cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients

Primary Objective:

- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.

Secondary Objectives:

- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone on:

* Percentage of patients reaching HbA1c \< 7%
* Percentage of patients reaching HbA1c \< 6.5%
* Fasting Plasma Glucose (FPG)
* Safety and tolerability

The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.

Eligibility Criteria:
Inclusion criteria

* Patients with type 2 diabetes mellitus, as defined by the World Health Organization (WHO), diagnosed within one year prior to the screening visit
* Signed informed consent, obtained prior to any study procedure

Exclusion criteria

* Age \< 18 and =\> 78 years old
* HbA1c \< 7.6% or \> 9%
* BMI \> 35 kg/m2
* Diabetes other than type 2 diabetes (e.g.: type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...)
* Subjects currently receiving or who have received any hypoglycemic agent within 3 months before screening visit

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke

The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.

Stroke is a leading cause of disability in the U.S., with more than 4 million stroke survivors in the U.S. who suffer from post-stroke hand disability. Post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation.

To fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. The objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* At least 6 months since stroke
* Wolf Motor Function Test (WMFT) total average time \>10 seconds
* WFMT hand task average time \<120 s

Exclusion Criteria:

* Currently undergoing other upper limb therapy
* Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment
* Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
* Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms
* Language barrier or cognitive impairment that precludes following instructions and/or providing consent
Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

This study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

Eligibility Criteria:
Inclusion Criteria:

1. Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self-reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wears of toric soft contact lenses binocularly.

   1. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;
   2. the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:

      * i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage)
      * ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))
      * iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%))
      * iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage)
      * v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage)
      * vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage)
      * vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage)
7. Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;
8. Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;
9. Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Has undergone refractive error surgery or intraocular surgery.
Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants

Graft versus host disease (GVHD) is one of the common complications after stem cell transplant. This is a complication, which happens when the new stem cells from the donor attack other cells in the body of the transplant recipient.

Recently, an antibody (protein) called alemtuzumab or Campath has been found to be effective in the prevention of Graft vs. Host Disease.

Previous studies have shown a low risk of GVHD with alemtuzumab, however the risk of disease recurrence was high. Previous studies have used a high dose of alemtuzumab. The purpose of this study is:

* To find if by lowering the dose of alemtuzumab, can serious GVHD be prevented without increasing the risk of relapse (your condition getting worse).
* To find whether low dose of alemtuzumab in combination with cyclosporine can prevent GVHD more effectively when compared to current standard of care and does not increase the risk of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a hematological malignancy
* Peripheral blood as source of stem cells
* Able to give informed consent
* Availability of 6/6 matched sibling donor
* Fit for transplant using a conventional or reduced intensity approach

Exclusion Criteria:

* AST/ALT \>3 x IULN at the time of transplant
* Serum creatinine \> 1.5 x IULN at the time of transplant
* Prior allogeneic transplant
* Syngeneic donor
* Active uncontrolled infection
* HIV positive
* Pregnancy at the time of BMT
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients

With the virtual reality application in patients with bronchoscopy, it is aimed to reduce the fear, stress and tension arising from the possibility of the development of pain and complications in the patients. The research will be carried out in the form of pretest-posttest application with 30 experimental and 30 control groups. The researcher aims to minimize the fear and stress in the patient by applying the virtual reality application to the patient in the experimental group 10 minutes before the procedure and 5-10 minutes during the procedure.

This study includes the examination of the effect of applying virtual reality interventions, which are used for the treatment of anxiety problems, to patients who will undergo bronchoscopy. For this purpose, first of all, a relaxation intervention will be designed in a virtual reality environment. The virtual reality environment will be organized on the basis of relaxation exercise. In this direction, first of all, an image will be created by taking 3D modeling service and the text of the relaxation exercise prepared in the presence of a professional sound artist will be transferred to the image with sound.

