cyrilzakka/clinical-trials huggingface dataset:
The Correlation Between Cotinine and Postoperative Acute and Chronic Pain After Hysterectomy

It is known that there is an association between smoking and acute/chronic pain. But it is so difficult to assess this relation with asking questions to the patients in the preoperative period. Because of that we want to measure the levels of the cotinine in the urine and later assess the correlation with acute and chronic pain in hysterectomy patients.

It is well-known that smoking is very common in the public. The chronic pain after hysterectomy is 20-40%. The open abdominal hysterectomy ratio is 75% of all hysterectomy operations in our country. We know that the reasons of postoperative acute and chronic pain is multifactorial. One of them is smoking which affects the postoperative pain. The best way of measuring the level of cotinine is assesing the urine of the patient. We collect the first urine after induction.

In this study, we aimed to investigate the correlation between the levels of urine cotinine and the acute and chronic postoperative pain in hysterectomy patents.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Open abdominal hysterectomy patients

Exclusion Criteria:

* Chronic pain
* Chronic pain killer users
* Axis I psychiatric disease
* Liver disease
* Renal disease
* Drug allergy
Dose Finding Study of STR-324

This study aims to evaluate the analgesic effect and the safety of 4 doses of STR-324 administered as an infusion, with or without initial bolus, to patients suffering from post-operative pain.

The sensitivity of the pain model used in the trial will be evaluated with a standard group treated with morphine under the usual care conditions.

The first step (single-blind standard group) aims to verify the sensitivity of the study pain model in the proposed surgery to confirm the validity of the surgery according to their pain and enrolment rate. 12 patients are planned to be enrolled.

The second step (dose-finding study) is a randomized, double-blind, parallel groups, controlled clinical trial involving a total of 106 patients divided into two groups in which patients will be randomized between STR-324 and morphine HCl:

* Group 1: Titration initiated with a bolus
* Group 2: Titration without initial bolus.

Eligibility Criteria:
Selection criteria:

1. Patient aged ≥18 to \<65 years old, at screening;
2. Having signed an informed consent prior to any study-related procedure;
3. Patients planned to undergo a major laparoscopic abdominal or pelvic surgery;
4. Surgery to be performed without local or regional anaesthesia nor infiltration;
5. Body mass index (BMI) between 18 and 30 kg/m² inclusive at screening, and with a minimum weight of 50 kg;
6. Women of childbearing potential must agree to use at least one effective contraceptive method upon enrolment and for 1 cycle following the last dose of the investigational product.

Inclusion Criteria:

The criteria for definitive enrolment must be checked in the Post-Anaesthesia Care Unit (PACU) at the inclusion visit:

1. NRS-measured pain intensity ranging from 4 to 8 inclusive at baseline PACU measurement;
2. With a sedation score ≤ S1 (awake or intermittently sleepy) at the time of pain assessment.

Exclusion Criteria:

1. Patient contra-indicated for morphine administration;
2. Unstable or poorly controlled psychiatric condition (e.g., untreated PTSD, major anxiety, or depression). Subjects who take stable doses (same dose \>30 days) of antidepressants and/or anti-anxiety drugs may be included;
3. Women who are pregnant or breastfeeding;
4. History of alcohol, opiate or other drug abuse.
5. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment might interfere with the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator. Minor deviations of values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance;
6. Clinically significant abnormalities, as judged by the investigator, in laboratory test results;
7. Participation in an investigational drug or device study within 1 month prior to dosing.
Assessment of the Health Literacy Among Arab Women in East Jerusalem

This is a two-stage study: The objective of the first stage is to explore health literacy (HL) needs and preferences of Arab women through conducting Focus Group Discussions (FGDs).

The second stage will employ conducting a HL intervention tailored to the participants' needs and preferences as presented in the FGDs. Objectives include increasing the percentage of women who utilize patient-doctor communication skills and increasing their cardiovascular disease (CVD) knowledge.The intervention consists of four sessions that will be conducted in municipality-sponsored women's groups in Jerusalem and other Arab communities. Questionnaires will be completed before and three months after the intervention. The study answers the following: Can HL workshops improve patient-doctor communication skills and CVD knowledge in Arab women.

