cyrilzakka/clinical-trials huggingface dataset:
iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients

The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric kidney transplant recipients who are trained to offer vital peer support and mentorship. Parents of children who received a kidney transplant at The Hospital for Sick Children will be invited to participate as mentors and mentees. The iP2P program can decrease feelings of isolation, improve mental health and have a long-term positive impact on patient health. This research will increase our understanding of one-to-one peer support and leverage eHealth technologies to improve the access to and acceptability of parent peer support interventions.


Eligibility Criteria:
Mentee Inclusion Criteria:

* Parent of a patient under 18 years of age who received a kidney transplant and is at least two months post-transplant,
* Access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software, and
* English-speaking.

Mentor Inclusion Criteria:

* Parent of a patient under 21 years of age who received a kidney transplant and is at least one year post-transplant,
* Nominated by their child's healthcare team as a good candidate to act in the mentor role (e.g., good communication skills, positive adaptation and adjustment post-transplant, strong support network),
* Access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software, and
* English-speaking.

Exclusion Criteria:

* Non-English speaking.
A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia

This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).


Eligibility Criteria:
Inclusion Criteria:

* Postherpetic neuralgia with pain present for at least 9 months

Exclusion Criteria:

* Active herpes zoster skin rash
* Anticipated treatment for postherpetic neuralgia during the first 3 months of the study, including oral and topical medications, acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS), or trigger point injection
* Anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the first 3 months of the study
* Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use during the first 3 months of the study
* Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study
Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients

This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 8-17 years old are selected as subjects. Esketamine is used as intervention before surgery, vital signs data, serum IL-6, CRP and other inflammatory indicators are collected during surgery, and the incidence and degree of anxiety and depression are evaluated after surgery. To determine the effect of esketamine on reducing anxiety and depression in adolescents after surgery, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. 8 years ≤ age ≤17 years;
2. Patients who plan to undergo elective surgery under general anesthesia, and the operation time is ≥2h;
3. ASA grade I-II

Exclusion Criteria:

1. Patients expected to be admitted to ICU after surgery;
2. Patients who need to return to the ward with tracheal intubation after surgery;
3. Allergic to the active ingredients or excipients of isketamine hydrochloride injection;
4. Patients with severe consciousness disorder or mental system disease (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
5. Patients with congenital heart disease and severe developmental delay;
6. Patients with one of the following contraindications to esketamine :(a) patients at risk of a significant increase in blood pressure or intracranial pressure; (b) Patients with ocular hypertension (glaucoma) or penetrating ocular trauma; (c) Patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmHg or resting diastolic blood pressure greater than 100 mmHg); (d) Untreated or undertreated hyperthyroidism;
7. Previous history of ketamine abuse or dependence, drug or alcohol dependence for more than 6 months, previous ketamine ineffective tests or adverse reactions.
Tricaprilin In Age-Associated Memory Impairment

The purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with "normal" loss of memory abilities since early adult life.

One physiological hallmark of aging in mammals is a decreased uptake and metabolism of glucose within the brain. The impaired glucose metabolism in the brain may contribute or exacerbate the cognitive deficits observed during normal aging. Facilitation of memory in elderly individuals occurs when glucose levels are elevated by the administration of carbohydrate. However, such a treatment poses challenges since elevated blood glucose levels are difficult to maintain and must be within a relatively narrow window, as excessive hyperglycemia is associated with cognitive impairments. The purpose of this study is to explore whether increasing levels of other substrates for the brain improves cognitive functioning in normal aged individuals with memory disorders.

Study participants will be 120 men and women aged 50-85 who have been diagnosed as having Age-Associated Memory Impairment (AAMI). During the double-blind period of the protocol, 60 participants will receive tricaprilin and 60 participants will receive a matching placebo. Tricaprilin or the matching placebo will be administered once a day for ninety days by mixing powder in 8 ounces of a liquid. Each participant will be seen six (6) times: at Screening; Baseline; treatment days Days 30, 60, 90; and 14 days after the conclusion of treatment (Day 104).

