cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma

The aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma.

In vitro data indicate that statins affect myeloma cells, mainly by inducing cell death and growth suppression.

This is a national, multicenter, phase IIa, single arm (not controlled), open label clinical trial of Simvastatin 80mg p.o. /day in a population of patients with progressive SMM. Patients will be treated with Simvastatin 40 mg and if no side effect will be seen the dose will be escalated to 80 mg for up to 18 months. All further treatment decisions after completion of the study are at the discretion of the investigator.Approximately 15 patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Patients fulfilling the criteria of SMM. (see Appendix I)
2. Patients with progressive smoldering Myeloma. (see Appendix II)
3. Age 18-80 years.
4. Signed informed consent prior to patient recruitment.

Exclusion Criteria:

1. Patients fulfilling diagnostic criteria of active MM .(see Appendix I)
2. Patients fulfilling diagnostic criteria of: solitary myeloma or non secreting myeloma or oligosecretory myeloma or light chain myeloma.
3. Patients on statin treatment on the day of recruitment.
4. Patients on chemotherapy or receiving steroids.
5. Patients with any contraindication to statin treatment:

   * Known intolerance or hypersensitivity to statin.
   * SGOT or SGPT above 1.5 times of upper normal level (UNL).
   * CPK above UNL
   * Concomitant treatment with macrolides and or antifungal agents (ketoconazole)
   * Creatinine level above 1.5 mg%
   * Any severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
6. Patients with second primary malignancy (except for non melanoma skin malignancy) unless they have been disease free for at least five years.
7. Patients who have a history of alcohol or drug abuse.
8. Patients who are mentally or physically unable to comply with all aspects of the study.
9. Participation to an investigational drug trial
Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of MFPP

Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor of female chronic pelvic pain. However, the effect of the patient's self-myofascial release (SMFR) is not clear. Current study is to investigate the effect of SMFR combined with biofeedback and electrical stimulation (BES) therapy compared with BES alone in patients with MFPP.

68 patients was enrolled and randomly allocated into two groups: BES-SMFR group (n=34) and BES group (n=34). Every patient received 4 weeks treatment, and was evaluated at baseline (T0), 4-week post-intervention (T4) and 12-week follow-up (T12). The primary outcome was pain intensity. The secondary outcomes were degree in activation of MTrPs, surface electromyography (sEMG) levels, and Patient Global Impression of Improvement (PGI-I).

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 70 years;
2. presence of persistent chronic pelvic pain ≥ 4 points on a 10 points numeric rating scale for at least 3 months;
3. at least one active MTrP in one of muscle group including obturator internus, levator ani, piriformis, coccygeus on pelvic examination.

Exclusion Criteria:

1. diseases of the urinary, genital, colorectal systems;
2. prolapse of the pelvic organ;
3. a history of pelvic rehabilitation within the 3 months prior to study;
4. psychiatric disorders;
5. pregnancy;
6. breastfeeding.
EGCG Improves Acne by Modulating Molecular Targets

Epigallocatechin-3-gallate (EGCG) may improve acne vulgaris

* major polyphenolic constituent in green tea
* known as potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and antimicrobial activities
* lipid-lowering and antiandrogenic properties was reported
* EGCG can improve acne vulgaris via one of the above mentioned actions.

Acne vulgaris is one of the most prevalent skin disorders of sebaceous follicles, affecting more than 85% of adolescents in United States. Acne can persist throughout the adulthood, and even a mild form of acne might progress to permanent scarring on the face, chest and back, thereby causing significant physical and psychosocial morbidities. Acne is a multifactorial disease of which etiology has not been fully elucidated, although considerable progress has been made in understanding its pathogenesis during last decade. The major pathogenic features of acne include abnormal ductal keratinization, sebum overproduction, Propionibacterium acnes, and inflammation. Common acne medications such as topical retinoids, antibiotics and isotretinoin are associated with irritation and incomplete responses, increased bacterial resistance or untoward side events, respectively. Thus there is a continuing need for a novel, effective agent targeting different aspects of acne pathogenesis, with minimal side effects.

