cyrilzakka/clinical-trials huggingface dataset:
Association of Jaw Dysfunction With Neck Disability in Subjects With Chronic Cervical Spine Disorders

Since TMJ and cervical pain incidence are rising and both structures are highly interrelated anatomically and functionally. And yet no standard protocol for TMD therapy The objective of this study is to state if there is a correlation between TMD and cervical dysfunction. To help reach a better diagnosis and a more holistic treatment. Forty volunteers (15 male and 25 female) between the ages of 20 to 40 were recruited. Cervical ROM was measured in all directions (rotation, flexion and extension, and sidebending) by CROM device, and a 10 cm plastic ruler marked in both centimeters and millimeters was used to measure TMJ vertical opening.

Background: The incidence of temporomandibular dysfunction has been rapidly increasing in the past years especially among women and still no definite treatment protocol and that's due to the inter lapping of anatomy and neurology of this joint with other structures all over the body. The cervical spine dysfunction has a high incidence as well, and they are common to coexist as they are highly interrelated. Objective: The objective of this study is to emphasize the interrelation between cervical dysfunction and TMJ dysfunction by examining the relationship between cervical spine ROM and TMJ vertical opening ROM to provide better recognition of the etiology of TMJ dysfunction thus a holistic intervention. Materials and methods: It is a bivariate correlational research design. Forty subjects between the age of 20 -40 years (15male/ 25females) were recruited. Cervical ROM was measured by CROM device for all 6 cervical movements. The TMJ vertical mouth opening was measured by a 10 cm ruler. The CROM will be used consistent with standard clinical procedures, with 3 takes for each measurement to decrease human error. The measurements were taken one shot.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 20 and 40
2. Female and Male
3. Suffering from a reduced cervical ROM
4. No reported TMJ pain

   Exclusion Criteria:
   * 1) Tumor (anywhere in the body)
5. Recent trauma to the neck, torso or upper limb
6. Active inflammation in the cervical region, upper thoraxic spine and chest or upper limb
7. Recent use of orthodontics prostheses
Evaluation of the 755nm Alexandrite Laser for the Treatment of Tattoos

The purpose of this study is to collect further data on the safety and efficacy of removing unwanted non cosmetic tattoos (including recalcitrant) using the 755nm Alexandrite laser.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old.
2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits

Exclusion Criteria:

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.
Interest of Oxygenated Hypothermic Perfusion (PHO) in Preservation of Hepatic Grafts From Expanded Criteria Donors

Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors.

The excellent results of liver transplantation (LT) have led to a significant increase in the number of patients awaiting transplantation. At the same time, the number of grafts remains stable. To extend the donor pool, the use of Extended Criteria Donor (ECD) donors graft increased each year despite the fact that these graft are known to be more vulnerable to ischemia-reperfusion injuries induced by cold storage preservation (CS). Their use is therefore associated with a greater risk of postoperative dysfunction of the graft. This risk can be reduced by improving preservation quality.

The preservation by hypothermic oxygenated perfusion (HOPE) consists of keeping the graft in hypothermia (4 to 12 °C) on an machine perfusion (MP) using a specific solution, saturated with oxygen. In kidney transplantation, the use of MP has been shown to improve graft function as well as graft survival, especially for ECD grafts.

In liver transplantation, experimental studies on animal models have demonstrated the superiority of HOPE over CS regarding graft function and survival. These results have been confirmed in humans on small retrospective series.

