cyrilzakka/clinical-trials huggingface dataset:
Modulatory Effects of Multichannel tDCS During Prolonged Experimental Pain

Corticomotor excitability, pain sensitivity, descending pain control and somatosensory evoked potentials (SEPs) is often altered in acute and chronic pain.

Topical capsaicin generates stable, long-lasting hyperalgesia and ongoing tonic pain in healthy participants, which significantly inhibits corticomotor excitability in the primary motor cortex (M1).

Recent studies (by Fischer et al 2017) indicated that multifocal Transcranial Direct Current Stimulation (tDCS) administered to brain regions linked to the resting state motor network (network-tDCS) could enhance corticomotor excitability in healthy participants compared to single site M1-tDCS.

It remains unknown whether network-tDCS has also the potential to modulate the inhibitory effects on motor cortex excitability, pain sensitivity, descending pain control and SEPs associated with prolonged pain

To date, pain modulation to M1 rs-network tDCS during 8% capsaicin induced pain has not been assessed (Mylius, Borckardt and Lefaucheur, 2012). Further, it is unknown how multichannel tDCS acts on tonic cutaneous pain for approximately 24 hours.

The main objective of these projects are to study and characterize quantitatively the effects of multichannel tDCS in the development of prolonged pain.

It is hypothesized that multichannel tDCS of left M1 resting-state network will reduce the severity of experimentally prolonged pain over the m. first dorsal interosseous (FDI), will increase descending pain control, might possibly increase pain thresholds and simultaneously will modulate the peak-to-peak amplitude of SEPs to electrical painful stimulation. Further, it is hypothesized that descending pain modulation of M1 tDCS will be related to interference with the suppression of cortical excitability

Eligibility Criteria:
Inclusion Criteria:

-Right-handed healthy men and women in the age 21-50 years who speak and understand English

Exclusion Criteria:

* Lack of ability to cooperate
* History of chronic pain or current acute pain
* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Present and previous neurologic, musculoskeletal or mental illnesses
* Chili allergies (subproject 1 and 2)
* Current use of medications that may affect the trial
* Previous experience with rTMS and tDCS
* Contraindications to rTMS application (history of epilepsy, metal implants in head or jaw, etc.)
* Failure to pass the questionnaire for tDCS
* Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen) (Rossi et al., 2001)
The PREMOD Trial: A Randomized Controlled Trial of Umbilical Cord Milking vs. Delayed Cord Clamping in Premature Infants

Premature babies can be very sick and have bleeding in the brain. Giving babies more blood before cutting the umbilical cord by delayed cord clamping or umbilical cord milking has been shown to reduce the risk of bleeding in the brain. This may be related to improving perfusion to the brain. However, some studies suggest that delayed cord clamping may not increase hemoglobin or blood volume in babies delivered by cesarean section. Milking the umbilical cord may give more blood in babies delivered by Cesarean Section may improve perfusion and reduce bleeding in the brain.


Eligibility Criteria:
Inclusion Criteria:

* Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 23 0/7 - 31 6/7 weeks gestation

Exclusion Criteria:

* Planned vaginal breech delivery
* Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
* Fetal death in utero
* Red cell isoimmunization
* Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
* Placenta accreta or abruption
Different Lipid Soluble Opioids for Gynecologic Laparoscopic Surgery Postoperative Patient-controlled Analgesia

The investigators noticed that Body Fat Ratio might have great influence on the efficacy of different lipid soluble anesthetics. The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.

The objective of this clinical trial was to compare the effect of that Body Fat Ratio on the efficacy of different lipid soluble anesthetics.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists grade I-II
* adults aged over 20 and below 50 years old,
* non-smoker,
* with normal hepatic and renal function.