In the recent decade, epigallocatechin-3-gallate (EGCG), the major polyphenolic constituent in green tea, has attracted much interest on account of its potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and antimicrobial activities. Preclinical, observational, and clinical trial data have indicated that EGCG can inhibit tumor initiation, promotion, progression, and angiogenesis. EGCG also suppresses neutrophil chemotaxis, and has been suggested to improve many diseases that have inflammatory components such as diabetes, kidney injuries, arthritis, allergies, dental caries, cardiovascular, gastrointestinal, and neurodegenerative diseases. In skin, EGCG has been investigated mainly in light of antioxidative, immunopotentiating and anticarcinogenic properties against chemicals or ultraviolet irradiation. Moreover, EGCG has lipid-lowering and antiandrogenic properties, and can downregulate peroxisome proliferator-activated receptor-γ expression. Based on these observations, it can be inferred that EGCG might be effective in the treatment of acne.

Eligibility Criteria:
Inclusion Criteria:

* age of at least 15 years
* clinical diagnosis of mild to moderate acne vulgaris

Exclusion Criteria:

* known pregnancy or lactation
* any medical illness that might influence the results of the study,
* a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.
Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery

To compare the safety/efficacy of the robotic-assisted lobectomy/segmentectomy (RAL/S) with the video-assisted lobectomy/segmentectomy (VAL/S) for lung resection.

Video-assisted lobectomy/segmentectomy (VAL/S) for lung resection is divided into uniport group and multiple- port group.


Eligibility Criteria:
Inclusion Criteria:

1. good cardio- pulmonary function to tolerate surgery;
2. minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;

Exclusion Criteria:

1. cardio- pulmonary function is not good enough to tolerate surgery;
2. huge tumor or extensive adhesion in thoracic cavity.
GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC

Through randomized controlled phase III multicenter clinical trials, GP induction chemotherapy vs TPF regimen adjuvant chemotherapy combined with DDP concurrent chemoradiotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial.
2. Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
3. III, IVa patients (AJCC version 8 staging).
4. Male or non-pregnant women.
5. Age ≥ 18 and \< 70 years old.
6. Functional status: Karnofsky scale (KPS) \> 70.
7. White blood cells (WBC) ≥ 4 × 109.

   /L, hemoglobin (HGB) ≥ 90 g / L, platelets (PLT) ≥ 100 × 109 / L (or within the normal range of the laboratory)
8. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.
9. Renal function: creatinine clearance ≥ 60ml / min or serum creatinine ≤ 1.5 × ULN.
10. The patient has signed an informed consent form.

Exclusion Criteria:

1. The pathological type is WHO's keratinized squamous cell carcinoma or basal squamous cell carcinoma.
2. Age ≥ 70 years old or \< 18 years old.
3. Treatment is palliative.
4. Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
5. Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception).
6. Previously received radiation therapy (if non-melanoma skin cancer and previous lesions are outside the target area of radiotherapy, then except).
7. Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment).
8. With other serious diseases, it may bring greater risk or affect the compliance of the test. For example: no need for treatment Stable heart disease, kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose \> 1.5 × ULN),And mental illness.
Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity.

Intravenous morphine Patient-Controlled analgesia is gold standard on post - operative liver resection. But, opioids tend to be ineffective for pain that is associated with movement and have significant short-term side effects including nausea, vomiting, sedation, pruritus, constipation, urinary, retention, and respiratory depression, which are factors that often hinder a patient's recovery. Prospective randomized trials has found continuous wound catheter analgesia as an accepted alternative to IV morphine PCA.

The researchers will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce morbidity and provide a better recovery.

This study is a prospective, double blind, randomized study. Subjects will be randomized using a computer-generated table of random numbers into 2 groups. The patients scheduled to undergo open liver resection will be randomly allocated to receive a continuous wound infusion of either 0.2% ropivacaine (ropivacaine group A) or 0.9% saline (control group B). The patients will be thereafter randomly assigned to receive through the catheter either 0.2% ropivacaine (study group) (10-ml bolus followed by an infusion of 10 ml/h during 48 h) or the same protocol with 0.9% NaCl (control group), thanks to a elastomeric pump (500ml), set to deliver a 10-ml/h connected with the catheter. In addition, all patients will receive patient-controlled intravenous morphine analgesia. The primary endpoint : the opioid-related symptom distress scale (SDS) will be performed at 48 hours after surgery. Secondary endpoints will be pain intensity on a visual analog scale at rest, and on coughing, morphine consumption, respiratory dysfunction, transit recovery and side effects at 48 hours, 5 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Scheduled for open hepatic resection
* Patients must be able to understand the IV morphine PCA
* Written informed consent
* Free from pain in preoperative period

Exclusion Criteria:

