cyrilzakka/clinical-trials huggingface dataset:
Clinical Implications of Genetic Variations of Venous Stasis Ulceration

Currently, there is no standard approach for the treatment of patients with venous stasis ulcers, and no means of accounting for the genetic factors that may contribute to a patient's response to different therapeutic interventions. In order to determine whether, or to what extent, genetic profiling of venous stasis ulcers can stratify patients according to their potential for disease progression or healing, and guide preventive strategies and levels of therapeutic interventions, the study will involve retrospective genetic profiling of patients with a healed or persistent venous stasis ulcer as a means of determining the efficacy of current therapies, and to establish a future prospective evaluation of treatment algorithms based on genetic phenotype and variation. Results obtained from the 2 aforementioned groups of participants will be compared with those of a control group of participants who have no history of venous ulcer nor peripheral vascular disease.

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A blood specimen will be drawn, medical and medication history taken, and wound/s will be assessed and followed for 2 years in regard to the enrollees w/active venous ulcer/s or healed venous ulcer/s.

A venous duplex ultrasound of right and left lower extremities will be done at no cost, a blood specimen will be drawn, and medical and medication history will be taken in regard to control group enrollees.

Eligibility Criteria:
Group 1-Active venous ulcer (CEAP 6) \& Group 2-Healed venous ulcer (CEAP 5)

Inclusion Criteria:

* \>/=18y.o.
* active venous ulcer (CEAP 6)
* healed venous ulcer (CEAP 5)

Exclusion Criteria:

* \<18 y.o.
* inability to comply w/compression therapy
* Inability to maintain f/u schedule
* ABI (ankle-brachial index) \< 0.5 if pedal pulses are not palpable
* Inability to ambulate w/active ulcer (N/A for Group 2)
* Diabetic w/ABI \<0.5
* Severe premorbid systemic disease such as pulmonary failure, heart failure, renal failure, or hepatic failure w/a life expectancy of \<1 year
* Chronic steroid therapy Group 3-Controls

Inclusion Criteria:

* \>/= 50y.o.
* no reported clinical symptoms of venous disease
* (CEAP 0 or 1)

Exclusion Criteria:

* \<50y.o.
* ABI (ankle-brachial index) \< 0.5 if pedal pulses are not palpable
* Diabetic w/ABI \< 0.5
* Severe premorbid systemic disease such as pulmonary failure, heart failure, renal failure, or hepatic failure w/a life expectancy of \<1 year
* Chronic steroid therapy
Developement and Evaluation of Serological Assays for COVID-19

The primary objective of the study aims to evaluate serological assays of virus Covid-19.

This is a retrospective monocentric study, which will include the patients who have hospitalized in Ambroise Paré Hospital and have sampling sent to the Laboratory of Microbiology of the hospital between the 15 March 2020 and 30 september 2020.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years;
* Have molecular diagnosis of positive or negative result in Covid-19 virus by the Laboratory of Microbiology in Ambroise Paré Hospital;
* Have diagnosed of a viral infection in respiratory.

Exclusion Criteria:

- Patient refusal.
The Internet Therapy for Depression Trial

The objective of this trial is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) interventions tailored towards the treatment of depression and chronic pain using a doubly-randomized, attention-controlled, non-blinded, patient-preference design.

The primary objective is to collect data on the feasibility, acceptability, and preliminary effectiveness of internet delivered Cognitive Beaviour Therapy (iCBT) and Acceptance and Commitment Therapy (iACT) on depressed mood among individuals with chronic pain relative to attention control (AC). The secondary objectives are to evaluate the efficacy of iCBT and iACT on clinically relevant outcomes endorsed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). Adults with chronic non-cancer pain and major depression will be randomized to receive iACT, iCBT, or AC. The interventions comprise 7 weekly online modules available through Therapist Assisted Online (TAO). Patients will be contacted weekly by a member of the study team who will be acting as their personalized "online therapy coach."

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* 18 years of age or older
* have a primary diagnosis of chronic non-cancer pain.
* meet DSM-5 criteria for a diagnosis of major depressive disorder
* have access to the internet, email, and telephone
* can commit to the demands and timelines of the trial.
* Given high comorbidity in this population, patients with sleep disturbance or comorbid anxiety will also be eligible to participate.

Exclusion Criteria:

* diagnosis of cognitive impairment (e.g., dementia)
* active suicidal ideation
* severe psychopathology (e.g., schizophrenia)
* unable to sign a safety contract for the duration of the trial
* concurrent participation in psychotherapy.
Tolcapone Treatment of Pathological Gambling

The goal of the proposed study is to evaluate the efficacy and safety of tolcapone in pathological gambling.

