cyrilzakka/clinical-trials huggingface dataset:
COL-1077 (Lidocaine Bioadhesive Gel, 10%) in Women Undergoing Transvaginal Pipelle-Directed Endometrial Biopsy

The purpose of this study is to determine if COL-1077 (10% lidocaine vaginal bioadhesive gel) will be effective as an acute-use anesthetic and can decrease the pain intensity associated with gynecologic procedures using endometrial biopsy as a representative procedure.

COL-1077 is to be self-administered by patients prior to an outpatient transvaginal pipelle-directed endometrial biopsy with tenaculum placement in otherwise healthy women requiring biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Female with an intact uterus, who is ≥ 40 and ≤ 75 years of age
2. For those women who are thought to be postmenopausal, postmenopausal will be defined as at least 6 months of confirmed amenorrhea with follicle stimulating hormone (FSH) levels of ≥ 40.0 mIU/mL
3. Scheduled to undergo a planned pipelle-directed endometrial biopsy with tenaculum placement
4. Able to intravaginally self-administer the study drug using the supplied drug applicator and plunger (eg, have adequate manual dexterity)
5. Willing and able to attend all study visits and complete the pain assessments
6. Willing to abstain from sexual intercourse 24 hours prior to completion of the endometrial biopsy and for 24 hours following the endometrial biopsy
7. Women of childbearing potential must use adequate birth control measures during the course of the study and for at least 7 days after completing study treatment.
8. Read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

1. Pelvic inflammatory disease (PID) within the past 3 months of the Screening Visit (Visit 1) or any ongoing vaginal infection requiring intravaginal treatment
2. Coagulation disorders
3. Experiencing daily baseline pelvic or chronic pain
4. Experiencing menstruation or anticipated menstrual cycle during the study period
5. Currently using an intrauterine device (IUD) or vaginal ring
6. Has active vaginal, vulvar or cervical lesions, or cervical or uterine carcinoma
7. Women who are pregnant or lactating.
8. Known history of hypersensitivity, allergies or intolerance to lidocaine or other amino amide-type local anesthetics
9. Known allergy or intolerance to aspirin or non-steroidal anti-inflammatories
10. Participation in any other investigational drug or device trial within 30 days prior to the Screening Visit (Visit 1)
11. Regular use of any concomitant medications that might confound efficacy and/or safety assessments
12. Chronic pain conditions that require regular (eg, daily) use of analgesic and/or anti-inflammatory medications
13. Use of Class 1 antiarrhythmic or a history of clinically significant cardiac arrhythmia as determined by the investigator
14. History of severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results
15. Evidence of current alcohol or drug abuse.
Study of the Effect of Neck Treatment on Shoulder Impingement

The purpose of this pilot study is to conduct research to determine the most effective physical therapy treatment for a condition called shoulder impingement. This condition occurs when tissue in the shoulder is caught between the humerus (arm bone) and the scapula (shoulder blade). This causes pain when one tries to reach overhead or behind the back.

Two treatment methods will be used in the study. The first method uses the traditional treatments of hands-on shoulder stretching, shoulder exercise, posture, and education. The second method will use the traditional methods of shoulder treatment in addition to treatment of the cervical spine.

It is hypothesized that a group of patients between 40 and 70 years of age with signs and symptoms of shoulder impingement who receive physical therapy to the cervical spine and shoulder will report a higher level of functioning, will report less pain, and will gain more range of motion than a group of patients receiving physical therapy solely to the shoulder.


Eligibility Criteria:
Inclusion Criteria:

1. the complaint of pain in either the anterior, lateral, or posterior aspect of the upper arm in an area extending from the acromion to the deltoid tubercle or to a point equally distal on the humerus.
2. production or increase in pain in any of the area(s) above with one of the following:

   1. active shoulder flexion or scaption (elevation in the scapular plane)
   2. impingement sign as described by Neer (1983)
   3. Hawkins-Kennedy impingement test (1980)
   4. resisted supraspinatus, shoulder internal or external strength testing
3. patient is between 40 and 70 years of age

Exclusion Criteria:

1. Any previous history of surgery or fracture in the cervical spine, upper thoracic spine, humerus, scapula, or clavicle
2. Any previous or current history of psychiatric or psychological treatment
3. Any medical condition that predisposes patients to shoulder pain such as past or current history of diabetes mellitus, fibromyalgia, adhesive capsulitis, rheumatoid arthritis, shoulder osteoarthritis, osteoporosis, ankylosing spondylitis, vertebrobasilar artery insufficiency, pregnancy, or shoulder instability
4. Any prolonged exposure to blood thinners or steroids
5. Constant lateral humeral pain that does not alter with movement, time of day, or position for the last 60 days
6. Subjects with an active worker's compensation claim related to the cervical spine, shoulder, or upper thoracic spine, or subjects with any impending or current litigation related to the same areas
7. A score of 11 or higher in the sensory plus affective dimensions of pain with the short-form of the McGill Pain Questionnaire
8. Any injections in the shoulder, cervical spine or upper thoracic spines in the last 6 months
9. Pain in the posterior shoulder, mid- and lower cervical spine, or upper thoracic spine that the patient wants treated
10. Onset of symptoms associated with trauma or trauma to the neck/shoulder area in the last 60 days
Assessment of the Impact of Whole Body Cryostimulation on Skin Physiological Indicators

The aim of the planned study will be to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of patients with atopic dermatitis (AD). The aim of the study will be also to measure the oiling, hydration and pH of the skin of patients with AD after a series of treatments in a cryogenic chamber.

Each participant will complete a Brief Questionnaire on Quality of Life, Life Satisfaction Index, Self Evaluation Questionnare and DERMATOLOGY LIFE QUALITY INDEX (before and after the WBC procedures).

In this research project will be performed 15 treatments in cryogenic chamber (1 once a day, every day, with a break on Saturdays and Sundays). Cryostimulation will be conducted in a cryochamber located in the Małopolska Cryotherapy Centre in Kraków, Poland (Polish: Małopolskie Centrum Krioterapii). The whole body cryostimulation (WBC) exposure will be administered in a special temperature-controlled unit which consists of two rooms (-60° and -120°C). Persons with any contraindications (both with AD and healthy) for whole body cryostimulation will be excluded from the study. Patients with AD in treatment by phototherapy, cyclosporin A, oral corticosteroids, which are topical calcineurin inhibitors such as pimecrolimus and tacrolimus and patients during or after immunotherapy, children and adolescents under 18 years of age, breast-feeding mothers and pregnant, patients with inflammatory diseases, infectious, autoimmune and cancer will be excluded from research.

The participants will be informed about how they should breathe and move in the cryochamber. Entry to the cryochamber will be preceded by a 30s acclimatization period in the vestibule at a temperature of -60° C, after which the subjects will go directly to the proper chamber (-120° C) for three minutes. During the procedure, all participants will be clothed in shorts, wool socks, gloves and hats or headbands for protection from frostbite, as well as wooden clogs. Additionally, participants will wear surgical masks with a layer of gauze over the mouth and nose for protection. Throughout the session, the participants will be under direct supervision of qualified doctor.

Eligibility Criteria:
Inclusion Criteria:

* informed consent for research;
* equal age and above 18 years of age;
* no contraindications to cryostimulation procedures;
* clinically diagnosed atopic dermatitis (people with AD);

Exclusion Criteria:

* lack of informed consent for research
* patients with AD in treatment by phototherapy, cyclosporin A, oral corticosteroids, which are topical calcineurin inhibitors such as pimecrolimus and tacrolimus and patients during or after immunotherapy,
* children and adolescents under 18 years of age,
* breast-feeding mothers and pregnant,
* patients with inflammatory diseases, infectious, autoimmune and cancer
Movement Dynamics of Knee Osteoarthritis and Total Knee Replacement

This research aims to explore differences in walking and functional movement mechanics, exercise response, and physical activity between people with osteoarthritis (OA), those who have undergone total joint replacement, and healthy individuals.

People living with OA tend to be less physically active than those without the disease, which is often due to pain, stiffness and joint instability. This reduction in physical activity can lead to additional health problems down the line. When the disease becomes severe, joint replacement surgeries are sometimes performed to relieve pain and improve individuals' quality of life. However, despite reducing pain, there is little evidence to show that joint replacement surgeries encourage individuals to return to healthy physical activity levels.

Reasons for the lack of change may include a failure to address unhealthy walking and movement patterns which could still be causing pain and instability and reduced physical fitness levels.

By investigating these reasons, we hope that findings from this study will help to inform future interventions that improve clinical outcomes and quality of life for individuals with OA and post-joint replacement.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed symptomatic bilateral or unilateral knee osteoarthritis, self-reported ability to walk without an aid for 10 minutes and to ascend and descend stairs, no neurological conditions or other musculoskeletal pathology/injury which would impact walking gait.

Exclusion Criteria:

* Unable to walk at 0.8 m/s, exclusion based on IMO screening, non-English speaking, lacking ability to consent.
Pharmacist - Physician Collaborative Approach to the Management of Metabolic Syndrome

This study devised an experimental focused pharmaceutical care program, allowed a clinical pharmacist to work in a physician office to assess and manage patients' metabolic syndrome status and its individual components. This study described the clinical benefits of physician- clinical pharmacist interaction in achieving improved glycemic control, lipid and blood pressure measurements, involving medication, diet, physical activity and patient heath care counseling.

A single blinded prospective randomized controlled trial conducted in family medicine outpatients clinics in Jordan. The study enrolled 199 patients met the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATPIII) criteria for the diagnosis of MS upon the time of enrollment. Patients were randomized into: 110 participants into the intervention arm (pharmacist-physician collaborative approach) and 89 into the control arm (physician only team). Only patients in the intervention arm were provided pharmacist recommendations and pharmaceutical care counseling.

Eligibility Criteria:
Inclusion Criteria:

* Meeting at least 3 of the 5 criteria for the National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATPIII) for the diagnosis of Metabolic syndrome upon the time of enrollment. :

  1. Abdominal circumference \>102 cm in males or \>88 cm in females.
  2. HDL cholesterol \< 40 mg/dl for males or \< 50 mg/dl for females.
  3. Triglycerides ≥ 150 mg/dl.
  4. Blood pressure ≥ 130/85 mmHg or receiving hypertension treatment.
  5. Baseline glycemia ≥ 110 mg/dl.

Exclusion Criteria:

1. Patients with hypertensive urgency or emergency with BP more than (180/110).
2. Patients with recent stroke or myocardial infraction (within past 6 months).
3. Patients with Class III or IV Chronic heart Failure (CHF).
4. Patients with Unstable angina.
5. Patients with Serious renal or hepatic disease.
6. Pregnant patients.
7. Patients with Dementia or cognitive impairment.
8. If the patient is unable to provide informed written consent.
The Influencing Factors and Prediction Model of Poor Prognosis of Spontaneous Intraparenchymal Hemorrhage

This study was designed to explore the influencing factors of spontaneous intraparenchymal hemorrhage's prognosis and develop predictive models for poor prognosis by establishing a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzing the correlation between collected variables and patients' outcomes.

Spontaneous intracranial hemorrhage is an important type of cerebrovascular disease. The disease has an acute onset, a serious condition, and a high mortality rate. Besides, the survivors always live with severe neurological dysfunction. It is essential to determine the influencing factors of poor prognosis, estimate patient's condition and predict the prognosis timely.

This study consists of two parts. The first part establishes a cohort of spontaneous intraparenchymal hemorrhage (including both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage), and analyzes the influence of different factors, such as surgical methods, on the prognosis. In the second part, a nested case-control study nested in this cohort will be established to analyse the influence of some other factors. The biological specimens are tested. The collected data were analysed to find out the risk factors of poor prognosis and establish a predictive model.

Recruitment and follow-up of the participants is expected to continue after the initial goal is achieved. As a large sample database of intracranial hemorrhage, this cohort will provide more research data for the future exploration of more clinical problems.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80；
2. Diagnosed with spontaneous intraparenchymal hemorrhage (both of the supratentorial intracerebral hemorrhage and cerebellar hemorrhage) by Computed Tomography;
3. Admitted within 24h of ictus；
4. Did not undertake treatment before enrollment;
5. Informed consent to participate in the study.

Exclusion Criteria:

1. The hemorrhage caused by tumor, arteriovenous malformation, aneurysm or coagulopathy；
2. Concurrent traumatic brain injury；
3. Multiple intracerebral hemorrhage；
4. Undertake any surgery after onset in other hospital；
5. Refuse the treatment after admission;
6. History of craniocerebral surgery；
7. Known advanced demential or disability before onset；
8. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
9. Confirmed malignant disease or life expectancy less than 6 months due to comorbid diseases;
10. Concurrent serious infectious disease (HIV, tuberculosis etc.)
11. Concurrent coagulation disorders or having taken anti-platelet or anticoagulant drugs;
12. With indications of terminal brain hernia
13. Pregnant or lactating females；
14. Participation in another simultaneous trial of intracerebral hemorrhage treatment；
15. Patients/relatives refuse to be followed up。
Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters

The purpose of this study is to evaluate the effects of intragastric balloon on bone, metabolic and respiratory parameters in 50 patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome (IDF criteria)

Exclusion Criteria:

* menopause
* older than 50 years
* diabetes mellitus
Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa

This study evaluate role of tranexamic acid in reducing blood loss among pregnant women undergoing cesarean section because of placenta previa .Half of participants will receive tranexamia acid drug While the other half will receive placebo.

Tranexamic Acid used in the field of obstetrics to decrease blood loss during and after cesarean section .

