cyrilzakka/clinical-trials huggingface dataset:
Intracavernous Injection of Botox 100 U for Treatment of PDE5Is Inconvenient Patients With ED

There is a new emerging concept that Botulinum Toxin Type A may have a potential role in treatment of erectile dysfunction with a longer duration of action. So, the investigators opted to perform this study to compare ICI of Botulinum Toxin Type A versus Trimix for treatment of ED.

Background: Direct Intracavernosal injections of vasoactive agents to treat erectile dysfunction were first described in 1982 using papaverine. Later on many agents have been introduced for ICI. one of most newly introduced ICI agents for treatment of ED is Botulinum Toxin Type A.

Purpose: The aim of this study will to compare the safety, efficacy, tolerability and adverse events s of ICI of BTX-A 100 unit in comparison with ICI Trimix in the treatment of Erectile Dysfunction for PDE5Is non-responders.

Design, Settings, and Participants: This study will be conducted on 124 patients at minimum, complain of erectile dysfunction not responding to different PDE5Is therapy presenting to Urology department and outpatient clinic at Banha University Hospital.

patients will be randomized into 2 equal groups: The treatment group A: will receive a single ICI of BTX-A 100 units . The treatment group B: will receive on-demand ICI of Trimix .

Assessment for all groups will be done by Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 \& SEP 3), and the global assessment question (GAQ) based on pre-treatment, 2 weeks, 3 months and every 3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 40 years with ED not responding to PDE5Is, non compliant or contraindicated to PDE5Is. A "No" response on Sexual encounter profile questions (SEP 2 \& 3)

Exclusion Criteria:

* psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
The Effects of Short-time High-intensity Interval Training on Tissue Glucose and Fat Metabolism in Healthy Subjects and Patients With Type 2 Diabetes

The objectives of this study are to investigate the effects of short-time high-intensity interval training on tissue glucose and fat metabolism in healthy lean subjects and type 2 diabetic patients using modern and noninvasive imaging methods positron emission tomography (PET), magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).


Eligibility Criteria:
Inclusion Criteria:

The healthy patients

1. Age 40-55
2. BMI 18.5-30
3. Fasting plasma glucose less than 6.1 mmol/l
4. Normal glucose tolerance test (OGTT)

The type 2 diabetic patients:

1. Age-, sex-, and BMI-matched with the study subjects in the phase 1
2. In a good treatment balance
3. Glycated haemoglobin (HbA1c) less than 7.5 mmol/l
4. Two hours glucose value in oral glucose tolerance test (OGTT) less than 10.0 mmol/l

Exclusion Criteria:

The healthy patients

1. Blood pressure \> 140/90 mmHg
2. Any chronic disease
3. Any chronic medical defect or injury which hinder/interfere everyday life
4. History of anorexia nervosa or bulimia
5. History of rest or exercise-induced asthma
6. Previous use of anabolic steroids, additives or any other substrates
7. Smoking of tobacco, taking of snuffs, or use of narcotics.
8. Significant use of alcohol
9. Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
10. Presence of any ferromagnetic objects that would make MR imaging contraindicated
11. Current or history of regular and systematic exercise training
12. VO2max \>40 ml/min/kg

The type 2 diabetic patients:

1. Any other chronic disease than diabetes
2. Blood pressure \> 140/90 mmHg
3. Any chronic medical defect or injury which hinder/interfere everyday life
4. History of anorexia nervosa or bulimia
5. History of rest or exercise-induced asthma
6. Smoking of tobacco, taking of snuffs, or use of narcotics.
7. Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
8. Presence of any ferromagnetic objects that would make MRI imaging contraindicated
9. Current or history of regular and systematic exercise training
10. VO2max \>40 ml/ min/kg
Neurological Complications - Pulmonary Transplant

A monocentric prospective open study to evaluate the frequency and nature of cognitive complications in the 3rd month post pulmonary transplant.


Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years of age.
* Enregistered in lung transplant waiting list
* Have given their agreement to be enrolled in the study

Exclusion Criteria:

* Patients had a previous lung transplant
* patients with insufficient level of french language that may affect the comprehension and answering the psychometric test
Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients

A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Experimental group receives robot-assisted-gait-training and conventional gait training.

Active comparator group receives conventional gait training only as the same number as the experimental group.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 19 and under 80
* Weight under 100kg
* Height less than 200cm
* Able to walk independently before onset of stroke
* Ischemic or hemorrhagic stroke patients
* Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment
* FAC(Functional Ambulation Category) under 3 (0\~2)
* Subacute stroke patients after 3 days and before 3 months of onset
* Be informed of the nature of the study and agreed on written consent voluntarily
* Patients taking medications or scheduled medications due to stroke

Exclusion Criteria:

* Patients with contraindications to weight bearing such as fractures, etc.
* Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension
* Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training
* Patients with severe skin damage and bedsore on wearing part of the trial device
* Pregnant or breast-feeding
* Participation within 30 days of the other clinical trials
* Patients whom the investigator considers inappropriate to participate in the study
Platelets for Acute Wound Healing

This study will examine whether platelet gel positively affects wound healing. Platelet gel will be used to treat punch biopsy wounds and the results will be compared to results from wounds treated with a control treatment.

Platelets contribute to the healing process in soft tissue by providing the initial hemostasis that occurs following injury, a framework for fibrin matrix formation and contribution of growth factors.

According to the US National Institutes of Health, surgical procedures are considered a form of controlled injury, so many of the complications faced by surgery patients are very similar to those faced by trauma patients. Scientists are currently investigating ways to treat wounds caused by trauma, burns or surgical inventions with biological agents (i.e. growth factors) or new drugs. Growth factor priming of acute wound sites pre-activates the cellular and molecular components of tissue repair, prior to tissue injury.

Objectives are aimed at gathering information to establish evidence that autologous platelet gel positively effects the healing of acute wounds.

Eligibility Criteria:
Inclusion Criteria:

* Normal volunteers
* 18 years old or older

Exclusion Criteria:

* Pregnant or lactating
* Diabetic, keloid former, collagen vascular disease
* Smoker
* Body mass index \>30kg/m2
* Known history of HIV/AIDS; Hepatitis A, B, or C
* Bleeding disorder
* Aspirin, non-steroidal anti-inflammatory drug (NSAID) or anticoagulant user
* Cancer, or treatment for cancer, in past 5 years
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.


Eligibility Criteria:
Inclusion criteria:

1. Signed informed consent consistent with ICH-GCP
2. Three month history of reversible (12% and 200 mL in forced expiratory volume in one second - FEV1) asthma (according to GINA) with following spirometry at randomisation: FEV1 60%- 85%.
3. Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.
4. Diagnosis of asthma prior to 40 years.
5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.
6. Male or female 18 to 65 years.
7. Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.
8. Able to perform pulmonary function testing.

Exclusion criteria:

1. Significant diseases other than asthma or allergic rhinitis.
2. Hepatic transaminases or total bilirubin greater than 1.5 ULN.
3. Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.
4. Uncontrolled asthma on iCS + other controller.
5. Respiratory tract infection or exacerbation within 4 weeks.
6. FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period.
7. Participation in another interventional study.
8. Pregnant or nursing women.
9. Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.
Short Term Immobilization of the Lower Limb

The purpose of this study is to determine the effects of one week of knee-joint immobilization on muscle size, strength, neuromuscular function, and brain function. In addition, the effects of two different interventions (i.e., neuromuscular electrical stimulation and action observation/mental imagery) throughout immobilization will be determined. Following the immobilization period, participants that have lost strength will be rehabilitated with twice weekly resistance training sessions, and sex-based differences in rehabilitation timelines will be examined.

