cyrilzakka/clinical-trials huggingface dataset:
An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial

Previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid arthritis, and psoriatic arthritis. In this same line of study, during the 2007 2008 period, we conducted a multicenter, double-blind, 12-week Study (LoadET, 0881A3-102090) comparing the efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100 mg/week) in subjects with AS refractory to conventional therapy. The interim results of said study do not appear to support the value of doubling the dose of etanercept in the treatment of subjects with AS. Once this study was finalised, the subjects continued to be monitored by their regular physician, who decided on the dose and treatment to follow according to the conditions of standard clinical practice.

The objective of this observational study is to evaluate the course of the disease in the long-term (three years) under the conditions of standard clinical practice, in subjects who had participated in the LoadET study. Therefore, we would like to follow-up on those patients by reviewing their clinical histories for the three-year period between the finalisation of their participation in the LoadET Study (0881A3-102090) and now. This will allow us to assess the efficacy and survival of the drug, as well as the possible appearance of side effects in the three years following the finalisation of the study by comparing the results according to if the subjects had received 50 mg/week or 100 mg/week during the LoadET study (0881A3 102090).

Given that this is a follow-up study of subjects who participated in the LoadET study (0881A3-102090), we have planned the inclusion of all subjects who completed said study, that is, 97 of the 108 subjects in the LoadET study.

Eligibility Criteria:
Inclusion Criteria:

* AS patients who had previously participated in the LoadET study (0881A3-102090).
* Subjects who completed the LoadET Study.
* Patients who grant their informed consent

Exclusion Criteria:

* Patients who participated in the LoadET study but who discontinued treatment and, therefore, did not complete the study.
* Patients without standard follow-up by the physician since the end of the study.
Assessing Clinical Outcomes in Alzheimer's Disease Agitation

This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.

Enrolled patients will first enter a 9-week, open-label stabilization period, during which they will be treated with AXS-05 and monitored for a treatment response. Patients who experience a treatment response during the stabilization period will then be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease (AD) based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
* Diagnosis of clinically signification agitation resulting from probable AD according to the International Psychogeriatric Association (IPA) provisional definition of agitation.

Exclusion Criteria:

* Patient has dementia predominantly of non-Alzheimer's type.
* Patient has symptoms of agitation that are not secondary to AD (e.g., pain, other psychiatric disorder or delirium due to a metabolic disorder, systemic infection, or substance-induced).
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.
Does Pre-operative Patients' Education Facilitates Emergence of Anesthesia Following Bariatric Surgery?

The recovery and emergences from anesthesia is a critical phase. Previous studies focused on pharmological and anesthetics techniques to improve the quality of this stage (duration, complications).

In this study, our first aim is to test the impact of pre operative education on the post operative recovery for morbidly obese patient underwent laparoscopic bariatric surgery.

The purpose of our study is to compare post operative immediate recovery and emergence for educated and non educated morbidly obese patients underwent laparoscopic bariatric surgery.

Elligibles patients are informed and consented by anesthesiologist. Patients are randomized in 2 groups (G1: educated, G2:non-educated) Patient of G1 are educated in OR before starting anesthesia. This education includes : information about anesthesia emergence, recovery and extubation.

Anesthesia and education are conducted by the same anesthesiologist. All patients are operated by the same surgeon. All patients receive same balanced general anesthesia protocol. The recovery starts immediately after the end of the procedure, when the patient has BIS ≥90 and TOF≥9.

Recovery assessment and data recording is done by a blinded anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

* Adults more than 18 years old.
* ASA 2.
* BMI more than 35.
* scheduled for laparoscopic sleeve gastrectomy or gastric bypass surgery.

Exclusion Criteria:

* Renal impairment.
* Hepatic dysfunction.
* Alcohol or drug abuse.
* Disabling Central nervous or cerebrovascular diseases.
* Treatment with opioids or any psychoactive medication.
* Inappropriate Mini mental state exam.
The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)

This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total knee arthroplasty
* American Society Anesthesiologists (ASA) physical status I- III.
* Mentally competent and able to give consent for enrollment in the study.

