedure carried out in the oral and maxillofacial Clinics. The surgical removal of the impacted mandibular third molar is usually associated with pain, swelling and inability to open the mouth. Those symptoms reach the maximum intensity between the third to fifth hours postoperatively for the pain and 24 to 48 hours postoperatively for the swelling and then, they gradually diminished until the 7th day postoperatively.

Kinesio taping (KT), also termed ''elastic therapeutic bandage,'' is a popular technique used for the management of postoperative lymphedema after maxillofacial surgery. KT is an elastic therapeutic tape invented by Dr Kase in the 1970s. KT originated from sports medicine and is primarily used to support damaged soft tissues (muscles and joints), helping to reduce pain. KT is considered to regulate the blood and lymph flow and also to remove the congestion of lymphatic fluid or hemorrhage and, thus, has achieved popularity in the control of lymphedema.

Many studies had evaluate the KT technique in reducing the morbidity after surgical removal of third molar. There is a lack of adequate evidence regarding effects of KT techniques versus placebo and the effectiveness of KT with that of other methods and medical agents.

Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years, with no systemic disease(s) Bilateral impacted mandibular third molar class II position B on Pell- Gregory classification.

Exclusion Criteria:

* Patients that had any local infection, tobacco use, oral contraceptive, pregnancy, lactation.
* sensitivity to the tapes
* reluctance to shave facial hair (for men)
* known allergies to medication administered in the study,
Study Comparing CT Scan and Stress Test in Patients With Known Coronary Artery Disease Hospitalized for Chest Pain

The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with known coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.


Eligibility Criteria:
Inclusion Criteria:

* patient admitted for chest pain / pressure or other suggestive symptoms
* patient has known coronary artery disease (with or without prior revascularization)
* patient has clinical need for non-invasive cardiac evaluation

Exclusion Criteria:

* evidence of ongoing myocardial infarction or hemodynamic instability
* ischemia on EKG (greater than 1mm ST segment deviation)
* contraindications to CT scanning with iodinated intravenous contrast (including allergies, asthma and renal dysfunction)
* heart rhythm precluding EKG gating
* pregnancy
EPA Supplementation in Cancer Patients Receiving Abdominal Radiotherapy -

Malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal (GI) area and can lead to negative outcomes. N-3 fatty acids from fish, especially eicosapentaenoic acid (EPA) may possess anticachectic properties. The aim of this study is to investigate the effect of two nutritional interventions; dietary counselling and an oral nutritional supplement (ONS) containing 2.2 g of the n-3 fatty acid EPA (Forticare®) or standard care, including dietary counselling and protein supplementation when needed.

Methods: Outpatients commencing radiotherapy to the GI area due to dissiminated cancer are randomized to receive dietary counselling and daily fish-oil supplementation over a 5-7 week period, or standard care. Outcome parameters are measured at baseline (onset of radiotherapy), week 5, and 12 weeks after commencing radiotherapy, with one additional measurement of body weight at week 2. Quality of life (QoL) is measured using the EORTC QLQ-C30 questionnaire. Radiotherapy-related side effects are assessed using a questionnaire developed specifically for this study. Data from a historical control group collected in a previous observational study is included in this study to compare incidence of weight loss.

Eligibility Criteria:
Inclusion Criteria:

* referred to radiotherapy for dissminated, abdominal cancer
* \> 18 years of age
* able to understand and comply with the intervention
* willingness to participate after oral and written conscent

Exclusion Criteria:

* conditions precluding evaluations of end-points
* dementia
* operations planned in the observation period
Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation

Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by non-medical usage, long and repeated exposure to addictive drugs and gradually increasing drug-taking dosage and frequency,and become a main threat against human being's public health, economic development and social safety.

Effective treatments for severe drug addiction are limited. China centers employing compulsory detoxification, reported a 3 year abstinence rate of only 15%. For the methadone maintenance therapy, relapse often occurs promptly after cessation of methadone. A Malaysian reports about taking naltrexone or buprenorphine treating,showed average relapsed time of 2 or 3 months,respectively.