Eligibility Criteria:
Inclusion Criteria:

* Complaints that memory has declined since young adult life
* Scores on standardized tests that are at least one standard deviation below the mean score of young adults

Exclusion Criteria:

* Dementia, including Alzheimer's disease and Mild Cognitive Impairment (MCI)
* Drugs that impair cognition
* Psychiatric conditions that may impair cognition (e.g.,depression etc.)
Validation of a Screening Test for Sarcopenia in Older People

Identify the threshold which the handgrip strenght can be used as a screening test of sarcopenia.

Handgrip strenght can be used in daily clinical practice to screen patients having sarcopenia to improve treatment and quality of life.

A cross-sectional multicentre study will be performed in hospital and retirement houses on patients ages 75 years old or more.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 75 years old

Exclusion Criteria:

* Palliative care,
* Protection of vulnerable adults
Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)

The Cannabinoide Hyperemesis Syndrom (CHS) is defined as a recurrent syndrome of intractable vomiting that occurs in chronic cannabis consumers. The diagnosis is linked to clinical criteria only. The physiopathology of CHS is unknown and we observe an increase of cases with this syndrom since 2016 (Schreck et al., 2018).

The aim of this study is to investigate the involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS.


Eligibility Criteria:
Inclusion Criteria:

* Subjects without protection by a legal regime (guardianship, trusteeship)
* Subjects affiliated to an appropriate social security system
* Subjects must sign an informed consent form

Inclusion Criteria for Group 1:

- Subjects must have the CHS diagnosis confirmed

Inclusion Criteria for Group 2:

- Subjects must be chronic cannabis consumers and never had CHS

Exclusion Criteria:

* Subjects must not have addictive comorbidities or psychoactive substance abuse (except alcohol and tabacco)
Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants

Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

The changes in cerebral perfusion have an important role on the development of intraventricular hemorrhage and periventricular leucomalacia. Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

1. \<32 gestational age and/or \<1500gr.
2. \>30th day preterm infants

Exclusion Criteria:

1. sepsis
2. shock
3. severe intracranial hemorrhage
4. NEC
5. abdominal and cranial surgery
Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 weeks
* HbA1c: 8.0-10.0%
* Current treatment with OAD on monotheray or OAD on combination therapy
* Body mass index (BMI): 21.0-35.0 kg/m2

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Recurrent major hypoglycaemia as judged by the Investigator
* Uncontrolled hypertension
* Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator
Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years

Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.

This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years.


Eligibility Criteria:
Inclusion Criteria:

* Age \>70 years and ≤ 75 years
* Liver transplant from cadaveric donor
* First liver transplant
* End stage liver disease or liver tumor

Exclusion Criteria:

* Age ≤ 70 years
* Living donor liver transplant
* Previous liver transplant
* Liver transplant for acute liver failure
Brisk Walk on Chronic Obstructive Pulmonary Disease

To determine the effects of 30 min brisk walk on Pulmonary Functions on COPD patients To determine the effects of 30 min brisk walk on Health related Health-related quality of life (HRLQ) on Chronic obstructive pulmonary disease (COPD) patients


Eligibility Criteria:
Inclusion Criteria:

* COPD patients (GOLD criteria Mild and Moderate).

Exclusion Criteria:

* Dyspnea more than 4
* Walking issues
* Rheumatoid arthritis
* Musculoskeletal disorder
* Acute infections.
The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children

Aim: The study was carried out in randomized control to determine the effect of two different distractions on pain and anxiety during blood collection.

Methods: The population of the study consisted of children between ages of 4-10 years who applied for venipuncture to a training and research hospital in Turkey between July and December 2018. A total of 139 children were included in the study, 46 of them with virtual reality goggles and 43 of them with control group. Information Form, Child Anxiety Scale, Visual Analogue Scale and Wong Baker Pain Scale were used in the collection of data.


