cyrilzakka/clinical-trials huggingface dataset:
Transcranial Stimulation (tDCS) For the Treatment of Neuropathic Facial Pain

A study to determine if transcranial direct current stimulation (tDCS, the device that regulates brain activity, can improve pain in people with neuropathic facial pain and compare which modality (inhibitory tDCS over the somatosensory cortex or excitatory tDCS over the motor cortex) can result in better pain-relief.)

This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS)to relieve pain in subjects with neuropathic facial pain,and to compare two pain-treatment tDCS modalities: inhibitory tDCS stimulation over the somatosensory cortex and excitatory tDCS over the motor cortex.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous facial neuropathic pain due to any of following:

  1. Trigeminal neuralgia, type 1, (TN1): facial pain of spontaneous onset with predominantly episodic pain.
  2. Trigeminal neuralgia, type 2, (TN2): facial pain of spontaneous onset with predominantly constant pain.
  3. Trigeminal neuropathic pain, (TNP): facial pain resulting from unintentional injury to the trigeminal system from facial trauma, oral surgery, ear, nose and throat (ENT) surgery, root injury from posterior fossa or skull base surgery, stroke, etc.
  4. Trigeminal deafferentation pain, (TDP): facial pain in a region of trigeminal numbness resulting from intentional injury to the trigeminal system from neurectomy, gangliolysis, rhizotomy, nucleotomy, tractotomy, or other denervating procedures.
  5. Symptomatic trigeminal neuralgia, (STN): facial pain resulting from multiple sclerosis.

  e) Postherpetic neuralgia, (PHN): facial pain resulting from trigeminal Herpes zoster (shingles) outbreak in the trigeminal distribution.
* Pain intensity score for "worst pain in the last 24 hours" \>4 on a numeric scale 0-10 at the time of enrollment and before the first stimulation of each treatment block.
* Pain intensity score for "pain right now" \>4 on a numeric scale 0-10 before the first stimulation of each block of treatment.

Exclusion Criteria:

* Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
* Other painful conditions than neuropathic facial pain, that are not related to and can't be distinguished from the neuropathic facial pain
* Pregnancy
* Implanted neurostimulation devices (e.g. a spinal cord stimulator, a deep brain stimulator, etc)
* Active illegal drug/alcohol abuse
* Unable to follow directions or complete tools in English.
Treatment and Complication of Bath PUVA in Vitiligo

The purpose of this study is to determine whether bath PUVA are effective in treatment of vitiligo and what is the complication of bath PUVA in vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Vitiligo

Exclusion Criteria:

* Pregnancy
A Prospective, Multicenter, Post-marketing Clinical Follow-up Research to Evaluate the Long-term Safety of Ellansé-S Dermal Filler Made of PCL Microspheres for the Correction of Moderate-to-severe Nasolabial Folds

This research is intended to evaluate the long-term safety of Ellansé-S PCL dermal filler for the correction of moderate-to-severe NLFs.

374 subjects. This clinical trial is designed as a prospective, multicenter, post-marketing clinical follow-up trial to evaluate the long-term safety of the investigational product, dermal filler made of PCL microspheres, for the correction of moderate-to-severe NLFs


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old and above;
2. Subjects with moderate-to-severe nasolabial folds (3-4 level of WSRS scores) on both sides of the face
3. Intended to be treated with PCL microsphere filler;
4. Voluntarily participate in this test, cooperate with follow-up, and sign an informed consent form

Exclusion Criteria:

1. Obvious acne scar, pigmentation, active infection, inflammation, tumor, precancerous lesion or unhealed wound in the intended injection area;
2. Patients who have used permanent fillers (PMMA, hydrogel polymer, liquid silicone for injection, polyvinyl alcohol (PVA), bone cement, autologous fat, etc.) for nasolabial groove injection;
3. Patients who have received semi-permanent fillers (polycaprolactone, L-polylactic acid, hydroxyapatite, platelet-rich plasma, etc.) injection treatment in nasolabial sulch area in the past 24 months;
4. Patients who have received temporary fillers (hyaluronic acid, collagen, etc.) injection treatment in nasolabial groove in the past 12 months;
5. Patients who have received botox injection treatment in nasolabial sulci in the past 6 months;
6. The nasolabial groove has been treated with beauty plastic, focused ultrasound, chemical stripping, photoelectric (laser, photon, radio frequency) in the past 3 months;
7. Use of hormones or immunosuppressants within the past 1 month;
8. Subjects who have used anticoagulants in the last 2 weeks;
9. Subjects with a history of crabfoot, hyperplastic scars or cicatricial constitution;
10. Subjects with active sepsis;
11. Subjects with coagulation dysfunction;
12. Subjects with autoimmune diseases;
13. Allergic to polycaprolactone or known product ingredients;
14. Pregnant, pregnant and lactating subjects;
15. Participated in other clinical trials in the past 30 days;
16. Other situations determined by the researcher to be unsuitable for participation in this study;
Early Initiation of Extracorporeal Life Support in Refractory OHCA

Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular fibrillation or tachycardia. It aims to determine the effect on survival and neurological outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.

