cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Creatine Phosphokinase and Pelvic Floor Muscle Strength in Postnatal Women

The purpose of this study is to determine the correlation between creatine phosphokinase and pelvic floor muscle strength in post-partum women.

Pelvic floor disorders (PFDs) are complex conditions affecting women's quality of life, including issues like pelvic organ prolapse, urinary incontinence, and pelvic pain. These disorders are prevalent, with 2.6-28.7% of women experiencing urinary incontinence and 20-50% suffering from pelvic organ prolapse. Accurate diagnosis requires a comprehensive understanding of pelvic musculoskeletal components and the interaction of multiple body systems.

Creatine phosphokinase (CPK) activity can be elevated in various conditions, including muscle diseases, burns, and after strenuous exercise. During childbirth, increased serum CPK levels have been observed, attributed to enzyme release from the uterus and placenta. CPK levels typically return to normal within six weeks postpartum.

To date, no study has explored the correlation between CPK levels and pelvic floor muscle strength in postnatal women. This research aims to fill this knowledge gap, potentially benefiting medical services and expanding understanding in women's health physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Post-partum women who delivered vaginally.
* Their ages will range from 25 to 35 years old.
* Their body mass index (BMI) will be \<30 Kg/m2.
* CPK will be measured within the first six weeks (2nd-5th weeks) after delivery for all women.

Exclusion Criteria:

* Any dysfunction or associated injury or any pathological conditions which may affect the result of the study as cardiac abnormalities, thyroid dysfunction recurrent urinary tract infections, uncontrolled hypertension or diabetes mellitus.
* History of pelvic inflammatory disease, myoma and tumors, pelvic infection, ovarian cyst, any gynecological disease, any hormonal abnormality and any psychological problem.
* Pelvic floor dysfunction: genital prolapse, incontinence.
* Previous surgical operations as hysterectomy.
* Inability to understand the written and verbal instructions.
Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves

this study aims to comprehensively evaluate the efficacy and safety profiles of rivaroxaban and warfarin during the initial postoperative period following surgical bioprosthetic valve in patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 80 years
* Patients who underwent successful surgical bioprosthetic valve replacement or repair to either the mitral, aortic position or both
* Signed informed consent

Exclusion Criteria:

* Aged below 18 or over 80 years
* Mechanical heart valves (MHV)
* Bioprosthetic valve transcatheter valve replacement (TAVR)
* Hemorrhage risk-related criteria

  1. Active internal bleeding
  2. Major surgical procedure or trauma within 30 days before the randomization visit
  3. History of intracranial, intraocular, spinal, gastrointestinal, or atraumatic intra-articular bleeding
  4. Chronic hemorrhagic disorder
  5. Planned invasive procedure with potential for uncontrolled bleeding, including major surgery
* Concomitant conditions and therapies

  1. Clinically overt stroke within the past 3 months
  2. Major surgery within 1 month
  3. Acute coronary syndrome within 1 month
  4. Active infective endocarditis
  5. Severe hepatic impairment、hepatic disease associated with coagulopathy or Moderate and severe hepatic impairment (Child-Pugh Class B or C)
  6. Uncontrolled severe hypertension
  7. Active malignancy
* Medication-related

  1. Hypersensitivity or contraindications to Rivaroxaban, VKA, heparin.
  2. Concomitant treatment with strong inhibitors of both CYP3A4 and P-gp (e.g., azole antifungals, such as ketoconazole and itraconazole, or HIV protease inhibitors, such as ritonavir)
  3. Concomitant treatment with strong inducers of CYP3A4 (e.g., carbamazepine, phenytoin, rifampin, etc.)
* HAS-BLED score\>3
* Others

  1. Abnormal local laboratory results, such as Platelet count \< 50 x109/L、Hemoglobin \< 8 g/dL (5 mmol/L)
  2. Female subjects of childbearing potential without using adequate contraception、
  3. Female pregnant or breast-feeding
  4. Participation is not likely to comply with the study procedures or will complete follow-up
  5. Participation in another clinical trial that potentially interferes with the current study
  6. Life expectancy less than 6 months beyond the targeted last visit
Acute Consumption of Pecan-enriched Meal

Pecans are a nutrient-dense food, but it is unknown whether substituting pecans for a portion of the butter in a traditional breakfast meal improves post-meal responses.

