cyrilzakka/clinical-trials huggingface dataset:
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.


Eligibility Criteria:
Inclusion Criteria:

* ED of more than 6 months
* At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
* Positive response to PDE-5 inhibitors
* IIEF-5 domain score of 12-20 denoting mild to severe ED
* Non-Neurological pathology
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* NPT - normal/flat
* Prior prostatectomy surgery
* Any cause of ED other than vascular related
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Cardiovascular conditions that prevent sexual activity
* History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
* Cancer within the past 5 years.
* Anti-androgens, oral or injectable androgens
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
The Effects of Chiropractic Care in Adults With Subclinical Spinal Pain

This study aims to investigate long term and retention (in a subgroup) effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in adults with subclinical pain.

There is growing evidence that chiropractic care positively impacts various aspects of central and autonomic nervous system function. A single session of chiropractic adjustment has shown to alter pre-frontal cortex (PFC) activity, but there is a lack of robust research investigating the long-term benefits of such PFC changes. This study aims to investigate long term and retention (in a subgroup) effects of Chiropractic care (CC) on neurological, behavioral, immunological functions and health-related quality of life in adults with subclinical pain. In these parallel-group randomized controlled trials, participants aged 18-60 years with subclinical spinal pain will be randomly allocated to receive either 12 weeks of CC intervention or control intervention. Primary outcomes include functional near-infrared spectroscopy, heart rate variability (HRV), serum Brain-Derived Neurotrophic Factors (BDNF) levels and resting-state electroencephalography (EEG). The secondary outcomes include PFC activity (measured by cognitive and behavioral testing), immune and inflammatory markers and health-related quality of life. As data collected in the project is a combination of extrinsic (sociodemographic, clinical questionnaires etc.) and intrinsic physiological data (physiological measures like EEG, HRV etc.), the machine learning or artificial intelligence (AI) will be used to help the development of optimal chiropractic care plans in future.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 60 years
* have subclinical spinal pain

Exclusion Criteria:

* no evidence of spinal dysfunction is present, they are in current pain (above 3/10 on VAS)
* have sought previous treatment for their spinal issues
* are unable to perform the assessment procedures due to contraindications or movement limitations
* diagnosed immune dysfunction
* utilizing a prescribed immunosuppressive medication
* they have uncontrolled asthma
* have nasal polyps
* use of an intranasal steroid spray one month or less before the study
* are HIV-positive
* unable or unwilling to comply with the study protocol
* a history of drug abuse
* are participating in another research study during the time of data collection.
* have any diagnosed comorbidity or concomitant disease
* donated blood within last month
* have allergies to yeast or yeast-derived products
* have chronic sinusitis and/ or recent (within the last six weeks) episodes of acute sinusitis.
MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

This serves as a registration trial. It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. Outcomes will be categorized as: 1- Procedure Related, 2- Perioperative - Adverse Events that may occur within 90 days, 3-Oncologic: Recurrence of cancer in treatment area, de-novo tumors, conversion to radical surgery, radiation or cryoablation, emergence of metastasis, 4- Functional: Sexual and Urinary function following treatment

CLINICAL REGISTRY OBSERVATION NATURE

This serves as a registration trial evaluating short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. The primary outcome measure is 1-year oncological control of the targeted ablated area. The following secondary aims are sought: PROCEDURE RELATED: tolerability, feasibility, pain during this office-based procedure. PERIOPERATIVE: Adverse Events (AEs) and Series AEs profile during the initial 90 days after the procedure. ONCOLOGIC - In addition to primary aim, determine risk and rate of emergence of de-novo tumors (so called Outfield Recurrence) at the 1 year fusion biopsy mark and overtime. Will also observe rate of progression locally and systemically. Conversion to whole gland treatment - surgery extraction, radiation or whole gland cryoablation is of particular interest as is the initiation of androgen suppression (castration). Moreover, the investigators will evaluate the impact of MRI in assessing tumor locations and of software registration guiding the location and extent of ablation of the laser ablation over fixed time intervals. Finally, incidence of metastatic disease - non castrate and castrate - as well as cancer specific and overall survival at 5, 10 and 15 years post procedure. FUNCTIONAL OUTCOMES - determine urinary function and sexual function including incidence of ejaculation, and climacturia at months 3, 6 and 12. These outcomes will then measured yearly for the extent of the study