There are approximately 275,000 cases of out-of-hospital cardiac arrest (OHCA) per year in Europe, of which two-thirds have a primary cardiac origin. However, despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of these patients fail to achieve sustained return of spontaneous circulation (ROSC).

Treatment of the underlying cause of the arrest, in most cases coronary artery occlusion, is paramount. But in the absence of ROSC, the possibilities to perform these life-saving interventions are limited. Continued CCPR is currently the standard of care for these patients. Initiation of extracorporeal cardiopulmonary resuscitation (ECPR) restores circulation, with the potential to minimize (or even reversing) organ damage, prevent re-arrest due to ischemia-triggered myocardial dysfunction and providing a bridge to possible diagnosis and treatment. Several studies have demonstrated that ECPR is feasible and may be advantageous with respect to survival and neurological outcome.

The INCEPTION trial aims to compare ECPR to CCPR in the population that is expected to benefit the most from this intervention: young patients presenting with ventricular fibrillation or tachycardia (VF/VT) and a refractory cardiac arrest. Furthermore, it will provide data on the cost-effectiveness of this intervention, which to date has been unavailable. Although the costs may prove to be high, the gain in quality-adjusted life years (QALY's) may be substantial given the fact that most patients are relatively young and the current alternative carries a poor prognosis. This can determine whether ECPR should be pursued as a standard of care in patients with refractory arrest.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 - ≤70 years
2. Witnessed OHCA (by bystanders)
3. Initial rhythm of VF/VT or AED administered
4. Bystander BLS

Exclusion Criteria:

1. ROSC within 15 minutes of conventional CPR with sustained hemodynamic recovery
2. Terminal heart failure (NYHA III or IV)
3. Severe pulmonary disease (COPD GIII of GIV)
4. Disseminated oncological disease
5. Obvious or suspected pregnancy
6. Bilateral femoral bypass surgery
7. Known contraindications for ECPR
8. Known pre-arrest CPC-score of 3 or 4
9. Known limitations in therapy or a Do Not Resuscitate-order
10. Multitrauma (Injury Severity Score \>15)
11. Expected time-to-start cannulation \> 60 minutes
Wearable Devices for Secondary Prevention of Ischemic Stroke

Ischemic stroke is an important cause of death and disability in Western countries. Different risk factors have been identified such as hypertension, diabetes, dyslipidemia, smoke, atrial fibrillation, obesity, and sedentary. The aim of this study is to evaluate the feasibility of an approach based on the use of wearable devices for the identification and reduction of risk factors in patients with previous history of ischemic stroke or transient ischemic attack.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal 50 years
* Recent transient ischemic attack or minor stroke

Exclusion Criteria:

* Patients with significant cognitive impairment
* Patients dependent in the instrumental activities of daily life
* Patients not able to respect the frequency of monitoring program
* Patients with history of atrial fibrillation
Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - PAST Extension

The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment in early stage Alzheimer's disease, based on archival spoken or written language samples, as measured by the AUC of the receiver operating characteristic curve of the binary classifier distinguishing between amyloid positive and amyloid negative arms. Secondary objectives include (1) evaluating how many years before diagnosis of MCI such algorithms work, as measured on binary classifier performance of the classifiers trained to classify MCI vs cognitively normal (CN) arms using archival material from the following time bins before MCI diagnosis: 0-5 years, 5-10 years, 10-15 years, 15-20 years, 20-25 years; (2) evaluating at what age such algorithms can detect later amyloid positivity, as measured on binary classifier performance of the classifiers trained to classify amyloid positive vs amyloid negative arms using archival material from the following age bins: younger than 50, 50-55, 55-60, 65-70, 70-75 years old.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are fully eligible for and have completed the AMYPRED (Amyloid Prediction in early stage Alzheimer's disease from acoustic and linguistic patterns of speech) study.

