cyrilzakka/clinical-trials huggingface dataset:
Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for Anterior Cruciate Ligament (ACL) Repair

About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the repairing and replacement of injuries of the anterior cruciate ligament. After less than 10 years it appeared that a relatively important number of patients showed complications on the basis of synovitis. The situation of another group of patients on the other hand evolved favourably without complications. The study to focuses on this group of patients and attempts to determine how the replacement without problems ab initio, evolved in the time.

It concerns a group of 57 patients who received an implantation in the UZ Ghent between November 85 and October 87 with the Stryker Dacron ligament and a group of 33 patients who received the Trevira ligament in the ASZ Aalst. The clinical result will be stipulated by means of standardized questionnaires and a clinical examination. The radiological result will be determined by the degree of integrity of the ligament that was implanted at the time. In this way the study could give an idea about the degree in which the technical success of the intervention correlates with the clinical success 20 years later.


Eligibility Criteria:
Inclusion Criteria:

* Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
* Max age: 75
* Min age: 49
* Minimum follow up: 22 years
Study to Evaluate the Efficacy and Safety of Aripiprazole

* To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder, as measured by change from baseline to endpoint on the irritability subscale of the aberrant behavior checklist (ABC-I).
* To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the treatment of serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder.

1. Study design

- Multi-national, Multi-center, 52 weeks open label, single arm design

Eligibility Criteria:
Inclusion Criteria:

* 6 to 17 years of age.
* Meeting the diagnostic criteria for autistic disorder specified by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), with a diagnosis corroborated by the Autism Diagnostic Interview-Revised (ADI-R) diagnostic instrument and demonstrated behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these.
* Clinical Global Impressions (CGI) Severity subscale score ≥ 4 at screening and baseline.
* Aberrant Behavior Checklist (ABC) Irritability subscale score ≥18 at screening and baseline.
* Mental age ≥ 18 months.
* Women of childbearing potential (WOCBP) have to use an adequate method of contraception
* WOCBP must have had a negative serum or urine pregnancy test.
* The patient and/or the designated guardian(s) or caregiver(s) who are able to comprehend and comply with the protocol requirements, in the opinion of the investigator and have consented to participate by signing an informed consent form.

Exclusion Criteria:

* Current diagnosis of bipolar disorder, schizophrenia, major depressive disorder, Rett's disorder, or Fragile-X syndrome.
* History of neuroleptic malignant syndrome.
* Significant risk of committing suicide based on history or routine psychiatric status examination.
* History of seizure in the past 1 year.
* History of severe head trauma or stroke
* History or current evidence of any unstable medical conditions
* Patient considered treatment resistant to neuroleptic medication
* Patient considered treatment resistant to aripiprazole
* Woman who is pregnant or breastfeeding
* ECG: QTc \> 475 msec
* Platelets ≤ 75,000/μL
* Hemoglobin ≤ 9 g/dL
* Neutrophils ≤ 1.0x10\^3/μL
* Aspartate or alanine transaminase (AST or ALT) \> 3xULN
* Serum creatinine ≥ 2 mg/dL
* Patient weighed \< 15 kg
* Patient who participated in any other clinical trial within 4 weeks
* Patient determined to require the administration of the prohibited medications during the study period
* Patient with other conditions determined by the investigator to be inappropriate for this clinical study
SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia

This study was designed to compare the \[123\]I-CNS 1261 binding to NMDA receptor between healthy volunteers and different subgroups of schizophrenic patients. Investigation of the potential influence of antipsychotic and concomitant medication on \[123I\] CNS 1261 binding is also relevant.Fifteen healthy subjects (male and female of non-child bearing potential) will be recruited and 40 schizophrenic patients divided in 3 subgroups as indicated before: Subgroup a) treatment-naive, (n=10); Subgroup b) on stable treatment with risperidone (without criteria of deficit syndrome on the SDS scale, (n=15);Subgroup c) on stable treatment with risperidone fitting criteria of deficit syndrome on the SDS scale, (n=15).