Eligibility Criteria:
Inclusion Criteria:

* Men between 50 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and \<50% positive core rate by prostate lobe
* Men older than 65 years of age with clinical diagnosis of prostate cancer \<50% positive core rate by prostate lobe
* Absence of extra-capsular extension
* Absence of seminal vesicle invasion
* Absence of regional or distant metastatic disease
* Multiparametric MRI of the prostate performed either before the biopsy or \>10 weeks after prostate biopsy
* Treated with Cryotherapy of the prostate
* Treatment based on co-registration between MP-MRI and Prostate Ultrasound

Exclusion Criteria:

* Prior treatment of prostate cancer in the form of surgery.
* Performance status greater than 0 based on ECOG criteria
* Mental status impairment
The World Federation of Hemophilia Gene Therapy Registry

The aim of the WFH GTR is to provide a database in which long-term data on PWH who receive gene therapy from around the world, will be collected and housed.

The first gene therapy product for hemophilia is expected to receive marketing authorization in 2020, with several others following closely behind. With these new therapies hitting the market in the near future, it is incumbent on us as a community to ensure that we have measures in place to allow monitoring of expected, unexpected and unknown safety issues, as well as duration of efficacy, over the long term. Low incidence adverse events require monitoring of a large number of patients, over a long period of time, necessitating a global initiative.

To fill this need, the World Federation of Hemophilia (WFH), under the guidance of a multi-stakeholder steering committee, is developing and implementation the WFH Gene Therapy Registry (GTR). The aim of the WFH GTR is to provide a database in which long-term data on PWH who receive gene therapy from around the world, will be collected and housed.

The WFH GTR steering committee is made up of hematologists, clinical trialists, methodologists, epidemiologists, manufacturers and patient advocates. All stakeholders have a role in ensuring the success of this important initiative.

The WFH GTR will collect a core set of demographic, safety and efficacy data, on all patients with hemophilia, who receive a gene therapy product via a clinical trial or post-marketing, from anywhere in the world. The core data set is currently in development; and the global implementation plan is being finalized. A database provider will be selected in Q1 2020, based on a request for proposals which was issued to several database providers. The database for the WFH GTR will begin development in Q2 2020, with the aim of having a final database ready for launch in by end of 2020, when the first gene therapy product is available to patients. At this time, we will also begin recruitment of patients who have received gene therapy through a clinical trial.

Patients will be recruited through hemophilia treatment centers (HTC) who provide gene therapy to patients with hemophilia. Investigators will recruit patients into the WFH GTR and enter baseline and follow up data over the long term. There is no determined end date for this registry. For countries who have an existing national registry, we offer the possibility of linking databases directly.

Eligibility Criteria:
Inclusion Criteria:

* People with hemophilia who have received a gene therapy product

Exclusion Criteria:

* None
Study Evaluating Venlafaxine ER in Patients With Panic Disorder

The primary objective is to determine the efficacy, safety, and tolerability of venlafaxine extended release (ER) capsules in the treatment of outpatients with panic disorder (PD) in comparison to those of placebo.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1
* Have sufficient symptoms to require anxiolytic drug therapy
* Have a score ≥4 on the Clinical Global Impressions Scale (CGI) severity of illness item at screening and baseline

Exclusion Criteria:

* Known hypersensitivity to venlafaxine (IR or ER), related compounds, or paroxetine
* History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma \[except basal cell epithelioma\], uncontrolled hypertension)
* Clinically important abnormality on screening physical examination, vital signs, electrocardiogram (ECG), laboratory tests or urine drug screen
Determination of Safety and Consumers' Satisfaction of Moussik Versus Desitin Creamy Ointment in Diaper Rash Prophylaxis

The purpose of this clinical observation is to evaluate the safety and consumers' satisfaction of Moussik vs Desitin Creamy ointment as a diaper rash protection product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female infants aged between 3-18 months who are routine users of disposable diapers

Exclusion Criteria:

* Children with symptoms of systemic disease or skin lesions.
* Children diagnosed as having diaper dermatitis at baseline
* Known hypersensitivity to any of the components of the trial preparations.
* Children suffering from atopic diseases.
* Children who have participated during the last month in another clinical trial.
Effect of Varying Levels of PEEP on Preterm Lung Recruitment Using Electrical Impedance Tomography- Feasibility Study

Babies born early (under 32 weeks) are at risk of developing lung problems after birth. A major reason for this is that the lungs are not fully developed. Lungs of preterm babies will often collapse in between breathing due to lung immaturity. Applying gentle pressure, using nasal device through their nostril or through the breathing tube helps to prevent this lung collapse. This would help in air-oxygen going to lungs and also makes the babies breathing more comfortable. This gentle pressure is medically called as PEEP/CPAP and could be delivered by breathing machine (ventilator) and CPAP machine, collectively called as "continuous distending pressure (CDP)".