This study will utilize a repeated measures design in healthy adults aged 18-40 years. After a thorough familiarization visit, muscular size, strength, neuromuscular responses, and corticospinal excitability/inhibition will be measured before (PRE) and after (POST) one week of unilateral knee joint immobilization of the left leg. Four groups will be examined: 1) immobilization only, 2) immobilization + daily neuromuscular electrical stimulation, 3) immobilization + daily action observation/mental imagery training, 4) a control group. Throughout the immobilization period, participants will be in a leg brace locked at 90 degrees knee flexion. They will perform daily range of motion exercises and wear a compression sock at all times to mitigate the risk of blood clots. Following completion of the immobilization period, participants that have lost strength will complete a supervised rehabilitation program of twice weekly lower body resistance training sessions until they have returned to baseline levels of strength. Group assignment will be randomized and blocked on sex to ensure an equal number of participants within each group consisting of a relatively equal number of males and females.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between the ages of 18-40 years
* Body mass index \>20 kg/m2 or \< 35 kg/m2

Exclusion Criteria:

* Body mass index \<20 kg/m2 or \> 35 c
* Experience of major joint pain/discomfort of the upper or lower limbs, back, or neck within the previous six months.
* History of major musculoskeletal injury or surgery
* Neuromuscular disease (e.g., Parkinson's, MS, ALS)
* Metabolic disease (e.g., diabetes, thyroid disorder, metabolic syndrome)
* Personal or family history of blood clots
* Trouble using or controlling one's muscles
* History of cancer
* History of stroke
* History of heart attack
* History of arthritis
* Use of an assistive walking device or mobility aids within the past six months
* Use of anabolic steroids within the past six months
* History of convulsions, seizures, or syncope
* History of concussion as diagnosed by a physician
* Certain medications (e.g., muscle relaxants, benzodiazepines)
* Very thick hair or certain hairstyles that would impede the TMS coil from making direct contact with the scalp
* Allergy to rubbing alcohol
* Lack of transportation to and from the laboratory
* Implant of any kind
* Pregnancy
* Allergy to silver
* Diagnosis of any psychiatric condition
Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.

This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days \& a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.

Eligibility Criteria:
Inclusion Criteria:

* non-toxic patients
* immunocompetent patients
* 3 months to 18 years old
* English-speaking patients
* skin abscesses
* not on antibiotics

Exclusion Criteria:

* toxic patients
* immunocompromising co-morbidities
* less than 3 months old or older than 18 years of age
* non-english speaking
* on antibiotics
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases

Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study.

The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 to 75 years
2. Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months
3. Moderate to severe pruritus
4. Female participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 10 weeks after final study drug administration
5. Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study

Exclusion Criteria:

1. Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
2. Is currently using medication known to cause pruritus
3. Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
4. Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
5. Has an active infection, including skin infection
6. Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the participant at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results
Clinical Subgroups in Patellofemoral Pain Syndrome

Patellofemoral pain syndrome (PFPS) is a multifactorial pathology characterized by diffuse retropatellar and peripatellar pain in the knee joint, exacerbated by overloading activities on the patellofemoral joint. However, this disease showed high degree of patients not responsive to therapeutic strategies. This condition occurred because several factors is related to disease such as: (1) proximal factors (involving trunk and hip), (2) local factors (surrounding and or within the patellofemoral joint) and (3) distal factors (involving ankle and foot). Thus, the identification of clinical subgroups based in anatomic changes (proximal, local and distal factors) is a recent strategy that could help in the therapeutic strategies focused on the etiology of the disease, improve responsiveness to treatment, clinical and functional benefits.


Eligibility Criteria:
Inclusion Criteria:

* Peripatellar or retropatellar pain in at least two of the following situations: squatting, running, kneeling, jumping, climbing or descending stairs and sitting for a prolonged period of time for at least three months.

Exclusion Criteria:

* Engaged in systematic exercise with focus on lower limb in the last six months and Had an injury to the hip and ankle joint in the last 12 months.
Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

The purpose of this study is to evaluate the effectiveness of transversus abdominis plane (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty surgery in children.