Exclusion Criteria:

* Patient refusal,
* allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
* Revision surgery will be excluded.
* Impaired kidney functions
* patient with coagulopathy will be also excluded.
* Chronic pain syndromes and patients with chronic opioid use in excess of a daily morphine equivalent dose (MED) of 40mg or greater for the past 3 months prior to the surgery.
* BMI of 45 or more
Antibiotics Against Amyloid Angiopathy

We will perform a randomized clinical trial with minocycline. Minocycline is an antibiotic of the tetracycline family and known to modulate inflammation, gelatinase activity and angiogenesis, which we know are central mechanisms in CAA-pathology. Our aim is to prove in a randomized clinical trial in a translational setting that minocycline treatment (duration 3 months) can decrease markers of neuroinflammation and the gelatinase pathway in the cerebrospinal fluid (CSF) of persons with D-CAA (n=30) and sporadic-CAA (n=30).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years for D-CAA and age ≥55 years for sporadic-CAA
* Probable-CAA according to the Modified-Boston-Criteria or genetically proven D-CAA
* ≤ 2 ICH (occurrence of ICHs at least 1 year ago) and presence of ≥ 2 lobar microbleeds +/-cortical superficial siderosis
* Written informed consent

Exclusion Criteria:

* Previous allergic reactions to minocycline
* Modified Rankin Score ≥3
* Contraindications, such as:
* Contraindications for 7T MRI as determined by the 7Tesla safety committee. Examples of possible contra-indications are: claustrophobia, pacemakers and defibrillators, nerve stimulators, intracranial clips, intraorbital or intraocular metallic fragments, cochlear implants, ferromagnetic implants, hydrocephalus pump, intra-uterine device, permanent make-up, tattoos above the shoulders. In case of specific contra-indications for 7T a 3T will be made instead. - Specific contraindications for checkerboard fMRI: seizure within prior year, photosensitive epilepsy, noncorrectable visual impairment. - Contraindications for lumbar puncture: compression of the spinal cord, signs and symptoms of increased intracranial pressure, local infections of the skin at the puncture site, a coagulopathy or thrombocytopenia (\<100). (Use of acetylsalicylic acid, NSAIDs, COX2 inhibitors or low-molecular-weight heparin are no contraindications for lumbar puncture.)
* Pregnancy/breast feeding
* Liver/renal failure
* Use of antibiotics \<1 month
* SLE or other diseases known to generate inflammatory responses
* Previous/current/planned use of retinoids (since this is related to increasing risk of increased intracranial pressure)
* Current use of anaesthetics like methoxyflurane, agents inhibiting peristalsis, barbiturates, carbamazepine or fenytoïne
A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement

First-in-human study to assess safety, tolerability, PK, and preliminary activity of PF-07284890 as a single agent and in combination with binimetinib in participants with BRAF V600-mutated advanced solid tumor malignancies with and without brain involvement.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥16 years at the time of consent
* Histologically confirmed diagnosis of advanced/metastatic solid tumor including primary brain tumor
* Documented evidence of a BRAF V600 mutation in tumor tissue or blood
* Confirmation of availability of adequate tumor tissue for submission to the sponsor/central laboratory
* Presence or absence of brain involvement unless specified below
* Dose Expansion (Part B)

  * Cohort 1, 2, 3, 4: melanoma with at least 1 parenchymal brain lesion
  * Cohort 1,3: asymptomatic in the brain for at least 14 days prior to start of study treatment
  * Cohort 2,4: symptomatic in the brain within 14 days prior to the start of study treatment
  * Cohort 5: any solid tumor that does not meet requirements for Cohorts 1-4, history of or current leptomeningeal metastases.
  * Optional Cohort 6 (DDI Sub-study) and 7 (Food-Effect): if brain involvement present, must be asymptomatic
* Disease progression despite prior treatment and no acceptable alternative treatment options available unless specified below
* Dose Expansion (Part B)

