cyrilzakka/clinical-trials huggingface dataset:
Transversus Abdominis Plane Block For Renal Transplant Recipients

The purpose of this study is to evaluate the efficacy of a local anaesthetic injection in the plane between the abdominal muscles in reducing the amount of pain relief required after surgery.

The aim of this study is to evaluate the efficacy of transversus abdominis plane block in reducing the morphine requirements after renal transplantation.

Eligibility Criteria:
Inclusion Criteria:

* renal transplant recipients
* 18 to 75 years

Exclusion Criteria:

* allergy to local anaesthetics
* chronic pain
* refusal
Cryotherapy -BEATS-RF Ablation Trial

The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Able to provide informed consent
* Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
* Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
* Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment

Exclusion Criteria:

* Age younger than 18 years old
* Life expectancy less than 12 months
* Pregnancy
* Presence of esophageal varices
* Esophageal stricture precluding passage of an endoscope and suction tubing
* Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)
* Esophageal cancer (T2 and above)
Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

Primary:

- to evaluate the efficacy of phenobarbital in reducing seizure frequency.

Secondary:

* to confirm dose response relationship,
* to assess the effects on Type I seizures,
* to assess the safety of phenobarbital
* to assess the drug tolerability.

Primary:

-to evaluate the efficacy of once daily (OD) administration of 60 mg and 100 mg phenobarbital, in reducing seizure frequency in participants with partial onset seizures (Type I seizures; complex or simple with motor symptoms only) not fully controlled despite treatment with 1 to 3 concomitant anti-epileptic drugs (AEDs) or AEDs with Vagus Nerve Stimulator (VNS)

Secondary:

* to confirm dose response relationship of 60 and 100 mg phenobarbital doses,
* to assess the effects of phenobarbital on Type I seizures,
* to assess the safety of phenobarbital
* to assess the tolerability of phenobarbital

Eligibility Criteria:
Inclusion Criteria:

* participants from 17 to 70 years old;
* history of Type I partial onset seizures (complex or simple with motor symptoms only);
* participants must have had electroencephalogram (EEG), magnetic resonance imaging (MRI) or computed tomography (CT) with results consistent with diagnosis of partial-onset seizures;
* participants having at least eight Type I partial onset seizures during 8-week baseline period;
* participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS);
* participant has been on a stable dose of their current anti-epileptic treatment regime

Exclusion Criteria:

* currently taking phenobarbital or primidone;
* currently taking felbamate or vigabatrin;
* history of prior allergic reaction to phenobarbital;
* history of psychogenic seizures;
* history or presence of status epilepticus;
* history or presence of seizures occurring only in clusters;
* participant taking any drug with possible Central Nervous System (CNS) effects except if stable from 1 month prior Visit 1;
* history of cerebrovascular accident (CVA) or transient ischemic attack (TIA);
* presence of any sign suggesting rapidly progressing brain disorder or brain tumor;
* presence of unstable arteriovenous malformations, meningiomas or other benign tumors;
* history of porphyria;
* presence of clinically significant findings on physical exam, vital signs, electrocardiogram (ECG) or safety lab assessments, including renal or hepatic insufficiency;
* history of alcohol or drug abuse within the year prior to screening;
* participant who is known to be non-compliant;
* participant who is male or female who refuses to use an acceptable form of contraception;
* female who is pregnant or lactating or intends to become pregnant;
* participant who has taken part in any investigational device or product within 2 months prior to the screening visit
Determination of Ustekinumab Levels in Patients With Crohn's Disease

Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.

Prospective follow-up observational study carried out with patients from the Virgen de Macarena University Hospital, under treatment with ustekinumab in the induction and maintenance phase in order to determine the cut-off points of the ustekinumab levels between which a clinical remission is expected in patients with inflammatory bowel disease.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years.
* Patients treated with ustekinumab in induction and maintenance phase.
* They must agree to participate in the clinical study, having previously signed the informed consent.