This study was a randomized, double-blind control trial consisting of 2 study visits for 2 different treatments. The treatments were high-fat breakfast muffins containing either butter (control) or pecans. The investigators recruited healthy, normal-weight adults between the ages of 15 and 45y. Study visits were completed in a random order with at least 72 hours between each visit. Anthropometrics, questionnaires, and fasting and postprandial blood samples were collected at each visit.

Hypothesis: The pecan-enriched meal will blunt the post-meal increase in glucose, insulin, triglycerides (TG), and lipid peroxidation while improving all measures of subjective appetite and TAC compared to the traditional meal without nuts.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women
* Normal-weight (body mass index = 18-24.9kg/m2)

Exclusion Criteria:

* Allergies to test meal ingredients (gluten, eggs, or nuts)
* Medication/supplement usage
* Chronic disease
* Pregnancy or plans to become pregnant
* Special diets
* Tobacco use
Post-authorization Safety Study of Iptacopan in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Using Data From the IPIG PNH Registry

This is an observational single-arm descriptive cohort study based on the secondary use of data collected on iptacopan-treated patients with paroxysmal nocturnal hemoglobinuria (PNH) through the International PNH Interest Group (IPIG) PNH registry.

This multinational, non-interventional, descriptive single-arm cohort study is based on secondary analysis of data collected within the iptacopan silo of the IPIG PNH Registry (data on iptacopan-treated patients made available to Novartis). This is a non-interventional study utilizing secondary data and is considered a "registry-based study." The IPIG PNH Registry (CT.gov NCT06524726), the parent registry, includes a dedicated drug silo to collect data from patients using iptacopan in routine care.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent to participate in the IPIG PNH Registry
* PNH confirmed by flow cytometry
* Incident users of iptacopan
* Aged at least 18 years at the iptacopan initiation

Exclusion Criteria:

* Participation in an interventional clinical trial
A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate

The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of accelerated phase or blast phase CML or Ph+ ALL
* Intolerant or resistant to imatinib mesylate
* 18 years of age or older
* ECOG performance 0-2 (greater than 50% of time out of bed)
* Adequate liver and kidney function

Exclusion Criteria:

* Pregnant or breastfeeding females
* History of significant cardiac disease
* History of significant bleeding disorder (not CML)
* Prisoners
Oral Anticoagulation in Hemodialysis

The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.

After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.

The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.

After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered.

Eligibility Criteria:
Inclusion Criteria:

* inclusion in the trial with clinicaltrials.gov identifier NCT02610933
* signed informed consent for this extension trial

Exclusion Criteria:

* none
Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency

It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR by MDRD as follows: \< 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based calculation.

This study will enroll 180 hospitalized patients with Type 2 diabetes and moderate to end stage renal insufficiency (estimated glomerular filtration rate is \< 30 ml/min/1.73m2 or dialysis) in the Chicagoland area. Participants will be randomized into 1 of 2 protocols after hospital admission. Blood glucose levels will be obtained before meals, at bedtime and whenever necessary for any signs or symptoms of hypoglycemia. The primary endpoint will be the percentage of blood glucose levels reaching goal of 80-180mg/dl. A secondary endpoint will be the percentage of hypoglycemic events, defined as blood glucose values \< 60 mg/dl. In addition the percentage of glucose levels within the goal range of 80-180mg.dl will be further separated into excellent control (80-140mg/dl) and acceptable control (141-180mg/dl).

The 2 study groups will be:

1. Glargine \& glulisine. The total daily insulin dose will be 0.6 units/kg. Half of this will be given as glargine once daily. The other half will be given as glulisine, divided equally between breakfast, lunch, and dinner with correction factor dosing as needed for elevated premeal hyperglycemia.
2. Glargine \& glulisine The calculation for the total daily insulin dose will be 0.3 units/kg. Half of this will be given as glargine in the morning. The other half will be given as glulisine, divided equally between breakfast, lunch, and dinner, with correction factor dosing as needed for elevated premeal hyperglycemia.

