cyrilzakka/clinical-trials huggingface dataset:
TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment

The main purpose of the study was to evaluate the overall clinical value of GERI+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development and automated scoring using a predictive algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Couples with less than or equal to (\<= ) two failed fresh In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) embryo transfer cycles
* Age greater than or equal to (\>=) 18 and \<= 40 years
* Body mass index (BMI): 18-30 kilogram per meter square (kg/m2)
* Normal uterine cavity under ultrasound
* Participant and her husband/partner must have read and signed the Informed Consent form (ICF)
* At least four normally fertilized oocytes (2Pronuclear stage (PN)) in the current cycle

Exclusion Criteria:

* Male with non-ejaculated sperm
* Participants with abnormal, undiagnosed gynecological bleeding or with genitourinary malformations
* Participants with any contraindication to Controlled Ovarian Stimulation (COS) for Assisted Reproductive Technologies (ART) or to gonadotropins
* Planned "freeze all" cycle (oocytes or embryos)
* Planned preimplantation genetic screening (PGS) or Pre-implantation genetic diagnosis (PGD) cycle
* Concurrent participation in another clinical study
Use of Compression Bandages in the Prevention of Post-mastectomy Lymphoceles

Lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery.

This can be the source of pain, skin complications, and infection with a significant impact on the length of hospitalization for patients treated for breast cancer.

There is no consensus regarding the management of lymphocele. The placement of a compression bandage after mastectomy and / or axillary dissection would allow a more efficient and rapid reduction of the lymphocele and a reduction in recurrences.

This would make it possible to reduce the duration of the wearing of the drain, which determines the length of hospitalization and reduce the recurrence of lymphoceles, the punctures of which can be one of the risk factors for secondary lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old,
* Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer
* Affiliated with a health insurance plan

Exclusion Criteria:

* Recurrence of breast cancer,
* Mastectomy with RMI (immediate breast reconstruction) at the same time of operation
* Anticoagulant treatment at curative dose
* Arteritis obliterans of the upper limbs,
* Other cancer during treatment,
* Decompensated heart failure,
* Acute infectious episode (cellulitis, erysipelas, lymphangitis)
* Acute deep vein thrombosis upper limb ipsilateral to mastectomy,
* Cutaneous atrophy of the upper limb,
* Bullous dermatoses,
* Hyperalgesia of the shoulder
* Inability to submit to the constraints of the protocol,
* Impossibility for the patient to achieve self-restraint at the thoracic level
* Pregnancy,
* Feeding with milk
* BMI\> 35
* Adult protected by law (guardianship, curatorship and safeguard of justice).
* Anyone who is not in a position to give their consent in writing
Effectiveness of Ear Plug, Eye Mask and Ocean Sound on Sleep Quality Among ICU Patients

The study evaluates the effectiveness of ear plug, eye mask and ocean sound on sleep quality among ICU patients. 60 patients were randomly allocated to group 1 and group 2 by lottery method i.e 30 in each group. Group 1 received earplugs and eye masks on the first night followed by washout period on second night and received ocean sound on third night, while the group 2 received ocean sound on the first night followed by washout period on second night and received earplugs and eye mask on third night.

a comparative study was done to assess the effectiveness of ear plug, eye mask and ocean sound on sleep quality.

Ear plug used in this study is a foam earplug made from polyurethane with noise reduction rating (NRR=29 dB, SNR=37dB). It is inserted into the ear canal to protect the user's ear from loud noise. The earplug used was manufactured by 3 M occupational health and environmental safety division company of India manufactured in Bengalaru560.Ear plug helps to reduce noise intensity which helps to decrease auditory perceptual processing.

Eye mask used in this study is a delicate dark colored cloth (black and blue) of fabric material, length -18.5 cm, width- 8.5cm, height- 30 millimeter filled with soft cushions like substance inside which cover both eyes and 2 elasticized strap that holds the mask on patients head which prevents incoming light away from patient's eyes and induces a state of pure darkness. The product detail of Eye mask was, model number-SM004 and was ordered from Amazon.Eye mask decreases the intensity of the light which enhances melatonin secretion (involve endocrine system). Additionally, eye mask helps to use of cognator subsystem as eye mask also helps to reduce visual perceptual processing.

Ocean sound is a type of white noise which is a soothing sound of waves crashing on the beach which is provided via ear phone for 30 min. It was delivered via the android application name relax melodies meditation of Ipnos software. Ocean sound is a type of white noise which prevents intense auditory stimuli less capable of stimulating the cerebral cortex during sleep which helps to decrease auditory perceptual processing.

Eligibility Criteria:
Inclusion Criteria:

* The patients who are 18 or more than 18 years of age.
* Patients who were oriented to the time and individual.
* Patients who could understand and respond in Hindi/English.
* Patients having no history of head trauma.
* Patients having no mental diseases.