Eligibility Criteria:
Inclusion criteria:

* Right-handed
* Smoker
* Healthy volunteer or schizophrenic patients as diagnosed by DSM IV criteria.
* Treatment naive patients or with Risperidone treatment for 2 months that have not received any depot neuroleptic during the last year.
* Women of childbearing potential must agree to acceptable method of birth control.

Exclusion criteria:

* Any clinically or laboratory significant abnormality.
* Subjects receiving a radiation dose from other activities of more than 10 mSv over any 3 year period.
* Heart pacemaker, metallic prosthesis or other metallic body implants.
* History or presence of CNS conditions.
* History of substance dependence.
* History of or suffers from claustrophobia.
* Positive test for HBV (hepatitis B virus), HCV (hepatitis C virus) or HIV.
* Pregnant or lactating women.
The Inner Ear Function in Psoriatic Patients

Psoriasis in a systemic disease that effects many systems of the body. few studies examined the hearing function of these patients but the results were inconclusive. No study, however, investigated the vestibular function of psoriatic patients.

In a prospective study, the investigators will compare audiovestibular function between psoriatic patients and healthy volunteers. .

Whether psoriatic patients have higher risk for developing inner ear dysfunction (hearing loss and dizziness) is an important issue that needs to be elucidated. Awareness to the elevated risk (if there is any) of inner ear impairment, early detection and treatment of the condition may reduce the morbidities resulting from undiagnosed audiovestibular impairment.

In a prospective study the investigators will examine the inner ear function (vestibular and auditory) of psoriatic patients and compare it to an healthy, young control group.

The study will include 2 groups of participants: psoriatic patients and healthy volunteers. psoriatic patients are recruited from the dermatology clinic while the healthy volunteers are members of the hospital staff.

The participants will undergo 2 sets of examinations:

1. auditory function examination: hearing test (that includes pure tone audiometry, speech audiometry and discrimination level), tympanometry and otoacoustic emissions.
2. vestibular function examination:

   * Video head impulse test: a ten-minute, non- invasive test that includes a computer and a set of goggles worn by the participant. The participants is sitting in front of a wall while wearing the goggles, the investigator moves the participant's head sideways with short, rapid movements. the computer calculates the accuracy and the velocity of the eyes movements.
   * The participants fills a dizziness handicap inventory questionnaire. The participants from the psoriatic group are recruited from the dermatology clinic. The healthy group participants are members of the hospital staff and are recruited from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Psoriatic patients that are treated in our institute.

Exclusion Criteria:

* Patients suffering from cardiovascular diseases (peripheral vascular disease,congestive heart failure, status post cerebrovascular accident).
* Conditions that are harmful to the inner ear (chronic renal failure,history of noise exposure, usage of ototoxic drugs, chronic otitis media, ear surgery in the past, significant head trauma in the past, ear drum perforation).
* participant that complains of vertigo/ dizziness/ unsteadiness.
* Participant who is/ was suffering from known inner ear disease: meniere disease, acoustic neurinoma, vestibular neuronitis.
Obstructive Sleep Apnoea in Patients With Intermittent Claudication

The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

In patients with peripheral artery disease (PAD), exercise induced limb ischemia (claudication) which limits walking capacity. Symptoms are due to pain at hip and/or buttock. Couple of origins may induce this pain such as vascular, cardiac, respiratory, musculoskeletal, neurologic, hematologic etc. The rate of associated respiratory pathology to patients with lower extremity artery disease (LEAD) is around 15%. The intolerance to walk could be link to an exercise hypoxia which appears with lower limb pain with or without associated dyspnea. The exercise hypoxemia becomes a diagnostic for an intermittent vascular claudication. Tests which are performed to diagnose an intermittent claudication are the Ankle to Brachial Systolic pressure Index (ABI), the echo-Doppler of lower limb arteries and the walking test on a treadmill associated to a measurement of the distal and chest transcutaneous oxygen pressure (tcpO2).

