cyrilzakka/clinical-trials huggingface dataset:
Pharmacogenetic Variation: Factors That May Affect the Efficacy and Safety of Medical Marijuana

The primary purpose of this research is to identify genetic factors that may affect the efficacy and safety of medical marijuana, regardless of condition. The pharmacogenomics test detects DNA variants, which may affect the way drugs work and are metabolized in the body and/or detect potential side effects.

This observational, population-based study will examine genetic differences between ultra-rapid, intermediate and poor metabolizers of various formulations of Columbia Care's medical cannabis products in order to identify genetic factors that may affect the efficacy and safety of medical marijuana, regardless of condition. The goal of the research is to establish relationships between cannabis consumers, cannabinoids, and consumer outcomes. The study is expected to enroll 150 subjects across three cohorts, high daily dose users (poor metabolizers) that take more than 50 mg of cannabinoids daily (n=50), low daily dose users (ultra-rapid metabolizers) that take less than 10 mg of cannabinoids daily (n=50), and a control group (intermediate metabolizers) that represents the median daily dose user taking between 11-21 mg of cannabinoids daily (n=50).

Columbia Care Inc. has identified trends amongst its medical cannabis users suggesting that there are some patients who are "high daily dose users" and others who are "low daily dose users", with both groups assumed to have similar satisfaction with the products. The complexity of the endocannabinoid system combined with individual genetic predisposition and gene-environment interactions likely result in the variation in response seen with cannabinoid treatment.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females age 18 and older
* Currently obtaining medical marijuana products from Columbia Care LLC
* Willing to participate and consent to a DNA analysis
* Purchased product from Columbia Care for three consecutive encounters spanning a 6-month period

Exclusion Criteria:

* Unwillingness to participate and consent to a DNA analysis
* Unwillingness to answer a survey/questionnaire on patient satisfaction as related to product efficacy
Irisin And Diabetic Nephropathy

Diabetes mellitus (DM) is a complex, multifactorial, chronic metabolic and endocrine disorder. It has become a threat to global health. It has two types. It is estimated that the number of people with type II will reach 700 million by 2045.

It is associated with acute and chronic complications, acute complications include hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar state, and hyperglycemic diabetic coma. Chronic complications are further divided into microvascular and macrovascular complications. Chronic microvascular complications are neuropathy, retinopathy, and nephropathy. The later one firstly diagnosed by microalbuminuria. whereas chronic macrovascular complications are coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease.

The conventional medications in diabetes treatment, oral and insulin, are focusing on insulin secretion and insulin sensitisation. Oral antidiabetics include, Biguanides, Sulfonylureas, Thiazolidinediones, DPP4 inhibitors, GLP-1 analogue, and SGLT2 inhibitors.

Irisin, a myokin and adipokine secreted by muscles and subcutaneous fat, is an interesting peptide performing significant functions in human health. Irisin has been linked to human obesity and insulin resistance status.

Irisin is involved in regulating the mitochondrial function of muscle cells, so increases energy consumption of the body, promotes metabolism and reduces body weight so improves insulin sensetivity. In our study we aim to clarify the effect of antidiabetics on serum irisin in patients with typeII DM who developed diabetic nephropathy.

Eligibility Criteria:
Inclusion Criteria:

Any patients above 40 years with type 2 diabetes of at least two years duration complicated with diabetic nephropathy.

Exclusion Criteria:

* Patients below 40 yrs.
* Patients with type 1 diabetes complicated with diabetic nephropathy
* Type2 diabetes without nephropathy.
* Diabetic nephropathy cases on dialysis due to other causes
* Blood pressure more than 160/100
* Acute coronary syndrome in the past 6 months
* Non alcoholic fatty liver disease, impaired liver function.
* Malignancy.
* Pregnancy
* Acute infection, acute inflammation.
* Severe renal impairment, and urinary tract infection.
Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging

The goal of this study is to evaluate the potential of comprehensive biliary Optical Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing cholangitis (PSC).

The study will be conducted in approximately 20 patients with known or suspected common bile duct or common hepatic duct stricture scheduled for endoscopic retrograde cholangiopancreatography (ERCP) with duodenoscope-assisted cholangiopancreatoscopy (DACP) and biopsy.

