cyrilzakka/clinical-trials huggingface dataset:
Retrospective Study With Patients Treated With STALIF® C or M and Ti or FLX Implants for 1 and 2 Levels

This is a Retrospective, Observational Multi-Center study, utilizing patients diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or symptomatic degenerative disc disease and treated with STALIF® C, or M, Ti and/or FLX implants at one or two levels.

The study is intended to codify the performance of the STALIF family of products. Its design is to provide retrospective data derived from the patient's medical and surgical chart and prospectively assess the treating surgeon and patient on their level of satisfaction post-operative up to present.

All subjects who sign an informed consent will be included in the prospective data collection via chart review at the individual investigational sites. The prospective data will come from subjects who complete the designated patient assessments as well as the treating surgeon. The data collection period will include surgeries performed between 2014 to present.

The analysis will support the safety profile of the product family and allow for comparison to the available literature as well as between device types (Ti versus FLX). Furthermore, data from this study will support post-market surveillance requirements for the STALIF family of products.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or degenerative disc disease of the cervical or lumbar spine at time of surgery.
* 2 levels, between:

  * C: C2-T1 (neck)
  * M: L2-S1 (low back)
* Skeletally mature at the time of surgery with clinical and radiological evidence of degenerative disc disease of the cervical or lumbar spine.

Exclusion Criteria:

* Subject who had surgery with the STALIF devices at more than 2-levels.
* In the Investigator's opinion, the subject diagnosed with a disease or condition, which precludes the possibility of healing at the time of surgery
Rehabilitation Team Functioning and Patient Outcomes

The purpose of the study is to determine if 1. Rehabilitation staff can be trained to work better together as a team; and 2. Better team work improves patient outcomes.

The benefits of team treatment are widely accepted. Prior research has shown that how rehabilitation teams go about their work makes a difference in the patients they treat. However, there is little information about what, specifically, the team does that results in patients who are able to do more for themselves. The objectives of this clinical trial was to test whether a team training intervention in stroke rehabilitation was associated with improved patient outcomes. We conducted a cluster randomized trial of 31 rehabilitation units comparing stroke outcomes between intervention and control groups. in thirty-one VA medical centers with 237 clinical staff on 16 control teams and 227 staff on 15 intervention teams. There were 487 stroke patients treated by these teams before and after the intervention.

The intervention consisted of a multiphase, staff training program delivered over six months, including: an off-site workshop emphasizing team dynamics, problem solving, and the use of performance feedback data; and action plans for process improvement; and telephone and videoconference consultations. Control and intervention teams received site- specific team performance profiles with recommendations to use this information to modify team process.

The main outcomes measures consisted of three patient outcomes: functional improvement as measured by the change in motor items of Function Independence Measure (FIM), community discharge, and length of stay (LOS). For both the primary (stroke only) and secondary analyses (all patients), there was a significant difference in improvement of functional outcome between the two groups, with the percentage of stroke patients gaining more than a median FIM gain of 23 points increasing significantly more in the intervention group (difference in increase = 13.6%, P=0.032). There was no significant difference on LOS or rates of community discharge. Stroke patients treated by staff who participated in a team training program were more likely to make functional gains than those treated by staff receiving information only. This study is a randomized cluster trial which tested used workshops to train rehabilitation staff. Patients treated by trained teams were compared with patients treated by teams that did not have workshop training. Stroke patients

Eligibility Criteria:
Inclusion Criteria:

* Randomized, controlled subjects were VA inpatient rehabilitation teams. Secondary data included telephone surveys from discharged patients treated by the rehabilitation teams.

Exclusion Criteria:

* VA sites which did not submit data to the VA-FSOD - the national functional outcomes database
Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma

Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or cell biology. Patients are randomized into 2 groups: The control group receive normal treatment only, the experimental group receive acupuncture therapy besides normal treatment. Clinical evaluation is based on the observation of the pain degree and life quality improvement. Blood biochemistry tests mainly include Prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male) etc.


Eligibility Criteria:
Inclusion Criteria:

1. General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;
2. Pathology diagnosed;
3. Brain, heart, lung, liver, kidney are at good condition before surgery;
4. No mental disorder, no conscious obstacle, no limbs disability.

Exclusion Criteria:

1. Severely complication after surgery;
2. Contraindication of the acupuncture;
3. Patients with mental disease;
4. Patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.
Group-Based Online Virtual Reality Gaming to Improve Mental Health Among Children With Physical Disabilities

COVID-19 has had a negative impact on the mental health of many children with physical disabilities. This project aims to test the potential effects of an online multiplayer virtual reality group-based, active video game program on social isolation and depression and will include a total of 12 children with physical disabilities.

