cyrilzakka/clinical-trials huggingface dataset:
Predicting Gastric Cancer Response to Chemo With Multimodal AI Model

This study aims to develop a multimodal model combining radiomic and pathomic features to predict pathological complete response (pCR) in advanced gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). The researchers intended to collected pre-intervention CT images and pathological slides from patients, extract radiomic and pathomic features, and build a prediction model using machine learning algorithms. The model will be validated using a separate cohort of patients. This research intend to build a radiomic-pathomic model that can outperform models based on either radiomic or pathomic features alone, aiming to improve the prediction of pCR in gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received NAC and radical gastrectomy;
* patients who underwent abdominal multidetector computed tomography (CT) inspection, gastroscope, and tumor tissue biopsy before any intervention started;
* Lesions that are assessable according to The Response Evaluation Criteria in Solid Tumors Version 1.1

Exclusion Criteria:

* Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection;
* patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling;
* patients with insufficient data.
The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients

This study will evaluate the effect of intranasal insulin on motor and non-motor symptoms of patients with Parkinson's disease over a 12-week period.

This study is a single-center, parallel and double-blind study. Patients with Parkinson's disease referred to Movement Clinic of Shohada-e-Tajrish Hospital will randomly receive intranasal placebo or insulin, every day, twice a day for 12 weeks. Motor and non-motor symptoms will be evaluated in four time points; baseline, 4, 8 and 12 weeks after treatments. Primary outcome is motor symptoms (MDS-UPDRS; part III, IV), and secondary outcomes are motor (gait balance) and non-motor (MDS-UPDRS part I, II, cognition, depression, anxiety and fatigue) symptoms. Patients, researchers (physicians, outcome assessors) and data analysts are blinded.

Eligibility Criteria:
Inclusion Criteria:

* Man and woman over 17 years old
* Patient with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
* Provide written informed consent to participate in the study.
* Understand that they may withdraw their consent at any time.

Exclusion Criteria:

* Pregnant and lactating women
* Patients with diabetes and taking anti-hyperglycemic drugs
* Patients with other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, Amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy, etc.
* Patients who cannot walk for more than one minute without help
* A history of allergic reaction to insulin
* The presence of inflammation of nasal cavity that may prevents absorption of insulin
Chicago Social Drinking Project

This study attempts to elucidate the factors that contribute to escalation and maintenance of excessive ethanol drinking in young adults by:

1. Examining subjective and objective response differences to alcohol and other common substances in a sample of adults with varying consumption patterns.
2. Determining whether response to alcohol and other substances is predictive of future consumption patterns through longitudinal follow-up interviews.
3. Examining the relationship between responses to alcohol and other substances at baseline and re-examination testing to evaluate if consumption patterns moderate this relationship.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-65
* Weigh between 110-210 lbs
* Drink alcohol at least once weekly with weekly "binge" drinking episodes
* Available to complete in-person screening and 2, 4 hour experimental sessions at the University of Chicago
* Available by phone, mail, or Internet for follow-up interviews for at least 2 years following sessions

Exclusion Criteria:

* Current or past major medical or psychiatric disorders including alcohol and substance dependence
IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD

The purpose of this study was to see if Intense Pulsed Light (IPL) can be used safely and effectively to help treat dry eyes from ocular rosacea after chronic graft-versus-host disease (GVHD). Current treatment options for this disease are limited.

Ocular rosacea and meibomian gland disease are major contributors to keratoconjunctivitis sicca after chronic GVHD. Rosacea exacerbates the aqueous deficiency caused by damage to lacrimal and accessory lacrimal glands similar to cholestasis damage in the biliary system.

Subjects who had inactive chronic GVHD after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea were recruited and treated with 4 monthly sessions of IPL and meibomian gland expression. Their charts were reviewed prior to treatment to confirm quiescence of active systemic disease. Symptom scores were quantified with Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness questionnaire (SPEED2). Baseline complete eye exam was performed, and subjects received an eyes assessment score based on the Chronic Graft-Versus-Host Disease (GVHD) Assessment and Scoring Form.