Exclusion Criteria:

* smoker ,
* any kind of mental disorder or
* history use of analgesics for more than 10 consecutive days,
* asthma; and
* those with digestion tract disorder who would get nausea or vomiting much more easily than normal people.
Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy

Research study designed to learn about and compare Shockwave therapy (SWT) vs placebo (no shockwaves) treatment in men with moderate to severe erectile dysfunction (ED) after Radical Prostatectomy


Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to provide informed consent.
2. Be male
3. Be ≥ 40 and ≤ 75 years of age (inclusive).
4. Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)
5. Be at least six weeks post radical prostatectomy.
6. Be in a stable sexual relationship for over 3 months prior to enrollment.
7. Have testosterone level of 300-1000 ng/dL within 1 month prior to enrollment.
8. Have an HbA1c level ≤ 7% within 3 months prior to enrollment.
9. Have undetectable PSA value at the time of enrollment

Exclusion Criteria:

1. Be currently participating in a clinical trial or have recently received an investigational therapy within the past 30 days that may interfere with the results of this study.
2. Be under judicial protection (prison or custody).
3. Be an adult under guardianship.
4. Refuse to sign the informed consent.
5. Have evidence of venous leak prior to surgery or use of PDE5i prior to surgery
6. Have past radiation therapy of the pelvic region or hormonal therapy with androgen deprivation within 12 months prior to enrollment.
7. Be recovering from any cancer within 12 months prior to enrollment (other than prostate cancer)
8. Have Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function (at the discretion of the investigator).
9. Have a Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications (at the discretion of the investigator).
10. Have an anatomical malformation of the penis, including Peyronie's disease.
11. Have testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment.
12. Be using blood thinners with international normalized ratio (INR) to be \> 3.
13. Have received shockwave therapy for at least 6 months before enrollment.
14. Have detectable PSA value after the radical prostatectomy.
15. Require radiation therapy after radical prostatectomy.
16. Require hormonal therapy after radical prostatectomy.
Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness

Chronic dizziness,or persistent positional perceptual dizziness (PPPS) is a common condition that results in impaired quality of life and work ability of those affected. Vestibular Rehabilitation (VR) is an evidence-based and recommended treatment for chronic dizziness. The treatment involves training in specific exercises that challenge the balance system and eventually improve dizziness. The main challenge with this treatment is that it is usually best provided with individual follow-up of therapists trained in the method. Limited resources and the lack of dissemination of this knowledge mean that only a minority of patients receive adequate treatment. An internet-based self-help program in vestibular rehabilitation has been developed in Norwegian with demonstration and instructions of exercises. The program has six lessons, together lasting for six weeks. Patients are given the opportunity to exercise at home, without the use of treatment resources and without spending time traveling to the treatment site. Patients will have access through their general practitioner or health institution at no extra cost. If it turns out that the program works according to the intention, the investigators will be able to offer VR to a large number of PPPS patients who previously would not receive treatment for their condition.

The aim of the pilot study is to find out if the internet program for PPPS works as intended and evaluate incoming data and make changes to the program. In addition, the investigators will gain experience in using the program before designing a randomized clinical trial (RCT). The aim of such an RCT would be to compare this internet based treatment to traditional treatment.


Eligibility Criteria:
Inclusion Criteria:

* Satisfy diagnostic criteria for persistent positional perceptual dizziness (PPPS) or satisfy criteria with a duration of \<3 months
* Vertigo symptom scale (VSS-SF) \>12

Exclusion Criteria:

* Cognitive dysfunction that is so pronounced that it will make participation difficult
* Unable to read, understand Norwegian
* Severe medical or psychiatric illness (including substance abuse) that reduces the patient's ability to follow the VR program
Collaborative Care Coordination Program for Alzheimer's Disease and Related Dementias

This is a randomized, pragmatic clinical trial to evaluate the effectiveness of a collaborative care-coordination program embedded in a health plan for people living with Alzheimer's disease and related dementias (ADRD) and their care partners versus usual care. The study population will include community-dwelling Medicare Advantage members living with ADRD and their care partners. Outcomes will be healthcare utilization outcomes of individuals with ADRD and include emergency department visits, outpatient visits, avoidable emergency department visits, and admission to long-term care facilities.


