cyrilzakka/clinical-trials huggingface dataset:
Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

The primary objective of the study is to describe the different phenotyping of pain in systemic scleroderma patients and perturbations of mechanisms of the pain.

As secondary objectives, the study aims to describe the importances of overall symptoms in alteration of quality of life and conserve the questions which will be associated in a unique questionnaire in order to evaluate the pain, the fatigue and the sleeping disorders in diffused systemic scleroderma patients.

This is a prospective, non-randomized, controlled study.

Beside the routine care, the patients will have only one visit in the study during which the informed consent will be signed, also the following will be performed: pain evaluation, blood sampling, questionnaires and Sudoscan, test QST.

100 patients will be enrolled in total with 50 in each group (scleroderma with pain vs. scleroderma without pain, 1:1 ratio), the duration of inclusion is estimated for 23 months.

2 centers will be involved in the enrollment of patients: rheumatology department and interne medicine department of Cochin hospital-APHP. One center will perform the evaluations of pain for all patients: center of pain of Cochin hospital - APHP.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years;
* Patients with diffused SSc according to ACR / EULAR Classification 2013 since at least 3 months;
* For group pain: pain intensity ≥4 of 11 points of scale (NRS);
* For group painless: pain intensity on the month before inclusion.

Exclusion Criteria:

* Patients unable to understand french language;
* Patients no-affiliated to the french social security scheme;
* Patients under the french AME scheme;
* Patients under guardianship;
* Pregnant and breastfeeding patients;
* Patients with thermoalgesic neuropathy;
* Articular pain from degenerative diseases (known osteoarthritis);
* Patients under antidepressant;
* Temporary discontinuation of analgesics which are not well tolerated.
Is Endothelial Function a Predictor of Successful Ablation Therapy Provided to Patients With Atrial Fibrillation?

The purpose of this study is to assess whether normal endothelial function in patients with Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable clinical outcome and maintaining sinus rhythm following ablation

In the recent years, increasing evidence is linking inflammation to AFib. In addition, it has been shown that ablation improves endothelial function, suggesting that AFib might be associated with the etiology of endothelial dysfunction.

The objective of this study is to assess endothelial function using Endo-PAT2000 and its correlation to clinical outcome following ablation of patients with Atrial Fibrillation (AFib).

Eligibility Criteria:
Inclusion Criteria:

* All patients with AF considered eligible for ablation treatment may be included in this study (following unsuccessful attempts with AAD).
* Patients on optimal anticoagulation therapy
* The minimum AF documentation required as defined by the Heart Rhythm Society

Exclusion Criteria:

* Patients age below 18 years
* Cases with extremely abnormal anatomy (i.e., inverted heart)
* Moderate or severe mitral valve disease or mitral prosthetic valve
* Ejection fraction less than 30%
* Left atrial anteroposterior diameter more than 50 mm evaluated by echo or CT data (up to 6 months old)..
* Previous atrial fibrillation ablation occurred less than 6 months prior
* Left atrium thrombus
* Acute infective disease or sepsis in the last 3 months
* Acute myocardial infarction in last 3 months
* Reduced expectancy of life (less than 12 months)
* Patient participating in another clinical study that investigates a drug or device unless prior approval is given by the sponsor
* Psychologically unstable patient or denies to give informed consent
* Deformities of the digits of the upper extremities, which preclude adequate signal acquisition
* Patients under the effect of short-acting Nitroglycerin (3 hours washout period)
* Patient suffering from a medical condition prohibiting blood flow occlusion in both arms
CBT in Patients With Medication Overuse Headache

According to the definition from International Headache Society, medication overuse headache (MOH) is diagnosed when patients takes painkillers for more than 10 or 15 days per month (depending on what kind of painkillers being used), for more than 3 months, which results in the deterioration of headache. The treatments of MOH include preventive medication of headache and withdrawal of the overused painkillers. Other than the simple oral advice, some researchers recommended non-pharmacological methods. Pryse-Phillips et al. (1998) reviewed the the treatment of migraine and suggested that biofeedback, relaxation, cognitive behavior therapy (CBT), psychological therapy, hypnosis and physical treatment are effective. Researches also point out CBT is effective on withdrawing medication in patients with MOH (Kroner-Herwig, 2009). Lake (2006) reported that behavioural therapy maybe an adjunct therapy to preventive medication to reduce the relapse rate of medication overuse.

The purpose of this study is to confirm the effect of CBT in patients with MOH. The target is to reduce the frequency of headache and use of painkillers. Patients could benefit from the education and relaxation training during CBT to cope with headache and reduce the use of painkillers.

