cyrilzakka/clinical-trials huggingface dataset:
Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia

The addition of morphine to a local anesthetic when performing an epidural analgesia during labor analgesia has improved the efficiency and the action duration of analgesia. One limitation of this technique is the time of installation of the analgesic effect (about 30 minutes) when using the only epidural. Therefore, the technique of sequential combined spinal epidural was introduced. This is to shorten the installation time by direct injection into the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the effect of the local anesthetic.

Compare the results of obstetric analgesia by sequential combined spinal epidural with local anesthetic injection associated with morphine and a sequential obstetric analgesia by sequential combined spinal epidural with local anesthetic injection alone

Eligibility Criteria:
Inclusion Criteria:

* pregnant patients
* patients who experienced a physiological course of pregnancy
* patients for which it was estimated eutrophic fetus without pathology found during ultrasound
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years and younger than 40 years

Exclusion Criteria:

* twin pregnancy
* contraindication to sequential combined spinal epidural
Urdu Version of Arthritis Impact Measurement Scales 2 Short Form:Reliability and Validity Study

In this study ,Investigators will observe the Reliability and Validity of Arthritis Impact Measurement Scale 2 Short Form translated in Urdu language in Pakistani population to check quality of life in patients suffering from Osteoarthritis.

The main aim of this study is to translate and culturally adapt AIMS2 SF into Urdu language and to investigate the reliability and validity of AIMS2 SF in Osteoarthritis patients among Urdu speaking Pakistani population.

The study will be completed in 5 steps such as translation ,synthesis ,back translation ,expert committee review and pre testing. The study will be a cross sectional survey .The result of the study helps to know the validity and reliability of AIMS2 SF in Urdu Version to check the quality of life .The reliability of the scale will be checked through internal consistency and test retest method .Internal consistency will be analyzed through Cronbach's alpha value to estimate whether each item of a scale is appropriate for assessing the underlying concept of its scale with 165 patients will be used.

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female Patient age 18 years or older.
2. Diagnosed with OA of the knee , hip and hand .
3. Patients diagnosed according to ACR criteria. 4 - X-RAY scored according to Kellgren and Lawrence Classification.

Exclusion Criteria:

1 - Radiograph not older than 6 months . 2- Age less than 18 are excluded from this study.
The PerX360º System™ Registry

This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.

For all patients participating in the registry, the following outcomes will be analyzed:

* Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain
* Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain
* Change in Oswestry Disability Index (ODI) score from baseline
* Proportion of patients with a device related complication
* Proportion of patients with lack of revision, removal, or reoperation
* Proportion of patients with radiographic fusion

Eligibility Criteria:
Inclusion Criteria:

* Patient understands the nature of the procedure and provides written informed consent
* Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment
* Age \> 18 years
* Patient is treated with the Optiport™ and Opticage™ products

Exclusion Criteria:None
Collection and Storage of Blood and Tissue Samples From Patients Who Are Undergoing Surgery For Lung Cancer

This research studies collecting and storing tissue and blood samples from patients with lung cancer who are undergoing surgery. Collecting and storing samples of tissue and blood from patients with lung cancer to study in the laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

OBJECTIVES:

1. To collect, catalog and store frozen samples of lung carcinoma and when possible, portions of involved lymph nodes, as well as adjacent grossly uninvolved lung tissue obtained from surgical specimens of patients undergoing surgical resection for previously untreated lung cancer as a source of quality DNA, messenger ribonucleic acid (mRNA) and protein for molecular analysis.
2. To collect, catalog and store frozen samples of blood pre- and post-resection from the same patients to provide a source of reference DNA to assess somatic mutations associated with tumor or preneoplastic "normal" lung, and to allow assessment of levels of circulating markers.
3. To associate these specimens with historical, clinical, pathological, and outcome information.

Grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the Cancer and Leukemia Group B (CALGB) Lung Cancer Tissue Bank for future use in research. Blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the Tissue Bank.

Eligibility Criteria:
1. Histologic Documentation: All patients with suspected or histologically documented previously untreated lung cancer undergoing surgical resection are eligible whether or not the patient participates in a CALGB-sponsored treatment trial; patients enrolled on a CALGB trial of preoperative chemotherapy for lung cancer will be eligible if a pre-treatment frozen sample of tumor (e.g., a positive lymph node from mediastinoscopy) can be submitted to the bank; patients enrolled on CALGB 140203, intraoperative sentinel node mapping in non-small cell lung cancer, are not eligible.
2. No patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C
A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age

The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable.
* Participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to Day 1 and for at least 90 days after the study intervention administration.
* Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with the last COVID-19 vaccine administered \>150 days prior to Day 1.