Arab women in Israel are at high risk of low health literacy due to lower levels of education and low socio-economic status. Health literacy (HL) refers to the skills and competencies enabling people to obtain and interpret health information and apply their knowledge to inform health-related decision-making. It's also defined as "the degree to which individuals have the capacity to obtain, understand, and process basic health information and services needed to make appropriate health decisions".

The objective of the first stage of the study is to explore health literacy needs and preferences of Arab women through conducting Focus Group Discussions (FGDs) with women in East Jerusalem. Six different focus groups will be conducted at three of the six municipality community centers in East Jerusalem. Participants will be recruited through identified community centers.

Each group will meet once for up to two hours. The study will be explained to them by an investigator who has been trained in the administration of focus groups, and they will be asked to sign a consent form. Discussions will be recorded without the names of the participants (they will be instructed not to use their names once the recording begins). At the end of the meeting, each participant will receive a bag and pamphlets with information regarding women's health.

The second stage will employ conducting a HL intervention tailored to the participants' needs and preferences as presented in the FGDs. Objectives include increasing the percentage of women who utilize patient-doctor communication skills and increasing their cardiovascular disease (CVD) knowledge.The intervention consists of four sessions that will be conducted in municipality-sponsored women's groups in Jerusalem and other Arab communities. Questionnaires will be completed before and three months after the intervention. The study answers the following: Can HL workshops improve patient-doctor communication skills and CVD knowledge in Arab women.

Eligibility Criteria:
Inclusion Criteria:

* All women aged 18-85 that attend and participate in the community's women's groups
* They must speak Arabic

Exclusion Criteria:

* Not in the age range of 18-85.
* Do not speak Arabic.
Exercise Therapy for Patients with Muscle Dystrophies

Muscular Dystrophies (MD) are a heterogeneous group of diseases characterised by muscle wasting that lead to progressive loss of function. Although exercise training has been traditionally neglected to these patients due to concerns regarding muscle damage, research has shown that exercise therapy is safe and tolerable in this population and can lead to potential gains in endurance and muscle strength, as well as other patient-reported outcomes such as health-related quality of life.Therefore, in this study, the investigators aim to examine the feasibility, tolerability and safety as well as the effects of a 12-week, exercise-training program in patients with MD on functional capacity, muscle strength, and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Clinical or Genetically diagnosis of Muscular Dystrophy including Limb-Girdle type I and type II, Myotonic Dystrophy type I and type II and facioscapulohumeral dystrophy.
* Age \> 18 years old
* Ability to walk independently for 10 or more metres

Exclusion Criteria:

* Inability to understand or read Spanish/Catalan.
* Patients engaging in a similar exercise-based program in the past 12 months
* Patients with severe cognitive, neurological or musculoskeletal impairment unable to participate in the exercise program
* Unstable respiratory, cardiovascular or metabolic disease
Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment

Neovascular age-related macular degeneration (nAMD) is characterized by the abnormal growth of blood vessels from the choroid into the subretinal space which leads to sub- and intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of central vision. Intravitreal anti-VEGF treatment is the standard of care. Intravitreal anti-VEGF application might temporarily increase intraocular pressure due to a volume effect. It remains unclear if repeated injections might have an impact on retinal capillary perfusion. Therefore this study aims to investigate the vascular microcirculation differences between patients who received longterm intravitreal Anti-VEGF treatment and patients who recently started Anti-VEGF treatment using Optical Coherence tomography Angiography (OCTA).

Main outcome parameters are:

* Vessel Perfusion Area (%) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement)
* Blood flux index(\*) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement).
* Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement)
* Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg)

(\*)Blood flux index is automatically calculated by ARI Network as the mean flow intensity in the vessel area, where the blood flow signal was normalized to 0 to 1 by dividing by the full dynamic range of blood flow signal intensity.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for participation, patients will be required to

* have been treated for sub- or juxtafoveal CNV due to nAMD with anti-VEGF intravitreal injections either for at least 20 times (longterm treatment eyes) or \<5 times (shortterm treatment eyes).
* give written consent to participation

Exclusion Criteria:

* diagnosis of glaucoma/ocular hypertension at baseline of anti-VEGF treatment

  * history of retinal vascular disorders like diabetic retinopathy, retinal vein/arterial occlusive disease, uveitis etc.
  * history of papillary disease which might interfere with interpretation of peripapillary OCT/OCTA evaluation such as severe tilted disc, parapapillar CNV, papillar drusen, optic nerve neuritis, papillar edema etc.
  * inability to perform OCTA examination of sufficient quality.
  * history of any side effects of Tropicamide eye drops
A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function