The proposed study will consist of 8 weeks of treatment with tolcapone in 10 subjects with pathological gambling. The hypothesis to be tested is that tolcapone will be effective in reducing the urges to gamble in patients with pathological gambling. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women age 21-75;
2. Meet diagnostic criteria for current pathological gambling based on DSM-IV criteria and confirmed using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (Grant et al., 2004);
3. Gambling behavior within 2 weeks prior to enrollment;
4. Women of child bearing age are required to have a negative result on a beta-human chorionic gonadotropin pregnancy test;
5. Women of childbearing potential utilizing a medically accepted form of contraception defined as double barrier, oral contraceptive, injectable contraceptive, implantable contraceptive devices, and abstinence.

Exclusion Criteria:

1. Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG;
2. Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, or physical examination at screen as determined by the investigator;
3. History of elevated liver enzymes (AST/ALT) or other liver abnormalities;
4. History of seizures;
5. Myocardial infarction within 6 months;
6. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
7. A need for medication other than tolcapone with possible psychotropic effects or unfavorable interactions as determined by the investigator;
8. Clinically significant suicidality (defined as score 2 or higher on HAM-D item 3);
9. Current co-morbid Axis I disorder determined by the Structured Clinical Interview for DSM-IV (SCID), (First et al., 1995) - except for nicotine dependence;
10. Lifetime history of bipolar disorder type I or II, schizophrenia, or any psychotic disorder determined by SCID;
11. Clinically significant cognitive impairment (defined as score less than 88 on 3MS);
12. Current or recent (past 3 months) DSM-IV substance abuse or dependence;
13. Positive urine drug screen at screening;
14. Initiation of psychotherapy or behavior therapy for pathological gambling within 3 months prior to study baseline;
15. Previous treatment with tolcapone;
16. Treatment with an investigational medication or depot neuroleptics within 3 months;
17. Refusal to sign the tolcapone information sheet.
TyG Index Levels in Klinefelter Syndrome

It is well known that the frequency of cardiometabolic diseases are increased in patients with Klinefelter Syndrome. The triglyceride-glucose index (TyG index) is a simple surrogate marker of insulin resistance and is also associated with various cardiometabolic diseases. The aim of this study to investigate the TyG index levels and its relationship with insulin resistance and endothelial dysfunction in patients with KS.

From the patient database of our Endocrinology department we randomly included a total of 30 patients with KS and 32 healthy controls in the study. All the recorded data in the database were registered under the approval of Local Ethical Committee of Gulhane School of Medicine.

The clinical and laboratory parameters, TyG index, asymmetric dimethylarginine (ADMA), homeostatic model assessment of insulin resistance (HOMA-IR) and high-sensitivity C-reactive protein (hs-CRP) levels were gathered from the database and the triglyceride-glucose index was calculated by the help of pre-measured laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a verified Klifelter Syndrome karyotype (all subjects included were 47, XXY) and who were not previously given testosterone replacement.

Exclusion Criteria:

* age \<18 years,
* acute infection, malignancy, any visceral organ dysfunction, nutritional derangements, clinical history of cardiovascular disease, cerebrovascular disease, drug use such as antidiabetic or lipid-lowering medications, or those lacking complete clinical data.
Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan

This study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis.

This prospective, observational cohort study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis from a hospital in Lankien, South Sudan.

Eligibility Criteria:
Inclusion Criteria:

* Primary visceral leishmaniasis patients who had a confirmed (serological and/or parasitological) diagnosis at admission, and who were discharged after successful treatment
* Availability for follow up visits
* Provision of informed consent, and in the case of minors 12 to 17 years of age, assent as well

Exclusion Criteria:

* Unavailability for follow-up visits due to distance, inaccessibility, or refusal to participate
* Diagnosis of prior primary visceral leishmaniasis done only on clinical basis
RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants

The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission

411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Born in San Francis Designated District Hospital of Ifakara

Exclusion Criteria:

* Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus
* Twins
* Birth weight \< 1,5 kg
* Clinical signs of cerebral asphyxia
* Clinical signs of neonatal or congenital infection
* Mother unreliable (deaf, mentally handicapped)
Performance During Menstrual Cycle

This project aims to investigate if muscle strength and muscle power fluctuate during the menstrual cycle.

The hypothesis is that the greatest performance will be measured right before ovulation, and at it's lowest on day 1 and 2 of the menstrual cycle in women not using any form for hormonal protection.

And that the performance in women using birth control pills, not will variated in the period where they are taking pills (day 1-21).


Eligibility Criteria:
Inclusion Criteria:

* Women
* 18-35 years of age
* BMI 18.5-25.

