cyrilzakka/clinical-trials huggingface dataset:
Effect of Statins on Crohn's Disease

The goal of this clinical trial is to learn if statins work to prevent strictures in adults with Crohn's disease. The main question it aims to answer is:

* Can statins reduce the formation of strictures in participants with stricturing Crohn's disease?

Researchers will compare statins to a placebo (a look-a-like substance that contains no drug) to see if statins work to prevent strictures from forming. Participants will:

* Take statins or a placebo every day for 6-12 months
* Visit the clinic for lab tests twice after starting either statins or placebo
* Complete questionnaires about symptoms and medications
* Respond to monthly check-ins (via phone call) during participation

Strictures are a formidable complication of Crohn's disease (CD), with more than half of patients experiencing clinically significant bowel obstructions. Stricturing CD is a primary driver of morbidity and hospital admissions and is frequently associated with treatment failures. Moreover, it is estimated that nearly 50% of patients with CD will undergo bowel resection surgery within ten years of diagnosis, highlighting the severity and persistence of this issue for patients as well as the healthcare system.

By modulating inflammatory and fibrotic pathways, the investigators posit that statins reduce primary stricture development and also recurrence after stricture resection.

The investigators will assess the impact of statin therapy on early stricture recurrence in a pilot, randomized controlled clinical trial in patients undergoing stricture resection, evaluating both clinical outcomes and detailed immune, microbiome, and metabolic profiling. Through this effort, the investigators will determine if statins reduce clinical and biological signs of stricture recurrence in the short term.

Eligibility Criteria:
Inclusion Criteria:

1. Established diagnosis of stricturing Crohn's disease
2. Scheduled for surgical resection of terminal ileum strictures at either

   * Stanford University, or
   * Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles

Exclusion Criteria:

1. Pregnant, nursing, or planning to become pregnant in the next 6-12 months
2. Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
3. Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
4. Current use of cyclosporine
5. Current use of statin therapy prior to study initiation
6. Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels
7. Current use of any of the following medications, without explicit clearance from a treating physician to enroll in the study:

   * Antifungals (e.g., ketoconazole, itraconazole, voriconazole)
   * Fibrate drugs
   * Macrolide antibiotics (e.g., erythromycin, clarithromycin)
   * Protease inhibitors (e.g., ritonavir, lopinavir)
   * Calcium channel blockers (e.g., verapamil, diltiazem)
   * Amiodarone
   * Warfarin
   * Colchicine
Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease

The purpose of clinical trials is to evaluate safety and tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells as a treatment for Patients with Parkinson's disease.

This study is phase I/II clinical trials which is accessible to those involved in the study and conducted by only Bundang CHA hospital.

The progress of the clinical trails is reported to and evaluated by Data monitoring committee before the enrolment of next human subject.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients with idiopathic or primary Parkinson's disease
2. Hoehn and Yare (HY) stage III or IV
3. more than 33% improvement Part III UPDRS score after one injection of levodopa in the morning
4. Patients aged less than 70
5. Great decrease of dopamine uptake in putamen, particularly posterior part, in Positron emission tomograph(PET) before surgery

Exclusion Criteria:

1. Atypical or secondary parkinsonism
2. Medical history of severe depression with Beck Depression Inventory(BDI) scores greater than 30
3. Psychological disorders (illusion, delusion, schizophrenia)
4. Dementia with K-MMSE(Korean mini-mental state examination) scores less than 24
5. Epilepsy
6. Medial history of brain surgery
7. Medical history of other brain diseases
8. Hemorrhagic tendency
9. Severe internal diseases such as poor general condition, hypertension, chronic respiratory disease, ischemic heart disease, cancer
10. Experience of participating in clinical trial within 30 days
11. Female patients who have the chances of getting pregnant during clinical trial and do not use the approved birth controls
12. Pregnant or lactating women
13. Patients who are not considered to be eligible to participate in clinical trial
Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

This is a study that will evaluate the utility of a scatter reduction technique in reducing dose and increasing the sensitivity of stationary digital chest tomosynthesis (s-DCT) in the detection of lung lesions.

Digital tomosynthesis is an imaging modality that produces 3D sectional information using x-ray projections acquired over a limited scanning angle. Scatter is known to be the primary source of image degradation in x-ray based imaging.