Following initial fluoroscopic evaluation, the study experimental procedure will begin. The catheter will be passed through the auxiliary channel of the duodenoscope, across the papilla and into the common bile duct. The extra-biliary portion of the catheter will be visible by the duodenoscope at all times. The intrabiliary portion of the catheter will be visible by fluoroscopy, and will be positioned across the biliary stricture. Rotational cross-sectional images of the bile duct will be obtained using the OFDI imaging catheter while pulling back the internal optical components over a pre-determined length. OFDI imaging will be conducted approximately from 1 cm distal to 1 cm and proximal to the stricture margins identified by fluoroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥18 and up to 75 years old
* Patients able to give informed consent
* Patients with bile duct measuring ≥4 mm in diameter
* Patients with established biliary enteric access - specifically, a previously performed biliary sphincterotomy, or a biliary sphincterotomy performed during the current ERCP for indications other than participation in the study
* Women of childbearing potential must have a negative urine pregnancy test obtained prior to the procedure

Exclusion Criteria:

* Patients with pancreatitis
* Pregnant women
* Patients on oral anticoagulant (warfarin) therapy
* Patients with known history of hemostatic disorder
* Patients found to have a biliary fistula on diagnostic ERCP
Compare Sacrospinous Fixation Versus High Uterosacral Ligament Fixation for Uterus Vaginal Prolapse III/IV

The purpose of this study is to compare the vaginal sacrospinous colpopexy and high uterosacral colpopexy in the treatment of genital prolapse grade III/IV in women with uterus.

Hysterectomy is often the traditional approach for women with uterovaginal prolapse. However, hysterectomy alone does not address the underlying problem of deficient apical support. Surgical options for patients with apical prolapse include transvaginal suspension procedures using pelvic structures for fixation, such as the sacrospinous ligament or uterosacral ligaments.The objective of this study is to compare the sacrospinous fixation with high uterosacral in the treatment of uterine prolapse POP-Q stage 3 or 4 in terms of recurrence of prolapse,quality of life,complications,post-operative recovery, hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* pelvic prolapse III/IV
* counselling and informed consent

Exclusion Criteria:

* abnormal cervical smears
* abnormal ultrasound findings of uterus or ovaries or abnormal uterine bleeding
* pelvic radiotherapy
Comparison of Effectiveness of Virtual Reality With Mirror Therapy in Improving Motor Function of Upper Limb of Stroke Patients

The purpose of the study is to compare the effectiveness of virtual reality and mirror therapy in stroke patients. Different studies has been done to find out the best therapy for stroke patients. Use of virtual reality in medical field is becoming more popular now-a-days. Different devices and applications are available to treat various conditions. Research has been done to find the clinical applications of virtual reality for upper limb motor rehabilitation in stroke. in another study, mirror therapy with bilateral arm training was used for hemiplegic upper extremity motor functions in patients with chronic stroke. After doing literature review, it was found that no research has been done to compare the effectiveness of mirror therapy with virtual reality in improving motor function of upper limb of stroke patients. So, In this study these two therapies are compared. For virtual reality Oculus Quest 2 has been used. Patients were allowed to use beat saber game on Oculus.


Eligibility Criteria:
Inclusion Criteria:

* Stroke affecting upper limb

Exclusion Criteria:

* mental problem cognitive problem
Effects of a Physical Exercise Program on Microcirculation and Pregnancy Outcomes in Obese Pregnant Women

This study aims to determine the effect of a physical exercise program on microcirculation and maternal and perinatal outcomes in obese women. A randomized clinical trial will be performed at IMIP with obese pregnant women assisted at the Instituto de Medicina Integral Professor Fernando Figueira (IMIP) prenatal service.

Obesity in pregnancy is an important risk factor for adverse perinatal outcomes. Obesity leads to oxidative stress and vascular damage including microcirculation inflammation. Physical activity prevents cellular damage and provide a protective effect to the health of the mother and fetus. Although physical activity has been recommended for obese pregnant women, studies assessing the effects on the microcirculation of these women are scarce. This study aims to determine the effect of a physical exercise program on microcirculation and maternal and perinatal outcomes in obese women. A randomized clinical trial will be performed at IMIP with obese pregnant women assisted at the IMIP prenatal service. The intervention group will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner. The control group will follow the routine prenatal IMIP. All pregnant women will be evaluated by a questionnaire to assess physical activity. Microcirculation function will be evaluated by a Laser-doppler flowmetry at baseline and eight weeks after intervention. All pregnant women will be followed until the delivery and immediate postpartum period to check their perinatal outcomes. All pregnant women will be advised to use a pedometer to record their daily steps. The study meets the recommendations of the National Health Council. This project was submitted and approved from the Ethics Committee for Research involving human subjets of IMIP. All participants will be duly informed about the aims of the study and will be included after signing the Informed Consent Form.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy between 14 and 20 weeks gestation;
* Literate women;
* sedentary lifestyle.