Symptoms, exam, and diagnostic data were obtained at baseline (month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 9 and month 12). IPL treatment and meibomian gland expression was performed at baseline (month 0), month 1, month 2, and month 3.

Eligibility Criteria:
Inclusion Criteria:

* Ocular rosacea with inactive GVHD

Exclusion Criteria:

* Active GVHD
* Facial laser treatment
* Accutane exposure
* Inability to wear sun protection factor (SPF) 30 sunscreen and avoid sun exposure
* Inability to meet study requirements
Effect of Single Dose Antenatal Betamethasone on Neonatal Respiratory Morbidity After Elective Cesarean

Patients undergoing elective C-section will be randomized into two groups. The first group will receive one dose of Betamethasone at least 24 hours before scheduled C-section. The second group will receive placebo.

This is a prospective double blinded randomized clinical trial. Patients will be randomized into two groups. Group A will receive one dose of Betamethasone at least 24 hours before scheduled C-section. Group B will receive placebo. The maternal and neonatal outcomes will be studied in order to assess the effect of Betamethasone on respiratory morbidity of the newborn infant.

Eligibility Criteria:
Inclusion Criteria:

* women with singleton or multiple gestation,
* between 37 and 40 weeks of pregnancy (as calculated from the first day of the last menstrual period)

Exclusion Criteria:

* any medical problem that could affect fetal well-being;
* evidence of intrauterine infection,
* oligohydramnios,
* fetal congenital malformations,
* preeclampsia,
* maternal hypertension,
* severe fetal rhesus sensitization,
* antepartum hemorrhage,
* Intrauterine growth restriction
* preterm rupture of membranes
* preterm delivery
* previously received antenatal steroids less than one month ago
* those who decline to participate in the study.
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion

The study is a randomized, open, prospective phase II study. The aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 NCI Common Terminology Criteria for Adverse Events (NCI-CTC-AE ) toxicity and / or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal Sarcomas using protons or carbon ions before a subsequent tumor resection.

With retroperitoneal sarcomas, the patient benefits from neoadjuvant radiotherapy. Due to the special physical properties of particles (protons and C12 carbon ions), in particular the steep lateral dose drop, an improved protection of adjacent risk organs is e.g. Intestine, kidneys, liver etc. during the process of applying radiotherapy is possible.

The primary study objective is to demonstrate the safety and conduct of study treatment and the incidence of Grade 3-5 NCI-CTC-AE toxicity and / or termination of preferred therapy for any reason. Further target parameter is the proportion of applied therapies without the occurance of degree 3-5 NCI-CTC-AE(s).

The patients are randomized 1: 1 into the two arms (carbon ions vs. protons). Patients receive 39 Gy in (SD 3.0 Gy) in 6 fractions per week.

Secondary study objectives are local control (LC), local progression-free survival from the start of therapy (LPFS), disease-free survival (DFS), overall survival (OS) and quality of life (QoL) determined according to the EORTC-Quality of Life Questionaire (QLQ)- C30 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable
* Karnofsky index of ≥ 70%
* Age from 18 years
* Completed patient information and written consent
* ability to give consent

Exclusion Criteria:

* Stage IV (distant metastases)
* Lymphogenic metastasis
* Metal implants at the level of the sarcoma, which influence the treatment planning
* Previous radiation therapy in the treatment area
* Desmoid tumors, peritoneal sarcomatosis, GIST
* Simultaneous participation in another clinical study that could influence the results of the respective study
* Active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator)
* Pregnant women
Immune Memory After Papillomavirus Vaccination

Vaccines for human papillomavirus (HPV) have been available in the United States since 2006. Early studies have shown a high rate of effectiveness of these vaccines, however it is not known how long this protection will last. The IMAP study will look at various parts of the immune system and potential markers for long lived immune responses to this vaccine.

Three groups of patients will be recruited for this study. One group will be women who have completed all three vaccinations. The second group will be women who are overdue for their final vaccination. We also recruit women who have not been vaccinated previously.

