cyrilzakka/clinical-trials huggingface dataset:
Comparative Effects of Radial and Focused Extracorporeal Shock-wave Therapies in Coccydynia

Comparison of the efficacy of coccydynia treatment with two different probes of the ESWT device


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of coccydynia by clinical examination and X-ray imaging.
* be aged ≥18 at the time of diagnosis
* be give informed consent

Exclusion Criteria:

* Malignancy
* Those who have received ESWT treatment before
* Pediatric patients
* Patients with infection.
Open-Label Safety Study of Solriamfetol in Subjects with Binge Eating Disorder

This is a Phase 3, multi-center, open-label study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.

Eligible subjects will have previously completed the SOL-BED-301 (ENGAGE) study.

This study consists of a Baseline Visit, a 2-week Titration Phase, and a 50-week Maintenance Phase, followed by a 1-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Completion of the treatment period in Study SOL-BED-301.
* Able to comply with study procedures.

Exclusion Criteria:

* Significant change in vital signs, medical history or concomitant medications since enrolling in the SOL-BED-301 study which, in the opinion of the Investigator or the Medical Monitor, would render the subject unsuitable to receive solriamfetol or participate in the study.
A Study of SYNT001 in Healthy Volunteers

This study is being done to compare the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of an intravenous (IV) formulation of SYNT001. This is the first-in-human (FIH) study of SYNT001.


Eligibility Criteria:
IInclusion Criteria:

Subjects must meet the following criteria to be included:

* Healthy as determined by comprehensive clinical assessment and clinical laboratory investigations
* Body mass index 18.5 to 30.0 kg/m2
* Must use medically acceptable contraception
* Willingness to complete all study measurements and assessments in compliance with the protocol

Exclusion Criteria:

Subjects meeting any of the following criteria are to be excluded:

* Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety or affect the PK evaluations
* Subject unable or unwilling to comply with the protocol
* Any exposure to an investigational drug within the 30 days prior to screening
* Use of any tobacco or nicotine-containing products
* Abuse of alcohol
* Positive drug test or history of drug abuse
Lipomas Treated with Subcutaneous Injections of Cooled Sodium Chloride

Lipomas are benign tumors composed of mature adipose tissue. While harmless, these are the most common type of soft tissue growths with some patients developing numerous lipomas. Patients often seek removal for cosmesis, or symptoms caused by location and/or compression of surrounding structures. This exploratory study aims to evaluate the effectiveness of subcutaneous injections of cooled normal saline as a treatment option for lipomas. The study will assess whether this technique could serve as a viable alternative to existing treatment options, especially compared to topically applied fat-freezing devices. The Investigators propose that this method may offer a more comfortable nonsurgical option for targeted fat reduction, as the cold temperatures are applied directly to the lipomas.


Eligibility Criteria:
Inclusion Criteria:

* At least one clinically diagnosed subcutaneous lipoma

Exclusion Criteria:

* Unable to give informed consent
* Participant has a lipoma on the face
* Lipomas located subfascial or within deep tissue (e.g., intramuscular lipomas)
* Lipomas larger than 10 cm in diameter (fat deposits exceeding 500 mL in volume)
* Rapidly growing lipomas
* Lipomas exhibiting abnormal ultrasound findings (e.g., complex hyperechoic patterns, internal heterogeneity, or multilobulated appearance)
* Pregnant women
Antioxidant and NMDA Receptor Blocker Wins Anoxic Brain Damage of KorEa OHCA Patients

This study aims to investigate the efficacy and safety of Neu2000KWL, a neuroprotectant, in patients resuscitated from out-of-hospital cardiac arrest and receiving therapeutic hypothermia.

Lack of good neurological recovery is the biggest hurdle in the treatment of out-of-hospital cardia arrest. Neu2000KWL, a N-Methyl-D-aspartate (NMDA) receptor antagonist and an antioxidant, attenuated cerebral neuronal death and reduced hypoxic injury of brain in preclinical studies. Phase I clinical study has revealed that Neu2000KWL is very safe for treating human. In current study, the investigators will assess the efficacy of Neu2000KWL to compare the neurological biomarker, brain imaging, and clinical outcomes of patients successfully resuscitated from out-of-cardiac arrest treated by 3-day infusion of Neu2000KWL with patients assigned to placebo arm.

