cyrilzakka/clinical-trials huggingface dataset:
Is Carotid Intima-media Thickness Affected by A1C Variability?

This study was conducted to evaluate the effect of A1C variability on the progression of carotid artery intima-media thickness in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* type II
* fluoroscopy in carotid once a year during 2 years

Exclusion Criteria:

* type 1 diabetes
* history or clinical evidence of coronary artery disease or cerebral or peripheral vascular disease
* the presence of albuminuria (defined as 24 hour urine albumin excretion ≥ 30 mg)
* renal dysfunction (defined as creatinine blood level ≥ 2.0 mg/dL)
* hepatic dysfunction (defined as alanine aminotransferase and/or aspartate aminotransferase blood level ≥ 3 × upper normal limit)
* smoking within the past 3 months prior to commencement of the study
* use of any medication likely to alter IMT such as calcium channel blocker, thiazolidinedione, antiplatelet agent (clopidogrel, cilostazol)
* use of glucocorticoid
* pregnancy
* severe concomitant disease such as cancer
* infection
* Cushing's syndrome
* acromegaly, or any other disorder likely to alter glycemia
* primary hypercholesterolemia
* hypothyroidism or hyperthyroidism
* use of any hormonal drugs
* alcoholism or drug abuse
Natural History Study of Exocrine Pancreatic Function in Infants With Cystic Fibrosis (CF)

The purpose of the study is to evaluate the natural history of exocrine pancreatic function by assessing Fecal elastase-1 (FE-1) in infants with CF during their first year of life.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with CF less than (\<) 6 months of age at the index date
* Participants not eligible to receive commercial Kalydeco™ (based on local product labels) and are not receiving Kalydeco or any other cystic fibrosis transmembrane conductance regulator gene (CFTR) modulator

Key Exclusion Criteria:

* Participant whose mother took any CFTR modulator while pregnant with the participant, or who has any history of exposure to a CFTR modulator

Other protocol defined Inclusion/Exclusion criteria apply.
Gemcitabine and Celecoxib Combination Therapy in Treating Patients With R0 Resection Pancreatic Cancer

The prognosis of pancreatic cancer is extremely poor, even in those patients who had underwent surgery, the 5-year survival is still less than 10%. Current guidelines recommend Gemcitabine monotherapy for R0 resection of pancreatic cancer. Inflammation plays an critical role in the development and progression of pancreatic cancer. Here we intend to assess the synergistic effect of using celecoxib in combination with gemcitabine on the treatment of R0 resection of pancreatic cancer.

We choose those patients who had underwent the R0 resection of pancreatic ductal adenocarcinoma patients, and divided them into two groups randomly, one group patients were given gemcitabine only according the current guidelines, while the other group patients were given gemcitabine combined with the anti-inflammation agent Celecoxib. The disease free survivals, drugs related side effects, overall survivals and other endpoints events were recorded and analyzed, to assess the celecoxib could or couldn't synergist the gemcitabine anti tumor effect on R0 resection pancreatic cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old and above.
2. Surgery for R0 resection.
3. The gemcitabine chemotherapy regimen was not previously used for the treatment of other malignancies.
4. Eastern Cooperative Oncology Group score 0-2 points.
5. Blood routine: The neutrophil count is at least 1.5\*10\^9/ml, and the platelet count is at least 100\*10\^9/ml.Hemoglobin is at least 80g/L.
6. Liver function: bilirubin does not exceed 1.5 times the upper limit of normal; alanine aminotransferase and aspartate aminotransferase does not exceed the upper limit of normal 3 times; kidney function: creatinine ≤ 1.2 mg/dL.

Exclusion Criteria:

1. Endocrine carcinoma, acinar pancreatic carcinoma, or cystadenocarcinoma (cystadenocarcinoma).
2. Surgery for pancreatic cancer fails to reach the R0 resection criteria.
3. Pancreatic cancer received radiotherapy before surgery.
4. Malignant brain metastases.
5. There are other serious cancer history.
6. Active infection, severe diarrhea.
7. Others: Those who are allergic to celecoxib; or who are intolerant to celecoxib, require continuous aspirin or Non-steroidal anti-inflammatory drugs; similar chemical or biological components and sulfa drugs that constitute the study drug History of allergies; allergies, asthma, and rubella after taking aspirin or non-steroidal anti-inflammatory drugs; pregnancy or breastfeeding; active gastrointestinal ulcer/hemorrhage/perforation; Severe mental illness; severe heart failure; past serious cardiovascular thrombotic adverse events, severe hypertensive patients.
Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy

my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises

my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises under supervisio. and use 2 scales,pediatric balance scale and gross motor scale re used for taking data .