Assessment for psychological craving degree of addiction patients is also a difficult thing.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years of age, male or female；
2. Opiate addictive over 3 years；
3. Physical detoxification completed（keep abstinent for at least 7 days，acute abstinent syndrome disappeared，morphine urinalysis and naloxone test showed negative)；
4. No obvious neuropsychiatry and personality disorders；
5. No severe infectious disease；
6. Good compliance and be able to complete follow up；
7. General health is good，no severe liver、kidney、heart and lung disease；
8. Informed consent issued

Exclusion Criteria:

1. Severe cognitive disorders（MMSE scale: illiteracy≤17，primary school≤20，secondary school or above≤24）,bad compliance because of dementia,unable to issue the informed content；
2. History of severe neuropsychiatric disease；
3. Epilepsy；
4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；
5. Malignant tumor；History of brain trauma；Pregnant female；
6. Patients are taking part in other clinical trials in recent 3 months；
7. Being deem as unfit for the trials by researcher.
The Foley's Catheter Balloon to the Bleeding From Placenta Previa

Post-partum haemorrhage due to placenta previa is usually from the placental bed at the lower uterine segment and it occurs after the placenta separation. Although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still one of the important causes of maternal mortality . Hysterectomy can be the only effective action to take, although it carries many morbidities for the women especially those with low parity.

Uterine packing considers as a line of treatment before performing surgical procedures in postpartum hemorrhage resulting from placental site bleeding. It can save life, avoid laparotomy and save uterus.

Nowadays, the use of intrauterine balloons have been developed and become effective for the control of placental site bleeding not responding to medical treatment. The 2-way Foley's Cather has many advantages over the gauze packing; First, it allows drainage of blood so no occult bleeding could be accumulated inside the uterus as in uterine gauze, second the removal of the Foley's Cather balloon is easy and not a painful, third, the removal of 2-way Foley's Cather could be gradually as a test of its effectiveness before complete removal .


Eligibility Criteria:
Inclusion Criteria:

* Patients with placenta previa
* Delivered by cesarean section

Exclusion Criteria:

* Patients with sever uncontrolled uterine bleeding after delivery
* Placenta accreta
Genetic and Histopathologic Characteristics of Interstitial Cystitis

Genetic and Histopathologic Characteristics of Interstitial Cystitis


Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 19 yrs or greater
* Patients diagnosed with Hunner lesion in Interstitial cystitis and who is scheduled to undergo transurethral resection
* Patients diagnosed with Bladder cancer and who is scheduled to undergo cystectomy

Exclusion Criteria:

* Male and female under aged 20 yrs
* A person whose area of bladder cancer is larger than that of the normal area
* A person who is going to have a cystectomy after chemotherapy on bladder cancer
Orodental Manifestations of Rare Diseases

OroDental anomalies are one of the phenotypical aspects of at least 900 rare diseases or syndromes affecting by definition less than 1 in 2000 individual within the population (almost 25 million persons in Europe).

They are often described in association with other organs or system malformations, which is understandable, because the same genes and signalling pathways regulate the oral cavity formation or odontogenesis and the development of other organs. The various dental and orofacial anomalies can be classified by type (anomalies of tooth number, shape, size, structures of mineralized tissues, eruption, resorption, tumors; anomalies of oral mucosa; anomalies of tongue...), by signalling pathways and by syndrome families.

These anomalies (for example hypodontia/oligodontia, amelogenesis imperfecta, dentinogenesis imperfecta...) become increasingly identified as diagnostic and predictive traits. Not only is it important to recognise, name appropriately and integrate these dysmorphic clues into the patient dysmorphology analysis but it is essential to synthesize the observations and confront them to existing data about similar orodental anomalies encountered in some of the corresponding mutant mouse models.

Translational approaches in development and medicine, are relevant to gain understanding of molecular events underlying clinical manifestations and to enhance diagnostic accuracy.

The aim of this study is to improve the knowledge, diagnosis and care of oral cavity pathologies encountered in rare diseases via the identification and gathering of national and international patient cohorts and to structure the molecular diagnosis behind these conditions via targeted next-generation sequencing assays. Data collection is implemented on validated accredited tools (databases) complying with the legal regulations about patient data protection and medical record collection. All information is anonymized.

New effective diagnosis and therapeutic tools are being developed.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with a rare disease

  * New patient or patient already known in the center
  * Child (in his primary dentition) or adult
  * Man or woman
  * Having signed a consent form or accepted to participate to the study
  * Patient affiliated to social security
  * Validation of the inclusion by the principal investigator looking at the patient file

Exclusion Criteria:

* Patient whose clinical diagnostic is not possible

  * Patient whose clinical file does not contain teeth photos
  * Patient who has not signed a consent form and accepted to participate to the study
  * Patient who is not affiliated to social security.
  * Non validation of the inclusion by the principal investigator looking at the patient file
Biospecimen Biorepository for the Study of ALS, ALS-FTD and Similar Neurodegenerative Disorders

The purpose of this study is to collect CSF and blood samples that can be used in future research studies to identify potential biomarkers in blood and cerebrospinal fluid (CSF) collected in Amyotrophic Lateral Sclerosis (ALS) patients.