Exclusion Criteria:

* Cognitive, auditory, visual or motor impairment, certified by a specialist;
* Any pregnancy disorders or previous maternal diseases: diabetes type 1 or type 2, hypertensive disorders of pregnancy, hemodynamic instability, renal disease or collagen, vaginal bleeding;
* Any medical or obstetric contraindication to perform physical activity.
REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

The aim is to prospectively assess the association between clinical parameters and the presence of maxillofacial fractures in trauma patients admitted to the emergency department. Our hypothesis is that a clinical decision aid of critical parameters reduces unnecessary produced CT scans in maxillofacial trauma patients.

The REDUCTION trial is a prospective multicentre cohort study conducted at the level I emergency departments of the University Medical Center Groningen, Isala hospital (Zwolle, The Netherlands) and the level II trauma center Nij Smellinghe hospital (Drachten, The Netherlands). The increased availability of Computed Tomography (CT) in the emergency department is leading to an overuse for patients with suspected maxillofacial injury. The use of a clinical decision aid could lead to more expedient use of diagnostic imaging within this population of patients. Therefore, all maxillofacial trauma patients admitted to the emergency department are included in this trial if the consultation is within 7 days after trauma. Both maxillofacial trauma patients admitted to CT scan and patients without a radiological confirmed diagnosis are included. The research protocol was approved by the institutional review board of the University Medical Center Groningen (Groningen, The Netherlands). Informed consent was waived as patients are treated according to the standards of care. Upon admission, each patient with maxillofacial injury will be allocated as a midfacial or mandibular trauma. During physical examination, either by the emergency physician or surgical resident, a pre-defined selection of clinical parameters will be assessed focussing on the assessment of potential presence of fractures in the maxillofacial region. The standardization of this examination will be ensured using a pocket map and easy accessible online instructional video's. The clinical parameters, fracture likelihood and physical examination findings will be structurally reported in electronic health record software using a smart tool dedicated for maxillofacial injury. Data regarding patient demographics, mechanism of injury, concomitant injury, diagnostic outcome and radiation dose parameters will be derived from the medical records.

Eligibility Criteria:
Inclusion Criteria:

* consultation within 7 days of trauma

Exclusion Criteria:

* history of maxillofacial surgery
Effects of Sleep, Fatigue, and Timing of Post-dates Inductions Among Nulliparas

This randomized clinical trial will examine if there are any differences between post-dates inductions (inductions after 40 weeks of pregnancy) begun in the morning compared to the evening for first-time mothers. Sleep and fatigue measures will be measured to see if they differ by time of induction. Other measures will include the rate of births within 24 hours of admission, length of labor, use of labor analgesics, and method of delivery.

Randomized clinical trial of first-time pregnant women requiring post-dates induction (induction after 40 weeks gestation). Women will be randomized to a labor induction time in the morning or the evening. On hospital admission once women have signed the study consent, they will complete sleep questionnaires and a fatigue assessment. Fatigue and sleep time assessments will subsequently done by the study subject every 4 hours until women enter active labor. At the onset of active labor, assessments will stop. Labor outcomes and patient satisfaction will be obtained once women deliver.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant at 40 weeks gestation or more
* Nulliparous
* 14 years old or older
* English or Spanish speaking
* Healthy maternal status
* Labor induction able to be scheduled

Exclusion Criteria:

* Less than 40 weeks gestation
* Multiparous
* Younger than 14 years old
* Not able to speak or write in English or Spanish
* Fetal or maternal status requires immediate induction
Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level

Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy.

* Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
* Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30mL) will be performed preoperatively in Patients followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of prostate tissue or metastasis will be analyze.

Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.