As HOPE is an expensive procedure, obtaining evidence of its effectiveness could result in a reimbursement of the additional cost.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Candidates for a first orthotopic liver transplantation, without transplantation of another associated organ (kidney, pancreas, heart, lung, intestine)
* With cirrhosis whatever its etiology and gravity
* With or without hepatocarcinoma
* Having given free, informed and written consent
* LT made from a whole graft, harvested from a brain-dead donor with ECD criteria, defined as the presence of at least one of the following criteria:

  * Age\> 65 years
  * BMI\> 30 kg / m2
  * Duration of hospitalization in intensive care unit\> 7 days
  * Natremia\> 155 mmol / l
  * AST\> 150 IU / ml
  * ALT\> 170 IU / ml
  * Occurrence of cardiac arrest before harvesting
  * Macrovacuolar steatosis\> 30% on liver histology

Exclusion Criteria:

* History of organ transplantation
* Transplantation in emergency
* Transplantation from a living donor, a reduced graft or a graft from a deceased donor by cardiac arrest (DCD)
* Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty
Reliability of Sensor-Derived Measurements of the SENSorized Fugl-Meyer (FMA) in Subjects with Stroke Outcomes

This study will be conducted at a single research center, the main objective of the study will be to evaluate the efficacy, safety, and accuracy of a medical device that has not yet been commercialized; therefore, it is still under development or testing and is not yet available for private use and is not for profit (nonprofit).

Fifty participants will be recruited from subjects afferent to the outpatient and inpatient neuro-motor rehabilitation clinics of IRCCS Fondazione Don Carlo Gnocchi in Florence, Italy, and afferent to the outpatient and inpatient rehabilitation clinics of Elias University Emergency Hospital in Bucharest, Romania.

In detail, it is deemed necessary to collect clinical and instrumental data. The study will be conducted by an interdisciplinary team composed of healthcare professionals and engineers afferent to the Department of Industrial Engineering.

Should you decide to participate in the study, a visit to verify the inclusion and exclusion criteria will be primarily conducted. Once the admission criteria have been verified, participants will undergo a series of assessments.

The first, involves the administration of some specific sections of the Fugl-Meyer scale (FMA), focusing on the upper extremities. Specifically, the following will be examined: section A for general upper limb function, section B assessing wrist mobility, and finally section D for limb coordination and speed.

During this phase, both upper limbs will be assessed, in addition, the first examiner will carefully place sensors on the participants and assign scores to the tests performed, according to the criteria established by the FMA scale.

Next, a second assessment (T1) will be conducted, in which a second examiner will be responsible for placing the sensors and recording data only on the most affected side.

At a third time, called "T2" and again with at least 15 minutes interval from T1, the first examiner will repeat the same assessments performed in "T1." While performing these assessments, a RealSense camera will be used.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older;
* stroke outcomes with the presence of sensorimotor impairment in the upper limb;
* willingness to participate in the project, with informed consent signed by the person himself or, when necessary, by the support administrator/legal guardian.

Exclusion Criteria:

* Severe concomitant pathologies that modify the subject's motor framework;
* severe visual and/or hearing impairments that cannot be corrected;
* severe neuropsychological impairments (aphasia, apraxia, other cognitive deficits ) such as to prevent cooperation in administering the scale;
* presence of signs of clinical instability, defined by a score greater than zero on the SIC scale (Clinical Instability Scale).
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.


Eligibility Criteria:
Inclusion Criteria:

* Medical history of gastric and/or duodenal ulcer
* A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion Criteria:

* Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
* History of esophageal, gastric or duodenal surgery
* Having severe liver disease or chronic renal disease
Intramuscular Benzathine Penicillin Injection Procedure

The aim of this study was the determination of the effect of applying VR and DC distraction methods on patients' pain and satisfaction levels during IM benzathine penicillin injection.

The research hypothesis:

1. Are Virtual Reality and Distraction Card effective in reducing pain due to injection of IM benzathine penicillin?
2. Does the use of Virtual Reality and Distraction Card during the injection process of IM benzathine penicillin have an effect on patient satisfaction?


