cyrilzakka/clinical-trials huggingface dataset:
TIME in Immunotherapy Combined With nCRT for Rectal Cancer

This is an open-label, prospective phase II clinical trial to evaluate the therapeutic and prognostic implications of tumor immune microenvironment in the neoadjuvant immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of 100 patients will be enrolled in this trial. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.

Objectives:

1. To clarify the efficacy and safety of combined therapy for locally advanced rectal cancer (LARC) patients and verify the efficacy and safety of neoadjuvant immunotherapy for dMMR/MSI-H LARC patients.
2. To clarify the effect of nCRT on TIME for rectal cancer, and the further effect of adding Immunotherapy.
3. To verify the feasibility of predicting the efficacy of combined therapy by the infiltration level of CD8+ PD1+ TILs in tumor tissue before treatment in pMMR/MSS LARC patients and explore the comprehensive prediction index of the efficacy of combined therapy for LARC patients.
4. To clarify the potential mechanism of immune response or immune escape to neoadjuvant immunotherapy for LARC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and ≤75 years on the day of signing informed consent.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
3. Histologically proven rectal adenocarcinoma.
4. \<12 cm from anal verge.
5. Clinical stage of T3/T4 or N positive and M0
6. No previous chemotherapy, radiotherapy, immunotherapy or surgical treatment
7. No immune system disease (e. g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic vasculitis, scleroderma, mixed connective tissue disease, dermatomyositis (DM), hyperthyroidism, hypothyroidism, ulcerative colitis (UC), autoimmune hemolytic anemia (AIHA) or human immunodeficiency virus (HIV) infection.
8. Adequate hepatic and renal function to chemoradiotherapy, immunotherapy and surgery.
9. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Allergic to any component of chemotherapy or immunotherapy;
2. Patients with multiple primary colorectal cancer;
3. Other malignant tumors within 5 years, except for adequately treated cervical carcinoma in situ or cutaneous basal cell carcinoma, or basically controlled localized prostate cancer or surgically excised ductal carcinoma in situ of breast;
4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgical resection;
5. Prior or planed organ/bone marrow transplant
6. Patients who receive systemic steroid therapy or immunosuppressive agents within 30 days before enrollment in the study;
7. Pregnant or lactating women
8. Patients with a history of severe mental illness or being unable to comply with the research protocols.
9. Patients who have contraindications to chemoradiotherapy, immunotherapy or surgery.
10. Patients who have any other conditions that investigator judges unsuitable to participate.
Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

To compare the effectiveness of vaginal dinoprostone with placebo in minimizing the pain experienced by primarily infertile patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes. The most commonly used agent is misoprostol, a synthetic prostaglandin E1 (PGE1) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening. In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

Exclusion Criteria:

* • women with suspected pregnancy

  * heavy vaginal bleeding
  * recent pelvic infection
  * those known to have hypersensitivity or contraindication to dinoprostone
  * those who received analgesics prior to OH
  * a concomitant neurologic disease that could affect the correct evaluation of pain
Endometrioma Sclerotherapy and Ovarian Preservation

A randomised controlled trial assessing ovarian reserve after laparoscopic ethanol sclerotherapy of ovarian endometrioma compared to standard treatment of surgical excision of endometrioma.

Secondary outcomes will include endometrioma recurrence, symptomatology and inflammatory environment.

Participants with endometrioma(ta), identified on imaging, who are opting for surgical management of endometriosis will be randomly allocated to laparoscopic ethanol sclerotherapy of endometrioma or laparoscopic surgical excision of endometrioma(ta). Any concurrent endometriosis identified at surgery will be excised as per routine care.

Ovarian reserve will be assessed by serum anti-Mullarian hormone (AMH) and antral follicle count (AFC), recurrence will me assessed by transvaginal ultrasound, symptomatology will be assessed by EHP-30 questionnaires and changes in inflammation assessed in serum and endometrial biopsy.