Those babies breathing on their own and receiving inadequate CDP would need more breathing support by placing them on breathing machine (ventilator). The longer the baby receives breathing machine support, higher chance of lung injury . Preterm infants who are already on breathing machine, providing sub optimal PEEP/CPAP could also lead to lung damage. Providing optimal PEEP/CPAP could prevent these negative outcomes. Currently there is not enough evidence to suggest optimal PEEP/CPAP in preterm infants. Neonatal units all around the world uses PEEP/CPAP ranging from 4 to 10cm H20 based on their unit practice. Currently available investigations provide limited one time information (e.g. Chest X-ray) regarding whether baby is receiving optimal PEEP/CPAP. Electrical Impedance Tomography (EIT) is a new technology which could provide better information regarding the pressure delivered. Also, this device would provide continuous information as if the clinicians are doing continuous chest X-ray but without any radiation. In this study, the team will assess the effect of different levels of PEEP/CPAP (4 to 10cm H20) on prevention of lung collapse using EIT. This would be studied in premature infants who are on breathing machine support and CPAP machine support.


Eligibility Criteria:
Inclusion criteria

1. Gestational age \<32 weeks based on mother's last menstrual period or first trimester ultrasound dating.
2. Receiving either CPAP or mechanical ventilation respiratory support.
3. Informed written consent from one of the parents.
4. Within the first two weeks of life. Investigators pragmatically chose this period, as there could be considerable lung injury after the first two weeks of life, making it difficult to test our hypothesis. Also, this time period would allow parents to settle down with their stressful preterm delivery and investigators could approach anytime within the first two weeks of life.

Exclusion criteria

1. Major congenital malformations including congenital lung disease and congenital heart disease as ascertained by the medical team.
2. Infants diagnosed with pneumothorax i.
3. Receiving high frequency mechanical ventilation.
4. Infants with concerns of skin integrity.
Observatory of Psychiatric Symptoms and Their Somatic Causes in Urgent Medical Care

Use of emergency department for psychiatric symptoms always addresses the question of a potential somatic cause to the symptoms. Despite the wide-spread use of standard biology test and systematic brain imaging (for a first episode), there are still up to 5% of patients sent in psychiatric wards that actually have a somatic explanation to their symptoms which induces an important delay in the diagnostic assessement We hypothesized that simple neurological clinical examination along with fast psychometric screening tests in the Emergency Room (ER) could help the physicians to better screen the patients and thus prevent inaccurate post-emergency orientation.

Every patient visiting the ER for psychiatric symptoms will be included. The usual physical examination by the ER physician will be associated with two psychometric tests (namely the Clock-drawing test and Frontal Assessment Battery test).

The follow up will be made after 3 months in order to have the final diagnosis. Neurological data and data from the FAB test and the Clock-drawing test will be compared between patients who were finally given a psychiatric diagnosis versus patients with a somatic diagnosis at the end of the follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years old
* Patient consulting the emergency room for psychiatric recourse
* Benefiting from a consultation with a psychiatrist in the emergency room
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient objecting to the conduct of this study and the collection of health data
* Patient with motor disorders preventing the performance of a test requiring a pencil
* Patient sedated before treatment in the emergency room
* Patient with visual disturbances
Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD).

The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.


Eligibility Criteria:
Key Inclusion Criteria:

* Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode.
* History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.

Key Exclusion Criteria:

* Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.
* Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder.
* Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
* Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.
Development of a Screening Tool By Utilising Cervical Length Measurement In Relation To Body Mass Index (BMI) For Early Identification And Intervention Of Preterm Birth

This is a prospective study where pregnant women between 16-24 weeks gestation attending the Antenatal Clinic, Fetomaternal clinic or Obstetrics \& Gynaecology Admission Centre (OGAC) at Hospital Serdang or Hospital Pengajar UPM will be recruited. BMI will be taken both during booking of pregnancy and at recruitment. Cervical length will be measured via transvaginal scan at recruitment time. We aim to assess the association between body mass index, cervical length and risk of preterm birth.

