cyrilzakka/clinical-trials huggingface dataset:
Effects of Early Sensory Reeducation Programs Using Mirror Therapy for Patients With Peripheral Nerve Injuries

This study evaluated the effects of an integrated program of touch-observation and task-based mirror therapy on sensorimotor function in nerve injury patients. Before the return of protective sense (Value of Semmes-Weinstein monofilament test \> 4.31), half of the participants received 15 minutes of mirror therapy program, followed by 20 minutes of regular hand therapy and 20 minutes of physiotherapy.While the other half received 15 minutes protective sensory reeducation programs, 20 minutes of regular hand therapy and 20 minutes of physiotherapy in each treatment session. Once the patients had regained the protective sense (Value of Semmes-Weinstein monofilament test \< 4.31), the discriminative sensory reeducation program was started for the participants in both groups. The hypothesis was that using the mirror therapy for sensorimotor reeducation in the early phase after nerve repair would yield better results with regard to the returning of sensation, sensorimotor control ability and hand function than using a classical reeducation program alone.


Eligibility Criteria:
Inclusion Criteria:

* median or ulnar nerve injury,
* a combination of nerve and tendon or vascular injury,
* injury sites between the level of mid-palm and elbow, and
* the protective sensation of the hand is lacking or impaired.

Exclusion Criteria:

* patients with deficits in cognition or language comprehension, as well as severe limitations in the range of motion of the upper limbs.
The Effect of Intravenous Lidocaine on Postoperative Cognitive Function in Elderly Patients

The purpose of this study is to investigate the efficacy of intravenous lidocaine on BDNF, NGF, miRNA-206 and miRNA-98 in serum in elderly patients undergoing abdominal surgery under general anesthesia.

Postoperative cognitive dysfunction (POCD) is a major complication following surgeries and anesthesia, especially in elderly individuals. Lidocaine, an inexpensive, widely available, and relatively safe compound, is a local anesthetic that readily crosses the blood-brain barrier. Intravenous lidocaine can reduce the incidence of POCD. However, the mechanism is still unclear.

Brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF), which are regulated by miRNA-206 and miRNA-98 respectively, play a key role in learning, memory, and cognition. Previous studies have shown that the levels of BDNF and NGF can be improved by lidocaine.

The objective of this study is to investigate the efficacy of intravenous lidocaine on the incidence of early POCD, and the levels of BDNF, NGF, miRNA-206 and miRNA-98 in elderly patients undergoing abdominal surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients were scheduled by following abdominal surgery under general anesthesia
* Aged 65 - 80 years
* ASA physical status Ⅱ-Ⅲ

Exclusion Criteria:

* Severe heart, pulmonary, hepatic and renal insufficiency
* History of neurological diseases (including Alzheimer's disease and stroke history)
* Psychological disorder, and drug or alcohol abuse
* History of anesthesia and surgery
* psychiatric illness
* Unwillingness to comply with the protocol or procedures
* Allergic to lidocaine
* Mini-Mental State Examination (MMSE) score\<23 before surgery
Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients

This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.

SpectralMD has developed an imaging device (DeepView), which simultaneously performs multispectral imaging (MSI) measurements across the visible and infrared spectrum to obtain a quantitative tissue viability assessment. These optical measurements are integrated using a CADe algorithm to categorize microvascular blood flow and provide a quantitative assessment to aid in selecting the appropriate amputation site.

The investigators intend to gather data to train the CADe algorithm to predict ultimate healing status of tissue in the lower extremities of individuals suffering from peripheral arterial disease (PAD). The investigators will demonstrate the feasibility of using such an algorithm to accurately predict the location and extent of small vessel disease prior to amputation. Eventually, the invesitgators expect the DeepView to reduce the rate of re-amputation in patients with peripheral arterial disease if used for routine assessment of patients prior to amputation.