Eligibility Criteria:
Inclusion Criteria:

* age range from 5-10 years.
* both male/female
* have good head control
* hypotonic cerebral palsy
* able to maintained ring sitting position

Exclusion Criteria:

* children will not respond to visual and auditory stimuli due to blindness or deafness or sever mental retardation
* children with un controlled convulsion or vp shunt
* children with severe medical problems children with orthopedic condition
Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery

The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which are 2 different nasal decongestants both of which are routinely used before sinus surgery) on blood loss and the surgeon's view of the surgical field during sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery (ESS) in which the same sinuses and procedures on both sides are the same for CRS with or without nasal polyposis.

Exclusion Criteria:

* pregnancy
* known coagulopathy
* an international normalized ratio greater than 1.3
* a partial thromboplastin time greater than 50 seconds
* use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)
* use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)
* poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg or greater or a diastolic blood pressure of 90mm Hg or greater
* having any adverse reaction to topical epinephrine or oxymetazoline.
Workplace Motivation, Job-Satisfaction, and Wellness, Among Nurses and Managers

The purpose of this research project is to assess the impact of a multi-level intervention designed to optimize work motivation and support physical and psychological health among employees. The intervention is based on the principles of self-determination theory; an empirically based approach to human motivation that has been applied to work and health and the job demands resources (JD-R) model; an empirically based model of occupational health.

This study will provide insight into the work climate conditions that are necessary to promote healthy, productive employees and organizations. Based on the knowledge gaps identified in the literature, this will be done by examining the motivational underpinnings related to this challenge to understand the temporal processes leading workplace factors to various occupational health consequences and organizational performance.

1. Aim 1: Develop, implement, and evaluate the effectiveness of a one-and-a-half-day training for nurse managers on 1) how to provide need support 2) facilitate job crafting and 3) how to conduct values interviews to employees (i.e., staff nurses). Following the training, managers will be prepared to implement a need-supportive style during interactions with employees and conduct a values interview.
2. Aim 2: Develop, implement, and evaluate the effectiveness of an intervention for staff nurses to include 1) a one-day training on job crafting and need crafting at work with weekly boosters; 2) a values interview with their manager; and 3) a preventive health assessment and intervention.

Eligibility Criteria:
Inclusion Criteria:

* • Registered Nurse, Manager, or Clinical Supervisor employed at the hospital.

  * Employed by Billings Clinic for a minimum of 6 months.
  * Plan to be in the community for 12-18 months.
  * Proficiency in spoken and written English.

Exclusion Criteria:

* • New employee, defined as \<6 months employment
Intra- and Inter-evaluator Reproducibility of Upper Limb Strength Measures in Patients With COPD

According to the recommendations of French and international learned societies, respiratory rehabilitation is part of the care of patients with Chronic Obstructive Pulmonary Disease (COPD). Indeed, scientific work carried out for more than 10 years on the respiratory rehabilitation of patients suffering from COPD shows that respiratory rehabilitation allows a reduction of the handicap caused by the disease and an improvement in the quality of life of the patients.

A respiratory rehabilitation program (PRR) includes: individual exercise re-training, therapeutic education, respiratory physiotherapy, help with smoking cessation and nutritional and psychosocial care. Exercise retraining includes training the muscles of the lower limbs in endurance and strength combined with training the muscles of the upper limbs. Strengthening the upper limbs helps reduce dyspnea in patients with COPD. In order to determine a precise muscle building protocol, it is necessary to assess at the start of the program the maximum voluntary strength (FMV) of the different muscle groups of the upper limbs. Measuring FMV quantifies a possible frequent strength deficit in patients with COPD and the effects of the strengthening program. Currently, tests to assess FMV using isokinetic dynamometers are used as a benchmark. However, this material is little used in current practice. Portable dynamometers are used to perform simple tests and to obtain muscle strength measurements. However, the reliability of the maximum voluntary force measurements of the different muscle groups of the upper limb has not been evaluated. Studies seem necessary to determine the reproducibility of the measurement in intra and inter-examiner (Schrama 2014) and to assess its sensitivity to change during a respiratory rehabilitation program. The objectives of this study are to study the reproducibility, validity and sensitivity to change of the measurement of FMV using a portable dynamometer.