The research will recruit 60 patients with MOH at Neurology Clinics, Far Eastern Memorial Hospital. They will be separated into two groups, 30 in control group and the other 30 in the experimental group. Education of MOH, relaxation and cognitive restructuring would be included in the four weeks training program. The training program is under the supervision of a neurologist from Far Eastern Memorial Hospital and a psychology professor from Fu Jen Catholic University. The control group will accept four weeks telephone interview to confirm their headache diary including the frequency of headache and use of painkillers. The frequency of headache and medication use will be used for analyzing the effect of CBT.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Medication overuse headache

Exclusion Criteria:

* other type headache
Wound Inflammatory Cells After Cardiac Surgery

One hundred patients, aged from 41 to 78 years, underwent open heart surgery in the years 1998-1999 and were studied by using the Cellstick device for harvesting wound inflammatory cells during the first 24 hours after surgery. The results of the differential count were computerized by using artificial neural network for obtaining wound inflammatory cell node (WICN). The patients were followed up for sixteen years or to the death. WICN values were compared with the patients´ survival.


Eligibility Criteria:
Inclusion Criteria:

* Elective operations

Exclusion Criteria:

* Urgency operations
Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis

The goal of this clinical trial is to evaluate the combined effects of radial extracorporeal shockwave therapy (rESWT) and evidence-based physical therapy (EBPT) interventions for patients with adhesive capsulitis. The main questions it aims to answer are:

What is the effectiveness of combining rESWT with EBPT interventions for the management of adhesive capsulitis compared to EBPT alone? How does the combination of rESWT and EBPT affect pain, range of motion, and functional outcomes in patients with adhesive capsulitis?

Researchers will compare rESWT plus EBPT to a sham rESWT plus EBPT to see if rESWT provides better results for subjects with adhesive capsulitis.

The study will randomly assign participants to receive either rESWT plus EBPT or sham rESWT plus EBPT over a 6-week intervention period. The primary outcomes will be pain and disability, while secondary outcomes will include shoulder range of motion, psychological distress, and health-related quality of life. These outcomes will be assessed at baseline, post-intervention, and 12 weeks post-randomization.


Eligibility Criteria:
Inclusion Criteria:

* Having a relapsed or episode of pain score ≥5 at the assessment with a past history of pain for at least 2 weeks.
* phase 1 or 2 frozen shoulder confirmed by a physician
* ROM restriction (\>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)
* no treatment other than analgesics with unresponsive ROM restriction for the past 2 months
* unwilling or waiting and did not undergo joint injection
* Diagnosed with shoulder adhesive capsulitis,
* ≥18 years
* Diabetes mellitus

Exclusion Criteria:

* bilateral shoulder involvement
* History of previous surgery on the shoulder
* Shoulder fracture
* Cancer
* Glenohumeral or Acromioclavicular arthritis
* Inflammatory disorders
* Bleeding disorders
* Presence of severe osteoporosis
* Pulmonary diseases
* Any neuromuscular disorders
* Pregnancy
* Implanted pacemaker
Diagnosis of Mucopolysaccharidosis Disorders in Patients Presenting With Bilateral Hip Disease

BACKGROUND/OBJECTIVE: Quantitative urine screening for mucopolysaccharides (MPS) has been the primary method for detecting mucopolysaccharidoses in children. This method may not be sufficiently sensitive and may miss some patients with arylsulfatase B (ARSB) deficiency. Investigators propose to identify patients retrospectively and prospectively who carry a diagnosis of spondyloepiphyseal dysplasia, multiple epiphyseal dysplasia, bilateral proximal femoral epiphyseal dysplasia, or bilateral Legg-Calve-Perthes. For these patients, investigators will perform enzyme testing on a blood sample which will identify MPS VI or IVA.

Patients who have an earlier diagnosis of MPS are likely to have better health outcomes with medical management. Therefore, it is important to determine effective diagnostic methods. Investigators believe that bilateral hip involvement should alert the clinician to the possibility of MPS VI and further examination. The purpose of this study is to test the hypothesis that the correct diagnoses of two MPS storage disorders are delayed in patients with bilateral proximal femoral epiphyseal dysplasia and normal quantitative urine MPS studies.


Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 21 years of age
* Diagnosis of spondyloepiphyseal dysplasia or multiple epiphyseal dysplasia or bilateral Legg-Calve-Perthes disease or bilateral proximal femoral epiphyseal dysplasia.

Exclusion Criteria:

* Definitive etiology for above-mentioned diagnosis (i.e. other MPS disease, known chondrodysplasia, Meyer's dysplasia)
Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis

Pulmonary inflammation is an independent risk factor for disease progression in cystic fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several inflammatory diseases. As children with CF have different faecal microbiota from their healthy siblings, modulating gut microbiota by lactobacillus rhamnosus diet supplementation might be a strategy to target the inflammatory state in CF. Study subjects (CF or healthy control) will receive either placebo or lactobacillus rhamnosus once daily as dietary supplementation for 12 weeks. After a one-week washout phase, they will be switched for another 12 weeks to the other trial arm. Effect on in intestinal and pulmonary inflammation as well as clinical outcome will be studied.