The purpose of this study is to assess how fast BGM0504 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* √ Age 18-65 years on the date of signing informed consent (inclusive);

  * Body mass index (BMI) within the range of 19.0-30.0 kg/m2 (inclusive);.
  * Stable renal function, assessed by two eGFR during screening (apart at least 3 days);
  * Diagnosed as stable, chronic renal disease for at least 3 months.
  * Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):

    1. Normal renal function: 90-129 mL/min (inclusive);
    2. Mild impairment: 60-89 mL/min (inclusive);
    3. Moderate impairment: 30-59 mL/min (inclusive);
    4. Severe impairment: 15-29 mL/min (inclusive);

Exclusion Criteria:

* ● Allergic constitution includes severe drug allergy or history of drug allergy;

  * 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;
  * Participants in clinical trials of any drug or medical device in the 3 months prior to screening;.
  * Suspected or confirmed history of alcohol or drug abuse;
  * Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
  * Donation or loss of 200 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 1 months after the end of the trial;
  * Pregnant or Breast-feeding women;
  * The investigator considers that the participant has any other factors that would make it inappropriate to participate in this study.
Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients With Knee Osteoarthritis

In this study, the investigators aimed to determine whether platelet rich plasma (PRP) and mesotherapy combined treatment is effective on pain and function compared to PRP alone in patients with knee osteoarthritis (OA).

42 patients diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR) (15) who applied to Physical Medicine and Rehabilitation outpatient clinic will be recruited. Patients' age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain will be questioned.

After the participants are informed about the study, their consent will be obtained.

Patients will be randomized using a random numbers table. The first group will receive intra-articular PRP therapy. The second group will receive mesotherapy treatment in addition to PRP treatment.

Group 1: Intra-articular PRP:

For PRP treatment, 8 mL of peripheral blood will be taken from the patient and centrifuged at 4000 rpm for 8 minutes. Then, 3-4 mL of PRP will be taken and used for intra-articular injection (16). Patients will receive a single session of PRP treatment.

Group 2: Intra-articular PRP + periarticular mesotherapy In addition to single session PRP treatment, patients will receive 3 weeks of mesotherapy treatment once a week (the first session will be with PRP treatment).

Sterile and disposable needle tip (0.26mm × 4mm and 0.3mm × 13 mm, Terumo) will be used in mesotherapy. Patients will be administered 1.5 ml of 2% lidocaine, 1.5 ml of 30 mg of pentoxifylline.

Among the injection techniques, profundal intradermic injection (IDP, injection depth: 2-4 mm) and superficial intradermic injection (IDS, injection depth: 1-2 mm) will be used (14).

All patients will be evaluated with the following evaluation parameters before the treatment, at the 1st month and at the 3rd month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-80 years
* To be diagnosed with knee OA according to the diagnosis of ACR
* Ability to give informed consent

Exclusion Criteria:

* History or symptoms of lower extremity surgery, ligament injury, balance disorder or lower extremity injury in the last 6 months
* Allergic to lidocaine, other local anesthetics and pentoxifylline
* Intra and periarticular injection in the last 3 months
* Use of NSAIDs for pain relief in the past 7 days
* Presence of local or systemic infection
* cancer history
* Heart failure, cardiac arrhythmia
* Bleeding diathesis, antiaggregant, anticoagulant use
* Cerebral hemorrhage
* Pregnancy or breastfeeding
* Presence of psychiatric or neurological disease affecting cooperation, cognitive and neurological functions
* Inability to complete the survey
The Efficacy of a Toothpaste to Reduce Sensitivity

Hypersensitivity


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, ages: 12 years or older.
* Availability for the eight-week duration of the study.
* Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
* Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force.
* Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
* Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study.
* Good general health with no known allergies to products being tested.
* Use of a non-desensitizing dentifrice for one month prior to entry into the study.
* Signed Informed Consent Form.