Eligibility Criteria:
Inclusion Criteria:

* Patient with COPD stages 2 to 4 (A to D) admitted to the pulmonary rehabilitation unit of Centre Hospitalier des Pays de Morlaix (4 weeks)
* Patient able to consent and having signed a consent form
* Patient 18 years of age or older

Exclusion Criteria:

* Patient with pain, arthritis, prosthetics, shoulder or elbow surgery.
* Patient with a history of pneumonectomy, lobectomy less than 6 months old
* Refusal to participate
* Patient with an inability to follow a full respiratory rehabilitation program
* Patient under guardianship or curatorship
Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch

One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization postoperatively. This study is the first prospective trial utilizing the Apple Watch to objectively track patients before and after elective spine surgery. The investigators hypothesize that the ability of patients to track their own activity and discuss with their surgeon objective mobilization goals will not only help patients achieve empowerment in their own care but also improve their overall satisfaction and self-reported outcomes after spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking.
* Undergoing elective spine surgery by attending physicians at Stanford University.
* Own iPhone

Exclusion Criteria:

* Patients with spine trauma, tumors, or infection.
Effect of Prolonged GnRh Agonists on Results of Intracytoplasmic Sperm Injection (ICSI ) in Endometrioma Patients

Investigators compare ICSI results for endometrioma patients with or without cyst aspiration if more than 5cm \&with or without GnRh agonists for all endometrioma patients

Group 1 consists of 30 patients of endometrioma more than 5cm subdivided into:

Group 1A;Cyst aspiration followed by standard long protocol in 15 patients Group 1B;Cyst aspiration followed by GnRh suppression for 3 months then standard long protocol in 15 patients

Group 2 consists of 30 patients of endometrioma less than 5cm subdivided into :

Group 2A;no intervention to the cyst. Standard long protocol Group 2B;GnRh suppression for 3 months then standard long protocol

Eligibility Criteria:
Inclusion Criteria:

* endometrioma patients

Exclusion Criteria:

* Follicle stimulating hormone(FSH)10 or more
* hydrosalpinx
* GnRh suppression in the last 12 months
Exploring the Effect of Footbaths on Increasing the Success Rates in Vitro Fertilization

To evaluate the effectiveness of warm-water footbaths in enhancing pregnancy rates during IVF and to explore the underlying mechanisms involved.

Additionally, this research will assess whether a complementary and alternative medicine (CAM) approach utilizing warm-water footbaths is effective in improving pregnancy rates for women undergoing IVF. Furthermore, the potential mechanisms by which footbaths may enhance IVF success rates will be elucidated.

The specific aims of this research proposal are as follows:

1. To explore the correlation between health statuses, sleep quality, stress, and infertility incidence.
2. To investigate the association between health statuses, sleep quality, stress, and multiple inflammatory indexes in infertile women, including:

   2-1. Systemic immune inflammation index (SII) 2-2. Lymphocyte count (LC) 2-3. Platelet and neutrophil count product (PPN) 2-4. Platelet-lymphocyte ratio (PLR) 2-5. Neutrophil-lymphocyte ratio (NLR) 2-6. Lymphocyte-monocyte ratio (LMR)
3. The effects of Footbaths on Stress and Sleep:

   To examine the effects of footbaths on reducing stress and improving sleep quality, which may enhance pregnancy success rates during IVF treatment in infertile women.
4. The impact on Inflammatory Markers:

To investigate whether footbaths can reduce levels of inflammatory markers and inflammatory cytokines during IVF treatment, potentially enhancing pregnancy success rates in infertile women.

Eligibility Criteria:
Inclusion Criteria:

* women aged 18\~45 years
* diagnosed with male factor infertility
* tubal factor infertility, or unexplained infertility, and undergoing an IVF treatment.

Exclusion Criteria:

* participants having adenomyosis, severe endometriosis
* a history of more than two IVF treatments
* any comorbidity or uncontrolled systemic diseases such as hypertension, diabetes, chronic heart disease or chronic renal disease that can affect the treatment process.
Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals

Investigators in the Division of Infectious Diseases are carrying out a study to determine if human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza vaccination develop an adequate antibody response. The study group will consist of individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the Seasonal Influenza vaccine.

This is a study to establish the immunologic response in HIV-seropositive individuals to the FDA approved seasonal influenza vaccine when it is available. HIV-seropositive individuals seen in the Infectious Diseases Clinic at George Washington University, Medical Faculty Associates and receive this vaccination, on label, as part of standard of care will be invited to participate.

The study will require a 10-ml sample of whole blood to be drawn from each participant prior to the dose of the seasonal influenza vaccine and at 3 weeks after the vaccine dose and at 3 months after the vaccine dose. No additional samples are envisioned. Serum will be separated and will frozen and stored in the Clinical Trials Unit until all patient samples have been obtained. At that time the antibody levels to the vaccine antigens will be measured.