The investigators have developed an approach that measures scatter through a low dose (3% of the conventional scan) scatter measurement technique. Preliminary studies have shown that scatter reduction in DCT can significantly improve quality. The approach will characterize the reader confidence in lung nodule detection in a scatter corrected chest tomosynthesis imaging approach as compared to the conventional chest tomosynthesis.

Fifty (50) patients who have undergone a clinical non-contrast CT with lung nodules will be asked to have an s-DCT (scan) within 4 weeks (+/- 2 week) of their clinical CT with no intervening procedures or therapies (i.e. biopsy of lung nodules). Investigators will then perform a reader study to evaluate the radiologist reader confidence in images generated from the scatter reduction technique versus more conventional chest tomosynthesis imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known lung lesion(s)
* Patients having undergone a chest CT
* Patients 18 years of age and older
* Patients able to provide informed consent

Exclusion Criteria:

* Patients who may not fit on a 35 x 35 detector (BMI \> 35)
* Planned procedures or therapies during study (in between SOC scans and study scan on s-DCT) (biopsy or removal of lung lesion)
* Any woman who is pregnant, has reason to believe she is pregnant, or is lactating
Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound

The study purpose is to help in the developement of 3 dimensional breast ultrasound imaging.

To assist in the developement of 3 dimensional breast ultrasound imaging and when possible compare the ultrasound results with 3D mammography (digital tomosynthesis mammography)or clinical mammography and ultrasound. Hopefully that this new, 3D ultrasound imaging can provide important information not found on mammograms or routine breast ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women OR
* Women with suspected benign masses who may/or may not be going to biopsy
* Women with cysts where no biopsy is recommended

Exclusion Criteria:

* Women who are pregnant
* Women with breast implants
* Prisoners
Strength At Home: Veterans' Program (PTSD-Focused Therapy for Anger and Relationship Conflict Among OEF/OIF Veterans)

This is a research study funded by the Department of Defense to test a therapeutic intervention for male combat veterans who engage in intimate partner violence (IPV). The investigators hope to decrease the recurrence of relationship aggression and help veterans manage anger. The primary aim of the study is to test the intervention.

The purpose of this project is to develop, standardize, and test an intervention for combat veterans exposed to trauma who engage in intimate partner aggression (IPA). This intervention, formerly labeled PTSD-Focused Cognitive Behavior Therapy for Partner Violence (PFCBT), and currently called the Strength at Home, Veteran's Program, incorporates components of interventions for IPA and trauma and will target mechanisms implicated in the relationship between trauma and IPA. This project addresses a number of the research gaps in this area of research including: (a) the development of a novel treatment approach to improve functioning and well-being of affected individuals; (b) tertiary prevention (of repeated IPA) during re-integration; and (c) examination of the efficacy of a program providing support for the families and caregivers of veterans with combat history.

Eligibility Criteria:
Inclusion Criteria:

* Any era veteran
* Over the age of 18
* In a relationship within a female partner within the last 6 months
* At least one act of male-to-female physical aggression over the previous 6 months or at least one act of male-to-female severe violence in the past 12 months
* Male participant must consent for partner contact

Exclusion Criteria:

* Participant evidences severe organicity or active psychosis
* Reading difficulties prevent valid completion of the assessment instruments
* Participant expresses prominent suicidal or homicidal ideation
* Participant meets diagnostic criteria for alcohol and/or drug dependence, if not in early full remission or sustained partial remission
Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared to daily G-CSF in chemotherapy-induced neutropenia.

Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 1 cycles of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of stage II or III breast cancer
2. Age : ≥18, ≤70
3. TAC regimen as adjuvant therapy
4. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1
5. Creatinine \< 1.5 x ULN
6. Total bilirubin/AST/ALT \< 1.5 x ULN, ALP \< 2.5 x ULN
7. Have given a written, informed consent

Exclusion Criteria:

1. Received any other investigational drugs within 30 days of informed consent date
2. Received systemic antibiotics within 72 hours of chemotherapy into this study or Radiation therapy within 4 weeks of informed consent date
3. Infective symptom before chemotherapy into this study
4. Pregnant or lactating women
5. Prior bone marrow or stem cell transplantation
6. Other malignancy history within 5 years
7. HIV positive
8. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date
9. Prior chemotherapy
Non-small Cell Lung Cancer Study US75 (Z-PACT)