* Age \< 18 years
* Severe hepatic
* Renal impairment
* Pregnancy or lactation
* Allergy to one of the specific drugs under study
Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia

The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone for nail-procedure associated pain management. The investigators hypothesize that ropivacaine with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for managing pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing fingernail or toenail, excision, or shave biopsy
* Must understand and voluntarily sign an informed consent form
* Must be male or female and aged 18-95 years at time of consent
* Must be able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

* Subject is unable to provide written informed consent for any reason
* Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy
* Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any other chronic pain
* Subject has a history of opioid or alcohol use disorder
* Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency or a history of kidney disease, or has underlying liver disease
* Subject has a history of severe constipation
* Subject is sensitive or allergic to any of the elements included in this study
* Subject is unable to complete the required pain dairy
* Subject is pregnant, planning pregnancy, or nursing
Perforator Mapping and Optimizing Design of the Lateral Arm Flap

The goal of this clinical trial is to optimize the design of lateral arm flap. Colored duplex will be done for all Participants and compared to intra operative findings.

flap modification (Supra facial) dissection to lateral arm flap will be done and the results will compared to the ordinary method of dissection.


Eligibility Criteria:
Inclusion Criteria:

* adult patients

Exclusion Criteria:

* children injury to pedicle
Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants

Recent advances in animal research have identified pharmacological agents that appear to both accelerate and consolidate extinction learning. One cognitive enhancers is Yohimbine hydrochloride (YOH). A finding in animal literature is that the administration of YOH during extinction trials accelerates fear reduction and may convert ineffective exposures in to successful ones. It is thought that the mechanism of enhanced emotional memory is through elevated norepinephrine. However, recent findings demonstrate mixed results. In a randomized controlled trial claustrophobic participants underwent exposure in combination with YOH or placebo. The YOH group showed significantly better results on anxiety improvement than the placebo group. In a more recent study with participants with fear of flying no additional benefits of YOH were demonstrated. Therefore, we intend to replicate and extend these studies by enhancing the dose of YOH in combination with VRET and by extending our experimental design with another group which receives propranolol in combination with VRET. Propranolol is β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation in healthy humans. In this randomized controlled trial a between groups design is chosen to further characterize the differential within and between trial extinction and to enhance possible between groups effects. Sixty participants with fear of flying or fear of heights will be randomly assigned to one of the following three conditions 1) VRET plus YOH, 2) VRET plus Propranolol, or 3) VRET plus placebo. Participants in all conditions will be offered three sessions of VRET over a period of two weeks.


Eligibility Criteria:
Inclusion Criteria:

* Marked fear of flying or acrophobia, indicated by a subjective fear rating of moderate or higher on anxiety specific measures.

Being older than 18 years and younger than 75 years.

Exclusion Criteria:

-
Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes

Our hypothesis is that aggressive preconception weight loss in obese women will improve the metabolic health of the mother and the intrauterine environment. An optimized developmental environment will normalize fetal growth and improve clinical fetal and infant outcomes, and theoretically reduce future susceptibility to obesity and cardiometabolic disease.

Further, our hypothesis is that the metabolic profiles in the mother and infant cord blood and epigenetic profiles in cord blood leukocytes will be improved in the very-low energy diet (VLED) group compared to standard practice nutrition counseling and support (SOC) group and approach the profiles found in normal weight (LEAN) individuals. We will relate these changes to the changes in the offspring clinical profiles. With these data in hand, we will develop a model to understand the potential molecular markers associated with offspring size and adiposity at birth, risk factors for later onset non-communicable diseases. We will use these insights to define, adopt and implement future interventions that mitigate the downstream risk of adiposity and cardiometabolic diseases.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 ≤ 45 for obese participants OR
* BMI ≤ 25 for healthy body weight participants
* No known infertility
* No known risk factors for tubal disease

Exclusion Criteria:

* Significant medical co-morbidities (e.g. heart, kidney, liver, autoimmune disease)
* Significant anemia
* Cancer other than minor skin cancers
* Conditions that would complicate pregnancy
* Recent use of anti-obesity drugs or appetite suppressants
* Previous bariatric surgery
* Endometriosis AFS (American Fertility Society classification class III or IV)
* Progesterone \> 10 IU/ml
* Current pregnancy
* Use of sperm donor
OSA-ACS Project: Association of OSA and CPAP Therapy With Outcomes in ACS Patients

Obstructive sleep apnea (OSA) is an increasingly common chronic disorder in adults that has been strongly associated with various forms of cardiovascular disease. Compared to the general population, OSA occurs more often in patients with acute coronary syndrome (ACS). Although percutaneous coronary intervention (PCI) is nowadays part of standard therapy and optimal medical therapy has been used to manage traditional risk factors, the long-term cardiovascular outcomes after index ACS remain suboptimal.