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe CF disease

Exclusion Criteria:

* acute gastroenteritis 2 weeks prior to inclusion
* chronic disease other than CF (except CF associated disorders)
* oral or parenteral antibiotics 2 weeks prior to inclusion
* systemic steroids 4 weeks prior to inclusion
* any probiotic intake
Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.

This study is designed to show if Carraguard® can protect women against HIV if it is used before sex, and is safe for long-term use.

Eligibility Criteria:
Inclusion Criteria:

* HIV negative and agree to be tested for HIV and told their results at all visits during the study
* Aged 16 - 40 years of age
* Have had at least one vaginal intercourse within the last three months
* Willing and able to give written informed consent (or if desired, consent provided by parent or guardian with written assent from the minor participant)
* Provide locator information to study staff throughout the trial
* Comply with all aspects of the study protocol, including random assignment to the Carraguard® plus condom or placebo plus condom arm, clinical valuations, specimen collection and testing, visit schedule and study drug regimen
* Citizen or permanent resident of South Africa
* Resident for the past year and intends to reside in the catchment area of the site for the next two years
* During the study, will not use any vaginal products except tampons or those prescribed or approved by the study clinician.

Exclusion Criteria:

* Currently pregnant, or indicate a desire to become pregnant in the next two years at the time of screening
* Within four weeks of last pregnancy outcome at the time of enrolment
* Pap smear at screening is graded as carcinoma.
* Injected illicit drugs in the 12 months prior to screening
* Participating in any other clinical trial/HIV prevention study
Evaluation of the Effect of a Probiotic in Patients Undergoing Orthodontic Therapy

Orthodontic patients need supplementary oral hygiene tools in addition to professional oral hygiene. The aim of this study is to evaluate the effects of Bifidobacterium animalis subs. Lactis HN019 on plaque accumulation and gingival bleeding in orthodontic patients.


Eligibility Criteria:
Inclusion Criteria:

* age range of 10 to 30 years old;
* good general health;
* patients undergoing fixed multibracket orthodontic treatment;
* patients undergoing invisible aligner orthodontic treatment.

Exclusion Criteria:

* physical, mental or motor disabilities;
* systemic conditions that influence the progression of gingivitis;
* presence of non-plaque-induced gingivitis;
* known allergies;
* smokers (if more than 5 cigarettes per day);
* use of antibiotics, anti-inflammatories, or probiotics in the 6 months prior to recruitment.
The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

To explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the rectum；
* The clinical stage evaluated by MRI was T3-4 and/or N+ and M1a(only liver metastasis)；
* ECOG PS 0-2；
* CHild Pugh A；
* Estimated survival ≥3 months;
* Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;
* Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;
* Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.

Exclusion Criteria:

* Pregnant or lactating women;
* No previous antitumor therapy；
* No previous liver local therapy；
* No contraception during the reproductive period;
* patients known to have a history of allergy to any study drug, similar drug or excipient;
* Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
* Patients with a history of thromboembolism, except those caused by PICC;
* Patients with active infection;
* Other conditions that the investigator determines are not suitable for inclusion in the study.
Mechanisms of Pulmonary Diffusion Limitation in Systemic Sclerosis

This study was designed to test the hypothesis that, irrespective of the degree of interstiaI lung disease and/or pulmonary arterial hypertension, the combined measurement of lung diffusing capacity for nitric oxide and carbon monoxide, might be useful to provide a mechanistic interpretation of changes of diffusion subcomponents in systemic sclerosis (SSc).

In systemic sclerosis (SSc) the impairment of lung function is generally inferred from measurements of forced vital capacity (FVC) and standard lung diffusing capacity for carbon monoxide (DLCO). However, FVC measurement does not provide an accurate estimate of lung restriction and DLCO does not allow separate the alveolar membrane (DMCO) from erythrocyte (DeCO) diffusive conductance for CO. Previous studies have shown that DMCO and DeCO may change irrespective of overt intersitial lung disease (ILD) and/or pulmonary arterial hypertension (PAH). These changes may be consistent with a limitation of alveolar-capillary erythrocyte recruitment which impairs DM.This study was designed to test the hypothesis that, irrespective of the degree of ILD and/or PAH, combined DLNO-DLCO measurement might be useful to provide a mechanistic interpretation of DM and De changes in SSc.