Eligibility Criteria:
Inclusion Criteria:

* be18 years and over
* Ability to communicate adequately
* Absence of psychiatric problems
* Those who are determined by the physician that they do not have a physical disability in exercising
* Volunteering to participate in the research
* Individuals who have the ability to use technological tools

Exclusion Criteria:

Those who have communication problems

• Those with psychiatric problems
Head-to-head Study of 68Ga-MGS5 Versus 68Ga-DOTATATE PET/CT in Patients With Medullary Thyroid Carcinoma

Cholecystokinin-2 (CCK2) receptor is overexpressed in more than 90% of MTC cases, and preclinical studies have shown that 68Ga-MGS5 (targeting CCK2) has good stability in vivo and is promising for diagnosis and staging of MTC. This prospective study will compare the diagnostic effects of 68Ga-MGS5 and 68Ga-DOTATATE on MTC primary foci, lymph node metastasis, and distant metastasis, and explore the effect of 68Ga-MGS5 PET/CT on the clinical staging (TNM staging) of MTC.

This study was planned to enroll 20 patients with suspected MTC and MTC recurrence who attended the First Hospital of Fujian Medical University from June 2023 onwards. Each patient completed PET/CT examination within 1 week, one 68Ga-DOTATATE PET/CT whole-body examination and two 68Ga-MGS5 PET/CT whole-body examinations (1 hour and 2 hours after injection, respectively). CCK2 immunohistochemical staining and expression scoring of primary foci and lymph node metastases were also performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender, aged ≥ 18 years and ≤80 years.
* Patients with pathologic findings confirming the diagnosis of MTC
* Patients with MTC recurrence
* Signed written consent

Exclusion Criteria:

* Pregnant or breastfeeding female patients
* Patients with claustrophobic behavior
* The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System

This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.

The study is prospective. Subjects will be implanted with an iTotal® PS Knee Replacement System. The study will include a minimum of 100 subjects across up to 10 sites. The patients enrolled in this study may represent the first cases of the iTotal PS KRS implanted at a particular site; data collected for the first 15 patients at each site will be analyzed separately from the rest of the enrolled population. This will provide visibility towards determining if there exists a learning curve in the implantation process of the iTotal PS KRS. The study sites will be located in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Clinical condition included in the approved Indications For Use for the iTotal® PS
* Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment.
* Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
* \> 18 years of age

Exclusion Criteria:

* Simultaneous bilateral procedure required
* BMI \> 40
* Active malignancy (defined as a history of any invasive malignancy - except non- melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
* Poorly controlled diabetes
* Neuromuscular conditions which prevent patient from participating in study activities
* Active local or systemic infection
* Immunocompromised
* Fibromyalgia or other general body pain related condition
* Rheumatoid arthritis or other forms of inflammatory joint disease
* Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified
* Diagnosed with or receiving treatment for Osteoporosis
* Other physical disability affecting the hips, spine, or contralateral knee
* Severe instability due to advanced loss of osteochondral structure
* Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO)
* Unwilling or unable to comply with study requirements
* Participation in another clinical study which would confound results
* Allergy to any of the implant materials
Quantitative Analysis of Precise Brain Volume in Amyotrophic Lateral Sclerosis

Using the original MRI images of 16 ALS patients and 16 normal controls matched by gender, age and education level in the previous study, the differences of brain volume in different parts of ALS patients and normal controls, and the correlation between brain structure and clinical characteristics were compared by precise brain volume quantitative analysis technology.

This study was a retrospective study. The subjects were 16 ALS patients and 16 normal controls. Previous studies have collected patients' age, gender and education level; The onset site, onset time, bulbar involvement, diagnostic grade, ALSFRS-R score, application of ventilator, application of lirutai, gastrostomy; Age, gender and education level were collected in the control group. Accurate quantitative analysis of brain volume was performed on the original brain MRI images of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed ALS patients
* healthy volunteers

Exclusion Criteria:

* none
Effect of the Involvement of a Medical Clown on the Labor Experience

The experience of labor for a woman can be rewarding but can be traumatic. Medical clowning may alleviate the potential for trauma.

The investigators plan to administer questionnaires to women who will agree to host a clown during their labor and to compare the feedback to those from women who did not.

Eligibility Criteria:
Inclusion Criteria:

Singleton pregnancy, Older than 18 years, Younger than 40 years, uncomplicated pregnancy

Exclusion Criteria:

Pregnancy complicated by PET, premature contractions Muktiple pregnancy, Older than 40 years, Younger than 18 years
The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.

Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 85 years male or female
* Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
* Acceptable surgical candidate, including use of general anesthesia
* Willing and able to provide written informed consent
* Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

* Cardiac valve surgical procedure via conventional full sternotomy
* Procedures that require a posterolateral thoracotomy
* Current pregnancy
* Current use of prescription opioids
* FEV1 \< 40% predicted
* Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF)
* Documented psychiatric disease
* Documented chronic pain syndrome
* Documented history of substance abuse
* Patient currently enrolled in another research study that could directly affect results of either study
* Physical or mental condition that would interfere with patient's self-assessment of pain
* Disqualifying medical condition per investigator
Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury

This study is being done to determine if an investigational study drug called Omegaven can help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth.

PAtients with direct bilirubin \>2gm/dL and short bowel syndrome are eligible for enrollment. Omegaven at 1gm/kg/day will be administered via central venous line instead of standard lipid preparations.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 2 months -10 years of age
2. Patients who are PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
3. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined by a direct bilirubin of \>2.0mg/dL. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
4. 2 consecutive direct bilirubin test results \>2.0mg/dl
5. The patient must have failed standard therapies to prevent the progression of liver disease such as surgical treatment, cyclic TPN, avoiding overfeeding, reduction/removal of copper and manganese from TPN, advancement of enteral feeding, and use of ursodiol (Actigall)
6. Subjects who are currently under treatment for PNALD with Compassionate Use Omegaven and have a direct Bilirubin of\< 2, but who remain TPN dependent and require continued therapy with Omegaven

Exclusion Criteria:

1. Other known causes of chronic liver disease (hepatitis C, cystic fibrosis, biliary atresia and alpha 1 anti-trypsin deficiency)
2. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
3. The parent, guardian, or child is unwilling to provide consent or assent
4. Allergy to any fish product, egg protein, and/or previous allergy to Omegaven
5. Active coagulopathies characterized by on-going bleeding or by a requirement for clotting factor replacement such as fresh frozen plasma or cryoprecipitate to maintain homeostasis
6. Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
7. Unstable diabetes mellitus
8. Stroke/embolism
9. Collapse and shock
10. Undefined coma status
11. Active infection at time of initiation of Omegaven® up until such time as child is afebrile with stable vital signs and one negative 48 hour culture
Reducing Posttraumatic Stress Disorder (PTSD) Symptoms in First Responders and Frontline Health Care Workers

This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs).

The central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).


Eligibility Criteria:
Inclusion Criteria:

* Are employees at an orginization served by a participating EAP
* Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33
* Have had psychotropic medication stability for at least 4 weeks

Inclusion criteria for the qualitative portion of the study:

- Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder

Exclusion Criteria:

* Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
* High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: found in protocol)
* Need for detoxification
* Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment
* Currently engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).
* Patients who do not speak English will be excluded for logistical reasons.
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach

In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.

Operative treatment of calcaneal features through an extensile lateral approach (ELA) has been the gold standard over many years despite high rates of infection and soft tissue complications.

Lately, there has been a trend towards less invasive fixation methods. Minimally invasive plate osteosynthesis using the sinus tarsi approach (STA) has gained popularity during the last decade.

Furthermore, percutaneous reduction and fixation techniques have been described and used for a few decades. In the early 2000s, Rammelt et al. were the first who introduced a percutaneous technique assisted by hindfoot arthroscopy. The percutaneous and arthroscopically assisted calcaneal osteosynthesis (PACO) is applicable in Sanders II and III fractures and has been shown to provide good clinical outcomes as well as a low rate of complications.

The study is designed as a superiority study. Our hypothesis is that the percutaneous and arthroscopically assisted technique provides superior outcomes compared to the sinus tarsi approach in Sanders II and III calcaneal fractures.

Eligibility Criteria:
Inclusion Criteria:

* Dislocated intraarticular calcaneal fracture, type Sanders II or Sanders III with an intraarticular step \> 2mm
* Patients between 18 and 70 years of age
* Acute presentation at one of our departments, enabling surgery within 10 days after injury

Exclusion Criteria:

* Intraarticular step of \< 2mm
* Sanders IV fractures
* Open fractures
* Bilateral injuries
* Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process
* Multitraumized patients
* Previous injury or surgery of the hindfoot
* Charcot foot
* Serious medical condition that contradicts surgery
* Noncompliant patients
* Insufficient Norwegian or English language skills
* Patients not available for follow-up
* Inability to conduct the rehabilitation protocol