Eligibility Criteria:
Community-dwelling Tufts Health Plan Medicare Advantage members with ADRD and their caregivers will be selected to participate in the trial based on the following inclusion/exclusion criteria:

Inclusion Criteria (for members with ADRD)

* Member of Tufts Health Plan Medicare Advantage plan
* Medical and pharmacy insurance coverage in at least the prior 12 months
* Have ≥1 ICD-10-CM diagnosis code for ADRD or dispensing for pharmacological treatment for ADRD in the prior 12 months

Exclusion Criteria (for members with ADRD):

* Reside in a nursing home or skilled nursing facility
* Enrolled in a hospice program
* Receiving or have received the Dementia Care Consultation program as part of the existing program at the time of enrollment

Inclusion Criteria (for caregivers)

* Age 18 years or older
* Assume primary responsibility for members
Application of Tracheal Intubation in Lateral Position in Thoracic Surgery

This study is a pilot study of DLT or BB intubation using a visual laryngoscope in lateral position,To investigate the feasibility of DLT and BB intubation in lateral position,To compare the influence of four endotracheal intubation methods on intrapulmonary shunt,It provides safety guarantee for chest operation under spontaneous breathing anesthesia.

With the popularization of rapid rehabilitation medical treatment, the application of anesthesia techniques such as laryngeal mask anesthesia under spontaneous breathing and carbon dioxide artificial pneumothorax in thoracic surgery is gradually increasing,However, it is necessary to replace the double-lumen tracheal catheter in emergency situations such as massive bleeding or single-lung ventilation during surgery. At this time, it is particularly important to master the skills of lateral decubitus intubation, which can shorten the rescue time and is of great significance to thoracic anesthesia. Secondly, the movement of body position under anesthesia has an impact on hemodynamics and limb injury.In addition, the influence of anesthesia induction in different positions on patients' intrapulmonary shunt can also be considered.The above indicators, intubation time and success rate were observed,To analyze the feasibility and significance of lateral decubitus intubation in thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients aged over than 18 years and less than 60 years
* The American Society of Anesthesiologists (ASA) score was grade Ⅰ to Ⅱ, and there was no serious cardiopulmonary disease
* Undergoing unilateral thoracoscopic surgery

Exclusion Criteria:

* patients aged less than 18 years or over than 60 years
* BMI is over than 30kg/m2
* patients have cognitive dysfunction and cannot coordinate with body position
* History of cervical vertebrae and expected difficult airway (e.g. Mallampati airway grade 4 or above, mouth opening \<3 fingers, nail-chin distance \<6cm)
* Patients were sent to ICU after operation and could not cooperate with follow-up
Brain Network Characteristics in Patients With Disorders of Consciousness

Simultaneous measurement of the three modalities, functional magnetic resonance imaging (fMRI), positron emission tomography (PET) and electroencephalography (EEG) was proven to be feasible and advantageous in evaluating brain structural and functional (via fMRI), metabolic (via PET) and electrophysiological (via EEG) signatures simultaneously under the same conditions. Investigators use trimodal PET-fMRI-EEG imaging to explore the characteristics of brain network damage in patients with disorders of consciousness(DOC), assess the trajectory of consciousness recovery in a prospective observational cohort study.


Eligibility Criteria:
Inclusion Criteria:

1. Coma, VS/UWS, MCS and EMCS according to diagnostic criteria
2. Age ≥18 years
3. Written informed consent obtained

Exclusion Criteria:

1. Patients with contraindications to PET, MRI, EEG examinations or inability to complete PET-fMRI-EEG examinations (presence of ferromagnetic metal implants or hyperthermia)
2. Hyperglycemia that is difficult to correct
3. Patients with long-term use of corticosteroids
4. Patients with coexisting severe systemic disease and limited life expectancy
Pain With Dementia

The purpose of the study is to develop a caregiver-assisted pain coping skills training program for older adults who have pain and mild to moderate dementia and are living at home with a family caregiver. The investigators are planning to recruit 30 patient-caregiver dyads (60 individuals).