This pilot feasibility study will investigate the potential effects of a revised multiplayer virtual reality exergaming program on depression, socialization, and loneliness among children with physical disabilities. This proposed study will use both quantitative and qualitative research methods, to gain a deep understanding of program benefits and implementation procedures that can be refined for a large clinical trial. The active video game program will last 1-month and include 2 supervised 1-hour sessions per week of group-based gaming. Game sessions will be supervised by 2 research staff who will act as gaming and mindfulness coaches. Outcomes will be measured by self-report questionnaires before and after the program. The program will be completed in two waves (6 people per wave). After the program, participants will undergo a one-on-one semi-structured interview, where they can describe their perceptions of the program.

Eligibility Criteria:
Inclusion Criteria:

* self-reported mobility disability (e.g., use of a mobility device or presence of a mobility impairment)
* access to a Wi-Fi internet connection in the home
* a caregiver to support the child if \<18 years of age
* a Facebook account to link to the virtual reality head-mounted display

Exclusion Criteria:

* physically active (defined as \>150 minutes/week of moderate-to-vigorous intensity exercise)
* cannot use the arms for exercise or operate the controller buttons using their fingers
* prone to seizures
* complete blindness or deafness
* unable to communicate verbally in English
Motivating Type O- Blood Donors to Return

This study develops a motivational interview and implementation intention intervention for blood donor retention and tests the efficacy of this new approach among first-time, Group O donors.

In this study the investigators will recruit first-time Group O- and O+ donors four weeks after their donation using the donor databases of New York Blood Center and Hoxworth Blood Center. Eligible donors will be contacted via email and invited to participate in the study. Interested donors will be randomly assigned to either the Intervention condition where they will receive a motivational interview and implementation intention intervention phone call or to the Control condition where they will receive a standard donor recruitment phone call. Outcome measures will be assessed before and after the telephone contact using online questionnaires, and donation attempts will be tracked for one year. The investigators will use survival analysis to examine the effects of this intervention on retention during this one-year follow-up. Path analyses will also be used to examine potential mediators of the intervention effect. The investigators hypothesis is that donors who receive the motivational interview and implementation intention intervention will have larger increases in positive donation attitudes and perceived behavioral control which will contribute to enhanced intention and donation attempts.

Eligibility Criteria:
Inclusion Criteria:

* donor with New York Blood Center or Hoxworth Blood Center
* one previous donation
* O- or O+ blood
* eligible to donate again
Establishment of Multimodal-multiparametric Progressive Prediction Models for Thyroid Associated Ophthalmopathy

Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.

The aim of this clinical study is to:

1. Found characteristic changes from baseline to the end of treatment.
2. Identify characteristic changes associated with treatment response.
3. Construct a multimodal and multiparameter prediction model by characteristic changes.


Eligibility Criteria:
Inclusion Criteria:

* According to the Bartley criteria，diagnosed TAO at our hospital from 2017/1/1 to 2024/3/31
* Moderate to severe patients defined by EUGOGO
* CAS ≥4 (on the 7-item scale) for the study eye
* Completed orbital MRI at our hospital
* Received complete medical treatment and completed assessment at our hospital

Exclusion Criteria:

* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision
* History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \&gt;1 g of methylprednisolone for the treatment of TAO.
* Any major illness/condition or evidence of an unstable clinical condition that, in the investigator\&#39;s judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study
* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant\&#39;s participation in the study
* Pregnant or lactating
* Any other condition that,would impair the ability of the participant to undergo orbital MRI
Influence of Walking Pilgrimage on Changes in Body Composition, Biochemical Parameters, Circulatory and Respiratory Efficiency and Foot Biomechanics in Healthy Women and Men of All Ages.

The aim of the study is to assess the health habits and changes in body composition and exercise capacity as well as blood biochemical parameters of people participating in 14-21-day walking pilgrimages. This type of physical activity can be classified as long-term and multi-stage hiking tours. Among the people participating in the pilgrimage, a significant part of the population are people aged\> 50 years. Moderate physical activity is an important pro-health element, however, it has not been determined yet how long and accumulated activity may affect the health of pilgrims. Suddenly taking up activity and the challenge of walking several hundred kilometres may be a heavy burden for the body, and its effects may have a negative impact on the body. The evaluation of the processes taking place in the body under the influence of this type of physical activity, motivated by religious goals, will expand the scope of knowledge about safety as well as health indications and contraindications for this type of activity. It will also allow identifying adaptive changes and their effects


Eligibility Criteria:
Inclusion Criteria:

women and men aged 18-65

BMI (body mass index) at the level of 18-39

Exclusion Criteria:

Chronic diseases Musculoskeletal injuries Mental disorders Surgery or hospitalization in the last year before the start of the study Pregnancy
Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)

This is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral therapy in patients with known mild to severe confirmed Clostridium difficile associated diarrhea (CDAD).

The intervention is adding Tigecycline (standard doses) to standard oral therapy for CDAD. Patients will then be observed for clinical outcomes and relapse of CDAD.