Eligibility Criteria:
Inclusion Criteria:

* patients fulfilling the 2013 American College of Rheumatology/European League Against Rheumatism criteria for a definite diagnosis of SSc with a total score ≥9

Exclusion Criteria:

* unstable subjects and/or who have suffered from respiratory exacerbations in the previous 4-wk
Genetic Frontotemporal Dementia Initiative for Neurodevelopment

This is an international multi-centre cohort study of first and second degree family members of individuals who carry Frontotemporal Dementia (FTD) mutations in MAPT, GRN or C9ORF72 repeat expansions for youths between the ages 9-17.

GENFI-NeuroDev will study genetic FTD and its associated disorders (including Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis(ALS)) in members of families with a known mutation in GRN or MAPT or an expansion in C9orf72. Participants with at-risk members of families (first-degree and second-degree relatives of known genetic mutation carriers). All GENFI-NeuroDev participants will be assessed longitudinally with a set of clinical, neuropsychiatric, cognitive, imaging and biosample protocols. Parents or guardians of potential GENFI NeuroDev participants are all aware of the autosomal dominant genetic nature of FTD in their family prior to being approached for potential participation in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained and documented (from the participant and their substitute decision maker). This can be obtained in person or remotely.
2. Youths between the ages of 9 and 16 inclusive at time of enrollment, followed until age 17.
3. Youths must have a 1st or 2nd degree biological relative who has participated (past or present) in the Genetic Frontotemporal Dementia Initiative (GENFI) study or with genetic FTD (i.e. a known mutation in biological parent or grandparent).
4. Parent(s)/guardian deem appropriate to participate.
5. Must have a study partner who can participate as required in the protocol (provide corroborative information). Study partner must have regular contact with the participant and must be parent/guardian of this participant.
6. Must have age-appropriate awareness that FTD runs in their family as determined by local PI.

Exclusion Criteria:

1. Current structural brain abnormality affecting cognition or behaviour not thought to be possibly related to genetic FTD that would prevent completion of study assessments (such as brain tumor, stroke, hydrocephalus).
2. Other concerns that participation in the study may not be in the best interest of the youth or parent, as raised by the participant's parent/guardian/primary care provider, local site PI or psychologist.
3. Lack of study partner.
4. For MRI: meeting any MRI incompatible criteria. Note: Participants may opt to decline MRI scans and complete the other measures.
The Treatment of Insomnia in Patients With HIV Disease

This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.

Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduction in the quality of life. The mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has been documented to be one of the most common psychiatric disorders in HIV disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population.

Comparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia
* HIV Seropositive
* Stable HIV Disease

Exclusion Criteria:

* Other psychiatric illnesses
* Unstable HIV disease
Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain

The purpose of this study is to determine whether the Torino II device, which emits a pulsed electromagnetic field), will help to decrease pain and swelling after knee replacement surgery, and thereby decrease the use of narcotic medications after surgery.

The investigators are conducting a research study to determine if the Torino II, a pulsed electromagnetic fields (PEMF) device is helpful in reducing postoperative pain and swelling after total knee replacement surgery. Postoperative pain and swelling may cause discomfort that may directly influence functional recovery after surgery. By reducing pain and swelling immediately following surgery,the use of high doses of narcotic, NSAID, and Tyelenol pain killers can be reduced, and possibly avoided. Recovery can be maximized, as well.

The PEMF device that is being used (the Torino II) is distributed by Ivivi Health Sciences, and has been approved by the FDA for the treatment of pain and swelling following surgery. The device is non-invasive, and is fixed onto the outside of the dressing with Velcro straps. The device will give off electromagnetic pulses to target pain relief in the knee. PEMF devices have been in clinical use for decades, and to date, no reported side effects have occurred.

It is important to note that treatment will still follow the standard Meritus Medical Center protocol for knee replacement surgery. This includes pain medication, icing, and physical therapy. This standard protocol will be followed no matter what study group patients are assigned to. Participation in this study or lack thereof will not change the treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age: greater than 18 years
* Weight: less than 300 lbs.
* Diagnosis: osteoarthritis
* Type of Surgery: unilateral knee replacement

Exclusion Criteria:

* No pacemaker or defibrillator.
* No infection of the affected knee.
* No previous open surgery of the affected knee.
* No history of Rheumatoid Arthritis.
* No more than 2 narcotic pills per month in the last 6 months for pain.
Optimizing Prograf® Therapy in Renal Transplant Patients

A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.

A 3 arm study (2 Active, 1 Active Control) to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients

Eligibility Criteria:
Inclusion Criteria:

* Patient was 18 years of age at the time of transplant.
* Patient is at least 6 months post-transplant.

Exclusion Criteria:

* Patient is the recipient of a solid organ transplant other than the kidney.
* Patient is a known carrier of any of the HIV viruses.