All oral agents will be discontinued on admission.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus of mor than 1year
* GFR less than 30 ml/min/1.73m2 or dialysis
* Age greater than 18years
* Entry blood glucose (fasting or random) greater than 180mg%

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* New onset hyperglycemia
* Pregnant
* Solid organ transplant within 1 year
* Steroids prednisone greater than 7.5mg/day or equivalent
* Hospital LOS predicted less than 2 days
* Severe liver disease
* Known hypopituitarism or adrenal insufficiency
* Patients in the ICU
* Patients with hypoglycemic unawareness
* Outpatient insulin dose less than 0.6 units/kg
Observational Study of Thrombogenic Properties in 220 Patients With Proximal Femur Fracture

Measurement of thrombogenic properties by TEG and MEA and observation of thrombotic events over 2 years in 220 patients with hip fracture.

Patients with proximal femur fracture have high incidences of thrombotic events. By the two "bed-side" methods TEG (Thrombelastography) and MEA (Multiple Electrode Aggregometry), the thrombogenic properties of 220 patients with proximal femur fracture will be measured at time of hospital admission and 4 times over a period of 6 months postoperatively, and the patients will be followed in a total length of 2 years to register thrombotic events.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years who are admitted to our hospital for orthopedic surgery of proximal femur fracture.
* The study participants must be capable to sign/accept informed concent

Exclusion Criteria:

* Patients with severe dementia or that of other causes not ar capable to give informed concent.
* Patients with known or suspected cancer, blood diseases or bleeding disorders
* Surgery last 6 months
* Severe renal- (eGFR (creatinine) \<30)
* Severe hepatic failure (2x UNL for bilirubin, 3x UNL for ALAT or INR \> 1,3 without anticoagulation treatment)
* Patients that, by drug spesification or -SPC, not are eligible for postoperative thrombosis prophylaxis
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C

12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C

Assess efficacy of FDC vs. ezetimibe vs. placebo for 12 week LDL-C lowering, changes in atherogenic lipids, hsCRP and exploratory glycemic measures as well as safety in patients with type 2 diabetes and elevated LDL-C.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for 6 months or greater
* Currently taking stable diabetes medication for 3 months or greater
* HbA1c between 7-10%
* LDL-cholesterol greater than 70 mg/dL
* Women must not be pregnant, lactating, or planning to become pregnant within 30 days after last dose of study medication; and must be postmenopausal, surgically sterile, or willing to use 1 acceptable form of birth control during the study through 30 days after the last dose of study medication

Exclusion Criteria:

* Body mass index \> 40 kg/m2
* History of documented clinically significant cardiovascular disease
* Fasting triglycerides \> 400 mg/dL
* History of Type 1 diabetes
* Uncontrolled hypothyroidism, liver dysfunction, renal dysfunction, gastrointestinal condition that may affect drug absorption, hematologic or coagulation disorder or active malignancy
* History of drug or alcohol abuse within 2 years
A Study of ONO-1110 in Patients With Social Anxiety Disorder

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder


Eligibility Criteria:
Inclusion Criteria:

1. Japanese participants (sex not specified)
2. Participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements
3. Participants diagnosed with social anxiety disorder based on DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria, as determined through an interview using the M.I.N.I. (Mini-international neuropsychiatric interview)
4. Outpatients
5. Participants with a LSAS-J (Liebowitz Social Anxiety Scale Japanese version) total score of 70 or higher and a CGI-S (Clinical global impression-Severity) score of 4 or higher

Exclusion Criteria:

1. Participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria:

   * Participants with a comorbid psychiatric disorder other than social anxiety disorder as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) (assessed using the M.I.N.I. (Mini-international neuropsychiatric interview))
   * Participants with a comorbid or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
   * Participants with neurodevelopmental disorders, neurocognitive disorders, or personality disorders (excluding avoidant personality disorder) as defined by DSM-5-TR
2. Participants who have been primarily diagnosed with a disorder other than social anxiety disorder according to DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria within 24 weeks prior to screening
3. Participants with a MADRS (Montgomery Åsberg Depression Rating Scale) total score of 15 or higher
4. Participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different SSRIs (Selective serotonin reuptake inhibitor), each administered at an adequate dose for at least 10 weeks, in treating social anxiety disorder
Predictive Value Of Muscle Tone And Perfusion Index In Supraclavicular Block Success.

The goal of this observational study is to define the usefulness of a new device to predict the supraclavicular block successfulness in the patients scheduled to orthopedic surgery. The main question it aims to answer is:

¿The combination between a flexometer and perfusion index is capable to predict the successfulness of a supraclavicular block in the first 15 min?