Tranexamic Acid is an antifibrinolytic agent which cause reversible and competitive blockade of the lysine binding sites in plasminogen molecules . It is a synthetic analog of amino acid lysine and its action is to reduce blood loss

Eligibility Criteria:
Inclusion Criteria:

* age 18 -38 Body mass index \<30 , Diagnosis of placenta previa

Exclusion Criteria:

* patient with bleeding disorder , hepatic and renal disease. contraindication to tranexamic acid as allergy , hypersensitivity to tranexamic acid and known thromboembolic event during pregnancy .

other causes ofantepartum haemorrhage eg :accidental haemorrhage, rupture uterus.

type 1,2 of placenta previa anterior type 3,4 of placenta previa posterior causes of overdistended uterus like :multiple pregnancy, polyhydraminos
Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)

Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo).


Eligibility Criteria:
Inclusion Criteria for all:

* Visual acuity normal or corrected to normal
* Affiliation to a social security scheme (copy of the vital card in support)
* Signed informed consent
* Medical examination according to the participation in the MRI examination
* MMSE score\> 23/30

For Parkinson patient:

* Diagnosis of Parkinson's disease
* Presence of asymmetric bradykinesia and rest tremor and / or stiffness
* Hoehn \& Yahr Stadium I-II / V

Exclusion Criteria for all:

* Unprotected Majors unable to express their consent
* Protected Major (Persons mentioned in Articles L1121-5,6 and 8 of the public health code)
* Significant hearing or motor impairment
* Past or present neuropsychiatric pathology (except benign epilepsy)
* Taking narcotics and / or drugs for neurocognitive purposes
* Existence of a severe condition in general (cardiac, respiratory, hematological, renal, hepatic, cancerous)
* Any other neurodegenerative pathology or treatment that may affect the oculomotor control

For Parkinson patient:

* Treatment for Parkinson's disease (except the inhibitors of monoaminoxidase B or MAO-B, such as selegiline and rasagiline).
Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects

The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class.

In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.


Eligibility Criteria:
Inclusion Criteria:

* Patient with confirmed HIV infection
* Age ≥ 18 years
* Written informed consent
* Male patient or non-pregnant, non-lactating female
* No previous treatment with any antiretroviral drugs
* HIV-1 RNA \> 1000 copies/ml
* Indication to start an antiretroviral treatment as long as subject has also a CD4 cell count ≤ 500/mm3 either at screening or on a sample taken within 3 months before screening
* No major IAS-USA mutations on genotypic testing at the screening visit or on any historical genotype, if available

Non-inclusion Criteria:

* Woman without effective contraception method (recommended contraception during the trial is mechanical + a second method other than an oral contraceptive)
* Pregnant or breastfeeding woman
* Woman expecting to conceive during the study
* HIV-2 co-infection
* Creatinine clearance \< 60 ml/mn (Cockcroft \& Gault equation), alkaline phosphatase, ASAT, or ALAT ≥ 5 ULN
* Patient with significant impairment of hepatic function, defined as serum albumin \< 2.8 g/dl or INR \> 1.7 or presence of ascites, in the absence of another explanation for the abnormal finding
* CD4 \> 500/mm3 at screening, except in case of symptomatic HIV disease (defined by conditions qualifying for CDC category B or C) or CD4 ≤ 500/mm3 on a sample taken within 3 months before screening.
* Any major IAS-USA mutation conferring resistance to one or more of reverse transcriptase or protease inhibitors on genotypic testing at screening
* Mycobacteriosis under treatment
* Malignancy requiring chemotherapy or radiotherapy
* Positive HBs Ag
* HCV infection for which specific treatment is ongoing or planned during the first year on trial treatment
* Known hypersensitivity to one of the trial drugs or its excipients
* Contraindicated concomitant treatment
* Anticipated non-compliance with the protocol
* Participation in another clinical trial with an on-going exclusion period at screening
* Subject under legal guardianship or incapacitation
* Subject, who in the opinion of the investigator, is unable to complete the study period
Formation of Health Professionals Through in Situ Simulation to Improve Performances During the Initial Step of Thrombectomy for Ischemic Strokes

The thrombectomy is an emergency care provided as soon as possible to selected patients suffering from ischemic strokes. Many steps are necessary to prepare this specialized procedure of interventional neuroradiology, including installation and preparation of the patient for this act. This first and essential time required the intervention of many health professionals.

The approach consists of a series of formation through in situ simulations for these health professionals, in order to improve and optimize this first step of the procedure (from the installation of the patient to the percutaneous punch by the neuroradiologist).


Eligibility Criteria:
Inclusion Criteria:

* voluntary professionals