Involving caregivers in a pain coping skills protocol is likely to optimize treatment outcomes in several ways.

First, people with dementia (PWD) are likely to have difficulty learning and remembering pain coping skills; training the caregiver to coach the patient in the use of the skills is likely to improve the patients' acquisition and ongoing use of learned skills.

Second, caregiver involvement in pain coping skills training may increase their understanding of how to gauge how much pain the PWD is experiencing and the impact of pain management strategies. This understanding is increasingly important as the patient's disease progresses, and s/he is less able to report pain verbally.

Third, caregiver-assisted pain management training may enhance caregivers' self-confidence for managing the patient's pain.

Finally, by participating in the pain coping skills training protocol, caregivers may learn coping skills (such as relaxation) that can help them manage the stress associated with caring for a PWD and pain which can be significant.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Mild or moderate dementia
* Pain on most days for at least 3 months that interferes with function
* Living at home (non-institutional)
* Age ≥ 50
* English Speaking

Caregivers:

* Provides on average at least 4 hours/day of care/assistance to the patient
* Age ≥ 18
* English Speaking

Exclusion Criteria:

Patient and caregivers

* Lacking capacity for interview or unable to provide informed consent/assent.
* Visual or hearing impairments or severe behavioral problems that preclude participation.
* Too sick to participate.
Premolar Extractions for Obstructive Sleep Apnea in Children with Overjet

This research aims to provide pediatric patients with polysomnography (a sleep study) before and after orthodontic treatment to determine if the extraction of upper premolars for treating excessive overjet results in an increase of the AHI (Apnea Hypopnea Index) compared to similar patients treated without upper premolar extractions.


Eligibility Criteria:
Inclusion Criteria:

* 10-15 years old
* registered orthodontic patients
* able to undergo routine orthodontic care and are registered to obtain an orthodontic appliance in the future.
* do not have a high care need
* no known hypercapnia or hypoventilation
* no known allergies or nose blockages
* diagnosed as Class II Division I (=6mm of overjet) and bilateral Class II half cusp or unilateral Class II full cusp.

Exclusion Criteria:

* known hypercapnia or hypoventilation
* patients with hypertrophic tonsils and adenoids
* patients with allergies or nose blockages that interfere with breathing
* patients who are not registered as orthodontic patients at research sites deemed acceptable to undergo routine orthodontic care
Triptorelin for Early Diagnosis of Hypogonadotrophic Hypogonadism

The goal of this clinical trial is to learn if Triptorelin test works to early diagnose hypogonadotrophic hypogonadism in adolescents. The main questions it aims to answer are:

• Does gonadotropin and gonadal steroids responses to Triptorelin test be useful to diagnose early hypogonadotrophic hypogonadism? Researchers will compare gonadotrophins and gonadal steroids in response to Triptorelin subucutaneos test with clasiccal GnRH infusion to diagnose hypogonadotrophic hypogonadism.

Participants will performed two test:

* Triptorelin test (subcutanous)
* LHRH infusion test


Eligibility Criteria:
Inclusion Criteria:

* Female patients presenting with Tanner breast stage 1 or 2 at age ≥ 13 years or male patients with testicular volume \&lt; 5 cc at age ≥ 13.5 years, or who have had pubertal changes but have arrested pubertal development for a period of one year. Female patients presenting with primary amenorrhea (absence of menarche at age 15) \&gt; 4 years after the onset of puberty or secondary amenorrhea \&gt; 6 months with no other apparent cause (having ruled out other hormonal disorders such as premature ovarian failure, hypothyroidism, hyperprolactinemia, non-classical congenital adrenal hyperplasia, and polycystic ovary syndrome) may also be included. Patients with or without olfactory disorders, and with or without a previous diagnosis of other pituitary deficiencies will be included. In the case of a history of CNS tumor pathology, inclusion in this study will be considered only if the patient is in remission from the oncological disease and if they have received CNS radiotherapy, at least one year has passed since the beginning of the treatment.

