cyrilzakka/clinical-trials huggingface dataset:
Improved Rehabilitation After Surgery and Hypnosis: Benefits Potentiated by a Preoperative Consultation

Today, patient management in the context of scheduled surgery must meet new requirements. The understanding of surgical aggression, the evolution of anesthesia and surgery techniques have allowed the birth of the protocol of Improved Rehabilitation After Surgery. The objective is a pain-free surgery, with a minimum of risks, with a global management of the patient and an active participation.

In 2019, the Nice University Hospital developed this program. Other non-medicinal techniques could promote the evolution of this program such as integrative medicine with, in this study case, hypnosis. Since 2002, thanks to its widely recognized effectiveness in the treatment of pain and in helping with care, its use has developed. A hypnosis session, proposed in the preoperative period, would considerably reduce the patient's anxiety, postoperative pain, a better and faster recovery with an easier healing: objectives of the Improved Rehabilitation After Surgery program. The patient's satisfaction would also be improved thanks to his active participation, in a greater comfort, which the investigators want to demonstrate by our work.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age ≥ 18 years
* Indication for laparoscopic gynecological surgery eligible for the Improved Rehabilitation After Surgery protocol
* Understanding of French essential
* Signature of informed consent
* Affiliation to a Social Security system

Exclusion Criteria:

* Patient with a history of psychiatric pathologies (Schizophrenia, Psychosis, Bipolarity)
* Deafness, intellectual deficiency not allowing comprehension
* Pregnant or breastfeeding women
* Women of childbearing age who are not using an effective method of contraception (pill, intrauterine device, vaginal ring, contraceptive skin patch, subcutaneous hormonal implant, surgical sterilization)
* Patient under guardianship or deprived of liberty
A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma

This pilot study will investigate the impact of dexamethasone (DEX) on anti-Xa levels in participants taking apixaban 2.5 mg twice a day by mouth (PO BID). Investigators propose a prospective, cohort study of 24 participants with multiple myeloma, in whom a lenalidomide-dexamethasone (LEN-DEX)-based myeloma treatment regimen is indicated. Eligible participants will initiate thromboprophylaxis with apixaban prior to starting their DEX-containing regimen and continue until the end of cycle 3. Anti-Xa levels, D-Dimer and plasma drug concentration will be measured.

This pilot study looks to investigate this potential interaction between apixaban and dexamethasone to see if it warrants further investigation in a larger study.

The sample size of 24 provides 90% power to detect a primary outcome of ≥ 50% reduction in peak anti-Xa levels from baseline. Secondary outcomes include changes in plasma apixaban levels, D-dimer, and symptomatic venous thromboembolism (VTE) and bleeding during a 3-month treatment period.

Study has terminated due to poor enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of multiple myeloma according to criteria of the International Myeloma Working Group
* Patients in whom a LEN-DEX-based treatment regimen is indicated
* Adult patients ≥ 19 years of age who are able to freely provide informed consent

Exclusion Criteria:

* Concomitant antiplatelet or anticoagulant use
* Calculated creatinine clearance \< 30 mL/min by Cockcroft-Gault formula
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times upper limit of normal (ULN)
* Total bilirubin \> 2 x ULN
* Thrombocytopenia \< 50 x 10 gigalitres (Gl)
* High bleeding risk or spontaneously prolonged prothrombin time or activated partial thromboplastin time \> 1.5 x ULN
* Body weight \<50 or \>120 kg
* Concomitant use of CYP3A4 or p-glycoprotein inducers or inhibitors
* Use of Ginkgo biloba or St. John's Wort within 14 days before first dose of study drug
* Dexamethasone use within last 3 months
* Women of Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
* Life expectancy less than 3 months
* Inability to swallow or issues with malabsorption
* Any other medical, social, logistical, geographical or psychological factors, which in the opinion of the investigator, would prohibit follow-up, compliance and study completion
Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease

Patients suffering of Parkinson's Disease will be treated with 50 mg/day of Safinamide per os for 2 weeks (escalation phase). Then, safinamide will be increased up to 100 mg/day and, if tolerated, the treatment will be taken for 10 more weeks (maintenance phase). Total treatment 12 weeks.

Adult patients affected by PD and suffering from motor fluctuations will be screened for participation.