Thus, the purpose of the present research is to determine the prevalence of obstructive sleep apnoea in patient with PAD.

Eligibility Criteria:
Inclusion Criteria:

* Register to the social health insurance
* Referred for a walk test because of claudication
* Maximal walking ditance \< 750m
* Older than 18 years old
* Able to understand the protocol of the study

Exclusion Criteria:

* Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months inclusion
* Severe reparatory disease already known
* Parkinson disease, hémiplégia ou paraplégia
* Does not want to participate to the protocol
* Pregnant women
* Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research
* Being in a period of exclusion from another biomedical study
Serious Game Therapy in Neglect Patients

The growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. Investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency. Twelve patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Six patients assigned to a group received both serious game training and conventional rehabilitation, and after only conventional rehabilitation; and six patients assigned to another group received first conventional rehabilitation and then serious game training and conventional rehabilitation. The investigators compared the two groups after rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral spatial neglect syndrome
* Right cerebral lesion

Exclusion Criteria:

* Epilepsia
* General mental deterioration
* Psychiatric disorder
* No prior history of neurological disease
A Drug-Drug Interaction Study of Furosemide and PA21

The purpose of this study is to determine if Furosemide is affected by PA21.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Written informed consent

Exclusion Criteria:

* No significant medical conditions
* Pregnancy
Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis

The aim of the study was to assess the safety, acceptability, and efficacy of product GV-328 for the treatment of childhood oral aphthous lesion.

Prospective study carried out in the Pediatric Dentistry Department of the International University of Catalonia. The sample was made up of children between 3 and 13 years old. Baseline pain status, functional limitation, edema and lesion diameter were evaluated. The treatment lasted 4 days. The parents recorded the intensity of the pain and the number of pills provided daily. Statistical significance was accepted with p≤0.05 and a 95% confidence interval.

A total sample of 33 patients, 11 boys (33 %) and 22 girls (67 %) was obtained. The average age of the children was 7.8 years (SD: 1.41). Numerical variables referring to pain, inflammation and edema presented statistically significant improvements (p-value \<0.05). Healing efficacy was demonstrated in 13 cases (39 %) and only 3 cases (9 %) reported poor taste acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 3-13 years.
* Children who presented canker sores.

Exclusion Criteria:

* Patients who presented canker sores with 48 h of evolution.
* Patients with diabetic disorders.
Effect of Group Led Creative Writing on Mood in Cancer Patients

The primary purpose of this study is to determine whether creative writing in newly diagnosed cancer patients and those with recent progression in their disease will have a positive impact on their mental health. Using a randomized controlled trial approach, emotion thermometers will be employed to evaluate participants' responses on a number of domains, such as anxiety, depression, despair, and anger along with a series of survey questions to monitor changes in depressive and anxiety symptoms. Open-ended survey questions will be used to capture how a creative writing intervention impacts participants' experience of their illness. Melissa Greene's Write from the Heart program focuses more on creative writing rather than cancer focused topics. Patients in the intervention arm will complete -one and a half hour group sessions every two weeks over the span of 3 months. Participants in the active control arm will be provided a book (i.e., Writing Down Bones by Natalie Goldberg) about creative writing and will be asked to do activities for 1.5 hrs every 2 weeks for a period of 3 months.

Mental wellness before and after intervention in both arms. A validated Emotional Thermometer Scales will be used to predict changes in parameters reflecting participants' mental health pre- and post-intervention. Survey questions focused on symptoms of depression and anxiety will be used to monitor for changes in mental wellness pre- and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed with any stage or type of cancer within 3 months OR progression of disease within 3 months of enrollment. Recurrence of cancer within 3 months of enrollment would also be eligible as it will be considered as progression of cancer Ability to understand English language and ability to write without any functional difficulty ECOG performance status 0-3

Exclusion Criteria:

Inability to give informed consent Severe psychiatry illness (e.g., uncontrolled depression, schizophrenia or psychosis) Severe cognitive impairment Pregnant females Inability to write or understand English
Development of Small Airway Disease Questionnaire

The aim of this study is to develop a patient reported outcome tool specific to small airways disease, which assesses symptoms and signs of small airways disease and may help in addition to FEF50% to discriminate between asthmatic patients with and without small airways disease.