Exclusion Criteria:

* Any patient who does not meet the inclusion criteria previously described and / or who refuses to participate in the study.
Communicational Program "Trust" to Improve Adherence to Medications

The trial was designed in such a way as to show that the proposed program "Trust" increases the proportion of patients who adhere to therapy in the cohort of those with coronary heart disease for two years after successful revascularization by using thrombolytic or stenting of the coronary arteries against the background of myocardial infarction.

The "Trust" program includes a set of measures aimed at increasing the level of adherence to therapy in patients with myocardial infarction. Differences in adherence rates between patients enrolled in the program and patients undergoing standard outpatient care will be monitored during the study. The study will be conducted according to the clinical approbation protocol, the principles of good clinical practice (GCP) and regulatory requirements.

The developed program is based on the experience of international research studies and includes the following sections:

* daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials;
* service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators;
* questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.

Information motivating to remain adherence to the therapy is structured as follows:

A) greeting and presentation, a reminder of the necessity for therapy, with the support of the patient's Trust in prolonging the quality of life by regular use of medications; B) the explanation of the action of the medicine taking into account the peculiarities of ordinary consciousness, warning the patient of the most common mistakes in treatment; C) recommendations for changing lifestyle and explaining their need; D) a reminder of the possibility to contact the attending physician, emotional support and counseling.

The establishment of an information and counseling center will allow the patient to be supported throughout the time when the likelihood of giving up therapy and the risk of complications due to failure are most likely.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Recent acute myocardial infarction within the past 2 months
* Successful revascularization via coronary stenting or thrombolysis

Exclusion Criteria:

* Concomitant cardiovascular disorders requiring surgical treatment
* Coronary revascularization via CABG
* Patient refused from participating
* Patient is not available for communication within 2 months
Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)

The purpose of this study is to compare the change in visual acuity of patients with post surgical cystoid macular edema who will be treated with two different regimens.

Compare the mean change in BCVA over 12 weeks of Prednisolone Acetate 1% q1h (every hour) WA (While Awake) + Ketorolac 0.5% qid (four times a day) versus Prednisolone Acetate qid + Ketorolac qid for post surgical cystoid macular edema.

Eligibility Criteria:
Inclusion Criteria:

* Age more than or equal to 18 years
* Diagnosis of PSCME in study eye confirmed by FA showing leakage from retinal vessels resulting in pooling of dye in the fovea and Spectralis SD-OCT showing intraretinal fluid in or around the fovea.
* BCVA score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters).
* In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from PSCME and not to any other reason.

Exclusion Criteria:

* Any patient who has other retinal diseases known to cause macular edema (choroidal neovascularization, vein occlusion, diabetic macular edema in the study eye). Patients with nonexudative Age Related Macular Degeneration (ARMD) or non-proliferative diabetic retinopathy without macular edema can be included in the study.
* Other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic atrophy).
* Pre-existing diagnosis of glaucoma in the study eye
* Inability to comply with study or follow up procedures
* Pregnancy (Women of child bearing age will be asked to take a urine pregnancy test prior to enrolling in the study).
Sintilimab Plus Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Phase II Study

This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of Sintilimab combined with Chidamide in the treatment of relapsed/refractory cutaneous T-cell lymphoma.

This is a single-arm phase 2 study with fixed does of combined Sintilimab and Chidamide regimen. This regimen is repeated every 21 days. Sintilimab (200mg) is administered intravenously on day 1 of every cycle. Chidamide is used 20mg twice per week continuously. From the beginning of the trial, sindilimab will be used for 96 weeks, until disease progress, intolerable toxicity or patient/investigator discretion. Patients will continue to receive Chidamide treatment until disease progression, unacceptable toxicity, or patient/investigator discretion.