Primary open pyeloplasty is a common elective surgical procedure at The Hospital for Sick Children. All children are given fentanyl plus local anesthetic wound infiltration for intraoperative analgesia. A retrospective audit demonstrated that 63% of children required additional opioid treatment in the early recovery period following surgery. Concern exists regarding potential side effects of opioids including nausea or vomiting, respiratory depression, pruritus, over-sedation and delayed transition to oral intake. More importantly, children may under-report their pain or pain may not be recognized by medical staff leading to inadequate provision of analgesia. This suggests that the use of a regional technique, such as a TAP block, may benefit children undergoing open pyeloplasty.

The ultrasound guided TAP block introduces a local anaesthetic to the transversus abdominis plane which is one of three muscle layers in the abdominal wall. This results in a block of the nerves leading to the abdominal wall thereby reducing pain sensations.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification score 1-3
* age 1 month to 6 years inclusive

Exclusion Criteria:

* children undergoing an additional surgical procedure at an anatomical location not covered by a unilateral TAP block during the same anesthetic
* children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection
* postoperative admission to the intensive care unit
* children with a known allergy to bupivacaine
* children with a history of chronic abdominal pain requiring opioid analgesics
* children with known renal insufficiency
* children with known impaired hepatic function
* children with known impaired cardiac function
* children known hypersensitivity to sodium metabisulfite
Influence of Pain Sensitivity on Lumbar Surgery Outcomes

Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.


Eligibility Criteria:
Inclusion Criteria:

1. patients aged 40-80 years
2. lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013

Exclusion Criteria:

* a history of major psychiatric disorders (schizophrenia, major depression) or peripheral vascular disease
* any concurrent serious medical condition that would cause disability or decreased general health status such as sepsis or cancer.
Prospective Comparison Between TE, SWE and MRE (FULLFIBRO01)

The main purpose of the present study is to compare the diagnostic performance of three non-invasive stiffness imaging methods (TE, SWE and MRE) in a consecutive cohort of patients with chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).

Primary Endpoint: Verify if Transient Elastography, Shear Wave Elastography, Magnetic Resonance Elastography (MRE) get comparable results in the measurement of liver fibrosis Secondary Endpoint: To evaluate if the level of liver iron overload and steatosis may act as a confounding factor in stiffness measurements by MRE.

Tertiary Endpoint: to provide information about the prevalence and grade of steatosis in a consecutive cohort of patients with chronic viral C hepatitis, and to verify if the presence and grade of parenchymal steatosis may affect the correlation between the different non-invasive stiffness imaging modalities.

Subject: consecutive 100 patients affected by chronic viral C hepatitis or co-infected by HCV+ Human Human Immunodeficiency Virus (HIV).

Eligibility Criteria:
Inclusion Criteria:

* enrollment of a consecutive cohort of at least 100 patients affected by chronic C virus hepatitis (HCV) or co-infected by HCV+ Human Immunodeficiency Virus (HIV).

Exclusion Criteria:

* contraindications to undergo MRI examination. Impossibility to obtain a valid TE measurement (e.g. narrow intercostal spaces; obese patients)
Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)

Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices and strategies have significantly evolved during these last years, influenced by Baker nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity and cardio-vascular pathology prevalence in this target population at adulthood. In this context many studies emerged since 2000 and try to assess the trade-off between neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between heterogenous proteic input dispensed in our NICU (described by tercil methods on population) and fat mass phenotype variations at discharge (described by tercil methods); and its consequences on neurodevelopmental growth. Understanding how particular nutritional exposition could determine "fatty" phenotype and impact neurodevelopment is clearly our main goal.


Eligibility Criteria:
Inclusion Criteria:

* Preterm newborns (\< 35 weeks gestation).
* Final clinical discharge (No transfer)
* Oral Parental consent.
* Nantes NICU Neonatal management in the first 5 days of life

Exclusion Criteria:

* Congenital pathology inconsistent with PEAPOD investigation (Beckwith-Wiedemann syndrome, lipodystrophia with abnormal constitutional fat mass level).
* Pathology inducing neurodevelopment troubles.
* Transfer in an other hospital before discharge
* Hemodynamic or cardiovascular instability requiring continuous monitoring or perfusion, incompatible with PEAPOD measurement