cyrilzakka/clinical-trials huggingface dataset:
The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy

Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non proliferative DR and proliferative DR. The damage is caused by either macular edema, macular ischemia that can be followed by vascular proliferation.

Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in the tissues and has been proven to be beneficial in treating different wounds in diabetic patients but its effect hasn't been tested in diabetic retinopathy yet.

This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due to different indications such as chronic wounds or radiation damages and who also have diabetic retinopathy. These patients will undergo opthalmic physical examination including fundus photography and OCT (Optical Coherence Tomography - optical IR retinal photography). Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe Medical Center for all diabetic patients prior to their first treatment.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

1. Patients between ages 18-90 with Diabetes type I or II and diabetic retinopathy who are scheduled for hyperbaric treatment for other indications than DR.
2. Patients who signed an informed consent form and agree to undergo an ophthalmic physical examination, Fundus photography and OCT prior to hyperbaric treatment and oCT exam following every 10 treatments in hyperbaric chamber. Total number of hyperbaric treatments will be conducted according to the main indication for which they have been assigned this treatment.

Exclusion Criteria:

1. Patients with Carotid stenosis of more than 70%
2. Anemia of \< 10mg/Dl
3. Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment.
4. Patients with claustrophobia or that cannot decompress properly.
5. Patients with any malignant disease
6. Patients with inability to sign informed consent

Decompression treatment will last 90 minutes in 2 atmospheres pressure with 100% oxygen.

-
Temple Touch Pro (TTP) Non Invasive Continuous Temperature Measurement System

In this study, the body temperatures of men and women undergoing elective surgery will be measured using the Temple Touch Pro. In the operating room, each patient's temperature will be measured with both the Temple Touch Pro and another one or two of the continuous reference methods used clinically for measuring the core temperature.

The Medisim Temple Touch Pro thermometer combines a noninvasive, biocompatible patch and a receiving unit. The former is attached to the skin, while the latter is placed near the patient or the vital signs monitor and receives data from the patch. The core temperature equivalent is displayed. The Medisim Temple Touch Pro is based on the measurements made by conductive sensors that perform skin temperature measurements and then applies a special algorithm in order to calculate the body's temperature.


Eligibility Criteria:
Inclusion Criteria:

The patients will be chosen for the trial if the following criteria are met:

* Male and female patients scheduled to undergo cardiothoracic surgery and major (surgeries scheduled to last more than 90 minutes) abdominal, vascular and general surgery.
* The surgical procedure requires temperature monitoring.
* Informed consent signed by the patient or his legal guardian.

Exclusion Criteria:

The patients will be excluded from the trial if one of the following occurs:

* The medical staff decides that the patient should not participate.
* Unavailable measurement site in case of operations performed in the head area.
Improved Patient Safety Through Continuous Bi-channel RR and SpO2 Monitoring With Masimo Patient SafetyNet

The investigator intend to perform an observational study, by adding Respiratory Rate monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be deactivated. Retrospective analysis of the observational data collected will be utilized to evaluate the potential benefits of additional continuous respiratory rate monitoring.

Addition of acoustic respiratory rate monitoring to an already existing standard of care patient surveillance system that includes oxygen saturation and heart rate monitoring by pulse oximetry will result in earlier and more sensitive detection of respiratory events and possibly early stages of developing sepsis in a post-surgical/orthopedic study population.

An observational study with RRa is an additional blinded parameter to the already existing standard of care monitoring with SpO2 and PR on one post-surgical floor, (includes Trauma and orthopedic patients), where patients receive opioids for pain management. 300 consecutive patients will be enrolled and monitored with RRa for at least the first 24hours post-surgery, after discharge from the Recovery Room, \& upon admission to the Surgical floor.

Eligibility Criteria:
Inclusion Criteria:

* • Adult 18yrs of age or older

  * Post-surgical patient receiving opioid pain medication

Exclusion Criteria:

* • Refusal of optical finger sensor and/or acoustic respiratory rate neck sensor placement

  * Finger or skin abnormalities at sensor sites
  * Expected opioid therapy duration less than 24 hours
The Effect of Virtual Reality Therapy on Balance and Knee Control in Stroke Patients

The aim of study is to determine whether the Virtual Reality training applied in addition to the exercises given inside and outside the parallel bar is effective on balance, daily living activities and knee control in stroke patients.