General Objective To assess the association between body mass index, cervical length and risk of preterm birth.

Specific Objectives

1. To examine the relationship between body mass index and cervical length
2. To identify cut-off value of cervical length leading to high risk of spontaneous preterm birth among Malaysian women
3. To assess the association between different cervical length and preterm birth
4. To examine the association between body mass index and preterm birth
5. To develop an individualised screening tool for assessing risk of preterm birth

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy between 16-24 weeks gestation
2. No history of previous spontaneous preterm birth (gestation between 24-36+6 weeks)
3. Agreement to follow up and consented for the study

Exclusion Criteria:

1. Major fetal anomaly
2. Multiple pregnancy
3. Uterine anatomic malformation
4. Those require iatrogenic preterm delivery due to various condition
Convalescent Plasma Therapy for Hospitalized Patients With COVID-19

Plasma from donors who have recovered from coronavirus disease 2019 (COVID-19) contain antibodies to SARS-CoV-2 and may be a potential therapy for hospitalized patients with COVID-19. The efficacy of high-titer convalescent plasma for COVID-19, however, still unclear. The present study aims to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19.

This is an open-label, randomized controlled trial aimed to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19. Participants must be adult hospitalized patients with a confirmed diagnosis of COVID-19 and time Between symptom onset and inclusion ≤ 7 days. Two hundred participants will be randomized in a 1:1 ratio to receive either 200-400 mL of high-titer COVID-19 convalescent plasma or standard care. The primary endpoint is the proportion of patients with clinical improvement at day 14 following randomization, defined by an increase of two points in the 7-point ordinal scale based on that recommended by the World Health Organization. Safety will be daily assessed by monitoring the occurrence of adverse effects and reactions to convalescent plasma transfusion. Study visits will occur on Day 1, Day 3, Day 7, and Day 14 or until hospital discharge, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients aged ≥18 years.
* Confirmed diagnosis of COVID-19 by RT-PCR or antigen test in respiratory samples.
* Time between symptom onset and inclusion ≤ 7 days.
* Enrolled within 5 days of hospitalization.
* Sign the consent form.

Exclusion Criteria:

* Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure.
* History of previous severe allergic reactions to transfused blood products.
* Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.
* Not currently enrolled another interventional clinical trial of COVID-19 treatment.
* Critically ill patient with COVID-19 being treated in intensive care.
Effects of Exercise and Relaxation Techniques on Tension Headache Pain Parameters of University Students

Tension headache is a common disabling disease and a worldwide public health problem. This research tries to demonstrate the efficacy of physical therapy, based on cervical training and postural self-correction instructions, which aims to increase the positive results obtained from traditional relaxation techniques (Schultz Autogenic Training). University students are selected, because headaches are very common in this sector of the population. The design is a non-pharmacological randomized controlled trial, with blinded evaluation of the response variables. The investigators compare two independent samples. One of them receives an only treatment (Autogenic Training) and the other group receives a combined program (Autogenic Training + specific cervical exercises and postural correction). Pain parameters (frequency, intensity and duration) and drug consumption are measured before treatment, and then, at 4 weeks and 3 months, to value the results.


Eligibility Criteria:
Inclusion Criteria:

* College students of Complutense University of Madrid, diagnosed with frequent episodic or chronic tension-type headache (according to the criteria of International Headache Society (IHS)).

Exclusion Criteria:

* Cases with other headaches
* Students with excessive state anxiety and / or trait anxiety (≥ 85 percentile, State-Trait Anxiety Inventory )
* Students that had received treatment for tension headache, based on physical exercise or relaxation techniques, in the last 6 months.
Delta Variation to Guide Hemodynamic Optimization

intraoperative hemodynamic optimization will be based on the percentage of variation of the parameters


Eligibility Criteria:
Inclusion Criteria: All patients \> 18 years old scheduled for major abdominal

Exclusion Criteria:

Body Mass Index \> 35 kg/m2 Pregnancy Refusal to sign written informed consent Urgent and/or emergency surgery