Exclusion Criteria:

* Smoking
* hormonal or metabolic disorders
* chronic sickness
* use of medication
* breast feeding, vegetarians
* diet containing a lot of soja based products
* injuries which make it impossible to do the tests
Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes

To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age \> 18 years
* Primary inguinal hernia
* Unilateral hernia
* Elective surgery

Exclusion Criteria:

* Recurrent inguinal hernia
Social Web Mining for Suicide Prevention

According to a recent and alarming WHO (World Health Organisation) report (September 4, 2014), one person dies of suicide every 40 seconds in the world. Suicide is the third-leading cause of death for 15- to 24-year-olds, according to the Centers for Disease Control and Prevention , after accidents and homicide.

This major public health issue need prevention strategies especially directed to at-risk populations. Since 2013, more than 2 billion users are enrolled in social networks such as Twitter or Facebook. Young adults (ages 18 to 29) are the most likely to use social media - fully 90% do.

Consequently, in this project, we focus on suicide prevention in social media network..

The aim of this project is the validation of the algorithm. This algorithm build a decision support system that monitor young people at-risk based on large volume of heterogeneous data collected through social media to improve suicide prevention.

This study is composed of two steps :

1. 9 subjects were recruited. After patients agreement, computer scientists were accessing to patient social network profile. Computer scientists were not able to visualize the content of publications, just run the algorithm that will analyse the content of messages (text, frequency, emoticons...)

   The algorithm defines the 3 most at-risk periods of suicide behaviors, on the next month. This result were compared to periods found by psychiatric interview. The psychiatrist then confirmed or not to LIRM whether periods found by the algorithm conrrespond to those defined by the psychitrist. No data of the social network were collected.
2. the 2nd step aim to improve the algorithm by collecting sociodemographic and clincal data related to patients included.

Eligibility Criteria:
Inclusion criteria:

* Major patient
* Minor patient with parents approval
* Patient hospitalized due to suicide attempt or suicide ideations
* Frequent active user of social netword (Facebook, Instagram, Youtube, Twitter)

Exclusion criteria:

- Patient's refusal to participate
Effects of Lumbar Transcutaneous Electrical Nerve Stimulation on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease is a leading cause of morbidity and mortality worldwide.

Pulmonary rehabilitation effectively improves outcomes in patients with chronic respiratory disease. There is a link between training intensity and physiological improvements following pulmonary rehabilitation. However, high intensity training is not sustainable for every patients.

Therefore, actual strategies for pulmonary rehabilitation aimed at decreasing dyspnea to improve muscle work.

Electrical muscle stimulation is widely used during rehabilitation to promote muscle function recovery. Transcutaneous electrical nerve stimulation was recently used to relief dyspnea and improve pulmonary function in patients with chronic respiratory disease. Moreover, spinal anesthesia with fentanyl has been shown to be effective in improving exercise tolerance in patients with chronic obstructive pulmonary disease (inhibiting group III and IV muscle afferents). As transcutaneous electrical muscle stimulation stimulates the same receptors in the spinal cord dorsal horn as fentanyl, it is hypothesized that it could also improve exercise capacity.

Therefore, the aim of this study is to assess wether transcutaneous electrical stimulation (high or low frequency) is effective in improving exercise capacity in patients with severe to very severe chronic obstructive pulmonary disease.

Design : cross-over.

Patients will perform three constant workload testing (CWT) on different days under three different conditions. The intervention during the tests will be randomly assigned (concealed allocation) :

* Sham transcutaneous electrical nerve stimulation ;
* High-frequency transcutaneous electrical nerve stimulation ;
* Low-frequency transcutaneous electrical nerve stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Chronic obstructive pulmonary disease Gold III-IV;
* Eligible for pulmonary rehabilitation;
* Never used electrical stimulation.

Non-inclusion Criteria:

* Pregnant woman or likely to be;
* Patient under guardianship;
* History of epilepsy, heart pace-maker or defibrillator, inguinal or abdominal hernia;
* Recent lumbar surgery or skin lesion;
* Allergy to surface electrodes;
* Lumbar sensitivity impairment;
* Opiate treatment during the last 3 months.

Exclusion Criteria:

* Acute exacerbation of chronic obstructive pulmonary disease
Residual Pain After Successful Implant of Metaphyseal Sleeves in Total Knee Arthroplasty

: Total knee revision arthroplasty is increasing in daily practice and will become more relevant in the years to come. Bone loss is a significant challenge in total knee arthroplasty (TKA) especially in revision procedures. Metaphyseal sleeves are widely used to bypass bone loss and improve stability. This study aims to report the results of primary and revision TKA (R-TKA) using metaphyseal sleeves.


Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they were older than 18 years and underwent a primary or revision TKA using cement-less metaphyseal sleeves, performed by the same senior surgeon

Exclusion Criteria:

* Patients were excluded from the final analysis if they did not have 18 months of minimum follow-up and if they were lost to the final control.
Male External Catheters' Comparison of Comfort and Efficacy

A Prospective, Randomized, Crossover, Single-blind, Single Center Healthy Volunteer Study conducted over 1 day, with 2 voids using the PureWick (PW) Male external catheter (MEC) vs. comparator Sage PrimoFit™. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter as compared to the comparator product.

In this prospective, post-market, crossover, single-blind, single center healthy volunteer study, healthy males will be randomized 1:1 to a treatment sequence using two devices (PureWick™ Male External Catheter and Sage PrimoFit™) and followed for 1 day through 2 voids. Approximately 50 participants will be enrolled in this study to obtain 44 evaluable subjects. This study is designed to assess the performance, comfort, and ease of use of the PW Male external catheter.

The purpose of this study is to provide clinical evidence to compare the effectiveness and comfort of PureWick™ Male against a comparator for non-invasive urine output management in patients with varying male anatomy. Specifically, the study will collect data about how the male external catheters perform when participants are positioned on their side using a turning wedge with the head of the bed elevated, mimicking common patient positioning in the hospital setting.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Male Patient ≥ 18 years old
2. Male anatomy at time of enrollment
3. Ability to speak and understand English
4. Willing to comply with all study procedures in this protocol
5. Able to independently void urine
6. Provision of signed and dated informed consent form

Exclusion Criteria:

1. Urinary incontinence which does not allow the subject to spontaneously void
2. Frequent episodes of bowel incontinence
3. Has Urinary Retention
4. Has any irritation, wound, open lesion, at the application site, on the genitalia, perineum, or sacrum
5. Recent surgery of the external urogenital tract, penis, or pubic area
6. Not able to comply with study procedures independently without required assistance
7. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study
Patient Reported Outcomes Reported Via PC / Tablet Home Versus Touch Screen at Hospital Among Patients With Arthritis

To investigate if electronic reporting of patient reported outcome measures from home is comparable to the traditional touch-screen solution to hospital among patients with rheumatoid arthritis and axial spondyloarthritis


Eligibility Criteria:
Inclusion Criteria

* Rheumatoid arthirtis OR axial spondyloarthritis
* Active treatment and monitoring of the Knowledge Center for Rheumatology and Spine diseases, Rigshospitalet, Denmark
* Patients must have reported patient reported outcome measures via DANBIOs touch-screen solution ≥ 3 times

Exclusion Criteria

* Impaired vision
* Non-Danish speaking
* No electronic device at home,, tablet or computer
Long Term Clinical and Radiographical Outcomes of Different Anterior Cruciate Ligament Reconstruction Techniques

The purpose of this study is to evaluate the long-term results of various anterior cruciate ligament reconstruction techniques. This assessment is necessary for the current context of anterior cruciate ligament research as several techniques and grafts are used in clinical practice, however, the various studies existing in the literature focus mainly only on the direct comparison of two techniques and usually with short-to-medium term follow-up. Since gonarthrosis is one of the most debated consequences of cruciate ligament reconstruction, a comparison of different long-term procedures would be desirable to have a clearer picture of the risks and benefits associated with different types of intervention.

In the beginning, the Database of our Institute is consulted, all the patients that underwent ACL reconstruction at least 15 years ago are selected. The original group will be divided into subgroups based on the surgical technique adopted, of the different techniques we took into consideration only these three: anatomical ACL reconstruction with patellar tendon, anatomical ACL reconstruction with hamstrings, non-anatomical ACL reconstruction "Over-the-top plus lateral plasty". The patients will be contacted to ask if they are interested to take part in the study; at least 25 patients for each group will be recruited. All the patients recruited will sign an informed consent about the study and the personal data treatment. After consent acquisition, patients will undergo a clinical examination and a questionnaire about pain and knee status will be administered; moreover, a radiographical examination of the operated knee will be performed to assess the osteoarthritis progression. Patients that reported graft rupture will be registered as failures.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent ACL reconstruction with single-bundle anatomical technique (patellar tendon, semitendinous and gracile tendons) or "Over-The-Top plus lateral plastic" technique and any associated procedures with at least 15 years of follow up;
2. Patients aged between 15 and 50 at the time of surgery;
3. Patients with isolated ACL tear;
4. Patients with healthy contralateral knee at the time of surgery.

Exclusion Criteria:

1. Patients with grade III-IV chondral lesions according to Outerbridge scale at surgery;
2. Patients no longer available;
3. Women of childbearing age who cannot exclude pregnancy;
4. Patients unable to give informed consent or patients unwilling to sign informed consent.