Eligibility Criteria:
Inclusion Criteria:

* agree to participate in the research,
* being over the age of 18,
* being native speaker,
* not having vision and hearing problems,
* being prescribed benzathine penicillin with a dose of 1.200.000 IU,
* being experienced of IM injection,
* not having IM injection for the last 1 month

Exclusion Criteria:

* volunteers who have scar, incision, lipodystrophy, abscess, necrosis, hematoma, ecchymosis, infection, pain and paralysis at the VG site
* volunteers are excluded if the injection process cannot be performed at one time
The Effect of Hydrodissection for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively used in clinical practice, current researches contain small participant without control group or randomized leading to foreseeable selection bias. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided hydrodissection in patients with CTS.

After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection and control side received one-dose ultrasound-guided injection at subcutaneous layer beyond carpal tunnel. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 2nd and 3rd month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old.
* Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

* Cancer
* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS
Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

The goal of this study was to explore the efficacy and safety of neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients with locally advanced esophageal squamous cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-75;
* Radical operation for esophageal cancer;
* Esophageal squamous cell carcinoma was confirmed by postoperative pathology; . Preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation were performed, and the stage was pIIB-IVA (AJCC eighth edition staging criteria: T≥3 or N+).
* More than or equal to 12 lymph nodes were surgically removed;
* Postoperative ECOG score 0-1, able to tolerate postoperative adjuvant radiotherapy and immunotherapy;
* Informed consent signed by patient or family member.

Exclusion Criteria:

* Less than 18 years old, more than 75 years old;
* did not receive radical resection of esophageal cancer, including palliative resection;
* Postoperative pathology showed non-esophageal squamous cell carcinoma;
* After preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation, the stage was pI, IIA, IVB (AJCC eighth edition staging standard); e. Less than 12 lymph nodes were surgically removed;
* Postoperative ECOG score 2-3 points, unable to tolerate postoperative adjuvant radiotherapy and immunotherapy;
* The patient or family member did not sign the informed consent.
POEM Trial: Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM)

The aim of the study is to compare the efficacy of per-oral endoscopic myotomy (POEM) to the efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It is hypothesized that POEM has a higher long-term efficacy than pneumodilation in treatment of therapy-naive patients with idiopathic achalasia.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 75 yr of age
* Manometric diagnosis of achalasia
* Eckardt score \> 3
* Informed consent

Exclusion Criteria:

* Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk previous treatment, except treatment with nitroderivatives, Ca++ channel blockers or sildenafil, or dilation with Savary bougies or balloons of 2 cm diameter or smaller.

Pseudo-achalasia Mega-esophagus (\> 7 cm) and/or sigmoid-like esophagus Previous esophageal or gastric surgery (except for gastric perforation) Not capable to fill out questionnaires (f.e. due to language barrier) Not available for follow-up Esophageal diverticula in the distal esophagus Malignant or premalignant esophageal lesions Patients with liver cirrhosis and/or esophageal varices Pregnancy
Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).


Eligibility Criteria:
Inclusion Criteria:

* 18-95 years old
* Diagnosied with actinic keratoses.

Exclusion Criteria:

* Patients who have had Isotretinoin therapy less that 1 year prior to screening.
* Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
* History of porphyria
Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy


Eligibility Criteria:
Inclusion Criteria:

* Documented invasive breast cancer
* Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor
* HER2+ and HER2- (Human Epidermal growth factor Receptor) disease
* Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane
* ECOG Performance status = 0 or 1

Exclusion Criteria:

* Prior hormonal therapy for metastatic disease
* Prior hormonal therapy with letrozole for adjuvant disease
* Symptomatic brain metastases
* Prior treatment with any tyrosine kinase inhibitor
Effects of Sarcopenia on Early Postoperative Outcomes in Patients Undergoing Surgical Treatment for Gastric Cancer

We aimed to establish the effects of sarcopenia on postoperative complications among patients undergoing surgical treatment for gastric cancer

Among gastrointestinal disease, gastric cancer is a malignancy which is diagnosed predominantly in advanced stages, mostly accompanied with malnutrition when diagnosed, has aggressive behavior with poor oncological outcomes. The only option for curative treatment is surgical resection in this malignancy; however, the surgical procedure itself causes high morbidity and mortality rates. Therefore, physicians combine various treatment modalities and risk assessment to decrease complication and mortality rates.