Biomarkers are non-genetic elements in your blood and CSF that may help diagnose and monitor ALS more easily. There are no readily available sources of longitudinal CSF, plasma or serum samples from people with ALS, ALS-FTD or similar neurodegenerative disorders or their family members for use in the identification of potential ALS biomarkers. Future research will examine potential biomarkers in blood and CSF collected over time to see if they change over time and can be used to diagnose and monitor people with ALS.

Eligibility Criteria:
Inclusion Criteria - Patient with ALS, ALS-FTD or Similar Neurodegenerative Disease:

* Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified eL Escorial criteria, suspected ALS according to original el Escorial criteria, or diagnosis of a similar neurodegenerative disorder.
* Willing to provide consent, or assent, if physically unable to consent owing to disease-related muscle weakness.

Inclusion Criteria - Spouse/Domestic Partner of Patients with ALS/ALS-FTD and Similar Neurodegenerative Disorder or Subject with Family History of ALS, ALS-FTD or Similar Neurodegenerative Disease:

* No personal history of ALS, ALS-FTD or other motor neuron disease.
* Subjects with family history of ALS, ALS-FTD the affected family member needs to be a first, second, or third degree blood relative.
* Willing to provide consent.

Exclusion Criteria - Subject with ALS/ALS-FTD or Similar Neurodegenerative Disease:

* History of medical disorder that leaves in question whether neurological signs and symptoms potentially related to a neurodegenerative disease may be caused by another unrelated disorder.
* Limited mental capacity rendering the subject unable to comply with lumbar puncture or standard phlebotomy procedures.
* For lumbar puncture, an increased risk of bleeding complications or allergy to local anesthetic administered or skin antiseptic used for lumbar puncture.

Exclusion Criteria - Spouse/Domestic Partner of Patients with ALS/ALS-FTD and Similar Neurodegenerative Disorder or Subject with Family History of ALS, ALS-FTD or Similar Neurodegenerative Disease:

* Limited mental capacity rendering the subject unable to comply with lumbar puncture or standard phlebotomy procedures.
* For lumbar puncture, an increased risk of bleeding complications or allergy to local anesthetic administered or skin antiseptic used for lumbar puncture.
Physical Activity Counseling During Pulmonary Rehabilitation

This randomized controlled trial will assess the effect of adding intensive physical activity counseling to an outpatient pulmonary rehabilitation program. Counseling including real-time feedback on daily activities from an activity monitor will be offered to improve participation in physical activities in daily life during and after an outpatient pulmonary rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Spirometry-proven COPD
* Referred for 6-month outpatient pulmonary rehabilitation program

Exclusion Criteria:

* Orthopedic problems impairing daily activities
* Progressive neurological or neuromuscular disorders
* Psychiatric or cognitive disorders
* Patients on the waiting list for lung transplantation
Evaluation of Accuracy of Guardian Sensor 3 in Diabetes Patients on Peritoneal Dialysis

Assessment of performance (precision and accuracy) of Guardian Sensor™ 3 as compared with a gold standard reference laboratory method (YSI glucose) in diabetes patients on peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 or 2 diabetes mellitus diagnosed for at least 3 months
2. On continuous ambulatory peritoneal dialysis (CAPD) for at least 3 months
3. Male or female age ≥ 18 years old and ≤ 75 year old.
4. Women who are not pregnant, lactating or planning a pregnancy during their participation in the clinical study.
5. Willingness, ability and commitment to comply with the testing, procedure and follow-up outlined in this protocol including (but not limited to) frequency of clinic visits and use of pre-specified glucose monitoring devices.
6. Willingness to abstain from swimming during their participation in the measurement phase.
7. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a good study candidate.
8. Written informed consent to participate in the study provided by the patient.

Exclusion Criteria:

1. Poorly controlled diabetes mellitus with HbA1c\>11%
2. Peritonitis within 1 month
3. On icodextrin PD solutions
4. Planned for switching to hemodialysis or living donor transplant in future 3 months
5. Currently pregnant, as demonstrated by a positive pregnancy test at screening
6. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
7. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
8. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
9. Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
10. Have a known allergy to medical-grade adhesives, or known hypersensitivity to any of the products used in the study.
11. Blood donation of more than 500 ml within the last three months
12. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.

13 Has a MRI scan, CT scan, or diathermy scheduled during the proposed study participation.

14. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

15. Women of reproductive potential who are unwilling to adopt contraceptive measures during the study period 16. Patients with history of pacemaker and prosthesis implantation.