Inflammation of the small airways contributes to the severity of the disease and affects the quality of life of patients with asthma. However, the exact role and relevance of small airways disease in asthma is still unclear. This is partly due to the difficulty of measuring small airways pathology with a sensitive and specific parameter. The most commonly used variable as an indicator of small airway obstruction is the FEF50%. Currently, it is not known which clinical symptoms are associated with small airways disease and how a patient will perceive small airway abnormalities. This knowledge is important to assess small airways disease in patients with asthma and adjust therapy to improve quality of life.The primary purpose of this study is to develop a questionnaire for patients with asthma with and without small airways disease for general and specialist practice.

Eligibility Criteria:
Inclusion Criteria:

* A doctor diagnosis of asthma
* Age: ≥ 18 and ≤ 75 years
* An FEF50% value that is included in either the lowest or the highest 25th percentile. (Percentiles based on the total asthma patient group present from Asthma/COPD service)

Exclusion Criteria:

* Recent exacerbation of asthma (\<2 months) or upper respiration tract infection (\<2 weeks)
* Severe airway obstruction at baseline, FEV1pred\< 50% or \< 1.2L
* Diagnosis of COPD or another pulmonary disease
* Pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator).
* Restriction, defined as FVC \< 80%pred with FEV1/FVC \>0.7
Limited Market Release - MotionSense Clinical Use Evaluation

Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.

During the proposed study, the MotionSense wearable system will be used by patients undergoing total knee arthroplasty (TKA) surgery leading up to and after their surgery. The patients will be using the system to monitor their recovery during daily activities, log daily pain scores and patient reported outcomes while also supporting their prescribed home exercise program. Each patient will thereby participate in outpatient physiotherapy in line with their current standard of care, while the physiotherapist will leverage the opportunities of the presented platform to give the patient personalized reminders for their patient-specific home exercise program. The surgeon / research nurse will additionally be able to monitor the patients recovery remotely as the sensor / app data is shared to the OrthoLogIQ platform.

Eligibility Criteria:
Inclusion Criteria:

* Planned for unilateral total knee surgery in the coming 4 weeks
* Age 50 to 80
* Owns a smart phone

Exclusion Criteria:

* BMI exceeding 35
* Severe skin conditions
Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET

Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has proved effective and cardiac biopsies have a very low sensitivity. 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of fasting has previously been demonstrated to have reasonable accuracy, however, in some patients physiological FDG uptake in the cardiac region hampers correct identification of sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue Nal3-octreotide (NOC) and gallium Ga 68-labeled 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether 68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with 18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.

Intervention:

* Study A: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement (prone to arrhythmias, cardiac failure, unexplained dyspnea) are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 18-FDG PET performed during a 2 hour somatostatin blockade (300 microgram/hour)/Heparin infusion.
* Study B: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement are studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 68Ga-DOTANOC PET preceded by at least 6 hours fasting.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven sarcoidosis
* Suspected cardiac sarcoidosis

Exclusion Criteria:

* Ischemic heart disease
* Diabetes
* Cardiomyopathy
A Degarelix Trial in Patients With Prostate Cancer

A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.

CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920).

In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).

It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms).

The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.

Eligibility Criteria:
Inclusion Criteria:

* Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
* Has completed the CS35 trial.

Exclusion Criteria:

* Has been withdrawn from the CS35 trial.
* Has had end of trial visit in CS35 prior to approval of the CS35A protocol.