If the inclusion and exclusion criteria are met, the participant will enter in the baseline assessment phase and undergo 1 night baseline PSG and 1 week baseline actigraphy. The patient will then start the treatment with 50 mg/day of Safinamide per os for 2 weeks (escalation phase). Then, safinamide will be increased up to 100 mg/day and, if tolerated, the treatment will last for 10 weeks (maintenance phase). At week 12 (end of treatment), the questionnaires, actigraphy and PSG will be repeated. A safety follow-up visit is scheduled 4 weeks after study treatment completion.

The treatment will be continued thereafter in all patients if medically indicated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Fluctuating idiopathic PD patients according to UK Brain bank Criteria
* Hoehn and Year II to IV under treatment
* Sleep disturbance with a Pittsburgh Sleep Quality Index (PSQI) \> 5
* Treatment with L-DOPA, alone or with other dopaminergic drugs, at a stable dose since at least 28 days prior to inclusion
* Treatment with all substances potentially acting on sleep and mood must be constant since at least 28 days prior to inclusion
* Written informed consent
* Willingness and ability to participate in the trial

Exclusion Criteria:

* Off label use of safinamide
* Early PD or absence of PD fluctuations
* Concomitant treatment with other MAO-B inhibitors (wash-out period: at least 14 days)
* Atypical Parkinsonism
* Severe known sleep-related breathing disorders with any specific treatment or severe known sleep-related breathing disorders (apnoea-hypopnea index score \>30/h) with or without a specific treatment
* Dementia (MoCA \< 26)
* Severe depression (BDI-II ≥ 29)
* Other severe psychiatric symptoms such as active psychosis or major hallucinations
* Any previous or concomitant severe medical conditions or clinical laboratory abnormality which, in the clinical judgement of the Investigators, does not allow patients' participation into the study
* Moderate or severe hepatic impairment, any type of retinopathy and/or any pathology that is deemed to be a contraindication according to safinamide's SmPC
* Any concomitant treatment not allowed or contraindicated in the safinamide SmPC
* Women who are pregnant or breast feeding
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
Efficacy and Safety of Lymphdiaral Basistropfen (HDC) in the Treatment of Chronic Low-back Pain

To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back pain in relation to pain, functional impairment, quality of life, and state of health during a 15-week treatment period.

Low-back pain is often provoked by inflammatory edema in the region of the facet joints. In naturopathy, a fixed homeopathic drug combination (HDC) is established in the treatment of edema and swellings. For the first time, the efficacy of HDC was investigated in the treatment of low-back pain.

Objective: To examine the efficacy and safety of HDC medication vs. placebo in the treatment of chronic low back pain considering constitution and diathesism in a double-blind, randomized controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Aged 18 - 75 years
* Chronic low-back pain lasting at least for 6 months
* Hanover functional ability questionnaire (FFbH-R) score less than 70%
* At least one of the following diagnoses:

  1. Chronic lumbar ischialgia with or without radicular radiation
  2. Chronic degenerative lumbar syndrome
  3. Spondylarthrosis
  4. Chronic facet syndrome
  5. Lumbago with protrusion of the intervertebral disc
  6. Lumbar radiculopathy
  7. Lumbar and other intervertebral disc impairments with radiculopathy
  8. Back pain at different locations of the spine
* Written, informed consent

Exclusion Criteria:

* Participation in another clinical trial/GCP-trial within 30 days prior to screening
* Participation in this trial in an earlier time
* Treatment with lymphdiaral basistropfen within 3 month prior to enrolment
* Pregnancy and lactation
* Non-compliance
* Incapability to understand the sense of the study
* Abuse of analgesics, opiates or other drugs
* Chronic pain that are as strong as or even stronger than the pain caused by the low-back and that need to be treated with analgesics
* Malign diseases
* Pathological neurological states
* Epilepsy
* Operation of the spine within 3 month prior to enrolment
* Fractures of the spine
* Bechterew's disease
* Alcohol abuse
* Consuming diseases
* Cachexia
* Palsy of the legs or anal sphincter due to acute impairment of the intervertebral disc
* Catheterisation or CT-controlled intra-articular injection in the lumbar region
* Hypersensitivity against one of the ingredients or excipients of the study drugs or against composite plants in general
* Systemic, progressive diseases like tuberculosis, leucosis, collagenosis, multiple sclerosis, acquired immune deficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection, or other auto-immune diseases
Lower Abdominal Pain During Office Hysteroscopy Can Assess Tubal Patency in Infertile Women

Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic with saline distension medium. The presence or absence of lower abdominal pain and the side of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the presence of free fluid in the pouch of Douglas. Then, laparoscopy with tubal chromopertubation was done.

Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic using a 4 mm endoscopic sheath \& 30 ᵒ endoscopic camera with saline distension medium using 90-100 mmHg pressure. Meanwhile, the presence or absence of lower abdominal pain and the side of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the presence of free fluid in the pouch of Douglas.Then, laparoscopy with tubal chromopertubation was done.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women normal semen analysis

Exclusion Criteria:

* Ladies with evidence of upper or lower genital tract infections,
* presence of free fluid in the pouch of Douglas before hysteroscopy or pelvic pathology or those with cervical stenosis that required cervical dilatation prior to hysteroscopy
Changes in Cerebrovascular Reactivity During Cognitive Activation After Cardiopulmonary Bypass: Relation With Intraoperative Embolic Load and Postoperative Neuropsychological Dysfunctions

The study aims to evaluate neuropsychological disorders in CABG patients. Measurements are performed 1 day before, 6 days, 6 months and 3-5 years after the surgery. The relation with cerebrovascular reactivity and embolic load (measured by transcranial Doppler Ultrasonography) is evaluated. Two surgery techniques (on- and off-pump CABG) are compared.


Eligibility Criteria:
Inclusion Criteria:

* CABG-patients (not urgent)
* \< 70 years old
* Righthanded

Exclusion Criteria:

* Neurological or psychiatric disease
* Psychoactive medication
* Valve operation
Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect

Safety and efficacy of DE-105 ophthalmic solution in patients with persistent corneal epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well.


Eligibility Criteria:
Inclusion Criteria:

* Has corneal epithelial defect and decreased corneal sensitivity.
* Has undergone continuous treatment for corneal epithelial defect for 1 week or longer.

Exclusion Criteria:

* Presence of disease such as active ocular infection, or abnormal lid closure.
* History or presence of chemical burn, Stevens - Johnson Syndrome, etc.
* History of corneal transplantation, LASIK, or hematopoietic stem cell transplantation.
Association Between Hidradenitis Suppurativa and Spondyloarthritis

Hidradenitis suppurativa is a chronic dermatosis, characterized by an inflammation of the follicular epithelium in the apocrine glands.

The hypothesis of a link between hidradenitis suppurativa and inflammatory rheumatism has been widely considered, with evidence in support of this theory accumulating from several case reports and small series. The most frequently cited rheumatismal disease thought to be associated with Hidradenitis suppurativa is spondyloarthritis.

Taken together, these data suggest that there may a link between hidradenitis suppurativa and spondyloarthritis, but literature data are sparse, and to date, no study has investigated or demonstrated such a relation. Indeed, existing studies to date were observational, descriptive, and retrospective, and did not use modern diagnostic approaches for documenting spondyloarthritis, such as magnetic resonance imaging (MRI) or the recent classification of spondyloarthritis.

The aim of the study was to test the hypothesis that the risk of spondyloarthritis is increased in patients with hidradenitis suppurativa.

Eligibility Criteria:
Inclusion Criteria:

* for case: patients with diagnosis of hidrosadenitis suppurativa in the Department of Dermatology of the University Hospital of Reims, regardless of the stage of severity and duration of their disease
* for control: patients without diagnosis of hidrosadenitis suppurativa matched to cases for age (±5 years) and sex
* for case and control: have accepted to take part in the research

Exclusion Criteria:

* for case and control: age \<18 years old
Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome

The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome

A randomized, open clinical trial was designed. Patients will be randomly divided into three groups，including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, and aged 18-70 at the time of screening visit.
2. Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
3. If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
4. Disease activity: ESSDAI≥4 points.
5. The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
6. The written informed consent form approved by the Ethics Committee of Peking University People's Hospital was signed and dated by the subject or legal representative.

Exclusion Criteria:

1. Severe chronic liver, kidney and heart dysfunction.
2. Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
3. Patients with tumor and tumor history.
4. Chronic respiratory failure.
5. Patients who are ineffective in high-dose hormone pulse therapy.
6. Those who use rituximab or other biological agents within 3 months.
7. Patients with active tuberculosis infection or potential tuberculosis infection.
8. There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.
AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction

Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 60 years of age must have a clinical scheduled ECG performed.