The aims of the study are as follows:

* Evaluate performance of a Computer Assisted Detection (CADe) algorithm trained to assist selecting the level-of-amputation in patients with PAD.
* Identify multispectral signatures that are strongly predictive of viable skin tissue at proposed amputation sites.
* Create a representative database for training the CADe algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Patient must require amputation on a limb secondary to PAD, defined as arterial insufficiency due to atherosclerosis based on one or more of the following assessments:

  * Ankle brachial index;
  * Duplex ultrasonography showing clinically significant occlusion;
  * Arteriography; or
  * Assessment demonstrating stenosis by arterial calcification.
* Able to give informed consent,
* Be at least 18 years of age.

Exclusion Criteria:

* No history of major amputation on the affected limb, or
* Life expectancy less than 6 months.
Knowledge and Perceptions About Human Papillomavirus and Cervical Cancer Risk Among Young Adults

RATIONALE: Learning about young adults' knowledge and perceptions about risk factors for the human papilloma virus and cervical cancer may help doctors learn more about how to prevent human papilloma virus infection and cervical cancer in the future.

PURPOSE: This clinical trial is studying knowledge and perceptions of the risk factors for human papilloma virus infection and cervical cancer in young adults.

OBJECTIVES:

* Describe the socio-demographic context of college students in an urban Midwestern setting.
* Assess knowledge of the human papillomavirus (HPV) and cervical cancer in these participants.
* Assess the population's perception of HPV risk.
* Assess the prevalence of risk behaviors that may place this population at risk for HPV.
* Identify the best predictors of HPV knowledge and cervical cancer knowledge.
* Assess vaccine knowledge and acceptance in these participants.

OUTLINE: Participants complete the Young Adult Survey online documenting demographic data; sexual history (i.e., whether they ever had sex, age of first sexual encounter, number of life time partners, condom use, sexually transmitted diseases \[STDs\], and pregnancy history); cigarette use; current and past drug use; knowledge of human papillomavirus (HPV) and cervical cancer; past history of Pap tests and STD screenings; attitudes towards HPV testing; vaccine knowledge and acceptability; sources of information about HPV; source of information about cervical cancer; identification of common STDs; perceived risk of acquiring STDs; perceived risk of acquiring HPV; social support; and religion.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Currently enrolled in a college, university, or community college in the Greater Cleveland metropolitan area
* Currently single and never married

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia

This project is a clustered randomized controlled trial of a knowledge translation intervention of new ACOG guidelines for the diagnosis of poor progress in labor. The intent is to reduce the rate of cesarean section (CS) in first time mothers at term (\>= 37 weeks), with a vertex presenting singleton fetus, without increasing maternal or neonatal morbidity. The guidelines were developed from data from the Consortium for Safe Labor. The unit of randomization will be sites in Alberta that deliver

Cluster randomized controlled trial of a knowledge translation intervention of new guidelines for the diagnosis of poor progress in labor. The intervention will be randomized to centres (the clusters) in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually, with stratification based on facility type and geographic location. Clustering by centre and not individual caregivers (nurses/physicians) is necessary to prevent leakage or crossover of the intervention to controls. As all participating centres will eventually receive the intervention, the biostatistician will generate a randomization into two "waves". The intervention will be introduced sequentially by strata (Calgary, Edmonton, regional centres, rural centres) to the first "wave" hospitals in multi-week run-in periods after which those strata will be revisited for roll-out to the second "wave" hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Centers in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually

Exclusion Criteria:
Patient-Centered Acupuncture for Pain (PCAP)

The objective of this study is to find out if acupuncture can improve the management of pain in cancer patients when used as part of a treatment plan that includes conventional pain medications. The investigators will enroll 36 cancer patients at Abramson Cancer Center and Penn Cancer Network sites. Participants will be enrolled in either the Conventional Pain Management group or Integrative Pain Management group.


Eligibility Criteria:
Inclusion Criteria:

* Women or men age 18 years or older
* Primary diagnosis of cancer with history of stage I, II, or III cancer
* Finished primary cancer treatments (surgery, chemotherapy, radiotherapy)
* Have a Karnofsky score of 60 or greater
* Can understand written English
* Have worst pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week
* Have been taking pain medications daily
* Have had at least 15 days with pain in the preceding 30 days.