Eligibility Criteria:
Inclusion Criteria:

1. 19 Years to 80 Years (Adult)
2. Out-of-hospital cardiac arrest caused by non-perfusing cardiac rhythm
3. Successful resuscitation accompanied by ROSC time of more than 20 min
4. Therapeutic hypothermia is planned or initiated
5. The first infusion is planned within 4 hours after ROSC
6. Informed consent is obtained from patient or family member(s)
7. No concern with previous cardiovascular surgery

Exclusion Criteria:

1. Hypersensitivity to aspirin or sulfasalazine
2. Unwitnessed cardiac arrest
3. CPR time \> 60 min
4. Therapeutic hypothermia is not planned
5. Use of extracorporeal membrane oxygenation (ECMO) at initiation of in-hospital resuscitation (E-CPR)
6. Very poor prognosis is expected: patients with (A) non-cardiac or respiratory arrest, (B) poor basal neurological status (C) secondary cardiac arrest caused by trauma, major bleeding, acute neurologic disease including stroke or tumor, (D) multiorgan failure or advanced malignancy
7. Pregnant or lactating women
8. Participated in other clinical studies within 90 days before randomization; or participating in other clinical trials at present
9. Intracranial bleeding verified by first brain CT imaging
10. The investigators consider the patients are not suitable for this trial
Validation Study of an Advanced Blood Pressure Monitor

The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.

The detection of cardiovascular disorders is oriented along three axes, namely the measurement of blood pressure, the identification of rhythm disorders such as atrial fibrillation and the identification of heart murmur indicating valvular heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years old,
* Subject who signed the consent form,
* Subject affiliated to a social security scheme or entitled.

Exclusion Criteria:

* Underage subject;
* Subject who refused to participate in the study;
* Subject participating in other research or clinical studies;
* Subject with body mass index greater than 35 kg/m2;
* Subject in linguistic or psychic incapacity to sign an informed consent;
* Subject with congenital cardiomyopathy;
* Subject with aorto-venous fistula;
* Subject with pulmonary pathology that may degrade the quality of the recording;
* Subject presenting a serious pathology compromising the realization of the examinations envisaged in the test;
* Subject with an arm injury incompatible with the use of an armband sphygmomanometer;
* Subject receiving an intravenous perfusion on the left arm;
* Subject with electrical stimulation by pacemaker, implantable cardioverter-defibrillator;
* Subject with prosthetic heart valve;
* Subject under kidney dialysis;
* Hemodynamically unstable subject (acute heart failure or cardiac assistance).
Optimization of Golimumab Treatment in Ulcerative Colitis

This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after failure (or exposure) to one anti-TNF, which aims to analyze serum golimumab levels and anti- golimumab antibody (ADA) levels during the induction (week 6) and maintenance phases (week 14, 30 and 54) and correlate them with efficacy parameters.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18 years or older, both sexes and any race) who will be treated with Golimumab according to clinical criteria.

Exclusion Criteria:

* Patients with Crohn's disease or colitis pending classification
* Patients with ileoanal pouch
* Patients with perianal fistulas related to the disease
* Patients with a history of hypersensitivity to golimumab, other murine proteins, or to any of the excipients included in the golimumab datasheet.
* Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections.
* Patients with moderate or severe heart failure (NYHA grade III / IV)
A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers

This is a randomized controlled trial over 5 years, using Stage II of the NIH-defined stage model for behavioral intervention development. We will evaluate the efficacy of the sleep intervention program (Care2Sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). Eligible participants will be randomly assigned to in-person Care2Sleep, telehealth Care2Sleep, or to an in-person education control group. The Care2Sleep programs and the control education program will consist of five sessions. The intervention and control programs will begin after baseline assessment and randomization. Posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.


Eligibility Criteria:
Inclusion Criteria for Patients

* Have a diagnosis of Alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record
* Community-dwelling
* \>1 sleep problems \>3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale, - - Aged \>60 years
* Have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome)
* Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
* Have no severe medical conditions with a life expectancy of less than 6 months
* Have an eligible caregiver

Inclusion Criteria for Caregivers

* Live with an eligible patient
* Aged \>18 years
* Is related to the patient as a family member, a significant other, or a friend
* Have regularly assisted patient with \>1 of 6 basic activities of daily living (ADLs; i.e., bathing, dressing, toileting, transferring, continence, feeding) or \>1 of 8 Instrumental ADL (IADLs; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months
* Pittsburgh Sleep Quality Index (PSQI) total score \>5
* Montreal Cognitive Assessment (MoCA) ≥23
* Can communicate in English

Exclusion Criteria:

* Patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months.
* Paid, professional caregivers will also be excluded.
* If the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.
Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.

At the child, the post-operative vomitings (POV) remain the main post-operative complication in term of frequency. They also represent the first cause of unforeseen hospitalization in day case surgery. The causes of POV are multiple, including in particular the post-operative prescription of opioids. The role of the premature refeeding remains discussed.