Participants will be anesthetized by residents or anesthesiologist with regional anesthesia training and then connected to a flexometer to measure the motor blockade and a pulse oximeter to measure the perfusion index related to sympathetic blockage at 0, 5, 10 and 15 min .

Prospective observational pilot study conducted at "Dr. Ignacio Morones Prieto" Central Hospital, Mexico, involving 33 patients (ASA 1, 2, 3) requiring surgery on the distal third of the upper limb with ultrasound-guided SCPB. The motor block was assessed with a conductive ink flexion sensor, and the sympathetic block was evaluated with perfusion index via pulse oximeter at 3, 5, 10, and 15 minutes. Block success was defined as a Numerical Rating Scale (NRS) for pain \<2 during surgical stimulation. Statistical comparisons were made between successful and unsuccessful blocks, with ROC curve analysis identifying optimal cutoff points for predictive variables.

Eligibility Criteria:
Inclusion Criteria:

* patients with 18 years and older.
* ASA 1, 2, and 3.
* patients who required surgical intervention in the distal two-thirds of an upper limb and warranted the application of an ultrasound-guided supraclavicular brachial plexus block.

Exclusion Criteria:

* infection at the puncture site
* allergy to local anesthetics
* diagnosis of coagulopathy
* restrictive pulmonary pathology
* diaphragmatic pathology
* dependence on supplemental oxygen
* brachial plexus radiculopathy
* uncontrolled type 2 diabetes mellitus
Equivalence Study of Tuberculin Purified Protein Derivative in Comparison With a Reference Standard (PPD-S2)

A study to determine bioequivalence of PPD material versus Reference Standard.

This study is a multicenter, double-blind, active-controlled parallel-group study to determine the bioequivalence of newly produced PPD material versus PPD-S2 in the detection of male and female subjects with current or previously diagnosed intrathoracic Mtb infection, as documented by a positive culture for Mtb (preferred method), by their primary care or attending physician and/or by the subject's current or prior medical records (ie, sensitivity determination).

Eligibility Criteria:
Inclusion Criteria:

1. Males or nonpregnant females age 18 to 60 years
2. Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be acc
3. Give written informed consent to participate
4. Generally healthy, as determined by medical history and targeted physical examination, if indicated
5. Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study prepar
6. Comprehension of the study requirements; expressed availability for the required study period, including readings at the nomina

Exclusion Criteria:

1. Prior PPD test within the past 30 days
2. Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
3. History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in
4. Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is
5. Presence of conditions that may suppress TST reactivity -
RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

The purpose of the study is to determine if the administration of a mix of Sufentanil and Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.

This study will compare the need for analgesia (Hydromorphone PCA) of two groups of patients post-VATS. The placebo group will only have a PCA for post-operative analgesia, witch is the standard care for patient post-VATS. The experimental group will have a intrathecal injection of a mix of morphine and sufentanil before the induction of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* VATS
* ASA 1,2 or 3
* Minimum weight of 50 kg
* Patient able to consent

Exclusion Criteria:

* Patient refusal
* Patient unable to understand PCA
* Contraindication to rachianalgesia
* Zona
* Pregnancy
* Over 30 mg of morphine during the last 24 hours
* Use of Pregabalin, Gabapentin, Doluxetin, Amitriptyline or NSAI in a context of chronic pain
* Severe allergic reaction to morphine, hydromorphone, sufentanil or local anesthetic
* Intubation over 1 hour after surgery (unability to use PCA)
* High risk of conversion to thoracotomy
* Unable to perform rachianalgesia due to technical difficulties
Usefulness of Chromoendoscopy in Diagnosing Microscopic Colitis

The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due to chronic watery diarrhea.

Microscopic colitis is a common disease found in 10% to 20% of cases having chronic watery diarrhea. Obvious endoscopically identifiable changes of the mucosal surface are usually absent, thus diagnosing microscopic colitis relies on multiple biopsy sampling from all segments of the colon. Chromoendoscopy using indigo-carmine dye spray might, however, unravel mucosal changes in microscopic colitis (Suzuki 2011).

The aim of this study is to investigate if chromoendoscopy using Indigo-Carmine 0.2-0.5% in patients with chronic watery diarrhea is useful in diagnosing microscopic colitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic non-bloody diarrhea for at least one month

Exclusion Criteria:

* Patients who decline to participate
* Unable to give informed consent