Each participant will be followed up for a total of 24 months from surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female (XX genotype, assigned female at birth)
* Age 18-40
* Finding of suspected uni- or bi-lateral ovarian endometrioma(ta) of ≥ 2cm on TVUSS and/or pelvic MRI scan (TVUSS, a uni- or multi-locular ovarian cystic lesion with low level echoes and diffuse homogeneous ground glass appearance; MRI any of, ovarian lesion hyperintense T1 without loss of signal on T1 fat-suppressed images, hypointense T2 exhibiting shading sign and/or T2 dark spot sign, variable restricted diffusion on DWI)
* Appropriate to be listed for laparoscopic excision of endometrioma (Endometrioma ≥2cm, pain symptoms attributable to endometriosis where medical management is unsuccessful or unacceptable to the patient, to facilitate ART)

Exclusion Criteria:

* Postmenopausal status
* Suspicion of malignancy
* Unable to undergo TVUSS
* Declines to take part in the study
* Unable to understand verbal or written information in English
* Lack of capacity to consent at the point of recruitment
* Known safeguarding issues
Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers

Childhood obesity is a contributing factor to health complications such as diabetes, heart disease, high blood pressure, cancer and asthma. It is of particular concern among Hispanic populations in the United States as that group has the fastest growing childhood obesity rate. Nearly two in five Hispanic children ages 2 to 19 are overweight or obese. This program aims to test whether it is beneficial to routinize a multi-disciplinary pediatric weight management program within the highest volume clinic (NYU-LFHC Women, Adolescents and Children), and to add a home-visit component to reinforce teaching on food selection and preparation. The intervention will include 27-hour intervention session which will be distributed into 12-session series over a 3 month period. The program will target Hispanic children between the ages of 9 and 11 with a Body Mass Index (BMI) between the 95th and 99th percentiles. To assess the effectiveness of this program, the investigators propose to conduct a general prospective study using randomized pre-test and post-test control group design with minimal risk for participants.

The proposed intervention will engage pediatricians at NYU Lutheran Family Health Centers (NYU LFHC) and providers at the school-based clinics in referring Hispanic children ages 9-11 years with a BMI between the 95th and 99th percentile to the study. In addition, a list will be generated from NYU Lutheran's Quality Improvement department if recruitment through providers is low. Providers will refer patients who meet the above criteria through eClincialWorks (ECW). A research assistant will then randomize the referrals after acquiring informed consent forms to either the control group or the intervention group. The control group will receive standard of care by nutritionists at NYU LFHC. The intervention group will receive a 27-hour intervention session which will be split into a 12-session series. The sessions will be conducted weekly over a 3 month period. This study will include three cycles with three separate cohorts.

The Healthy Families Intervention Group will include:

1. Bilingual English and Spanish group nutrition education, behavioral social support, and physical activity (e.g. kickboxing, Zumba, yoga, aerobics).
2. Monthly home visits by a nutritionist for family including specific recommendations on food purchasing and preparation.

Children randomized to standard of care will attend monthly sessions with a nutritionist.

Eligibility Criteria:
Inclusion Criteria:

* Patient of NYU-LFHC Women's, Pediatric, and Adolescent Medicine (5610)
* Hispanic ethnicity
* BMI percentile between the 95th and 99th
* Ages between 9 and 11 years old at the time the program begins

Exclusion Criteria:

* Autism Spectrum Disorder (299.0)
* Pervasive Developmental Disorder-Not Otherwise Specified (PDD NOS 299.9) and
* Other PDD (299.8)
Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis

Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, Investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

A secure and easily feasible vascular access is crucial for oncology patients because of the therapeutic need. Although intravenous port has been utilized for 3 decades, catheter-related complication still remain and had to deal with. According to investigators clinical experience, investigators summarized a standard algorithm as a recommendation for intravenous sport implantation. The complication before and after standard algorithm was 20 % and 3.5 %, respectively. However, catheter related infection and malfunction still could not be avoided. If patient was identified with these 2 complications, re-intervention is needed and cancer-related therapy has to be postpone. Investigators deconstructed the port that removed from patients and identified there were structural weakness, old blood clot and fibrin deposits. Investigators consider the problem may be exist in maintenance. After thoroughly examination the maintenance protocol, investigators identified the problem and try to remodel the maintenance protocol. The Goal of this study was to testify the clinical value of standard maintenance protocol.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer with new Port-A inserted

Exclusion Criteria:

* No
Double-Blind Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide

The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in patients with Type2 Diabetes Mellitus treated with Biguanide.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients treated with Biguanide
* Criteria for postprandial plasma glucose and HbA1c are met

Exclusion Criteria:

* Type 1 diabetes
* Patients treated with other antidiabetic drugs or Insulin
Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy

The purpose of this study is to determine whether aromatherapy with lavender oil compared to placebo lowers anxiety levels in women during colposcopy.