Some preliminary data suggest OSA is associated with higher risk of subsequent cardiovascular events in ACS patients. However, the study population was heterogeneous and these studies were not done in the context of new-generation drug-eluting stents and intensive antiplatelet therapy, thus precluding definite conclusions. Furthermore, a cardioprotective role of OSA in the context of acute myocardial infarction (AMI), via ischemic preconditioning, has also been postulated.

Due to the inconsistent evidence, the investigators performed a large-scale, prospective cohort study to delineate the whole picture of the association of OSA with short- and long-term outcomes of patients with ACS. Whether treatment of OSA (eg. continuous positive airway pressure (CPAP)) would prevent these events will also be evaluated. Moreover, the investigators will assess the potential mechanisms of OSA-induced atherosclerosis and myocardial injury in ACS patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Admission with an ACS (including STEMI, NSTEMI, and unstable angina)
3. Written informed consent

Exclusion Criteria:

1. Cardiogenic shock (systolic blood pressure \<90mmHg)
2. Cardiac arrest on admission or during hospitalization
3. Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep duration \<4h/night)
4. Predominantly central sleep apnea (CSA, ≥50% central events or central apnea hypopnea index (AHI) ≥10/h)
5. Previous or current use of CPAP
6. Known or planned pregnancy
7. Severe comorbidities: eg. malignancy (life expectancy \<2 years)
8. Patients who cannot tolerate the sleep study or refuse it
Energy Expenditure and Body Composition in Pseudohypoparathyroidism 1a

The investigators would like to learn more about the metabolic consequences of pseudohypoparathyroidism type 1a in children, adolescents and adults with this condition. People with pseudohypoparathyroidism 1a are at risk for development of obesity. To better understand the cause of overweight or obesity, investigators are measuring body composition and resting energy expenditure (REE), which is the amount of calories burned while completely at rest. The investigators also want to determine the amount of body fat.

Pseudohypoparathyroidism 1a (PHP1a) is a disorder that is associated with many endocrine problems. People with PHP1a are at risk for the development of obesity. The objective of the study will help determine if obesity is related to abnormalities energy expenditure, meaning that people with PHP1a may not burn as many calories while at rest as those without the disorder.

In order to further evaluate obesity in PHP1a, investigators are planning to measure resting energy expenditure (REE), which is the amount of calories burned while completely at rest. Investigators will also evaluate body composition by looking at measures of growth and development and determining the amount of body fat using dual energy x-ray absorptiometry (DXA) as well as blood and urine biologic markers of obesity. The investigators plan to evaluate people with PHP1a at all weights.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pseudohypoparathyroidism 1a
* Any body weight

Exclusion Criteria:

* Absence of above diagnosis
Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache

Postdural puncture headache (PDPH) is a major complication of neuraxial anesthesia that can occur following spinal anesthesia and with inadvertent Dural puncture during epidural anesthesia. The presence of Pyridostigmine in CSF would be expected to increase the level of acetylcholine in CSF and subsequently in the brain through inhibition of cholinesterase. The increased level of acetylcholine would produce cerebral vasoconstriction.


Eligibility Criteria:
Inclusion Criteria:

* Patients American Society of anesthesiologists' physical status (ASA) II because of pregnancy.
* Patients diagnosed with Postdural puncture headache following intrathecal spinal anesthesia for elective caesarean delivery.

Exclusion Criteria:

1. Patients with PDPH and a visual analog scale (VAS) score \<5.
2. Patients with history of chronic headache, cluster headache, migraine, convulsions.
3. Patients with history of cerebrovascular accident, previous neurological diseases.
4. Patients with preeclampsia, eclampsia, coagulopathy.
5. Patients with severe bleeding (\>20% of blood volume).
6. Patients undergoing treatment with vasopressors.
7. Patients with bronchial asthma.
8. Patients with arrhythmia, and any type of heart block.
Study in Patients With Asthma

The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Require the regular use of an inhaled beta-2-selective adrenergic agent.
* No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.

Exclusion Criteria:

* Active acute or chronic disorders of the respiratory system within one month prior to screening.
* Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history.
* Debilitating systemic and/or life-threatening diseases.