Eligibility Criteria:
Inclusion Criteria:

* being aged between 4 and 10 years for the child,
* applying for health control purpose,
* not having any chronic, mental or neurological illness,
* not using any analgesic in the last 6 hours before the venipuncture procedure.

Exclusion Criteria:

-having a chronic, mental or neurological illness,
Osmotin Plant Protein for Progressive Multiple Sclerosis

The aim of this study is to explore the anti-inflammatory and neuroprotective effects of a novel nutraceutical product (commercial name Forza™️), consisting of the plant osmotin protein, in patients with progressive multiple sclerosis (PMS). The potential effect on brain metabolism and microstructure will be evaluated by magnetic resonance imaging (MRI) performed six months before starting treatment, at baseline, and after one and six months of treatment. At the same timepoints, electrophysiology, neurofilaments (NfL) quantification, optical coherence tomography (OCT) and clinical assessments will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Diagnosis of progressive multiple sclerosis (PMS)
* Expanded Disability Status Scale EDSS ≤ 6.5

Exclusion Criteria:

* Contraindications to MRI
* Pregnancy
* HIV positivity
* Severe renal, hepatic, oncological, hematological and psychiatric diseases
A Clinical Trial to Evaluate the Efficacy of ConcenTrace to Buffer pH Levels Within the Body.

This virtual single-arm trial will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12.

Urine pH measurements will be taken at Baseline, Week 4, Week 8, and Week 12 using pH test strips.


Eligibility Criteria:
Inclusion Criteria:

* Male or female. Aged 18+. Generally healthy - don't live with any uncontrolled disease. Willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study.

Exclusion Criteria:

* Anyone with a pre-existing chronic condition that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.

Anyone with known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.
Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients

The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast cancer patients with different doses and multiple injections.

To observe the pharmacokinetic characteristics of recombinant human serum albumin /granulocyte colony-stimulating factor fusion protein after single and multiple administration

This experiment adopts the method of multicenter, open, dose escalation study injection with recombinant human blood clean protein/granulocyte stimulating factor fusion protein after single and multiple doses of tolerance, security, and pharmacokinetic characteristics.

Breast cancer patients with reduced white blood cells after chemotherapy were selected as subjects of this study.

The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg respectively, each of which was studied by single and multiple doses.

Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65.
* Diagnosed breast cancer，received chemotherapy.
* ECOG performance status 0 or 1.
* ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
* Leukocyte reduction occurred after chemotherapy,WBC≤3.0x109/L or ANC≤1.5x109/L.
* No obvious abnormal ecg examination.
* Cr，TBIL, AST, ALT≤1.5×ULN，no serious underlying disease.
* Signed informed consent.

Exclusion Criteria:

* Chemotherapy within past 4 weeks.
* Uncontrolled inflammatory disease,axillary temperature≥38℃.
* Merging other malignant tumor.
* Pregnancy or nursing status.
* Participation in another clinical trial with and investigational product within 3 months prior to study entry.
* Severe diabetes mellitus, or poor blood sugar controller.
* Allergic disease or allergic constitution. History of protein allergy.
* History of drug addiction and alcoholism.
* Hematopoietic stem cell transplantation or organ transplantation.
* Received antibiotic treatment within 72 hours before chemotherapy.
* Long-term use of hormones or immunosuppressive agents.
* Severe mental or neurological disorders.
* Chronic disease of severe cardiac, kidney and liver.
* Other conditions that would be excluded from this study according to doctors'judgment.
Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth

Adults with stroke-related disability spend more time sedentary than adults without stroke-related disability, which places them at risk for poor cardiovascular health outcomes. Few interventions are designed to reduce post-stroke sedentary time.

The purpose of this research is to test whether the teleABLE (Activating Behavior for Lasting Engagement) Intervention is feasible and acceptable to adults within the first 12 months post-stroke. The hypothesis is that teleABLE can be feasibly delivered using videoconferencing within the first 12 months post-stroke. 10 participants will complete assessments and activity monitoring (activPAL micro3) at 0 (baseline) and 8 (post-intervention)-weeks. Participants will complete 12 sessions of the teleABLE intervention.

Findings from this study will be used to guide the intervention protocol in the planned next phase of this research.


Eligibility Criteria:
Inclusion Criteria:

* Stroke diagnosis ≤12 months prior to study enrollment
* ≥6 hours of sedentary behavior on a typical weekday (assessed by Sedentary Behavior Questionnaire)
* Ambulatory with or without assistive device (assessed by Functional Independence Measure, mobility score ≥5)
* Able to access an electronic device (smartphone, tablet, or computer) that is compatible with a videoconferencing application
* Able to identify a support person with whom the participant has face-to-face interaction at least one time per week
* Able and willing to participate fully in the study and provide informed consent

Exclusion Criteria:

* Currently receiving care in an inpatient rehabilitation, transitional care unit, or skilled nursing facility
* Severe cognitive or communication impairments (inability to respond accurately to complete study telephone screening or complete informed consent)
* Comorbid neurodegenerative disorder (e.g. Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis, dementia, Alzheimer's disease, Huntington's disease, glioblastoma)
* Comorbid cancer, currently undergoing chemotherapy or radiation treatment
* Comorbid major depressive disorder (assessed by Patient Health Questionnaire-2, score ≥2)
* Received inpatient treatment or hospitalized for psychiatric condition and/or alcohol or substance abuse within the past 12 months
* Diagnosis of a terminal illness and/or in hospice care
* History of skin sensitivity that precludes the use of medical tape necessary for adherence to activity monitor measure
* Inability to speak, read, or understand English
* Concurrent participation in another rehabilitation intervention research study
* Investigator discretion for safety or adherence reasons
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).


Eligibility Criteria:
Inclusion Criteria:

* OEF/OIF/OND Veteran
* Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
* Age 21 - 55 years old
* One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey
* GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L) and IGF-I lab values have to be less than or equal to +1 SDS at baseline
* Score of 11 or more on QoL-AGHDA
* 4-week stability on any psychotropic medications
* 3-month stability on all other hormone treatments
* Able and willing to provide informed consent to participate in this study, and complete study protocol.

Exclusion Criteria:

* History of moderate or severe TBI
* History of neurologic disorder other than TBI with substantial impact on quality of life
* History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
* Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months
* Contraindication to rhGH therapy
* Contraindication to macimorelin use, including QTc interval \>470ms
* Acute medical illness, active infection, cancer or decompensated chronic medical illness
* Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed.
* Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory Malingering (TOMM).
* BMI \> 35 or body weight \> 350 lbs
* Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass)
* Women who are pregnant or of child-bearing potential not on contraception
* Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses
* Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)
Algorithm of Muscle Function Tests to Detect Residual Neuromuscular Blockade.

Objective neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologist just use qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this study is to develop an algorithm of muscle function tests to identify PORC

Background: Quantitative neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologists, however, use insensitive, qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this multicentre, prospective, double-blinded, assessor controlled study is to develop an algorithm of muscle function tests to identify PORC.

Methods: After extubation a blinded anesthetist performs eight clinical tests in 165 patients. Test results are correlated to calibrated electromyography train-of-four (TOF) ratio and to a postoperatively applied uncalibrated acceleromyography. A classification and regression tree (CART) is calculated developing the algorithm to identify PORC. This is validated against uncalibrated acceleromyography and tactile judgement of TOF fading in separate 100 patients.

Eligibility Criteria:
Inclusion Criteria: The patients were scheduled for elective low risk surgical procedures:

* laparoscopic abdominal procedures
* orthopedic
* minor visceral surgery

Exclusion Criteria:

* participation in another study
* body mass index over 30
* history of neuromuscular diseases
* gastro-esophageal reflux disease.