Aromatherapy is a modality that might reduce anxiety. Women experience high levels of anxiety and negative emotional responses at all stages of cervical cancer screening. High levels of anxiety before and during colposcopy can be bad. If lavender oil aromatherapy reduces anxiety, then simple use of this modality may improve experiences during colposcopy.

Eligibility Criteria:
Inclusion Criteria:

* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
* All women at least 18 yrs of age undergoing colposcopy who have not previously participated in this protocol.

Exclusion Criteria:

* age \<18 years
* pregnancy
* breastfeeding
* asthma
* poor sense of smell
* allergy to one of the essential oils
* consumption of any analgesic
* short-term anxiolytic (i.e. benzodiazepines) or chronic anxiolytic medications (i.e. SSRI)
Study on the Efficacy of Speed-Feedback Therapy for Elderly People With Dementia

The purpose of this study is to verify the efficacy of speed-feedback therapy in improving the cognitive function of elderly people with dementia by a randomized controlled trial, and to demonstrate how that affects ADL and QOL.

Dementia is a syndrome caused by diseases of the cerebral parenchyma, and it is a state in which cognitive functions, including attention, memory, thinking, comprehension, judgment, and computation, are diminished. Because of the mental symptoms, problem behaviors, and decreased activities of daily living (ADL) it is also recognized as a major social problem. However, rehabilitation of elderly people with dementia is still at the trial-and-error stage, and establishing a method of rehabilitation is an urgent task. In 2004, the authors devised and created a training method that integrates exercise therapy with feedback therapy to treat the cognitive dysfunction of elderly people with dementia. To do so the authors introduced speed-feedback therapy with a bicycle ergometer as a feedback therapy intervention. The results of a preliminary study of the efficacy of this method in improving cognitive dysfunction in 17 elderly persons with dementia showed improvement in cognitive dysfunction, and their attentiveness also improved, suggesting that the impaired attentiveness may have improved in response to treatment by this method and, as a result, have led to improvement of cognitive dysfunction. However, it became clear that it would be necessary to further improve and develop the system, and to demonstrate its efficacy in a controlled trial and verify associations between improvement of cognitive dysfunction and improvement of the ADL of dementia patients and their quality of life (QOL).

Eligibility Criteria:
Inclusion Criteria:

1. 65 years of age or older
2. Diagnosed with dementia by a physician
3. Mini-Mental State Examination score of 23 points or less
4. Capable of participating at least once a week for 6 weeks in succession

Exclusion Criteria:

1. Management of a medical risk required
2. Impaired ability to pedal the ergometer because of an orthopedic or surgical disease of the lower extremities or central nerve paralysis
3. Never having been on a bicycle, and incapable of pedaling well
Reducing Opioid Use for Chronic Pain Patients Following Surgery

Patients with chronic pain are often prescribed long-term opioid therapy, despite the serious risks and growing concerns related to opioid use. The Toronto General Hospital has created the world's first multidisciplinary perioperative Transitional Pain Service Program (TPSP) aimed at reducing the incidence and severity of chronic post-surgical pain. The TPSP incorporates a variety of mechanisms and interventions to help patients manage pain and to wean off opioids. The approach consists of: pain education, Acceptance and Commitment Therapy (ACT), and an e-mobile self- management tool to help patients manage chronic pain more effectively. With the TPSP team, the investigators hope to continually assist patients to achieve a balance between the benefits and potential harms of opioid use to promote long-term health and well-being.

The proposed research program encompasses several study designs to evaluate the effectiveness and potential implementation of the TPSP across Ontario. The investigators will use three approaches to create a comprehensive evidence-base that can be used to guide future policy and programs related to the management of surgical patients with complex pain and chronic opioid use. In the first phase, a multicenter randomized controlled trial will be conducted in 6 hospital sites to evaluate the effectiveness and potential implementation of TPSP across Ontario. The aim is to recruit a total of 210 patients who are currently taking opioids and also undergoing a surgical intervention. The randomized controlled trial will determine the effectiveness of the TPSP at weaning patients completely off opioids while still managing pain after one year. Secondly, an economic and healthcare utilization analysis of the program via linkage to provincial administrative databases will be carried out to understand the impact the TPSP program has on the healthcare system as a whole. Lastly, a qualitative study will be conducted on both the treatment and control groups. The investigators hope to capture further insight to understand patients and providers experiences of the TPSP intervention.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Taking 20 -- 200 mg of preoperative oral morphine equivalents daily
* Any type of surgical procedure, with the exception of those with palliative intent or organ transplantation
* Able to read and understand English as posed on the questionnaire surveys prior to informed consent
* Must be taking opioids for at least one month prior to their operation
* Must have a personal email address for the set-up of the Manage My Pain (MMP) App or online multimedia tool