(See https://clinicaltrials.gov/ct2/show/NCT04828122)

* Subject has access to audio or written recordings created by them that are available for collection.
* Subject consents to take part in PAST extension study.

Exclusion Criteria:

* Subject hasn't completed the full visit day in the AMYPRED study.
Validation of a Muscle Relaxation Monitor

The objective of this study is to determine the accuracy of a hydraulically coupled twitch monitor compared to the EMG twitch monitor in current use to measure the extent of neuromuscular blockade in patients undergoing general anesthesia.

Neuromuscular blockade (paralysis) is necessary for many surgical procedures to provide optimal surgical conditions. The extent of paralysis typically assessed during routine clinical care by examining the muscle response of the thumb ("twitch") following delivery of a series of the "train-of-four".

Quantitative assessment of neuromuscular block can be assessed using electromyography (EMG) This technique measures action potential in the muscles of the thumb.

The proposed method is a simple technique that can constructed with equipment that is readily available in most operating rooms. If validated, it would provide a simple method to assess quantitatively the extent of neuromuscular blockade and recovery of muscle strength.

Eligibility Criteria:
1. Age \>18
2. Surgery is elective
3. Subject has been NPO for fluids for \>2 hours and for solids \>8 hours
4. General anesthesia with tracheal intubation is required
5. Mask ventilation is expected to be without difficulty
6. Subject voluntarily consents in writing to the protocol
7. ASA Physical Status 1-III (healthy individuals, those with mild comorbid conditions, or those with more serious co-morbid conditions that are well controlled)

Exclusion Criteria:

1. Lack of ability to provide written, informed consent
2. Airway examination indicates a likelihood of difficult mask ventilation
3. Symptoms of active reflux at the time of induction, at risk of having food in their stomach at the time of induction, expected abnormal response to non-depolarizing neuromuscular blockers
4. Age ≤18 years
5. Pregnant women
6. Presence of carpal tunnel syndrome
7. Prisoners
8. General anesthesia not being provided
9. Tracheal intubation will not be performed
10. Anticipated length of surgery \<60 minutes
11. Emergent or urgent surgery
12. Disease that might alter the normal neuromuscular response to electrical stimulation (e.g., muscular dystrophies, myasthenia gravis, quadriplegia).
13. ASA Physical Status IV or V (individuals with major comorbid conditions that are a constant source of risk to health)
Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma

This trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma. In arm A of the study, 40 adult patients will be randomised into two groups. One group will get standard chemotherapy and the other group will get Zoledronic acid in addition to chemotherapy. The investigators will assess the histological necrosis as well as disease status for up to 2 years.

In Arm B, adult patients with relapsed disease or advanced disease who are unable to take any other therapy and are given only symptomatic care will be given 6 doses of zoledronic acid and followed up for disease status. This will be to determine the role of zoledronic acid as a single agent.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity
2. Non Metastatic at presentation. The metastases are ruled out by a CT scan of the chest and a PET scan.
3. Patients are willing and able to afford the standard chemotherapy.

Exclusion Criteria:

1. Non-extremity sarcomas. (pelvis and spine)
2. Age less than 18 years or greater than 65 years
3. Metastatic at presentation
4. Pregnant or lactating women
5. Renal dysfunction in the form of elevated serum creatinine
6. Dental treatment anticipated after evaluation.
7. Patients who have received or are likely to receive steroids.
Effects of a Dipeptidyl Peptidase-4 Inhibitor Sitagliptininsulin on the Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes

This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.

This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on progression of coronary atherosclerosis in patients with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18, \< 80 years old, with type 2 diabetes mellitus and coronary heart disease.

Exclusion Criteria:

* Allergy or hypersensitivity to any of the drug's components. Severe liver failure, moderate or severe kidney failure Malignant disease. Active infectious disease. Pregnancy or breastfeeding.
Evaluation of the Effect of rTMS on Attention in Adults Diagnosed With Attention-Deficit Hyperactivity Disorder (ADHD)

The aim of the study is to evaluate the immediate effect of rTMS on attention in adults diagnosed with ADHD. the design is a double blind sham controlled crossover study.

The subjects were randomly assigned to two groups. group 1 starts with the real rTMS session followed within one week with a sham session. group 2 starts with a sham session and within one week recieve a real session. the subjects go through a neurocognitive evaluation before and after rTMS sessions and a clinical evaluation questionnaire modified for attention.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* diagnosis of ADHD according to DSM IV criteria

Exclusion Criteria:

* other axis I diagnosis
* risk factors for seizure
PGL4001 Versus Placebo in Uterine Myomas

This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.