  * Cohort 1, 2: No prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of study treatment
  * Cohort 3, 4: Required prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of treatment
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* Brain metastasis/primary brain tumor requiring immediate local intervention
* History of or current leptomeningeal metastases
* Any other active malignancy within 2 years prior to enrollment
* Radiation therapy to visceral metastases within 14 days prior to study treatment. WBRT within 28 days prior to study treatment.
* Systemic anti-cancer therapy or small-molecular therapeutic(s) within 2 weeks prior to start of study treatment; Antibody based agents within 4 weeks prior to start of study treatment.
* History or current evidence of RVO or current risk factors for RVO; History of retinal degenerative disease
A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases

This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.

This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years；
* ≥70% diameter stenosis or occlusion in the target below-the-knee lesion；
* Rutherford Category 3-6；
* Subjects are willing to sign informed consent；

Exclusion Criteria:

* Planned major limb amputation within 30 days after the procedure;
* In-stent stenosis in the target lesion;
* Severely calcified target lesions；
* Creatinine\>2.5mg/dL;
* History of allergies to anesthetics, contrast agents；
* Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint；
* Other circumstances judged by researchers that are not suitable for enrollment.
The Efficacy and Safety of the COMBO Endoscopy Oropharyngeal Airway in Gastrointestinal Endoscopy Procedure

Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing gastrointestinal endoscopy under propofol sedation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18≤ Age ≤60.
* Patients undergoing gastroendoscopy and/or colonoscopy procedure.
* Patients have signed the informed consent form.
* The ASA classification ranges from I to II.
* The estimated duration of the procedure does not exceed 45 minutes.

Exclusion Criteria:

* Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement.
* Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs).
* Profound renal insufficiency necessitating preoperative dialysis.
* A confirmed severe liver dysfunction.
* Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy.
* Elevated intracranial pressure.
* Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions.
* Fever, defined as a core body temperature exceeding 37.5 degrees Celsius.
* Pregnancy or lactation.
* Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape.
* Urgent surgical intervention.
* Polytrauma.
* Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively.
* BMI\<18.5 or BMI\>30.
* Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu.
* Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis.
* Presently engaged in concurrent participation in additional clinical trials.
* Patients considered ineligible by researchers for inclusion in this clinical trial.
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family

The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):

  1. Patient with a percutaneous intervention to a native coronary, saphenous vein graft, or peripheral arteries;
  2. Patient with angiographic evidence of thrombus;
  3. Patient \> or = 50 kg;
  4. Patient \>18 years;
  5. Patient who understands the trial requirements and the treatment procedures and provides written informed consent.

Exclusion Criteria:

* Patients will be excluded as per IFU, Hospital standard of care and GCP, also if there are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
Children Affected by Rare Disease and Their Families Network

Families of children with rare diseases (i.e., not more than 5 out of 10.000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and his/her siblings. The project at hand will test two innovative forms of care (CARE-FAM and WEP-CARE) at 17 sites in 12 federal states of Germany. The goal is to improve the mental health and quality of life of children affected by rare diseases and their relatives in a sustainable manner. If successful, these interventions will be introduced into regular care.

The central objective of the study at hand is to close the supply gap for families with children and adolescents affected by rare diseases. Two innovative forms of care (CARE-FAM and WEP-CARE) will be implemented and evaluated at the 18 participating study sites. Both interventions include psychological diagnostics, early detection and treatment of concomitant mental diseases. The study is a prospective, randomized controlled multicenter study (RCT) with a factorial design with four groups: CAREFAM (face to face), WEP-CARE (online), both interventions, control group (TAU = treatment as usual). Central psychosocial outcomes will be assessed at four time points (i.e., Baseline and after six, 12 and 18 months) from the perspectives of the parents, the affected child and the siblings (0 - 9 years only external assessment; from 10 years of age additional self-assessment) and the professionals.

Eligibility Criteria:
Inclusion Criteria:

1. Family with at least one child between 0 and 21 years with a rare disease or a suspected rare disease.
2. Consent to participate in the study.
3. Sufficient knowledge of the German language of parents and children.
4. Insured at the participating insurance companies.