Exclusion Criteria:

* \< 59 years of age
* Is not scheduled for a clinical ECG
* Unable to provide consent.
A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)

This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years.
* Clinical diagnosis of nonsegmental vitiligo and meet the following:

  * T-BSA ≥ 5%
  * T-VASI score ≥ 4
  * F-BSA ≥ 0.5%
  * F-VASI score ≥ 0.5
* Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Other forms of vitiligo or skin depigmentation disorders.
* Clinically significant abnormal TSH or free T4 at screening.
* Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1.
* Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin®.
* History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
* Spontaneous and significant repigmentation within 6 months prior to screening.
* Women who are pregnant, considering pregnancy, or breast feeding.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or recurrent dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
* Evidence of infection with TB, HBV, HCV or HIV.
* History of failure to JAK inhibitor treatment of any inflammatory disease.
* Laboratory values outside of the protocol-defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Effect of Curcumin on Lung Inflammation

Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason for deterioration of lung function in COPD. Currently there is no medication available that can modify or reduce this inflammation. Furthermore, from literature review it has been shown that chronic inflammation can result in cancerous changes.

Curcumin is a food additive used for centuries. Several studies showed that curcumin suppress the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down regulated by this substance. This study was designed to evaluate effect of combination of curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Age equal or more than 45 with moderate COPD: FEV1/FVC ratio less than 70 percent; post bronchodilator FEV1 less than 50 percent
* 20 pack year cigarette smoking
* Stable clinical course (symptoms/ medications) for 8 weeks
* Fixed address/Not planning to leave
* Being able to perform spirometry
* Able to understand and consent

Exclusion Criteria:

* Other chronic respiratory diseases such as asthma, interstitial fibrosis, sarcoidosis
* Heart failure NYH III \& IV; symptomatic liver or renal failure
* Dementia or other neurocognitive deficit preventing completion of symptom diary
* Use of inhaled or systemic corticosteroids within 8 weeks of enrollment in the study
Efficacy of Laser Acupuncture on Neurophysiological Parameters of Median Nerve in Postpartum Women

BACKGROUND: Carpal tunnel syndrome (CTS), the most common entrapment neuropathy of the upper extremity, is caused by compression of the median nerve as it travels through the carpal tunnel CTs is a very common complication found in pregnancy, which is reported as high as 62% in pregnant females. The functioning of median nerve is compromised in almost all pregnant females especially during the third trimester of pregnancy, the majority may still feel some symptoms up to 3 years after delivery. Many clinicians have used LLLT on acupuncture points, which is called laser acupuncture (LA), to treat many clinical problems, such as musculoskeletal pain, lateral epicondylitis, headaches, etc. In contrast with traditional acupuncture needles, LA is a non-invasive therapy that does not cause tingling/pain during procedures Objective: to determine efficacy of laser acupuncture on electrophysiological parameters of median nerve in postpartum women

Intervention description

1. Experimental Group:

   Each patient in this group will receive laser acupuncture on PC4 (Ximen), PC6 (Neiguan), PC7 (Daling), PC8 (Laogong), LI4 (Hegu), LI10 (Shousanli), LI11 (Quchi), HT3 (Shaohai), HT7 (Shenmen), LU10 (Yuji) acupoints in addition to wearing night splint. LA will be applied to each acupuncture point for 10 s with at least 4J/points based on the recommended LLLT treatment doses for CTS of the World Association of Laser Therapy.
2. Control Group:

Each patient in this group will wear night splint every night for 4 weeks

Eligibility Criteria:
Inclusion Criteria:

* Their BMI will be range from 25 to 30 Kg/m2.
* The electrophysiological evidence of mild or moderate median nerve lesion at wrist (mild: sensory nerve latency \>3.5 ms at third digit, moderate: sensory nerve latency \>3.5 ms at third digit and median motor latency\>4.2 ms)
* Positive phalen's test.
* Positive tinel's test.
* Carpal tunnel of dominant hand could be participated.

Exclusion Criteria:

* History of brachial plexopathy or malignancy.
* Radial, ulnar neuropathy, proximal median neuropathy or polyneuropathy.
* Previous wrist surgery or steroid injection for carpal tunnel syndrome.
* History of trauma, fracture, deformity or inflammation in the wrist, such as rheumatoid arthritis.
* Coagulation abnormalities, pregnancy, fever and infections.
* Skin disease and skin cancer.
* Spots, birthmarks or tattoos over the work points. 8- Pacemaker and implementable medical devices.