The response will be evaluated every 2 cycles in the first 36 weeks and every 4 cycles from week 36 till the end of treatment. The patients who achieve complete remission (CR), partial remission (PR), and stable disease (SD) will receive further treatment. The patients with progressed disease (PD) will be continue on the treatment and reassess after 4-8 weeks to rule out false progression. On confirmation of PD , patients will be withdrawn from the trial and receive salvage regimens.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed cutaneous T-cell lymphoma according World Health Organization (WHO) classification.
* ECOG≤2
* Patients with measurable lesions, with or without extra-dermal lesions, clinical stage of IIB-IVB.
* Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment.
* Absolute neutrophil count (ANC）≥0.75×109/L，platelet (PLT) ≥ 50×109/L，hemoglobin (HGB）≥ 80 g/L
* Thyroid stimulating hormone (TSH) within normal range

Exclusion Criteria:

* Pre-existing uncontrolled active infection
* Alanine aminotransferase (ALT) \>3 times upper limit of normal (ULN), total bilirubin (TBIL) \>1.5 times ULN, serum creatinine \>1.5 times ULN
* Patients with clinically significant QT interval prolongation (male \> 450ms, female \> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), acute coronary syndrome (ACS) within 1 year, congestive heart failure (CHF), and symptomatic coronary heart disease.
* Patients who have received organ transplantation or hematopoietic stem cell transplantation.
* Active bleeding or recent thrombotic disease
* Patients with known interstitial lung disease
* Patients with active autoimmune disease or history of autoimmune disease in the past 2 years
* Patients with CNS involvement
* Pregnant or lactating women
* History of mental illness
Vestibulo-Ocular Reflex Function in Individuals With Chronic Motion Sensitivity Cross-Sectional Study

Chronic motion sensitivity refers to a sensation of unwellness caused by physical or discerned motion and has a prevalence of 28% in the general population and it is more common in women (27.3%) compared to men.

The investigators theorize that individuals with chronic motion sensitivity will have an impaired inner ear reflex and will be less physically active. Hence, the purpose of this study is to;

1. Determine whether the function of an inner ear reflex is different between young adults with/without chronic motion sensitivity
2. Assess relationships between reflex function and balance in young adults with/without CMS
3. Assess relationships between physical activity and balance in young adults with/without CMS.

Chronic motion sensitivity (CMS), also known as motion sickness, refers to a sensation of unwellness caused by physical or discerned motion. CMS has a prevalence of 28% in the general population and it is more common in women (27.3%) compared to men.

Based on established evidence that individuals with chronic motion sensitivity demonstrate impaired postural stability with vestibular system impairment adjudged to be an inciting stimulus for chronic motion sensitivity, and individuals who practiced more physical and sporting activities have less motion sickness susceptibility than individuals who did not, the investigators theorize that individuals with chronic motion sensitivity will have an impaired inner ear reflex, causing them to be more reliant on other sensory systems like their muscles and joints, and their vision, we also theorize that individuals who are physically active will be less susceptible to chronic motion sensitivity.

The purpose of this study is to;

1. Determine whether the function of an inner ear reflex is different between young adults with/without chronic motion sensitivity
2. Assess relationships between reflex function and balance in young adults with/without CMS
3. Assess relationships between physical activity and balance in young adults with/without CMS.

Participants between the age of 20 and 40 with and without a self-reported history of chronic motion sensitivity (i.e, experiencing nauseousness and/or dizziness during while using various means of transportation such as, car, train, bus, boat, and airplane and/or, recreational fun-fair rides and/or when exposed to conflicting visual images). Participants will be excluded if they report a medical diagnosis of central nervous system disorder, impaired cervical spine range of motion, migraines, seizure disorder, vestibular dysfunction, or any musculoskeletal dysfunction that can limit their participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-40
* With and without a history of CMS

Exclusion Criteria:

* CNS disorder
* Impaired cervical spine ROM
* Migraines
* Seizures
* Vestibular dysfunction
* Musculoskeletal dysfunction
* Medications causing dizziness
Post-Market Clinical Follow Up for Total Knee Arthroplasty System Madison

MADISON Total Knee Prosthesis is intended to be used for total knee arthroplasty to reduce pain and restore joint mobility of the knee.