Exclusion Criteria:

* History of a diagnosis or condition that is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
* Tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.
* History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 150 days prior to Day 1.
* Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 or plans to do so during the study.
* Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection.
* Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
* Received a licensed/authorized COVID-19 vaccine within 150 days prior to Day 1.
* Received any investigational influenza vaccine, investigational COVID-19 vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1.
* Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline).

Other protocol-defined inclusion/exclusion criteria may apply.
Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis

Using a double-blind, randomized controlled design to investigate the additional therapeutic effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of hyaluronic acid injections to patients with knee osteoarthritis.

A total of 56 patients will be enrolled and randomized into two groups, including 3 times of triamcinolone combined hyaluronic acid injections group and 3 times of hyaluronic acid injections group.

The triamcinolone combined hyaluronic acid injections group will receive 3 times of triamcinolone combined hyaluronic acid injection per week in three weeks; the hyaluronic acid group will receive hyaluronic acid injection in three weeks.

Physical activities and functional performance will be evaluated at before injection, at after one week, one month, three months, and six months of completion of 3 times of injections.

Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis with Kellgren/Lawrence grade II or III

Exclusion Criteria:

* who have neurological deficit, such as stroke who have implant in knee
Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery

Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients with obesity. Many patients stop or reduce their medication after surgery and this can happen fairly quickly. The investigators do not know whether strict control of blood glucose/sugar after the operation makes any difference in the long term. Additionally many patients prefer their blood sugars to be a "bit high" because they are afraid of hypos.A number of studies have described patients whose eye, nerve and kidney disease has deteriorated when high sugars are controlled very quickly. The investigators want to ensure that surgery provides maximum benefit and remains safe in patients with diabetes. This study will help us decide if the investigators should be strict with blood glucose after obesity surgery operations or not and whether obesity surgery is safe for the eye, nerve and kidney complications of diabetes.

Subjects would be randomised into intensive glycaemic control and conventional glycaemic control after obesity surgery. Data on complications of diabetes such as eye, nerve and kidney will be collected before obesity surgery and 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus who have been approved for obesity surgery

Exclusion Criteria:

* Patients with Type 2 Diabetes Mellitus who do not require insulin immediately after obesity surgery
Effect of Administering Intravenous Magnesium Sulfate on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients

Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute will be adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and mode of delivery will be labelled on CTG.

Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:

* Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
* Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.

Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels

Admission CTG:

Admission CTG will be performed for 20 minutes

I-Settings:

1. Settings on a CTG machine will be standardised to enable a consistent approach of interpretation of traces.
2. Paper speed of 3cm per minute will be adopted.
3. CTGs will be labelled with mother's name, hospital number.
4. Date and time settings on machines will be labelled at commencement of tracing.
5. Maternal heart rate will be recorded and noted on CTG.
6. Following birth date, time and mode of delivery will be labelled on CTG.

Magnesium Sulphate hepatahydrate administration:

Magnesium sulphate will be administered by continuous intravenous infusion according to our hospital protocol as follows:

* Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
* Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
* Magnesium toxicity was monitored by hourly assessment of:

  1. Patellar reflexes should be present.
  2. Respiratory rate not \< 16/min.
  3. Urine output not \< 100ml / hr. Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant Women in the third trimester.
2. Severely preeclamptic patients.
3. Singleton Pregnancy.
4. Patients with normal admission CTG

Exclusion Criteria:

1. Evidence of fetal anomalies on scan.
2. Concomitant maternal morbidities as diabetes, cardiac disease.
3. Patients contraindicated to take MgSo4 e.g.: advanced renal disease.
4. Abnormal admission CTG.
5. Morbid obesity.
Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab given as neoadjuvant treatment in HER2 positive early-stage or locally advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

Female patients, 18 years ≤ age ≤ 80 years； Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 Histologically confirmed invasive breast cancer（early stage or locally advanced） HER2 positive (HER2+++ by IHC or FISH+) Known hormone receptor status. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO Signed informed consent form (ICF)

Exclusion Criteria:

Metastatic disease (Stage IV) or inflammatory breast cancer Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.

Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); Unable or unwilling to swallow tablets.
The Effects of Caffeine on Deep Inferior Epigastric Perforator (DIEP) Flap Perfusion

Women that require breast reconstruction and meet eligibility will be enrolled in this study. The study is being completed to determine the effect of caffeine in deep inferior epigastric perforator (DIEP) flap perfusion using the Vioptix tissue oximeter monitor and to determine if caffeine in the acute postoperative period affects overall flap complication or loss (complete loss from anastomotic issue).

The researchers hypothesize that a single 8 ounce cup of regular coffee will not affect free flap perfusion as indicated by the Vioptix, and that it will not affect overall free flap survival at thirty days.