The hypotheses of the study are:

Hypothesis 1:

H0: Virtual reality training has no effect on balance in stroke patients. H1: Virtual reality training has an effect on balance in stroke patients.

Hypothesis 2; H0: Virtual reality training has no effect on activities of daily living in stroke patients.

H1: Virtual reality training has an effect on daily living activities in stroke patients.

Hypothesis 3; H0: Virtual reality training has no effect on knee control in stroke patients. H1: Virtual reality training has an effect on knee control in stroke patients

In recent years, virtual reality systems are widely preferred technology-assisted rehabilitation methods due to the many advantages they provide in stroke rehabilitation. Virtual reality increases the quality of movement and functional capacity both by providing a sensory environment and by motor learning.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-70
* Having a stroke for the first time
* Patients who can stand and walk independently

Exclusion Criteria:

* Having neglect syndrome
* Being bilaterally affected
* Botulinum toxin application in the last three months
* Having additional neurological diseases such as Parkinson's, multiple sclerosis
The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain

This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme.

This study aimed to address whether a water exercise programme improves pain and quality of life in pregnant patients with Pelvic Girdle Pain (PGP) compared to a land-based exercise programme and the feasibility of undertaking a large-scale research programme. Twenty-three participants with diagnosed PGP, recruited at St George's Hospital London, were randomised into two groups (water or land exercise). Each group received, four, once-weekly exercise sessions on land or water. Exercise effects on PGP were measured using a variety of outcome measures. Outcomes were assessed at baseline and post four weeks exercise.

Eligibility Criteria:
Inclusion Criteria:

Participants were over eighteen years old, over twelve weeks pregnant and able to speak English.

Exclusion Criteria:

Participants were excluded from the study if they had uncontrolled blood pressure, placenta praevia, pre-eclampsia, obstetric cholestatsis, uncontrolled asthma, unstable respiratory or cardiac conditions, had open skin wounds or MRSA
Telerehabilitation for the Hand and Arm After Stroke and Traumatic Brain Injury

The goal of this project is to develop a low-cost, user-friendly, portable telerehabilitation system for physical therapy of the upper limb after stroke or traumatic brain injury. The system is based on the use of a commercially available force feedback joystick and will work with an ordinary home PC and a standard high-speed internet connection. Using the joystick, the patient will perform exercises designed to aid in recovering motor function of the hand and arm. The joystick will be programmed to either assist or resist the patient's movements. The system will include sophisticated analysis of patient status and progress to provide the therapist and physician with detailed information. In the first phase of the study, we will develop the system in cooperation with the physical therapy staff and other rehabilitation specialists. The investigators will examine the usability, comfort, safety and therapeutic benefit of the system. In the second phase of the study, the investigators will employ the system in patients' homes, using the internet to connect to rehabilitation specialists in the clinic. The study hypothesis is that it is possible to adapt commercially available, low cost gaming equipment such as force feedback joysticks to provide therapy for patients in their own homes, and that patients will be able to work with this system and will find it enjoyable and helpful for recovering motor function.


Eligibility Criteria:
Inclusion Criteria:

* Post-cerebrovascular accident or post-traumatic brain injury
* In medically stable condition
* Resident in Israel

Note: In addition there will be healthy, age-matched volunteers

Exclusion Criteria:

* History of psychiatric illness
* Grade of less than 23 in the Mini-Mental Test
* Inability to understand informed consent form
* Inability to follow 3-step instructions
* Pregnancy
* Receptive aphasia
Comparison of Effect of Equi-MAC Anesthetics on PSI

The aim of this study is to compare the patient state index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent volatile anesthesia.

There have been several studies comparing electroencephalogram-derived indices produced by sevoflurane and desflurane. However, to the best of our knowledge, there has been no study which compared the two inhaled anesthetics using patient state index. Therefore, the aim of this study is to compare the patient state index values produced by sevoflurane and desflurane at equi-MAC in patients undergoing single-agent inhalation anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 19 and 65 yr
* patients with American Society of Anesthesiologists physical status classification I or II
* patients scheduled for elective surgery under volatile anesthesia
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients receiving any medication affecting the autonomic or central nervous system
* patients with a history of alcohol or drug abuse
* pregnant or lactating women
Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.

We therefore conducted a French multicentric phase II trial (IFCT 0401) to evaluate activity and tolerance of gefitinib (250 mg/day) administered as first line treatment in patients with non-resectable P-ADC.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically / cytologically proven ADC-P
* Non-resectable disease
* 3-month expected survival
* No prior radiotherapy or chemotherapy
* Age \>= 18 years old
* Performance status \< 4 (WHO)
* Adequate blood biological parameters

Exclusion Criteria:

* Abnormal initial fibroscopy
Use of FDG PET/CT to Evaluate Crohn Disease

The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn Disease and recurrence of Crohn disease after having compared results of PET/CT's with results of exams routinely performed(colonoscopy and bowel follow through).

Crohn disease is an inflammatory disease of the digestive system that may affect the small and large intestines. Remission and recurrence clinically characterized its development. When recurrence occurs, a careful examination is necessary in order to determine the extent and the severity of the disease. Actual exams performed are invasive and uncomfortable(colonoscopy and bowel follow through). Compare to these exams, PET/CT is less fierce to undergo and has less risks. Two groups are proposed in this project: 15 patients will be enroll in the active disease group and 15 patients will be enroll in the remission group. In regards of the area and the extent of the disease,PET/CT exams shall provide similar information than what usual tests provide. PET/CT exams shall also provide more information in order to better differentiate inflammatory stenosis from scars stenosis especially located in the small intestine.

Eligibility Criteria:
Inclusion Criteria:

* Men or women known having a Crohn's disease de novo diagnosis or a Crohn's disease recurrence based on a seven days questionnaire and a physical exam.
* Men or women with a past history of Crohn's disease but considered clinically in remission based on a seven days questionnaire, a physical exam and a Crohn's disease activity index (CDAI) score \< to 150.

Exclusion Criteria:

* Men or women less than 18 years of age
* Pregnancy
* Breastfeeding
* Renal failure
* Suspicion of a Crohn's disease infectious complication (abscess,fistula)
* Infectious colitis determined at the initial checkup
* Diabetes
* Severe allergy to iode contrast
Pharmacokinetics and Pharmacodynamics of a Novel Pegylated Recombinant Human Granulocyte-Colony Stimulating Factor

This study is a four arm, parallel study.

Ten were administered a single subcutaneous administration of 30, 100 and 300 μg/kg of GCPGC or placebo for each group (active:placebo=8:2). Eight were administered a single subcutaneous administration of 100 μg/kg of Neulasta (an active comparator).

Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug via subcutaneous around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic and pharmacodynamic samplings. Subjects were discharged on Day 8, and visited Clinical Trials Center on Day 9, Day 11 and Day 14. Study participation was terminated on post-study visit (Day 20 - 22).

Eligibility Criteria:
Inclusion Criteria:

* Age: Between 20 to 40 years of age, inclusive (Age based on the date to give the informed consent)
* Weight: Between 60 - 75 kg, within ±20% of ideal body weight
* Normal clinical laboratory findings, especially for ANC value between 2000 to 7500, inclusive
* Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

* History of hypersensitive reaction to medication (aspirin, antibiotics)
* History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
* History or evidence of drug abuse
* Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
* Participation in clinical trials of any drug within 60 days prior to the participation of the study
* Donation of whole blood within 60 days or a unit of blood within 30 days prior to the start of study
* Judged to be inappropriate for the study by the investigator
A Study of Treatment Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China

This study will be conducted to retrospectively evaluate the treatment patterns in first-line, second-line, and subsequent lines of therapy for HER2-positive Gastric Cancer/Gastroesophageal Junction Cancer (GC/GEJC) patients.