Up to the age of 4 years, acute pain is difficult to distinguish from other causes of distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in post-operative.

The main objective of this study is to estimate the POV in pediatric day case surgery after early refeeding with clear liquids in the recovery room or only in the day case wards (usual practice).

The secondary objectives are to estimate the time on returning to the day case ward, at home, the post-operative opioid consumption, early refeeding adverse effects (desaturation, swallowing trouble)


Eligibility Criteria:
Inclusion Criteria:

* Patient of less than 4 years old
* A pediatric day case surgery scheduled

Exclusion Criteria:

* Child lower age or 3 month old equal
* Premature child of conceptional age lower than 60 weeks
* Anesthetic or surgical constraint dissuading day case surgery or early refeeding
* Digestive pathology predisposing to the VPO (Hernia hiatal, gastro-oesophageal reflux)
* treatment interfering with emesis (imidazoles, neuroleptic)
* Period of exclusion defined by another study
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study

This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old;
* Surgical placement of an ePTFE patch for large carotid repair;
* Written informed consent given by the patient.

Exclusion Criteria:

* Known or suspected allergy or sensitivity to any test materials or reagents;
* Concomitant intake of immunosuppressive medications;
* Prior radiation therapy to the operating field;
* Previous surgical procedure performed on the same operating field;
* Current or recent (\<3months) participation in another investigational study;
* Refusal to receive blood products;
* Pregnant or breast-feeding women
Changes in Serum Electrolytes at Different Glucose Concentrations + Impact on a Non-invasive Glucose Monitoring Method

In healthy subjects: Continuous monitoring of the glucose concentration in the skin by means of a non-invasive glucose sensor during a glucose clamp when systematically changing the blood glucose concentration (e.g. to hyperglycemia). Simultaneous frequent determinations of serum electrolytes.

Non-invasive continuous glucose monitoring is a promising approach in diabetes therapy. It is known that changes in glucose concentration in the skin can be registered by means of optical, spectroscopic measures in subjects with diabetes. The precision of such measures, however, so far has been unsatisfactory.

This study evaluates the changes in skin glucose concentration by means of a non-invasive glucose sensor and compares these to blood glucose concentrations during a glucose clamp. It is also known that with hyperglycemic blood glucose concentrations there is a consecutive hyponatraemia. This study shall evaluate to which extent and how fast serum electrolyte parameters change when establishing a hyperglycaemic blood glucose level. This shall help estimate which impact these changes in electrolytes have on the non-invasive glucose sensor.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age between 18 and 65 years

Exclusion Criteria:

* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHG and/or systolic blood pressure \> 180 mmHg)
* Pregnancy or lactation period for female subjects
* Serious clinical signs of a liver disease, acute or chronic hepatitis, acute or chronic kidney disease, or ALAT \> 2.5 times the upper level of normal values, or serum creatinine \> 1.3 mg/dL (women)/1.5 mg/dL (men)
* Any serious acute illness (at the decision of the investigator), e.g. sepsis, gastric or duodenal ulcer, acute myocardial infarction, acute asthma attack
* Any other serious chronic illness (at the decision of the investigator), e.g. chronic obstructive pulmonary disease, any kind of cancer
Optimized Referral of Knee Patients to the Orthopedic Outpatient Clinic

The purpose of the study is to evaluate an algorithm to screen patients with suspected knee osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and patient-reported symptoms. It will be investigated whether the algorithm is able to identify which patients that are deemed relevant to undergo an orthopedic assessment. This will be evaluated by estimating the sensitivity of the new algorithm compared to with the traditional clinical assessment of the patients.

Further description is provided as eligibility criteria and outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis.

Exclusion Criteria:

* Cognitive or language problems that precludes the filling in of the questionnaires
* Unwillingness to answer the questionnaires
* Patients with rheumatoid arthritis, neurological diseases or cancer
European Long-acting Antipsychotics in Schizophrenia Trial-II

Schizophrenia is a chronic psychiatric illness with a heterogeneous disease course, varying from periods of symptomatic remission to relapse. Relative to the wealth of scientific data on the course of schizophrenia during the two years following the first psychotic episode, the outcome of schizophrenia patients over the first decade of their illness has been studied to a lesser degree. In this follow-up cohort study the aim is to investigate the long-term outcome of schizophrenia patients who participated in the previously conducted EULAST-I clinical trial, in the first decade after being diagnosed.