Exclusion Criteria:

* Patients having any trauma in head, ears, and eyes.
* Patients reporting discomfort with eye mask and ear plug.
* Patients who had a hearing deficit.
* Patients taking sleep inducing drugs like Narcotics, Sedatives.
Improving Adherence to Recommended Surveillance in Breast Cancer Survivors

Evidence-based guidelines recommend cancer surveillance procedures for breast cancer survivors including physical examination, mammography, breast self-exam, and gynecologic follow-up. The early detection of recurrent and new cancers can best be achieved through the combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55% of breast cancer survivors do not undergo these procedures as recommended. This study tests a telephone-based psychosocial intervention aimed at improving adherence to recommended surveillance in breast cancer survivors. The psychosocial intervention for improving adherence is compared to treatment as usual.


Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* Diagnosis of Stage I to IIIA breast cancer
* Within 1 to 5 years post primary cancer treatment (i.e., surgery, chemotherapy, and/or radiation therapy)
* No diagnosis of recurrent breast cancer or a new primary cancer
* Able to provide meaningful consent

Exclusion Criteria:

* \< 21 years of age
* Unable to provide meaningful consent
* Surgically treated with bilateral mastectomy
Home-based Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD)

We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD.

The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of COPD (III-IV)
* receive help from homecare nurse
* not suffering from any other serious disease, with expected lifespan less than 6 months

Exclusion Criteria:

-
The Effect of De-Prescribing Antipsychotics on Health and Quality of Life for People With Dementia

This study aims to analyze how warning letters sent to physicians prescribing high levels of the antipsychotic quetiapine affected the health and quality of life of their patients with dementia. Using a randomized controlled trial conducted by the Centers for Medicare and Medicaid Services (CMS) in 2015, this secondary study looks at the effects of potential de-prescribing of antipsychotics by study physicians induced by the letters. The central question is whether the intervention led to better health and quality of life outcomes by encouraging more guideline-concordant care and whether changes in physicians' prescription behavior caused unintended harms.


Eligibility Criteria:
Inclusion Criteria:

* Fully enrolled in Fee-For-Service Medicare Parts A, B, and D
* For nursing home patients: Residing in a nursing home and has a usable nursing home assessment to measure outcomes
* For community-dwelling patients: Not residing in a nursing home
* Has Alzheimer's or dementia related disease diagnosis
* Attributed to study physician (see study population description)

Exclusion Criteria:

* Died during 90 day period used to attribute patient to physician
* For nursing home patients: Short-stay nursing facility patient
Dance Exercise as Novel Complementary Therapy for Parkinson's Disease

The purpose of this study is to gather data to see if so-called enriched forms of exercise programs such as dance is more effective in improving balance and quality of life in patients with idiopathic Parkinson's disease than regular exercise programs that are currently provided by physical therapists.

Comparison of traditional PT to dance in people who have parkinsons disease to measure which is better for gait, balance and QOL.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD at least 3 years ago
* Less than 80 years of age
* Have gait and balance issues

Exclusion Criteria:

* Diagnosis of PD for less than 3 years
* 80 years of age or older
* Not have gait and balance issues
Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali

Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 months to 10 years
* Agree to seek initial medical care for all medical illness in the study clinic during the study period
* Written informed consent by a parent or legal garden,
* No plan to travel for a long time during the study period.

Exclusion Criteria:

* History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
* Chronic illness or symptomatic malaria at the time of enrollment
Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer

This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

This is a single center, single arm, open-label, phase II study to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.

Patients younger then 65 will be treated with irinotecan 100 mg/m2 on day 1 and 8 and capecitabine 1,000mg/m2 twice daily from day 1 to 14 every 3 weeks.For patiens equal to or older then 65, doses of irinotecan and capecitabine will be reduced to 60 mg/m2 and 750 mg/2, respectively.

Response assessment will be performed every 3 cycles of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic colorectal cancer
* ECOG performance status 0-2
* Mesurable lesions
* No prior chemotherapyk or radiotherapy for metastatic disease. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
* Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment
* Adequate organ functions
* Expected survival is longer then 6 months
* Informed consent

Exclusion Criteria:

* Prior systemic chemotherapy for metastatic disease
* Prior treatment with oxaliplatin or irinotecan
* CNS metastases
* Uncontrolled or severe cardiovascular disease
* Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
* Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
* Psychiatric disorder or uncontrolled seizure that would preclude compliance
* Pregnant, nursing women or patients with reproductive potential without contraception
* Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucytosine, phenytoin, or warfarin et al.
* Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
* Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
Effect of Use of Ureteral Access Sheath on Levels of Netrin-1 in Patients Undergoing RIRS

In this study, it is aimed to evaluate whether use of a ureteral access sheath (UAS) during retrograde intrarenal surgery (RIRS) due to kidney stone has any effect on protecting the kidney functions by measuring blood and urine and Netrin-1 levels.