Eligibility Criteria:
Inclusion Criteria:

* Be a pre-menopausal woman between 18 and 50 years inclusive.
* Have excessive uterine bleeding due to myoma.
* Have a myoma-related anaemia.
* Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size.
* Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
* If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
* Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

* Has a history of or current uterine, cervical, ovarian or breast cancer.
* Has a history of or current endometrium atypical hyperplasia.
* Has a known severe coagulation disorder.
* Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
* Has abnormal hepatic function at study entry.
* Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
* Has a current (within twelve months) problem with alcohol or drug abuse.
* Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
CD19 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With B-cell Malignancies

This is a single arm, open-label, phase 1/2 study to evaluate the safety and efficacy of anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CAR-T therapy showed great effect on patients with relapsed or refractory B cell malignancies. CAR consists of single chain variable fragment (scFv) and activation domain of T cell. In preclinical study, the researchers constructed a second generation CAR containing CD137 costimulatory domain. This study aims to evaluate the safety and effectiveness of anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy or autologous hematopoietic stem cell transplantation (auto-HSCT); or patients voluntarily choose CD19 CAR-T cells as a first treatment;
2. B cell hematological malignancies include the following three categories:

   * B-cell acute lymphocytic leukemia (B-ALL);
   * Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
   * Aggressive B-cell lymphoma (DLBCL, BL, MCL);
3. \< 70 years old;
4. Expected survival time \> 6 months;
5. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
6. Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.

Exclusion Criteria:

1. With a history of epilepsy or other central nervous system diseases;
2. Having graft-versus-host reaction, requires the use of immunosuppressants;
3. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
4. Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
5. Not curable active infection;
6. Patients with active hepatitis B or hepatitis C virus infection;
7. Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
8. Using product of gene therapy before;
9. Creatinine\> 2.5 mg / dl (221.0 umol/L); ALT / AST\> 3 X the normal amount; Bilirubin\> 2.0 mg / dl (34.2 umol/L);
10. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
11. Patients with HIV-infection;
12. Any situation that may increase the risk of patients or interfere with test results.
Feasibility and Acceptability of Click's EMA and Text Message Intervention for STRESS Management

The purpose of this study is to evaluate feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management in participants with higher-than-average perceived stress conducted in a remote setting.

Study details include:

Study Duration: 7 months Intervention Duration: 3 weeks


Eligibility Criteria:
Inclusion Criteria:

1. Age 22 years or older
2. Must reside in an Eastern Standard Time or Central Standard Time zone
3. Able to read and write in English as demonstrated by review and completion of an Informed Consent Form
4. Own an SMS enabled smartphone
5. Scoring \>5 on the 4-item Perceived Stress Scale (reflecting higher-than-average perceived stress)

Exclusion Criteria:

1. Reported cognitive impairment and/or psychiatric disorders of the psychotic spectrum
2. Enrolled in another support study
3. Currently receiving psychotherapy through telehealth
4. PHQ-9 score of 20 or greater.
Anatomic Congruent Prosthetic Knee Design

This double-blinded randomized control study will use kinematic and kinetic measures to compare an anatomical congruent prosthetic knee design to a standard prosthetic knee design. The patients will be measured pre- and post-operative and compared to a healthy non-osteoarthritis control group.


Eligibility Criteria:
Inclusion Criteria:

* Informed and written consent.
* Primary knee osteoarthritis in capable men and women.
* Indication for cruciate-retaining total knee arthroplasty.

Exclusion Criteria:

* Patients who do not speak and read Danish.
* Patients who are pregnant or at risk of becoming pregnant during the project.
* Patients with active cancer and/or radiation or chemotherapy.
* Patients who are alcoholics or have some form of abuse that impede information and follow-up.
* Patients with severe psychiatric disease that might complicate compliance with follow-up.
* Patients with surgically implants in the affected leg and/or pace maker.
* Patients with greater thigh circumference then 60 cm.
* Patients cannot perform the described exercises.
* Patients with knee instability due to multiligament injury.
* Patients with conditions that severely compromise their gait other than knee osteoarthritis in the affected knee.
* Patients with severe fracture sequelae or severe malalignment at knee level.
* Patients with osteosynthesised fractures using bone graft at knee level.
* Patients with need of an augmentation and/or stem-elongation.
* Patients with metabolic bone disease.
* Patients with rheumatoid arthritis.