Sarcopenia is a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. For the diagnosis of sarcopenia, using the presence of both low muscle mass and decreased muscle function (strength or performance) is recommended. Previous studies showed that colorectal or pancreatic cancer accompanied with sarcopenia has adverse effects on not only for short term and also for long term outcomes. The majority of studies regarding gastric cancer was published from Eastern countries owing to their high incidence. There are few studies from western countries which are mostly retrospective and does not meet the diagnostic criteria of sarcopenia. In the western population, there is no high-quality evidence so far regarding the impact of sarcopenia on early outcomes of gastric cancer surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing gastric surgery for gastric cancer
2. Histologically proven gastric adenocarcinoma
3. Patients over 18 years
4. Patients who agreed to participate in the study

Exclusion Criteria:

1. patients treated by non-surgical treatment such as endoscopic treatment, palliative chemotherapy)
2. patients received palliative surgery without gastric resection (bypass procedures)
3. patients required thoracotomy/thoracoscopy
A Novel Conditioning Approach to Counter Loneliness in Adults

This study aims to test the efficacy of a 6-session conditioning paradigm by investigating the conditioning-induced change in the socio-affective processing, loneliness, depressive symptoms, and neural correlates of lonely adults.

Potential participants will first be invited to complete a loneliness questionnaire online. Lonely adults will then be invited to our laboratory to undergo further screening. At baseline prior to the intervention training sessions, participants will first complete tests and questionnaires on loneliness, mood and depressive symptoms in addition to other socio-affective measures, and they will also receive resting-state functional MRI scanning in a 3T MRI scanner. Participants will then be allocated to one of the two intervention arms (the evaluative conditioning, and the control) in a randomized fashion with approximately half in each group. They will then complete the pre-conditioning phase of the allocated intervention arm at the laboratory. Based on their ratings on the stimuli presented during this phase, stimuli will be selected for the conditioning phase. In the conditioning phase, they will be invited to attend 6 sessions . After completing the conditioning phase, participants will be invited to complete the post- conditioning phase at our laboratory, providing ratings on the stimuli like the pre-conditioning phase. Immediately after, and also 3-months after, participants will be invited to complete again tests and questionnaires at laboratory on loneliness, mood and depressive symptoms in addition to other socio-affective measures, and they will also receive resting-state functional MRI scanning in a 3T MRI scanner.

Eligibility Criteria:
Inclusion Criteria:

* No histories of learning impairment, major psychiatric disorders or neurological disorders other than depression
* Normal intelligence
* At least primary school education

Exclusion Criteria:

* On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions
MENDD Tolerance Assessment Study

This study will utilize approved devices in an off-label manner to create forces required to induce intestinal lengthening. Radial and longitudinal forces are both required, and two devices will be used to create forces in order to test tolerability of said forces. This is to provide evidence that humans could tolerate the forces produced by a proposed commercially built device.

This study will test the hypothesis that radial and longitudinal forces necessary to produce enterogenesis will cause low levels of discomfort in healthy adults. Approved devices will be utilized in an off-label manner to reproduce forces similar to our novel medical device which is designed to treat short bowel syndrome (SBS).

This trial will not be testing a treatment for SBS, and individuals with SBS are ineligible for recruitment.


Eligibility Criteria:
Inclusion Criteria:

* Existing Ileostomy older than 6 weeks Undergoing any existing procedure in endoscopy suite or operating room.

Exclusion Criteria:

* Inflammatory bowel disease of small bowel Pregnant Short bowel syndrome Bleeding disorder Chronic pain disorder Individuals taking chronic pain medications including prescriptions, cannabinoids or over the counter.

Individuals taking pain medications at the time of the procedure Cognitive Impairment to the extent that the questionnaire cannot be completed