At this point, given the heterogeneity of published studies, it remains unclear if depot medication can reduce relapse rates and improve clinical outcome when offered to all patients in need of continuation treatment with antipsychotics. Before anyone can conclude whether or not all schizophrenia patients could benefit from a switch to depot formulations, several questions remain to be answered. Is depot medication associated with better continuation rates and outcome? How are depot medications tolerated as compared to oral medication? In order to clarify these important issues this study aims to perform a large multi-center trial in which schizophrenia patients in need of continuous treatment who are randomized 1:1:1:1 to two different depot preparations or to two different oral medications; patients will be followed up for a total of 19 months.

The primary objective of this trial is to compare all cause discontinuation rates in patients with schizophrenia randomized to oral antipsychotic medications (i.e., aripiprazole or paliperidone) versus depot antipsychotic medications (i.e., paliperidone palmitate or aripiprazole depot) over an 18 month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Capable of providing written informed consent / have a legal representative to provide written informed consent. \*
2. Having been randomized to one of the four treatment arms (aripiprazole oral, aripiprazole depot, paliperidone oral, paliperidone depot) in the 2014-002765-30 EULAST-I clinical trial or having participated in the EULAST-I naturalistic cohort study.

   * Unless prohibited by local law (e.g. due to incarceration).

Exclusion Criteria: No exclusion criteria are applicable in this study.
One-stage Versus Two-stage Inverted U-shaped Ridge Splitting

Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria.

The participants were randomly allocated using a computer system into two groups:

Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant placement in the same surgery.

Group B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four weeks, ridge expansion and implant placement will be performed with only envelop flap.

Assessment included measurements of bone gain at the undercut defect and bone density labial to implants in each group from the cone-beam computed tomography


Eligibility Criteria:
Inclusion criteria

* Adult patients (20-45) years of age with no sex predilection
* At least one tooth missing in the anterior maxilla
* The presence of a labial undercut \>2 mm in thickness which is not able to house an implant
* The presence of adequate bone width near the alveolar bone crest
* The absence of a vertical bone defect.

Exclusion criteria

* History of any systemic disease that would contraindicate surgery example uncontrolled diabetes.
* Pregnancy or lactation.
* Long-term amino-bisphosphonate therapy.
* Smoking more than 10 cigarettes per day.
* Alcohol or drug abuse.
* Uncontrolled periodontal disease.
* Active infection.
* Inadequate inter-incisal space.
* Bruxism or clenching.
Personalized Prospective Study Evaluation of the Efficacy and Safety of Noninvasive Neuromodulation of TMS in Subjects With Catatonia

Evaluation effectiveness and safety of TMS in subjects with catatonia

Non-pharmacological strategies for influencing brain structures show great potential, particularly transcranial magnetic stimulation (TMS), which allows targeting specific areas of the brain and activating neuroplastic processes that contribute to the restoration of lost functions. According to study hypothesis, therapy for catatonia is possible through the stimulation of the dorsolateral prefrontal cortex (DLPFC), given its accessibility and role in the syndrome's development because. It has been established that a key process in the pathogenesis of catatonia is the disruption of the structural-functional connectivity and activity of several regions within the fronto-temporal network

The design of the study involves following stages:

* diagnostic stage and randomization
* two personalized stimulation protocols (high- and low-frequency delivery of magnetic pulses) with placebo control
* initial analysis of the effectiveness of protocols after 10 sessions of stimulation, followed by the transfer of all patients, including the placebo group to the most effective protocol.
* the stage of active neuromodulation of 20 sessions (4 weeks) according to the protocol of effective stimulation regiment
* final analysis of the effectiveness after 20 sessions of TMS, as well as after 1 and 6 months

Eligibility Criteria:
Inclusion Criteria:

Verified diagnosis of schizophrenic or affective spectrum (schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder)

Patient's ability (possibly accompanied by caregivers) to undergo diagnostic and therapeutic procedures;

The presence of residual catatonia in the form of such psychomotor anomalies as:

* disorganisation of thinking with speech disturbance with verbigerations and/or sperrungs
* hypo- and hyperkinetic psychomotor phenomena;
* substupor without disturbance of consciousness;
* elective mutism;
* echo phenomena (echolalia and/or echopraxia);
* phenomena of "wax flexibility"
* speech and behavioral stereotypy
* pathetic exaltation phenomena
* the phenomenon of irritative asthenia
* dysuric phenomena (monotonous activity and rigidity of affect)

Exclusion Criteria:

* patient's refusal to participate in the study
* acute hallucinatory-delusional symptoms
* suicide risk
* a patient taking prohibited therapy products
* neuroleptic complications of antipsychotic therapy
* irritative asthenia
* dysuric phenomena by the type of monotonous activity and rigidity of affect