Clinical data for MADISON Total Knee Prosthesis available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product.

Thus, in order to maintain compliance with the EU regulation (2017/745) related to medical devices and following ISO 14/155:2020, SERF has set up post-market clinical follow-up study (PMCF) to confirm safety and performance of Total Knee Arthroplasty system MADISON. This study is designed to cover the expected 15-years follow-up, to retrieve data according to implant feature (Posterior Stabilized or Ultra Congruent) or fixation method and to gather data related to the revision of partial knee prosthesis.

The primary objective of this study is to assess the clinical safety of MADISON total knee prostheses. The secondary objective is to evaluate the survival rates, the clinical performances and clinical benefits of MADISON total knee prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults (≥ 18 years) covered by French social security system
* Diagnosed with:

  * Osteoarthritis (primary and secondary),
  * Revision of a unicompartmental knee prosthesis.
* Patient requiring a surgery and implantation of a Madison TKA (Total Knee Arthroplasty)
* Patient physically and mentally able to comply with protocol, meet the follow-up visits as deemed by the investigator and fill in quality of life questionnaire.
* Patient having signed a written informed consent

Exclusion Criteria:

* Progressive, acute or chronic infection, local to the operative site or systemic that may affect the prosthetic joint,
* Any loss of musculature or serious lesions of muscles, nerves and/or blood vessels deficiency, putting the affected limb at risk,
* Lack of bone substance or inadequate bone quality on femoral or tibial surfaces, as it might compromise the stability of the prosthesis components,
* Skeletal immaturity,
* Pathologies that may compromise the functionality of the implant in any way (i.e. osteomyelitis, neuropathic joint),
* Parameters incompatible with satisfactory long-term results (i.e. age, weight,
* Neurological condition of the patient incompatible with the post-operative constraints associated with this type of intervention,
* Known allergy to one of the implant components.
* Severe obesity with or without comorbidities
* Pregnant or nursing women,
* Patients with a contraindication to radiography
* Patients deprived of their liberty or hospitalised without their consent
* Patients under legal protection (e.g. guardianship)
A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)
* Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)
* Adequate organ function as assessed by laboratory tests
* Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
* Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria:

* Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment
* Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only)
* History of Grade \>= 3 fasting hyperglycemia or diabetes requiring regular medication
* Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)
* History of clinically significant cardiac or pulmonary dysfunction
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Clinically significant history of liver disease
* Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
* Active autoimmune disease and/or need for corticosteroid therapy
* Known brain metastases that are untreated, symptomatic, or require therapy
* Pregnancy, lactation, or breastfeeding
Efficacy of Ethnodyne Visio in Parkinson's Disease

ETHNODYNE VISIO is a food supplement composed of an innovative plant-based active ingredient acting alongside vitamin B2. It is proposed in patients with visual problems. Based on clinical and experimental data, the investigators propose a pilot open study in order to test the efficacy of "Ethnodyne visio" in patients with Parkinson 's disease (PD). The hypothesis is that Ethnodyne visio may improve motor and non motor signs of PD. 24 patients with PD will be evaluated before and after 3 months of add on treatment by Ethnodyne visio.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson disease (PD) with at least 3 years of evolution
* Hoehn and Yahr score 2 or 3
* with moderate fluctuations (score 1 or 2 for item 3 score IV MSD UPDRS)
* with no modification in anti-parkinsonian drugs since at least 1 month
* minimental test \>24

Exclusion Criteria:

* known intolerance to Ethnodyne visio
* woman of childbearing potential or breastfeeding
* anticipated anti-parkinsonian treatment modification during the 3 months of the study
* antidepressant or anxiolytic drugs modified within one month prior to inclusion visit
* other chronic disease
* concomitant participation in a another clinical trial
* Subject under legal guardianship