Exclusion Criteria: Severe psychiatric disorders and impairments with acute symptoms such as suicidal tendencies, severe depression, addictions, acute psychotic symptoms etc., which will not be sufficiently supplied by this new low-frequency intervention. Children and parents with acute treatment demand in the control group will be placed at psychotherapists. Nevertheless, they stay in the control group.
Bone Mass Accrual in Adolescent Athletes

The adolescent and young adult years are a critical window in time for bone mineral accrual. More than 90% of peak bone mass is achieved by 18 years, and data indicate that insults sustained during adolescence and young adulthood may result in permanent deficits in bone accrual. Adult athletes with amenorrhea (AA) have low bone mineral density (BMD) secondary to hypogonadism, associated with increased fracture risk and associated co-morbidities. We will examine whether estrogen replacement will increase BMD and improve measures of bone microarchitecture in adolescents and young women with AA, thus optimizing peak bone mass.

Young female athletes 18-21 years old will be randomized to estrogen (and progesterone) with lifestyle modification versus lifestyle modification alone for a 12 month period. Bone density and structure will be assessed over this period. Hormonal evaluations will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-21 years of age
* Hypothalamic amenorrhea
* Greater than or equal to 15 years bone age
* BMI between 10th-90th percentiles for age

Exclusion Criteria:

* Use of medications affecting bone metabolism including estrogen/ progesterone, anabolic steroids and glucocorticoids except local application of glucocorticoid creams (washout period of three months necessary prior to study enrollment if medically permissible to discontinue these)
* Presence of anorexia nervosa or %IBW of \< 85% based on the 50th %ile of BMI for age
* Spine BMD Z-score \< -3
* Conditions other than endurance training that may cause amenorrhea including PCOS (clinical or preceding laboratory evidence of hyperandrogenism with amenorrhea)
* Conditions other than endurance training that may cause bone metabolism to be affected
* Abnormal TSH, elevated FSH, hematocrit \< 30%
* Pregnancy

For girls with AA (to be randomized to estrogen and progesterone or no treatment)

* History of migraines, hypertension, allergy to peanut oil, undiagnosed abnormal genital bleeding, known, suspected or history of breast or genital cancer or estrogen dependent neoplasia, known hypersensitivity to progesterone or estrogen or other product ingredients, liver dysfunction or disease
* LFTs greater than 1.5 times the upper limit of normal
* Family history or personal history of conditions that may increase risk of thromboembolism:

  1. Family history of myocardial infarction or strokes occurring at less than 50 years
  2. Family history of clotting disorders: normal coagulation profile will be necessary for enrollment
* History of smoking \>10 cigarettes a day (history of smoking \>14 cigarettes a day is a contraindication for estrogen, but we will be more conservative in our exclusion criteria)
* Personal history of blood clots
Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout

This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.The 8 intervention sessions will target the five domains of Quality Of Life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent.
* Ability to speak, read, write and understand English language
* Has cancer caregiver status defined as an unpaid individual who provides physical, practical, and/or emotional care and support to a cancer care recipient in the home or other healthcare setting.
* Has a care recipient:

  * ≥ 18 years of age who
  * has a malignancy (either solid tumor or hematologic) diagnosis.
  * who has signed a research authorization form
  * who is undergoing or in the last 6 months has undergone cancer treatment
* Ability to use and access to a computer, tablet or other device with internet access and video capabilities

Exclusion Criteria:

* Diagnosis within the past 12 months of active substance abuse (alcohol or drugs)
* Diagnosis within the past 12 months of active mental health condition that has required psychiatric hospitalization
* Diagnosis within the past 12 months of suicidal thoughts or attempt
* Care recipient is currently participating in another psychosocial clinical trial
Organ Retractor Device Study

This study aims to assess the safety and efficacy of an organ retraction device. The study is low risk as it is only being used in patients already undergoing primary robotic bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* undergoing minimally invasive primary bariatric surgery

Exclusion Criteria:

* known liver disease