This study will include patients aged between 18 and 65 who will undergo retrograde intrarenal surgery (RIRS) due to renal stone(s). A total of 60 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 30 patients in each group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or not affects the kidney functions. Besides the routine kidney function tests, namely urea and creatinine, and Netrin-1 (more specific and early marker of kidney function) will be used to assess the differences in the kidney functions. Preoperative blood urea, creatinine and Netrin-1 levels and urine Netrin-1 levels will be studied for all patients. After the surgery, blood urea and creatinine levels will be again studied as well as blood Netrin-1 levels at postoperative 48th hour; and urine Netrin-1 levels at postoperative 24th hour.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18-65 years old
* Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone

Exclusion Criteria:

* Patients with uncontrolled diabetes mellitus and diabetic nephropathy
* Patients with blood pressure \> 140/80 mmHg despite regular use of antihypertensive agent(s)
* Patients with chronic kidney failure who need dialysis
* Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier
* Patients who have had pyelonephritis 3 months or much earlier
* Patients younger than 18 years or older than 65 years
* Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests
* Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
Effect of Interscalene Block Methods on Rebound Pain

In this study, the hypothesis that local anesthesia, not directly injected into the nerve root, may reduce the incidence of rebound pain in the interscalene block with an extraplexus approach during arthroscopic shoulder surgeries will be investigated. Rebound pain is defined as a short-term but severe pain before and after the resolution of the interscalene block and will be evaluated using the Numerical Rating Scale (NRS) (NRS ≥ 7).

The study will include patients aged 18-65 years, with an American Society of Anesthesiologists (ASA) physical status of I or II, scheduled for arthroscopic shoulder surgery in the lateral decubitus position, accompanied by interscalene nerve block performed by the same surgeon. Patient characteristics (age, gender, body mass index, etc.), block procedure duration, number of needle passes, onset time of sensory block, onset time of motor block, and possible complications related to the block (paresthesia, Horner's syndrome, dyspnea, hoarseness), postoperative nausea and vomiting (PONV) status, and Quality of Recovery-15 (QoR-15) scores on the preoperative first day and postoperative days 1 and 7 will be recorded. The primary outcome parameter will be the incidence of rebound pain. Rebound pain will be defined as a short-term but severe pain before and after the resolution of the interscalene block, assessed using the Numerical Rating Scale (NRS) (NRS ≥ 7). Secondary outcomes will include the number of needle passes, block application time, onset time of sensory block, onset time of motor block, intraoperative dexmedetomidine requirement, duration of block effectiveness, postoperative pain, PONV, need for rescue analgesics, incidence of paresthesia and Horner's syndrome, dyspnea, hoarseness, duration of stay in the recovery room, duration of rebound pain, and postoperative Quality of Recovery-15 (QoR-15) scores.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years.
* Patients with ASA physical status I or II.
* Patients planned for arthroscopic shoulder surgery in the lateral decubitus position with interscalene nerve block.

Exclusion Criteria:

* Patients who do not consent to participate in the study.
* Block failure.
* Language acquisition deficiency.
* Obesity (body mass index \> 35 kg/m²).
* Diabetes.
* Psychiatric disorders.
* Central nervous system diseases.
* Vestibular diseases.
* Presence of neuropathy and paralysis.
* Pregnancy.
* Previous open shoulder surgery.
* Allergy to local anesthetics.
* Coagulopathy.
* Severe thrombocytopenia.
* Infection at the puncture site.
* Pre-existing neuropathy in the limb to be operated.
* Use of dexamethasone.
* Use of opioid and antiemetic medications before surgery.
* Severe cardiopulmonary disease.
* Low baseline oxygen saturation.
* Conditions that prevent cooperation in the postoperative period (e.g., mental retardation, delirium).
The Health Log: A Randomized Clinical Trial

The goal of the present study is to determine if a health management tool improves self-efficacy, satisfaction with the doctor's visit, and agreement of the statement "How satisfied are you that your concerns were addressed during your clinic visit today" over time.

The Patient-Centered Outcomes Initiative (PACO) was developed at Brigham and Women's Hospital (BWH) to create a replicable model of patient-centered care that will improve treatment for patients with rheumatoid arthritis (RA) and lead to improved outcomes. This work began with focus groups of RA patients to determine which changes or programs they felt were needed. Among the suggestions was a health management tool to improve doctor-patient communication. The Patient Advisory Committee (PAC), a part of PACO which grew out of the focus groups, worked to develop the current Health Log. It consists of a permanent booklet and a refillable health log version that is filled out before each doctor's appointment.

Health management tools have also been developed for patients with other chronic conditions. Dr. Paul Fortin of the University Health Network developed the Lupus Health Passport, which helps patients keep track of their health and also has information about lupus as well as prevention of coronary artery disease (CAD) and osteoporosis.

However, although these health management tools have been well received, they have not been studied to see if they improve self-efficacy. We would like to determine if the use of the Health Log improves self-efficacy in RA patients over time.

Specifically we will be looking to:

1. Determine if this health management tool improves self-efficacy over time with use, as measured by the Self-Efficacy Other Symptoms Scale of the Arthritis Self-Efficacy Questionnaire.
2. Determine if this health management tool improves satisfaction with the doctor's visit as measured by a VAS scale 10-100.
3. Determine if this health management tool improves agreement with the statement "How satisfied are you that your concerns were addressed during your clinic visit today", as measured by a VAS scale 10-100.

Eligibility Criteria:
Inclusion Criteria:

* billing diagnosis of rheumatoid arthritis (714.0) or seronegative inflammatory arthritis and a member of the BRASS study at Brigham and Women's Hospital

Exclusion Criteria:

* less than 18 years of age