Eligibility Criteria:
Inclusion Criteria:

1. Female ages 18-26 inclusive (18-30 for women who have been previously vaccinated
2. If sexually active and enrolled in unvaccinated group, must use a reliable form of birth control for the first seven months of the study. For the purposes of this protocol a reliable form will be hormonal or barrier contraception. Intrauterine devices and a history of sterilization will also be considered reliable forms of birth control. Abstaining from sex is also a reliable form of contraception.
3. Able to give informed consent
4. Negative urine pregnancy test at enrollment

Exclusion Criteria:

1. Currently pregnant, breast feeding or planning a pregnancy
2. Underlying immunological disease, such as previously diagnosed HIV infection or history of transplantation, history of splenectomy
3. Use of medications with potential immunological effects such as systemic corticosteroids or chemotherapy
4. Prior therapy for cervical dysplasia or cervical cancer such as loop excision, laser ablation, cryotherapy or hysterectomy
5. Unable to comply with protocol
6. Severe allergic reaction (e.g., anaphylaxis) after a previous vaccine dose or to a vaccine component
7. An acute illness, including an oral temperature of 100.4 degrees F within three days of visit

other more specific exclusions may apply to one of the three cohorts
VR High Tech Pain Control Burn Wound Care

Using virtual reality as a form of distraction for pain during wound care. Virtual reality involves looking into a set of goggles and then moving through a computer-simulated world.

This study has three different groups. Patients will be randomly assigned to one of three groups (two treatments and one control). Treatment for Group 1 is Virtual Reality Distraction during wound care. Group 2 will listen to an audio recording called "Sounds of Nature". Group 3 will be the control group.

Subjects in all three groups will receive the following questionnaires:

Graphic Rating Scale McGill Short-Form pain questionnaire Sullivan Catastrophization scale (only on Day 1/Baseline) The Nurse GRS

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Compliant and able to complete questionnaires
* No history of psychiatric disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* English-speaking

Exclusion Criteria:

* Age less than 18 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Evidence of traumatic brain injury
* History of psychiatric disorder
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
* Unable to communicate orally
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history
A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)

In this prospective, single-center, randomized, placebo-controlled, double-blind clinical trial, parturients with primary PPH are eligible for treatment with fibrinogen concentrate following both vaginal delivery and cesarean section complicated by an estimated blood loss (EBL) \>1000 mL and an ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, and uterotonic agents).

The proposed trial targets early detection and treatment of fibrinogen depletion in PPH. A widespread belief in the benefits of early fibrinogen substitution in cases of PPH has led to an increased use for this indication. The PERFECT PPH aims to provide an evidence-based knowledge for the recommendation of the early use of fibrinogen concentrate in PPH.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent from participant
* Age ≥18 years and \<50 years
* Primary PPH defined as bleeding from uterus and/or the birth canal within 24 hours postpartum
* Vaginal delivery or Cesarean delivery (irrespective of etiology of PPH, such as accreta), with EBL \>1000 mL and ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, uterotonic agents)
* FIBTEM®- A10 \<18 mm (corresponding to a MCF value of \<20 mm and to a plasma fibrinogen level approximately \<3 g/L)

Exclusion Criteria:

* Refusal to give written informed consent
* Refusal to receive blood transfusion
* Known inherited deficiencies of coagulation
* Personal history of thrombosis
* Either pre-pregnancy or ante-partum antithrombotic treatment due to increased risk of thrombosis
* Administration of Platelets, FFP or cryotherapy prior to study drug
Evaluation of the Effects Using the Combination of Sedative Agents on Dental Anxiety in Pediatric Patients

The aims of this study were firstly, to evaluate the changes in the anxiety level after deep sedation with various intravenous sedative agents using salivary cortisol level in pediatric dental patients and secondly, to compare clinical effectiveness of this sedative agents, perioperative complications, recovery time and adverse effects.