Steroids concentration will be determined using Gas chromatography-mass spectrometry. The analyzed steroids are :

FSH :Mul/ml LH: mUI/ml SHBG: µg/ml BT: ng/ml TT: ng/ml DHT: ng/ml DHEA: ng/ml D5: ng/ml D4: ng/ml E1: pg/ml E2 : pg/ml DHEA-S : µg/dl

Eligibility Criteria:
Inclusion Criteria:

* Men aged over 18 years
* Surgical indication justifying protatique prostatectomy, or complete prostatocystectomie, or removal of a metastasis of prostate cancer.
* Patients affiliated to a social security scheme or benefiting from such a regime.
* Patients who have given their consent to participate in writing

Exclusion Criteria:

* Patient received local therapy or hormonal treatment (LHRH analogue, therapy blocking androgen receptors) before surgery.
* Treatment reductase inhibitors 5ARI ongoing or stopped for less than 3 months before the intervention.
* Patient included in another clinical trial inconsistent with the conduct of this research.
* Patient receiving treatment that could interfere with hormone levels (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride).
Research of Prevention and Intervention of Mental Health Problems

The purpose of this research is to establish a suitable community-based model for Chinese culture,to improve the community recognition of common mental disorders,as well as its treatment and control.

The project will select seven metropolis,through multi-center collaborative research,use of interdisciplinary methods and combining qualitative and quantitative research methods.Community resources will be integrated so as to build the Chinese model of community mental health services and to establish the routine for common mental disorders. Evaluation criteria for community mental health needs to be developed for the process of health education and intervention techniques.

Eligibility Criteria:
Inclusion Criteria:

1. general population: 13-65-year-old,
2. high-risk groups: not yet shown symptoms of mental disorders, but exposed to epidemiological risk factors for anxiety,depression and alcohol abuse.A part may be at risk for future depression,anxiety and alcohol abuse,for example: post-disaster population,Stress-related groups, the unemployed and laid-off people, high risk of psychological disorders (chronic treatment of various medical institutions and disabled, the mentally ill family members).
3. early stage of mental disorders in population:the subjects have the problem of depression, anxiety or alcohol abuse, but not yet diagnosed with depression, anxiety disorders or alcohol abuse.

Exclusion Criteria:

those who have been diagnosed with depression,anxiety or alcohol abuse and other psychiatric disorders will be excluded from this study.
Safety and Efficacy of BC LisPram

This pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) BC LisPram delivery and ii) rapid insulin delivery.

Subjects will be randomized to intervention sequences. The first 6 participants will be randomly allocated to a sequence of three treatments composed of (i) treatment with active comparator insulin lispro, (ii) treatment with BC LisPram, and (iii) treatment with BC LisPram (dual wave bolus). The following 10 participants will be randomly allocated to a sequence of either two or three treatments. Each treatment period will last 50 hours. PK/PD assessment will be performed under an open-loop system and will be followed by a 24 hour of closed-loop assessment.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age.
* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
* Insulin pump therapy for at least 3 months, with daily insulin needs ranging between 30 and 80 U.
* Most recent HbA1c ≤ 9.5% (over the last two months).
* Effective birth control in female participants of childbearing potential. Medically acceptable contraception methods include condom, pills, and intrauterine device.

Exclusion Criteria:

* Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc....).
* Current use of glucocorticoid medication.
* Use of medication that alters gastrointestinal motility.
* Planned or ongoing pregnancy.
* Breastfeeding individuals
* Severe hypoglycemic episode within one month of admission.
* Severe diabetic ketoacidosis episode within one month of admission.
* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
* Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
* Known hypersensitivity to any of the study drugs or their excipients.
* Allergy to paracetamol (acetaminophen).
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
* Clinically abnormal significant values for haemato, biochemistry, or urinalysis screening test as judged by the Principle Investigator for underlying disease.
* Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
Comparison of USG- Guided Modified Pectoral Nerve Block and Erector Spinae Plane Block on Postoperative Analgesia in Video Assisted Thoracoscopic Surgery

This study aims to compare the effects of the erector spinae plan block (ESP) and modified pectoral nerve block (PECS II) on postoperative analgesia in patients undergoing video- assisted thoracoscopic surgery (VATS).

55 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo VATS, were randomized and divided into two groups. (26 patients in each of the PECS and ESP groups). Three patients were excluded from the study because thoracotomy was performed. ESP block was performed for ESP group and a modified pectoral nerve block was performed in the PECS group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure. Perioperative remifentanil use, numeric rating scale values, time of the first analgesic request, and additional analgesic consumption were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18-65
* Patients who will undergo VATS
* ASA I-II-III patients

Exclusion Criteria:

* Clinically diagnosis of spinal or chest wall deformity or pathology
* Clinically known local anesthetic allergy
* Morbid obesity (body mass index\>40 kg m2)
* Clinically diagnosis of opioid, alcohol and substance dependence
* Clinically diagnosis of psychiatric disease
* Coagulopathy
* Patients with ASA IV-V