Data that will be collected from the subject's medical record includes the following:

* Age, gender, race
* CD4 count
* HIV viral load
* History of prior influenza immunization including the 2009-2010 trivalent vaccine
* HIV antiviral medication history

Data that will be collected from the subject during participation in study

* Antibody levels prior to vaccination
* Dose date of the seasonal influenza vaccination
* Antibody levels 3 weeks after the vaccination

Eligibility Criteria:
Inclusion Criteria:

* Males or female patients ages 18 or older
* Diagnosis of HIV infection
* No contraindications to being able to receive influenza vaccine by the treating physician
* No acute active illness
* Able to provide informed consent

Exclusion Criteria:

* Previous history of hypersensitivity reaction to influenza vaccine
* Unable to return for follow-up blood draw
Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA) kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Adhexil™ contains the components that form the anti-adhesive barrier, BAC and Thrombin. Thrombin is a sterile solution, containing highly purified human thrombin. BAC is a sterile, solution whose principal component is a concentrate of human fibrinogen. Adhexil™ is supplied in two vials and an application device.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18-45 years at screening
* Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease

Exclusion Criteria:

* Pregnant (including ectopic pregnancy) or breastfeeding patient
* Patients with a documented diagnosis of cancer
* Patients with a lymphatic, hematologic or coagulation disorder
* Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™
* Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
* Patients who have participated in another clinical study within 30 days of enrolment.
* Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.
Treatment of Partial-Thickness Rotator Cuff Tears

The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (\>50%) partial-thickness tears.

The objective of this study is to demonstrate arthroscopic surgical treatment of high-grade (\>50%) partial-thickness tears using REGENETEN yields statistically superior patient post-operative recovery outcomes, faster return to activities of daily living, and less health care utilization versus standard surgical repair techniques.

Eligibility Criteria:
Inclusion Criteria:

Patients will be considered qualified for enrollment if they meet the following criteria:

1. Male or female ≥18 years
2. High-grade (\>50% tendon thickness) partial-thickness tear
3. Failed conservative medical management of the tendon tear defined as:

   1. Four (4) to six (6) weeks of formal physical therapy or guided home exercises
   2. Activity modification
   3. Shoulder injection at the discretion of the surgeon
4. Able to comply with the post-operative physiotherapy and follow-up schedule
5. Able to speak and read English Provide written informed consent

Exclusion Criteria:

Any one (1) of the following criteria will disqualify a patient from participation in the study:

1. Prior shoulder surgery on index shoulder within 12 months of enrollment
2. Failed primary rotator cuff surgery of the index shoulder
3. On steroids within 1 month of enrollment
4. Metastatic disease
5. Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP)
6. Concomitant biceps tenodesis
7. Rheumatoid arthritis
8. Advanced osteoarthritis
9. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
10. Chronic pain disorders (i.e., fibromyalgia)
11. History of insulin dependent diabetes
12. History of heavy smoking (\> 1 pack per day) within 6 months of enrollment
13. Currently involved in any injury litigation or workers compensation claims
14. Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study
Study of the Effect of Lactisole on the Intestinal Glucose Uptake

Study of the effect of lactisole on glucose uptake


Eligibility Criteria:
Inclusion Criteria:

* Male subject, between 18 and 50 years
* General good health condition

Exclusion Criteria:

* Overweight (Body Mass Index ≥30)
* Metabolic disorders
* History of gastrointestinal disorders
* Regular (daily) intake of medication
* Smoking more than 10 cigarettes/day
* History of drug abuse
* Exhaustive (\> 3 units/day) alcohol consumption
* Exhaustive (\> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)
* Recent (in the last 14 days) donation of blood
* Recent (in the last 2 days) donation of blood plasma
* Participation in another trial within 4 weeks before the start of the study
Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women

Iron deficiency is the most prevalent nutritional deficiency and the most common cause of anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells that are abnormally small (microcytic) and contain a decreased amount of hemoglobin (hypochromic).


Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin \< 10 g/dL
* Gestational age between 14-28 weeks.
* Willingness to participate and signing the informed consent form.

Exclusion Criteria:

* Iron overload or disturbances in utilization of iron
* Decompensated liver cirrhosis and active hepatitis
* Active acute or chronic infections
* History of multiple allergies
* Known hypersensitivity to parenteral iron or any recipients in the investigation drug products
* Erythropoietin treatment within 8 weeks prior to the screening visit
* Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
* Planned elective surgery during the study.