Exclusion Criteria:

• Subjects who are undergoing palliative care or procedures, organ transplantation, or prescribed with Methadone/Buprenorphine will be excluded from the trial
Optimal rhCG(Ovidrel®) Dose in Poor Responder During IVF and ICSI Cycles

Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from genetically engineered Chinese hamster ovary cells, which is widely used for final oocyte maturation triggering in assisted reproductive technology (ART).Recombinant hCG has been investigated about its safety and efficacy comparing with urinary hCG, but still the optimal dose of rhCG is questionable. From former studies, there only have been proven that high dose of hCG can make ovarian hyperstimulation syndrome (OHSS) in usual condition. On the other hand, we hypothesize that high dose of hCG may improve oocyte maturity in poor responders who cannot easily provoke OHSS. Hence, this study will assess the comparative efficacy and safety of 250mcg and 500mcg of rhCG in ART treatment cycle.

Randomized prospective clinical study that compare the two doses of rhCG (250mcg vs. 500mcg).

Eligibility Criteria:
Inclusion Criteria:

* poor response in prior IVF cycle (≤ 4 oocyte retrieved)
* women's age ≥ 40 years
* FSH ≥ 10mIU/mL or AMH ≤ 1.1ng/mL
* Antral follicle count \<6

Exclusion Criteria:

* patient without informed consent
The Effect of Reiki Applicatıon on Sleep and Qualıty of Life in Epılepsy Patıents

After the general period of positive social adjustments, epilepsy is in a high life cycle to control seizures. During seizures in epilepsy, patients' quality of life and antiepileptic life span can be seen in daily life such as daily life and daily awakenings.

Reiki, which has been proven by studies in health problems such as fatigue and pain; an energy that can be unblocked or applied in a non-applicable way can benefit from a therapy that can be applied by touch or remotely, without negative effects. In the literature, reiki applied to epilepsy patients has sleep and quality of life. This thesis is planned to do research on sleep and living areas of reiki applied to epilepsy patients.

This research; It will be carried out on a voluntary basis with the treatment of 60 patients with epilepsy, 30 of which will be tested, 30 of which will be comprehensive, from the University of Fır Hospital Neurology Clinic Polyclinic and those over 18 years of age, who can communicate adequately, who have psychiatric problems, who are in the last six body mind, who can control the phone, who will come to the scale, who will come to sleep. The study will be a pretest-posttest controlled group study. Data; Patient Information Form will be collected with Pittsburgh Sleep Quality Scale, Quality of Life in Epilepsy Scale. The control method will not interfere. If we try, first the application places and the way of doing it will be shown. Administration through 4 weeks, first consecutive week; 1 session face-to-face 30-45 minutes, then 3 sessions of 21 minutes of training, 2 sessions of 21 minutes of training in the other 3 training courses, a total of 4 weeks 10. For face-to-face reiki; A room will be used inside the hospital. Reiki to 7 different chakras to be taken in the first session. For the other sessions, before the application, all will be called and informed about the reiki will be sent, and then he will apply reiki from a distance for 21 minutes by using the training and reiki symbols. The scales will be reapplied by the researcher, either face to face or face to face, during the experiment and 4 weekends to be controlled. Finally, there will be a significant difference between the pretest and the son test.

Eligibility Criteria:
* be over 18 years old
* Ability to communicate adequately
* Absence of psychiatric problems
* Not having received body-mind therapy (yoga, reiki, massage, meditation) in the last six months
* Volunteering to participate in the research
* Own a phone
* Having a scale score of greater than 5 according to the Pittsburgh Sleep Quality Scale
* Not using sleeping pills 4.4.2. Exclusion Criteria from Research
* being under the age of 18
* Having trouble communicating
* Having a psychiatric problem
* Having received body-mind therapy (yoga, reiki, massage, meditation) in the last six months
* Not being willing to participate in the research
* Not having a phone
* Having a scale score of less than and/or equal to 5 on the Pittsburgh Sleep Quality Scale
* Using sleeping pills