If patients have started HRT, they may be included as long as they stop taking it for two half-lives of the compound used, therefore a 2-month free period is necessary for oral tablets or patches and 3 months for monthly testosterone injections or 7 months for testosterone undecanoate injections.

Exclusion Criteria:

* Patients will be excluded if, due to previous history or relevant clinical history or initial laboratory study, another cause is determined to explain their pubertal disorder: primary hypogonadism (hypergonadotrophic or premature ovarian failure), low weight with BMI \&lt; 18, untreated hypothyroidism, hyperprolactinemia, hyperandrogenism, Cushing\&#39;s syndrome, current prolonged corticosteroid treatment, active systemic disease, CRF or competitive training \&gt; 10 hours/week, diabetes mellitus without adequate control or celiac disease without compliance with a gluten-free diet.

Patients who do not provide an updated medical history, who do not provide consent, or whose parents or guardians do not provide assent will be excluded. Patients who are receiving hormone replacement therapy and refuse to stop during the 2-month period for oral tablets or patches and 3 months for monthly testosterone injections or 7 months for quarterly depot injections of testosterone undecanoate will be excluded.
Comparing Use of Radiographs Versus Patient Empowerment (CURVE)

Objective: To evaluate the (cost-)effectiveness of a new patient-empowered follow up (FU) protocol in patients with Adolescent idiopathic Scoliosis (AIS) that is based on patient-reported outcome measures (PROMs), self-assessment tools and physical examination, which is compared to standard FU care by: 1) Effect evaluation, 2) Economic evaluation, 3) Implementation (process) evaluation.

Study design: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial \[PRPT\]).

Study population: A total of 812 AIS patients (age 10-18 years) treated by the Dutch AIS Consortium, representing the scoliosis treatment centres in the Netherlands, will be included.

Three subgroups of AIS patients are distinguished, which are monitored over two years:

1. Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264)
2. Post-brace treatment group (n=122 per arm; total n=244)
3. Post-surgery group (n=152 per arm; total n=304)

Intervention: The new patient-empowered FU protocol (PE-FU) is based on PROMs, self-assessment tools and clinical assessment including physical examination. The protocol aims to detect curve progression or postoperative complications based on these patient-based and clinical parameters to substitute the need to obtain routine x-rays. X-rays will only be taken when progression or postoperative complications are suspected in the pre- and post-intervention groups based on predefined criteria. The standard FU protocol consists of routine full-spine radiographs and routine clinical evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Patients with adolescent idiopathic scoliosis (AIS).
* Age: 10-18 years old.
* Patients scheduled for follow up in one of the participating centres.
* Understanding of the Dutch language.
* Signed informed consent.
* Biplanar (Posterior-Anterior \[PA\] and Lateral) full-spine x-rays within the last 3 months.

Specifically for the pre-treatment group:

* Girls aged ≤14 years (i.e. 10-14 years) and boys \<16 years (i.e. 10-15 years). These patients still have generally 2 years of remaining skeletal growth. Patients above this age with a curve below 25 degrees have a limited risk for progression
* Girls: pre-menarche up to 6 months post-menarche (to estimate end of growth)
* A primary coronal curve of 10-25 degree.

Specifically for the post-brace group:

* Patients aged 12-18 years
* Within 3 months after termination of brace treatment
* Minimum of 6 months of brace treatment

Specifically for the post-surgery group:

• Patients aged 12-18 years

Exclusion Criteria:

* Patients with juvenile or infantile idiopathic scoliosis with the diagnosis of onset under the age of 10.
* Patients who are undergoing brace treatment. These patients are not included because of the need to monitor brace therapy with radiographs.
* Patients who have undergone previous spinal surgery and are undergoing revision surgery.
* Skeletally mature patients.