This clinical study was included 69 healthy pediatric patients aged 3 to 7 years with high anxiety. The patients were divided into 3 groups according to the sedative agents: Group 1 (n=23) was received Propofol, Group 2 (n=23) was receieved Ketofol 1:3, and Group 3 (n=23) was received Ketofol 1:4. The anxiety levels were assessed using Facial Image Scale (FIS) anxiety scale and changes in salivary cortisol levels were assessed using ELISA before and after the drug administration. Perioperative vital signs, depth of sedation were recorded at intervals of 5 minutes. Preoperative and postoperative complications, operation and recovery time were recorded in the follow-up form.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients age between 3-7 years old
* Having no systemic condition and ASA 1 healty status
* Having high dental anxiety
* Having no dental treatment under the sedation or general anesthesia before
* Having no dental treatment before

Exclusion Criteria:

* Having obstructed nasal passages, raised intracranial or intraocular pressure, allergy
* Using any drug which effected saliva construction
* Having enough saliva for saliva cortisol evaluation
CTPVB for Hepatectomy

Moderate to severe postoperative pain often influence patients quality of recovery after hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after hepatectomy in many medical center, but the analgesic effect can be limited and undesirable side effects may bring about negative effects on patients recovery. Regional block has been proved to improve patients postoperative recovery in many kinds of surgeries.

The investigators therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral block increase patients quality of recovery score on the 7th postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with morphine.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo hepatectomy with J-shape subcostal incision
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity

The goal of this research is to explore cancer survivors' and their romantic partners' interest in a couples-based physical activity intervention and whether cancer-specific exercise education influences exercise beliefs and intentions.

This study will assess multiple predictors of couples-based physical activity interest among both survivors and partners including gender, age, current exercise, relationship satisfaction and partner support for exercise. Additionally, this study will include an experimental manipulation in which half of the sample will be randomized to receive cancer-specific exercise education.

Eligibility Criteria:
In order to be eligible, individuals must answer "Yes" to all of the following statements:

* I am a cancer survivor OR I am the romantic partner of a cancer survivor
* I am not currently undergoing chemotherapy, radiation or surgery nor do I have plans to undergo chemotherapy, radiation or a cancer-related surgery in the next 6 months
* I am in a committed, romantic relationship
* I have access to a computer or tablet with internet
* I have an email address that I am willing to share with the study team
* I am at least 18 years of age and less than 90 years of age
Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA)- Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease

This study postulates that the application of Sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via Sirolimus coated balloon (SCB) will be safe and will result in better arterial patency in infrainguinal peripheral arterial disease (PAD). The aim is to evaluate the efficacy (12 month freedom from clinically driven target lesion revascularisation) and safety (freedom from major adverse events) of sirolimus coated balloons in the treatment of infrainguinal PAD.

It is imperative to have effective treatment strategies for PAD which can maintain the patency of arteries. The current standard of care for PAD is angioplasty which includes usage of drug coated balloons (DCB). Paclitaxel is the only anti-proliferative drug available in all currently available DCB technology. Sirolimus is another highly effective anti-proliferative drug of immense potential as demonstrated by superior results in Sirolimus drug eluting stents in coronary disease. The physical properties of Sirolimus have made it challenging for it to be similarly applied to DCB technology and it is only due to recent advances in nanotechnology that it is now possible to develop Sirolimus coated balloons (SCB), which is the study device used in this study. The study device allows delivery and deposition of sirolimus to the arterial wall. By applying this agent into lesions in peripheral arterial disease, this study aim to effectively reduce neointimal hyperplasia, and therefore prolong the patency of the artery and improve our limb salvage rates for PAD and CLI patients. Subjects will be followed up in the clinic at 6 month, 12 month, and 24 month post-intervention to assess primary and secondary outcome of safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years or minimum age
* Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable
* Lesion(s) in the infrainguinal arteries between 3 to 6mm which are suitable for endovascular treatment treated with the Xtreme Touch - Neo sirolimus PTA balloon catheter. For below the knee (BTK) arteries, lesions located in the proximal 200mm of the artery.

Exclusion Criteria:

* Life expectancy ≤ 1 year
* Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet
* Subject is pregnant or planning to become pregnant during the course of the study
* Failure to achieve less than 30% residual stenosis in pre-existing lesion after plain balloon angioplasty
* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations