cyrilzakka/clinical-trials huggingface dataset:
BMI and Ultrasound/Clinical Assessments of RA Disease Activity

Comparison of the level of agreement between Power Doppler ultrasound measured number of synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen joints in obese (i.e. BMI\>30) versus normally weighted RA patients.

Clinical evaluation of synovitis in rheumatoid arthritis (RA) is difficult in obese and overweighted patients, due to the fat pad located around the joint, that can over- or under estimate the number of joints regarded as swollen by clinical examination. RA in obese and overweighted patients has several distinctive characteristics as compared to the disease observed in normally weighted subjects: diease activity (assessed by composites scores such as Disease Activity Score (DAS28) or Simple Disease Activity Index (SDAI)) is higher, while response to treatment and severity (asessed by radiographic progression) are lower.

Objectives:

Primary end point: Comparison of the level of agreement between the number of joints considered abnormal by Power Doppler ultrasound synovitis (≥ grade 1 on a semi-quantitative scale) and clinical examination (swollen joint count (SJC) as componant of SDAI) in obese (i.e. BMI\>30) versus normally weighted RA patients.

Secondary end points :

* Comparison of the level of agreement between clinical and ultrasound findings in overweighted versus normally weighted patients, when joint count evaluation is based on another composite index ((DAS28-CRP et DAS44-CRP), based on the number of tender joints, and based on a joint by joint evaluation
* Comparison of agreement between obese and non obese
* Evaluation of the impact of other factors than BMI on the level of agreement between Power Doppler ultrasound defined number of synovitis and clinically defined swollen joint count
* Reliability between Ultrasound and clinical examination across the different investigation centers Study design: prospective multicenter observational study Inclusion criteria: RA patients fulfilling ACR/EULAR 2010 criteria Exclusion criteria: patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients Outcome measure : Level of agreement between SJC and power Doppler US synovitis

Eligibility Criteria:
Inclusion criteria:

* RA patients fulfilling ACR/EULAR 2010 criteria

Exclusion criteria:

* Patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients, pregnancy.
Electrocochleography Function for Monitoring Residual Hearing

This trial is a pilot study to assess the feasibility of using Electrocochleography recorded from a cochlear implant intra-operatively in real time to monitor the progress of its insertion. Correlation between:

1. Observed changes in this signal during surgery and residual hearing loss post-operatively and
2. Recordings of this signal post-operatively and actual pure tone audiometry results will also be assessed.

Cochlear Implants (CIs) can provide deaf individuals the ability to hear. CIs are electronics packages inserted into the cochlea (hearing organ). An external processor digitises sound and transmits it to the implant. An electric stimulus from the implant mimics the change in electrical potential normally caused by the movement of stereocilia in the cochlea when a sound occurs. This change generates an impulse along the auditory nerve to the brain resulting in perception of sound.

CIs are available in the UK to people who have profound hearing loss. The improvement of CI technology means individuals with less significant losses, or profound losses at only some pitches may now benefit from a CI over a hearing aid. Patients having useful residual hearing has led to interest in better preserving that hearing during surgery. Thus allowing benefit from traditional acoustic amplification in addition to electrical stimulation from the implant.

The investigators propose recording a measurement via the implant during surgery and at audiology appointments called a cochlear microphonic using a technique called electrocochleography (ECochG). This is essentially recording the electrical signal generated by the movement of hair cells in the cochlea in response to a sound. It is hypothesised that reduction of this signal during implantation may correspond to cochlea damage occurring and that with development this signal might be useful feedback for surgeons. The signal is known to be correlated to actual hearing ability so a better understanding of this may allow us to fit the acoustic amplification portion of implants in individuals who are unable to respond reliably to a normal hearing test.

The purpose of this study is a pilot to assess the correlation between observed changes in this signal during surgery and residual hearing loss post-operatively and the degree correlation between recordings of this signal post-operatively and actual hearing test results.

Eligibility Criteria:
Inclusion Criteria:

* Meets normal candidacy requirements for cochlear implantation
* At least 1 year of age at time of consent being given
* Patent cochlea as verified by CT or MRI scan
* No cochlear abnormality that might prevent insertion of the electrode array
* Measurable residual hearing in the ear to be implanted
* No additional complex needs that would prevent study procedures or normal clinical follow-up protocol being followed
* AB Implant selected by patient or MDT
* Written informed consent obtained

Exclusion Criteria:

* Medically complex cases where minimal duration of surgery is required
Irritable Bowel Syndrome Hypnotherapy

The primary goal of the study was whether gut focused hypnotherapy, in a group format, was successful in reduction of symptoms in patients with irritable bowel syndrome. The secondary goal was to see if any outcome predictors could be determined.

Patients with Irritable Bowel Syndrome entering a group hypnotherapy program are asked to complete a series of questionnaires at the outset, and repeat a symptom severity scale at intervals over the one year period after termination of treatment. Eligibility was limited to patients with age greater than 20.

Outcome measures were improvement in symptom score. Outcome predictors studied included quality of relationships, measured with a Quality of Relationship Inventory and attribution of IBS to physical or emotional cause, measured with a Mind-Body IBS Questionnaire, both administered before onset of hypnotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of irritable bowel syndrome by Rome II criteria, age 20 and older

Exclusion Criteria:

* Age below 20
Effect of l S Exercises on Balance and Spatiotemporal Gait Parameters in P M Women

Menopause is a natural process in women's life with hormonal fluctuations that cause physical and emotional symptoms such as(Hot flashes, insomnia, physical in activity, unstable mood, difficulties in memory and concentration, anxiety, stress, irritability, unstable body mass, sexual dysfunction, feelings of sadness, infertility, and depression).

Balance disturbances are common in the community as a whole and increase in frequency with age. The risk of falling increases from age 45 in women and peaks in the 55-59-year age group. Around the time of the menopause, estrogen production decreases dramatically and bone loss accelerates, which predisposes for fractures if a fall occurs.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women: Their age will be ranged between 45-59 years old, with low back pain.

Exclusion Criteria:

* Infection disease or fever.
* Foot ulcers.
* Foot infection or undergoing foot surgery.
* Recent fracture in foot and toes with unhealed wounds.
* Thrombotic disease of lower extremities.
* Deep proprioception loss.
* Peripheral neuropathy.
* Gout or advanced arthritis affecting the foot and toes.
A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
* Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
* Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses

Exclusion Criteria:

* Participants must not have active brain metastases or leptomeningeal metastases
* Participants must not have uveal melanoma
* Participants must not have an active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply
Impact of Intraduodenal Acetic Acid Infusion on Pancreatic Duct Cannulation During Endoscopic Retrograde Cholangiopancreatography: a Double-blind, Randomized Controlled Trial

Intraduodenal acetic acid can stimulate secretion of water and bicarbonate from pancreatic ductal cells. In this study, acetic acid spraying to duodenal bulb was compared with saline solution for the facilitation of pancreatic duct cannulation in patients.The primary outcome was successful deep pancreatic duct cannulation. The secondary outcomes were the appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct cannulation in the acetic acid group versus saline group.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were(1)those with intact native papilla (2)who underwent endoscopic retrograde choledochopancreatography for pancreatic duct, (3)age≥18 years，≦80years,and (4)agreement to participate in the study.

Exclusion Criteria:

* Exclusion criteria were (1) a previous sphincterotomy, (2) previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation, (3) indwelling biliary or pancreatic stent(s), (4) active acute pancreatitis, (5) altered/postsurgical anatomy, (6) history of gastroparesis, and (7) endoscopic retrograde choledochopancreatography for sphincter of Oddi (SO) manometry.
RITUAL Ultivision AI CADe Randomized Controlled Trial

Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas).

Ultivision AI CADe is indicated for white light colonoscopy only.

Ultivision AI contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (CNN).

The algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.

Eligibility Criteria:
Inclusion Criteria:

1. Age 45 to 75 years;
2. Screening or surveillance colonoscopy.
3. Iinformed consent

Exclusion Criteria:

1. Colorectal cancer;
2. Inflammatory bowel disease, including Crohn's disease or ulcerative colitis;
3. Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X;
4. Positive Fecal Immunochemical Test;
5. Use anti-platelet agents or anticoagulants that prevent polyps removal;
6. Colon resection, not including the appendix;
7. Subject is pregnant or lactating.
A Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Tiotropium Inhalation Solution Delivered by the Respimat Inhaler

The objectives were to collect information on vital status and pulmonary medication use at the predicted exit date for patients who participated in two one-year trials and withdrew prematurely. The primary objective was to ascertain the vital status (dead or alive) of these patients in the time interval between the patients' withdrawal from the trial and their predicted exit date (i.e: 48 weeks from first intake of randomised treatment + 30 days). The secondary objective was to collect information on classes of pulmonary medication and some other specified pulmonary interventions used by these prematurely discontinued patients at the time of their predicted exit date (i.e 48 weeks from the first intake of randomised treatment + 30 days) or at date of death (if this occurred during the time interval of interest, i.e 48 weeks from the first intake of randomised treatment + 30 days).


Eligibility Criteria:
Inclusion Criteria:

* Patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255.

Exclusion Criteria:

* Not applicable.
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.

This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated metastatic colon or rectal cancer;
* Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.

Exclusion Criteria:

* Prior chemotherapy for metastatic colon or rectal cancer;
* Planned radiotherapy for underlying disease;
* central nervous system metastases;
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.
Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy Volunteers

The objective of the study is to compare the safety of ASP2151 to valacyclovir and placebo in healthy male and female adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject weighing at least 45 kg with a Body Mass Index (BMI) of 18-35 kg/m2, inclusive
* If female, subject is using a medically acceptable contraceptive method along with a double-barrier method to prevent pregnancy and agrees to continue using this method throughout study; and is not lactating or pregnant as documented by a negative serum pregnancy test
* The subject is medically healthy, with a normal 12-lead electrocardiogram (ECG)

Exclusion Criteria:

* History of any clinically significant disease or malignancy excluding non-melanoma skin cancer
* History of liver disease, liver dysfunction, liver enzyme elevations, or Gilbert's disease
* History of acute or chronic pancreatitis or pancreatic insufficiency
* History of gout, hyperuricemia, or crystalluria
* History of chronic pain requiring medical therapy
* Positive test for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
* Positive test for human immunodeficiency virus (HIV) antibody
* Clinical laboratory tests outside the normal limits and considered by the investigator to be clinically significant
* The subject has difficulty swallowing tablets
* Clinically significant illness within one month prior to study drug administration
* History of drug or alcohol abuse within 2 years prior to study drug administration
* Treatment with prescription medication (with the exception of contraceptives and hormone replacement therapy (HRT)) or complementary and alternative medicines (CAM) within 14 days; over-the-counter products with exception of ibuprofen within 14 days; or alcohol, grapefruit or grapefruit juice containing beverage within 72 hours
* Donated blood or has had significant blood loss within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
The Effect of Fruit and Fruit Juice on Plasma Total Antioxidant Capacity

The aim of the study is to compare the effect of consumption of a fruit beverage on plasma antioxidant capacity with that of the consumption of fruit.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* body mass index between 20-25

Exclusion Criteria:

* use of any medication
* smoking
* consumption of 3 or more glasses of alcohol per day
* involved in top sport
Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.

This study will be conducted using a double-blind, placebo-controlled, randomized, multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or inhibiting the occurrence, time-course and severity of angioedema episodes.

Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed by an 8-week follow-up. The study aims to enroll approximately 70 patients.

The study is divided into a 2-week screening period, a 28-week double-blind treatment phase with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1-antihistamine treatment
* Presence of itch an hives for more than 6 weeks
* UAS7 score of more than 14 (range 0-42)
* Patient has history of insufficient response to 4x of the approved dose of H1-antihistamines
* CSU diagnosis for more than 6 months
* Angioedema at least 4x in the last 6 months

Exclusion Criteria:

* Patients with non urticaria associated angioedema
* History of hypersensitivity to omalizumab or the rescue medication or to drugs of similar chemical structure
* Evidence of parasitic infection
* Previous treatment with omalizumab within the last 6 months prior to screening
* History of anaphylactic shock
* Woman who are pregnant or breast feeding
* Other protocol-defined inclusion/exclusion criteria may apply.
Prevalence of Major Depression Among Immigrants in Santiago, Chile

The general aim of this study is to explore the prevalence of major depressive disorder and the use of mental health services in the immigrant populations in the Metropolitan Region of Santiago, Chile.

The hypotheses are:

1. A healthy immigrant effect will be observed in the studied population by which their prevalence of major depressive disorder will be lower than the prevalence in the general Chilean population.
2. A significant association will be observed between the loss of socio-economic position after migration and a greater probability of major depressive disorder.
3. A significant association will be observed between the report of victimization experience(s) in the previous year and a greater probability of major depressive disorder.
4. A significant association will be observed between financial difficulties and a greater probability of major depressive disorder.

The sampling framework of the Chilean National Institute of Statistics (INE) from the 2016 Census will be used for the purpose of this research. The sampling units are as follows:

1. Primary sampling units (PSUs): conglomerates or groups of adjoining houses, organized in spatial blocks (200 households on average)
2. Secondary sampling units (SSUs): individual households within each of the conglomerates selected in the first stage
3. Final sampling units: persons meeting the study's inclusion criteria Multi-stage random probability sampling involving a 3-stage sampling design will be used - first, the sampling of the primary sampling units (PSUs); second, the sampling of households within the selected PSUs and finally, the random sampling of a household member.

Participants (n=1,100) will then take part in a 45-minute interview. This interview will be a household survey using the modular version of the Composite International Diagnostic Interview (WHO-CIDI) looking at exploring a broad spectrum of factors traditionally associated with increased risk of affective disorders:

1. Sociodemographics
2. Finance
3. Variation in socioeconomic position
4. Experience of victimization
5. Discrimination
6. Experience of childhood adversity


Eligibility Criteria:
Inclusion Criteria:

* Country of birth other than Chile
* Time since arrival to Chile: 3 months

Exclusion Criteria:

* Unable to understand Spanish
Patient-Specific Computational Walking Models in Improving Surgical and Rehabilitation Treatment in Patients With Pelvic Sarcomas

This trial studies the development of patient-specific computational walking models to improve the surgical planning and rehabilitation treatment of patients with pelvic sarcomas. Every pelvis and pelvic sarcoma are different, and the orthopedic oncologist faces significant challenges when removing a tumor from the complex anatomy of the pelvis. These challenges make it difficult to achieve excellent oncological and functional outcomes together. Computational walking models may be used to predict the best combination of surgical methods and how to implement them to maximize each patient's post-surgery walking function.

PRIMARY OBJECTIVES:

I. To develop patient-specific computational walking models to predict the optimal combination of pelvic sarcoma surgical and rehabilitation decisions that will maximize each patient's post-surgery walking function.

II. To collect experimental movement and imaging data prospectively and retrospectively from individuals who have already received, or are going to receive, a type I or type II hemipelvectomy.

III. To use the data to develop computational modeling and simulation methodologies that can predict an individual patient's post-surgery walking function given pre-surgery movement and imaging data and the surgical decisions made by the surgeon.

OUTLINE:

Patients undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging pre- and post-hemipelvectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have received or are scheduled to receive an internal hemipelvectomy with or without reconstruction at UT MD Anderson Cancer Center.
2. Patients who are 18 years of age and older

Exclusion Criteria:

1. Patients who have undergone an external (hindquarter amputated), or an isolated type III internal hemipelvectomy.
2. Previous surgery or significant injury to either hip (prospective patients only)
3. Relevant surgery, procedure, injury, or condition in the last two years which may affect hip pain or general movement patterns on either side (prospective patients only)
4. Pregnant women or women nursing an infant
5. Persons with a pacemaker, hearing aid, aneurysm clips or artificial heart valves, and other forms of loose metal implants will be excluded from the study as assessed by a pre-MRI questionnaire administered by the MRI technician at the time of the scan.
6. Radiological exclusion criteria (assessed after MR scan is conducted on the first visit, prior to DSX/CT radiation exposure): evidence on preliminary MRI of fracture, slipped capital femoral epiphysis (SCFE), masses, lesions, or other anomalies not consistent with an FAI diagnosis.