This is a multicenter, non-interventional, retrospective real-world study to analyze the treatment patterns for patients with GC/GEJC in the first-line, second-line, and subsequent lines of treatment. The study will also assess different HER2 sample types, testing methods, and HER2 re-biopsy situations. By evaluating the treatment and testing patterns in clinical practice, this study aims to provide evidence and recommendations for improving the strategies for the treatment and testing of HER2-positive GC/GEJC patients.

Eligibility Criteria:
Inclusion criteria

* Patients with pathologically diagnosed locally advanced unresectable or metastatic GC/GEJC (limited to those diagnosed since October 1, 2017) and initiating first-line treatment between January 1, 2018, and March 31, 2023
* Patients aged ≥ 18 years at the time of diagnosis with locally advanced unresectable or metastatic GC/GEJC; HER2-positive status2, determined by either tissue samples from the first biopsy or liquid biopsy samples (if a patient has both tissue and liquid biopsy samples, tissue samples will be the standard).

Exclusion criteria

* Patients with other primary malignant tumors
* Patients enrolled in clinical trials and receiving active anti-cancer therapy after July.1, 2017 (excluding retrospective studies).
* Patients with critical missing data in medical records or otherwise deemed for inclusion by the investigator
Application of VR-based Working Memory Screening Test

We propose to validate an interactive, immersive spatial memory test from the laboratory test. This VR-based working memory test (VRWMT) is a first-person, self-pacing game embedded within a virtual reality environment, the program is easily implemented with minimal instructions and no supervision that can be community-users friendly. It is specifically designed to assess rapid spatial working memory - a common deficit in all NCD subtypes. Its ability to detect pathological models of dementia, age-related deterioration, and hippocampal dysfunction are well established in literature

The proposed research aims to study the ability of VRWMT to discriminate between older adults with known mild NCD, healthy age-matched older adults and participants with non-communicable diseases and to predict their deterioration in cognitive function over a period of 12 months. Moreover, this study is to characterize and evaluate any concurrent validity between emergence of deterioration in the VRWMT and clinical tools of functional performance in older adults. Additionally, the potential of inflammatory and metabolic dysregulation biomarkers to increase our ability to detect early NCD risk over and above the predictive validity of the VRWMT. The study findings will bring both social and clinical significance to ageing and NCD research. The combination of behavioural and biomarkers of pathological significance offers an innovative approach that potentially addresses the limitations intrinsic to either measure alone.

Eligibility Criteria:
Inclusion Criteria:

* the ability to understand verbal and written Chinese instructions
* the ability and willingness to provide informed consent and sign the relevant document.

Exclusion Criteria:

* a history of substance abuse including alcohol, drugs, or any medication/substances indicative of chronic abuse;
* participants with major NCD.
Remotely Delivered Yoga Program for Chronic Low Back Pain

The purpose of this research is to integrate the meditative components of integrative restoration (iRest) yoga nidra with simple and safe movement sequences derived from established yoga postures and physical therapy interventions for chronic nonspecific low back pain and to use telemedicine technology to facilitate the intervention in a diverse socioeconomic and racial/ethnic population. This project will first systematically adapt the iRest yoga intervention for the incorporation of movement using a consultative and iterative process followed by a pilot intervention to assess the acceptability and preliminary efficacy of this program for pain, back related function and to address body-mind regulation and biopsychosocial-spiritual well-being. Hypothesis: a yoga intervention emphasizing meditative movement and relaxation will be safe for remote delivery and effective for biopsychosocial-spiritual outcomes for people with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-64 years who report chronic nonspecific low back pain, defined as low back pain of unknown etiology persisting for at least 12 weeks,

  * Participants must report an average pain intensity in the previous week of 4 or greater on an 11-point (0 to 10) numerical rating scale,
  * Demonstrate medium to high risk on the STarT back screening tool,
  * Understand English
  * Have access to technology including a computer and internet access

Exclusion Criteria:

* Specific causes of low back pain (e.g. spinal fractures, cancer-related pain)

  * Severe or progressive neurological deficits
  * Severe chronic medical and/or psychiatric comorbidities that may prevent safe participation in the study
  * Established pregnancy
  * Current yoga practice or regular yoga class attendance in the last three months;
  * Current application for a receipt of workers compensation
  * lack of access to technology including a computer and the internet