This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients at least of 18 years old
* Patients with diagnosed non-small cell lung cancer that cannot be treated by surgery
* Women must not be pregnant or attempting to become pregnant
* Able and willing to sign informed consent

Exclusion Criteria:

* Patients with cancer that has spread to the bone
* Patients with cancer that has spread to the brain who are receiving treatment
* Patients with kidney disease
* Patients treated with other investigational drugs
Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

Menopause greatly increases cardiovascular disease risk (CVD). Current exercise guidelines are inadequate to ameliorate this risk and higher intensity exercise may be necessary for cardiovascular benefits in postmenopausal females. Oral nitrate supplementation enhances exercise performance and CVD risk profile in several clinical conditions. The investigators recently reported that 3-days of nitrate supplementation in postmenopausal females enhances acute post-exercise vascular function, in an intensity dependent manner. The effects of nitrate supplementation and exercise training over a longer training program remains unexplored. This investigation will examine the impact of exercise training intensity with and without inorganic nitrate supplementation, on CVD and fitness outcomes. Postmenopausal females will be tested for maximal oxygen uptake and lactate threshold before randomization to one of four groups: that inorganic nitrate-rich tablets, or tablets with nitrate extracted; and assigned to one-month of calorie matched high-intensity or moderate-intensity exercise training. Vascular function and fitness will be evaluated before and after training.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal female (greater than age 45 but less than age 75)
* Sedentary (does not exercise regularly or less than 2 bouts of exercise per week)
* No major changes in medication in the last 3 months

Exclusion Criteria:

* Smokers within last 5 years
* Weight unstable (loss/gain of more than 3kg in the past 3 months)
* Any medical condition that prevents the subject from exercising safely
* Hormone replacement therapy (current or within last 3 months)
* Diabetes
* Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)
* Oral antibiotic use within previous four weeks
* Oral disease or poor oral health as determined by the Oral Health Questionnaire
* Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

The purpose of the study is to determined whether the administration of alkalized 4% lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous oxide as an anesthetic agent.

The diffusion of nitrous oxide inside the endotracheal cuff leads to increase pressure, pain and coughing. Studies have shown benefit of alkalized lidocaine and other mediums within the cuff with nitrous oxide. No study has yet evaluated the benefit of alkalized lidocaine in long surgeries without the use of nitrous oxide.

Eligibility Criteria:
Inclusion Criteria:

- ASA 1,2 or 3 patients requiring general anesthesia for an elective urological or gynecological surgery predicted to last more than 2 hours

Exclusion Criteria:

* Patient refusal
* Lidocaine allergy
* Any allergies to drugs or anesthetics used during the study
* Under 18 years of age
* Pregnant
* Previous airway surgery
* Cormack 3 or 4 or anticipated difficult airway
* Upper respiratory tract infection in the last month
* Active respiratory disease
* Chronic cough or throat pain
* Gastro-esophageal reflux disease or at risk for aspiration
Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The adsorber is frequently used in series with continuous renal replacement therapy. Up to date, no data on the removal of antibiotic drugs during combined renal replacement therapy and cytokine adsorptive therapy is available. Therefore, we want to investigate

- whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during combined continuous renal replacement therapy and cytosorb adsorption in patients with severe sepsis and septic shock

Patients in this trial are undergoing renal replacement therapy as part of their routine care. Thus, this is an observational trial.

Eligibility Criteria:
Inclusion Criteria:

* Intensive care patients with severe sepsis or septic shock and acute kidney injury requiring continuous renal replacement therapy and cytokine adsorption
* Age \> 18 y

Exclusion Criteria:

* \< 18 y
* Pregnancy
* Contraindications against citrate-anticoagulation or continuous renal replacement therapy or cytokine adsorption
A Study of JNJ-70075200 in Healthy Participants

The purpose of the study is to evaluate safety and tolerability of JNJ-70075200 compared with placebo after administration of single ascending doses of JNJ-70075200 as oral solution (Part 1); multiple ascending doses of JNJ-70075200, administered as oral solution over 14 consecutive days (Part 2); and the option of a single dose of JNJ-70075200 administered as an oral solid formulation (Part 3).