Exclusion Criteria:

* Women or men with metastatic (stage IV) cancer
* Unstable and progressive medical conditions as judged by the PIs or designated research nurse at the community hospitals (e.g., progressive cancer, uncontrolled heart failure) that may require hospitalization in the next 12 weeks
* Planned surgical procedures in the next 12 weeks
* Patients currently in a pain crisis as judged by the PI or designated research nurse that may warrant acute titration of medications or hospitalization
* Women who are pregnant or breastfeeding
* Unwillingness to adhere to study related procedures.
A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations

This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.


Eligibility Criteria:
Inclusion Criteria:

1. Signed the ICF and Age ≥ 18 years old, either sex.
2. ECOG ≤ 1.
3. Life expectancy of at least 3 months.
4. Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
5. Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
6. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.

Exclusion Criteria:

1. Prior treatment with selective FGFR inhibitors or FGFR antibodies.
2. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
3. Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.
Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.

The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.

Eligibility Criteria:
Inclusion Criteria:

* Postoperative Perforated Appendicitis (documented by intraoperative photo)
* Postoperative Laparoscopic Appendectomy

Exclusion Criteria:

* Nonperforated Gangrenous Appendicitis
* Nonperforated Purulent Appendicitis
* Open Appendectomy
The Effect of Aerobic Exercise Training for Migraine Prevention.

This study has been designed in order to know the effect of 12 weeks of aerobic exercise training for migraine prevention. We hypothesized that the exercise training could reduce the number of days with migraine and the number of attacks per month in the treated group.

The study will cover 20 weeks. The first 8 weeks has been designed as "baseline" period, to assess the migraine status and classification, colect blood exam, perform a cardiopulmonary exercise test to determine the maximal oxygen uptake, and fill psychometric questionnaires. The remaining 12 weeks will be the "intervention" period, where participants after randomization will be allocated to perform an aerobic exercise training (on treadmill) performed on a 3 times per week-based program of 40-min duration each session, or will wait for the equal period to repeat all the assessments, then begin the same exercise protocol.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary (\> 6 month) healthy subjects and sedentary (\> 6 month)subjects with migraine without aura, migraine with aura and chronic migraine;

Exclusion Criteria:

* Physically active(\> 1 day/week);
* Tobacco user;
* Alcohol or abuse drug user;
* Taking any prescribed medication or, in the case of medication for migraine prevention, if taking \< 6 months.
* Having any cardiovascular, pulmonary, endocrine-metabolic, rheumatic or other neurologic disease or psychiatric disorder such as bipolar disorder and post-traumatic stress disorder.
* Undergoing surgical procedure less than 3 months before entering the study.
Comparison of CTG and T-PRF on Peri-Implant Soft Tissue

The present study aimed to increase the thickness of the gingiva and prevent possible crestal bone resorption by placing the CTG or T-PRF membrane under the mucosa immediately after the implant treatment in individuals with thin gingival phenotype. The null hypothesis was that T-PRF used simultaneously with implant placement can be considered an alternative to CTG.

Although connective tissue graft (CTG) is considered as the best technique for soft tissue augmentation, limited supply of donor tissue because of palatal vessels and nerves, and postoperative pain may require alternative methods.

The purpose of this study is to reduce the crestal bone resorption around the implant site by augmenting the Peri-Implant Soft Tissue with T-PRF (titanium prepared platelet-rich fibrin) or CTG and to compare the effectiveness of the two techniques.

Through simultaneous augmentation of the soft tissue by T-PRF or CTG, a total of 30 implants were implanted in 30 patients (12 males, 18 females) with a mean age of 38.4 years. In the test group, implants were placed in thin tissues and thickened with T- PRF membrane at the same time, while in the control group, implants were placed in thin tissues and thickened with CTG at the same time. During the surgery (T 0 ) and at postoperative 3 months (T 1 ), keratinised tissue width (KTW) and Peri-Implant soft tissue thickness (STT) were measured from three points: occlusal part of the alveolar crest (OAC), midbuccal mucosa level (MBML), and over 1 mm of mucogingival junction (MGJ1).

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years,
* thin gingiva biotype,
* one missing tooth in the incisor, canine and premolar area and presence of two natural adjacent teeth
* no bone increasing procedures prior to and during dental implant,

Exclusion Criteria:

* history of a bleeding disorder or on anticoagulant therapy,
* immunocompromised state and debilitating disease,
* smoking and alcoholism,
* poor oral hygiene,
* diabetes.
Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry

Objective: Posttraumatic stress disorder (PTSD) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. Reminder focused positive psychiatry (RFPP) has been shown as well tolerated feasible trauma focused intervention that is associated with improved core PTSD symptoms, decreased severity of reactivity to PTSD trauma reminders, and increased vascular function. This study evaluates the clinical and biomolecular characteristics of RFPP in adolescents with PTSD.

Research Design/Overall Impact: After obtaining parents' informed consent and adolescent's assent, 60 adolescents aged 11-15 years old with PTSD, and free of known medical and other major psychiatric disorders will be recruited from the pool of eligible adolescents at Olive View UCLA Pediatrics Clinics (\>3000 adolescents with PTSD). Eligible adolescents will be randomized to 1) RFPP group intervention, or 2) an attentional control condition (group process). Thirty subjects in each group will receive twice weekly telehealth intervention of either RFPP or group process, for 6 weeks, and undergo 4 blinded neuropsychiatric assessments at baseline, 3, 6, and 24 weeks. Parents will receive weekly interventions of either positive psychoeducation or group process, for 6 weeks and undergo baseline, 3, 6- and 24-weeks neuropsychiatric assessment. Vascular function, inflammatory biomarkers including CRP, homocysteine, and stress involved gene expression biomarkers (i.e. changes in gene expression of FKBP5, DDX6, B2M, LAIR1, RTN4, NUB1, and a multi-gene Conserved Transcriptional Response to Adversity score (CTRA) will be measured at baseline and 6-week. The primary and secondary endpoints are a) changes in PTSD core and reactivity to trauma reminder severity score in response to RFPP intervention, b) changes in wellbeing, biopsychosocial trait, vascular function, neuroinflammation and gene expression biomarkers in response to RFPP, and c) changes in parents' wellbeing and biopsychosocial trait as well as child-parent interactions.


Eligibility Criteria:
Inclusion Criteria:

* Boy/Girl with documented PTSD,
* aged 11- 15 years old,
* able to read/write in English

Exclusion Criteria:

* presence of intellectual disabilities,
* presence of psychotic or self-injurious behavior,
* presence of seizure disorder,
* presence of language disorder,
* presence of eye disorders,
* presence of other neurodevelopmental disorders,
* presence of diagnosis of substance use disorder.
Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy


Eligibility Criteria:
Inclusion criteria:

1. Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
2. Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
3. PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.

4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.

Exclusion criteria:

1. Extensive-stage SCLC
2. Active or prior documented autoimmune or inflammatory disorders
3. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
4. Active infection including tuberculosis, HIV, hepatitis B and C
5. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)
Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye

This study will access changes in tear protein levels and symptoms of dry eye following insertion of a punctal plug.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe dry eye

Exclusion Criteria:

* Previous punctal plug insertion in the last 3 months or presence of plugs at the time of study
* Contact lens wear in the 7 days prior to study start or during the study
* LASIK procedure in the last year
* Cataract or other eye surgery in the last 3 months
* Corneal grafts
A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain

The hypothesis of this study is that distraction cards used by the caretaker along with a vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine pediatric immunizations when compared to a placebo device or standard care.

Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10$ of adults. Current standard of care for immunizations in the US is no pain relief. An inexpensive, immediately effective form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain.

Distraction can decrease procedural distress in children by 50%. The effect of using a multi-modal pain and distraction relieving approach has not been rigorously studied.

Eligibility Criteria:
Inclusion Criteria:

* children receiving routine immunizations

Exclusion Criteria:

* no caregiver present
* chronic illness requiring frequent injections
* clear cognitive impairments affecting communication