Eligibility Criteria:
Inclusion Criteria:

* non pregnant adults (≥18 years old) with a diagnosis of mild to severe CDAD (initial or recurrent) by positive C. difficile toxin assay along with clinical symptoms (watery stools, fever, abdominal pain). Patients will receive a minimum of 3 days of tigecycline.

Exclusion Criteria:

* pregnant patients
* allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.
Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome

Previous trials have demonstrated that the use of physiological assessment of stenosis severity using fractional flow reserve (FFR) is superior to angiographic assessment in percutaneous coronary intervention (PCI) and improves clinical outcome. Despite the clinical utility, FFR is used only in 10-15% of patients today. The main reasons for the low adoption rate of FFR are the prolonged procedural time, Adenosine related discomfort and cost associated with Adenosine.

Instantaneous Wave-Free ratio (iFR®) is a novel method to assess coronary lesions for functional significance. The main benefits of the method compared to FFR are that the measurement is instantaneous and does not require Adenosine infusion. Thus, the patient does not experience any discomfort from the measurement and procedural time could be shortened compared to when using FFR. This could potentially increase the adoption rate of physiologic assessment of coronary lesions.

The aim of this trial is to compare the clinical outcome of patients assessed by iFR® with patients assessed by FFR.

Furthermore, the trial will be conducted as a registry based randomized clinical trial (RRCT) which is a novel strategy to conduct clinical trials. The randomization will occur online in the Swedish angiography and angioplasty registry (SWEDEHEART) using a web based platform.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected stable angina pectoris or unstable angina pectoris/non-ST-segment elevation myocardial infarction (NSTEMI) who are scheduled to undergo coronary angiography, and who has an indication for physiology guided assessment of coronary lesions (usually 30-80% stenosis grade). In patients with suspected stable angina pectoris, any lesion may be assessed. In patients with unstable angina pectoris/NSTEMI, only the non-culprit lesion may be assessed.

Exclusion Criteria:

* Inability to provide informed consent
* Age below 18 years
* Previous randomization in the iFR-SWEDEHEART trial
* Known terminal disease with a life expectancy of less than one year.
* In patients with multi-vessel disease and other indication than stable angina pectoris, difficulty in assessing which the culprit lesion is.
* Patient with unstable hemodynamics (Killip class III-IV)
* Inability to tolerate Adenosine
* Previous Coronary artery bypass graft (CABG) with patent grafts to the interrogated vessel.
* Heavily calcified or tortuous vessel where inability to cross the lesion with a pressure wire is expected.
Relationship of Endometrial Cancer and Serum Soluble L1CAM Level

The aim of this study is to evaluate the effect of serum soluble L1CAM (sL1CAM) on the diagnosis and prognosis of endometrial cancer. This prospective randomized controlled trial will be conducted in patients who have undergone endometrial biopsy and whose pathology results are reported as benign endometrial changes, endometrial hyperplasia, or endometrial cancer. The sL1CAM level between groups will be compared. The relationship between prognostic factors and serum sL1CAM will be evaluated in patients with endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent endometrial biopsy due to abnormal uterine bleeding and whose pathology results were reported as benign endometrial changes, endometrial hyperplasia or endometrial cancer were included in the study. All patients participating in the study signed informed consent.

Exclusion Criteria:

* Patients who did not have consent, received neoadjuvant therapy and who would not have surgery despite endometrial cancer were excluded from the study.
Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC

The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy
2. Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Sensitive EGFR gene mutation(19/21)
5. Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation

Exclusion Criteria:

1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
2. Female subjects should not be pregnant or breast-feeding
3. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
4. Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc)
5. Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination
Prostatectomy Prospective Database

The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health.

The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health. Participation in the study will allow collection of medical information related to prostate cancer treatment from hospital and doctor's office records. Questionnaires will be completed reflecting bladder, bowel, and sexual function, and quality of life at three, six, twelve, eighteen, and twenty-four months after surgery, and yearly thereafter.

Eligibility Criteria:
Inclusion Criteria:

* males greater than 18 years of age
* patients having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital.

Exclusion Criteria:

* dementia
A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 14 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
* Are between the body mass index (BMI) of 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, at screening
* Are agreeable to receiving study treatment by injections under the skin

Exclusion Criteria:

* Have known allergies to tirzepatide or related compounds
* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
* Have a prior history of malignant disease(s) in the past 5 years prior to screening
* Smoke more than the equivalent of 10 cigarettes per day
* Is a known user of drugs of abuse
Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching

This study investigates the impact of endometrial scratching on endometrial secretion, when correlated to pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* IVF or ICSI patients with ≥1 previous implantation failure, despite transfer of a top quality embryo or blastocyst.
* Antagonist treatment
* FSH: 2-12 IU/L
* BMI: 18-32
* Regular menstrual cycle
* Written consent

Exclusion Criteria:

* Suspected intrauterine abnormalities Planned use of specialized media or AHA