Exclusion Criteria:

* Gross oral pathology, chronic disease, or history of allergy to test products.
* Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
* Sensitive teeth with a mobility greater than one.
* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
* Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics.
* Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month.
* Current participation in any other clinical study.
* Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients.
* Medical condition which prohibits not eating/drinking for 4 hours.
Non-Interventional Study on Effectiveness of Elxaban Tab. in Patients With Non-valvular Atrial Fibrillation

This study is prospective Cohort study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients with atrial fibrillation taking Elxaban (generic drug of apixaban) who visit hospital. The purpose is to analyze bleeding (major bleeding, minor bleeding), stroke, systemic embolism, death, other clinical events (acute myocardial infarction, pulmonary embolism, transient ischemic attack, hospitalization), drug adherence, questionnaire of life quality (AFEQT), cognitive function (KDSQ) according to the use of Elxaban.


Eligibility Criteria:
Inclusion Criteria:

1. patients with atrial fibrillation taking Elxaban (patients with age more than 19)
2. Patients who agree with study inclusion

Exclusion Criteria:

1. patients who do not agree with study inclusion
2. patients with age less than 19
3. Pregnancy, Breastfeeding
Efficacy of Collagen Sponge on Palatal Wound Healing

The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting.

The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting. The included patients will be randomized into two groups. The patients in control group will be treated with gelatin sponge and those in the test group will be treated with collagen sponge. The postoperative pain will be assessed by VAS scale at day 1, 3 and 7 after surgery. Epithelialization of the palatal wound will be evaluated by hydrogen peroxide test and digital photography at 1 week postoperatively. Additionally, postoperative pain, consumption of analgesics, willingness to repeat the treatment and the existence of delayed bleeding will be recorded at 1 week. At 2 weeks, 3 weeks and 1 month after surgery, epithelialization of the palatal wound and aesthetic scores will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Clinical indications utilizing free gingival grafts or de-epithelialized gingival grafts to treat either insufficient keratinized tissue or gingival recession defects
3. Full-mouth plaque score and full-mouth bleeding score lower than 20%

Exclusion Criteria:

1. Smoking
2. Pregnancy or lactation
3. Untreated periodontal disease
4. Severe systemic conditions that contraindicate surgery (diabetes, heart disease, cancer etc.)
5. Presence of coagulation disorders (history of Haemophilia, von Wille-brand disease, or anticoagulant therapy)
6. Taking medications affecting periodontal health or healing
7. Previous surgery for a palate graft harvested from the experimental sites
European Study of POBA Versus Cotavance(R) Paclitaxel Coated Balloon for the Treatment of Infrapopliteal Lesions in Critical Limb Ischemia (EURO CANAL)

To evaluate the procedural safety and to identify and characterize therapeutic and functional endpoint assessments in subjects with documented critical limb ischemia who received treatment with the Cotavance Paclitaxel-Coated Balloon vs. those who received POBA only.


Eligibility Criteria:
Inclusion Criteria:

- Subjects with CLI

Exclusion Criteria:

* Participation in another research trial
* Medical conditions the study doctor will assess
Effects of 3% Sodium Chloride on Post-operative Dysphagia Following Anterior Cervical Spine Surgery

Post-operative dysphagia is a significant issue following anterior cervical spine surgery. The investigators are studying the effects of perioperative 3% sodium chloride, given over a period of 24 hours, on post-operative dysphagia. The goal is to reduce the incidence and severity of post-operative dysphagia.

Based on a priori analysis the investigators will need 100 subjects in a placebo arm (normal saline) and 100 subjects in a treatment arm (3% sodium chloride), for a total of 200 patients. This study will be conducted on healthy subjects with normal renal function undergoing anterior cervical discectomy and fusion for degenerative indications only. Subjects will be randomized to the treatment or placebo arm (which will be double blinded). Subjects in the treatment arm will begin to receive intravenous 3% sodium chloride before the incision is made. The solution will be given at a rate of 10 cc/hour over a period of 24 hours. Baseline, post-operative, and delayed post-operative dysphagia surveys will be administered either in person or by telephone. The investigators hope to decrease the incidence and severity of post-operative dysphagia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing anterior cervical discectomy and fusion for degenerative indications

Exclusion Criteria:

* history of cervical trauma
* baseline dysphagia
* age less than 18 years old
* history of previous anterior neck surgery
* Creatinine clearance less than 30
* Creatinine greater than 1.0
* baseline sodium greater than 145
* patients with known electrolyte abnormalities
* congestive heart failure