Eligibility Criteria:
Inclusion criteria:

* Participants be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant
* Participants be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
* No history of pathogen driven cancers (carcinomas, sarcomas, gastric cancer, bladder cancer,Cholangiocarcinoma)
* Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range 18 and 30 kilograms per square meter (kg/m\^2) (BMI = weight/height\^2) (inclusive)
* All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening

Exclusion criteria:

* Participants having a history of liver or renal insufficiency (estimated creatinine clearance \[CL\] below 60 milliliter per minute \[mL/min\]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Participants having a QT interval corrected according to Fridericia's formula (QTcF) greater than (\>) 450 milliseconds (msec) for males, and \>470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at Day -1
* Known allergies, hypersensitivity, or intolerance to JNJ-70075200 or its excipients
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participants having a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day -2
Impact of Hypnosis for Performing Lumbar Infusion Tests

Infusion tests are now the gold standard for the diagnosis of chronic adult hydrocephalus (CAH), also known as normal pressure hydrocephalus. It is an invasive procedure using the same approach as a lumbar puncture. Once the intrathecal puncture is performed, the intracranial pressure is measured in lateral decubitus via a pressure head. Dynamic tests (injection of 0.9% NaCl at a constant flow rate) are performed after recording the basal pressure. This type of test lasts 30 to 45 minutes in lateral decubitus. Patients with CAH have cognitive-behavioral disorders that can alter the gesture and its interpretation in case of movements or contractures. Movement artefacts lead to a longer recording time. The longer the test, the more the patients' tolerance tends to decrease. Moreover, the patient's feeling towards this test is important because it may have to be repeated. Pain, anxiety and patient comfort are essential parameters to consider. Non-medicinal techniques (hypnosis, music therapy) have shown a tendency to reduce anxiety in pediatric and adult populations with an impact on instantaneous anxiety but also on personality-related anxiety. Most studies are focused on specific pathologies, primarily in palliative care, or on pediatric application. The use of these techniques in an elderly population with mild cognitive-behavioral disorders has not been explored.

The objective is to evaluate the impact of hypnosis on anxiety, pain and comfort during the lumbar infusion test.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 65 years old undergoing assessment for suspected CAH in day hospitalization for a lumbar infusion test
* No major cognitive impairment (MMSE\>20)

Exclusion Criteria:

* Patient less than 65 years old
* Major cognitive impairment (MMSE\<20)
* History of lumbar surgery
* Contraindication to lumbar puncture or infusion test
* Hearing impairment
Study Protocol/ Registry of MultiPoint™ Pacing in Brazil

This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 10 centers.

Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability and who meets the inclusion criteria and none of the exclusion criteria is eligible for enrollment in the study.

Patients will be followed for 12 months after implant. Data will be collected after device implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and during unscheduled visits.

Eligibility Criteria:
Inclusion Criteria:

* Patient willing and able to sign Informed Consent Form
* Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model quadripolar device with MPP capability

Exclusion Criteria:

* Is likely to undergo a heart transplantation within 12 months
* Is less than 18 years old
* Is pregnant or is planning to get pregnant during the study
* Is currently taking part in a Clinical Trial with an active treatment group
* Life expectancy is under 6 months
Screening of Postpartum Depression in Egyptian Women

The goal of this cross-sectional study is to assess the Edinburgh Postnatal Depression Scale as screening tool for Postpartum Depression among women delivering at Egyptian tertiary health care system, University Hospital, regarding Prevalence and risk factors.

participants of this study with fill the Edinburgh Postnatal Depression Scale and their socio-demographic, obstetric and psychological data will be collected and analysed.

prevalence of postpartum depression in Egyptian women will be assessed as well as the associated risk factors


Eligibility Criteria:
Inclusion Criteria:

All patients who underwent vaginal/cesarean delivery and reported for follow and willing to participate in the study.

Exclusion Criteria:

* Patients who were unwilling to participate in the study.
* Patients who are having difficulties comprehending the questionnaire of the study.
* Women who were on psychiatric medication during pregnancy.