Eligibility Criteria:
Inclusion Criteria:

* regular caffeine consumers undergoing unilateral or bilateral microsurgical breast reconstruction with DIEP flap(s) at the University of Michigan Health System

Exclusion Criteria:

* smokers
* hepatic or renal disease (comorbidities that affect caffeine metabolism)
* male
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

The following abbreviations were used in the Adverse Event section:

* international normalized ratio (inr)
* Common Terminology Criteria for Adverse Events (ctcae)
* Not Otherwise Specified (nos)
* Gastrointestinal (gi)
* Central nervous system (cns)
* Absolute Neutrophil Count (anc)
* Alanine aminotransferase (ALT)
* Aspartate aminotransferase (AST)
* Creatine phosphokinase (cpk)
* Gammaglutamyltransferase (ggt)
* Genitourinary (gu)
* Atrioventricular (av)

Eligibility Criteria:
Inclusion Criteria:

* Ages eligible for study: 18 years and above, Genders eligible for study: both
* Patients who have a life expectancy of at least 12 weeks
* Patients with histologically or cytologically documented Hepatocellular Carcinoma (HCC)
* Patients must have at least one tumor lesion that meets both of the following criteria: (1) Accurately measured in at least one dimension according to RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
* Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2

Exclusion Criteria:

* Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\] \& T1 \[Tumor invades subepithelial connective tissue\]). Any cancer curatively treated \> 3 years prior to entry is permitted
* Renal failure requiring hemo- or peritoneal dialysis
* History of cardiac disease
* Active clinically serious infections
* Known history of human immunodeficiency virus (HIV) infection
* Known central nervous system tumors including metastatic brain disease
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs

Evaluation of the feasibility, acceptability, patient satisfaction and economic benefits of smartphone video-based telehealth in the management of Crohn's disease patients

Patients were examined by two gastroenterologists (HY, AED) either at a video conference based visit or face to face visit in outpatients clinics. We used the WhatsApp business application.The online visit notion was the same as traditional face-to-face visit except physical examination.

Eligibility Criteria:
Inclusion Criteria:

* The study group included patients with documented Crohn's disease, based on clinical, endoscopic, and histologic findings
* Patient between 18-80 years old
* Participants who have been receiving treatment for more than six months

Exclusion Criteria:

* Patients were excluded from the study if they had no internet connection
* Unable to use smartphones because of blindness, deafness, or mental disorders
ArtiAid® Plus for Knee Osteoarthritis: A Post-market Study

The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Plus Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:

* the safety profile of ArtiAid® Plus;
* the clinical performance of ArtiAid® Plus, such as pain relief and satisfaction of treatment.

Participants will receive weekly injections of ArtiAid® Plus for 3 weeks and be follow-up for 26 weeks.

An open-label study will be performed in single center to monitor about 60 patients with knee osteoarthritis(OA), each treated with 3 injections of ArtiAid® Plus 1.5% (MAXIGEN BIOTECH INC., Taiwan). Follow-up visits will be at 4 weeks, 12 weeks(a telephone contact by the investigator) and 26 weeks after the injections. The primary endpoint of this study is to monitor the adverse events after injecting ArtiAid® Plus. The secondary endpoints of this study are demonstrating the clinical performance of ArtiAid® Plus, such as resting knee pain and satisfaction of treatment by using the visual analog scale (VAS). Analysis of variance (ANOVA) will be applied to the clinical data and T-test will be used to test for the differences between baseline and each visit. The paired student t-test was used to analyze variations in each group over a period of time. Statistical significance was established at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged older than 40 years old.
* Able to sign informed consent prior to the study.
* Subjects have Kellgren-Lawrence (KL) grade 2 to 3 knee osteoarthritis.
* Subjects have failed to respond adequately to conservative non-pharmacological therapy.
* Plasma pregnancy test at screening visit must be negative for fertile female subjects.
* Subjects in stable progress of disease as judged by the investigator.

Exclusion Criteria:

* Subjects with known hypersensitivity to hyaluronate preparations.
* Subjects with infections or skin diseases in the area of the injection site.
* Pregnancy or breast-feeding woman.
* Significant drug, alcohol abuse.
* Joining any clinical trial within 3 months prior to dosing.
* Subjects have traveled abroad within 3 months prior to the screening visit.
Microbiota-targeted Diet for Pediatric UC

Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors. Currently, no effective therapy targets the microbiota or its interaction with the colonic epithelium. Diet has a significant impact on the composition of the microbiota; however, no dietary intervention to date has proven effective for induction of remission. The primary objective of this study is to determine whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC patients with active mild to moderate UC on a stable medication.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Established diagnosis of UC
* Age: 8-19 (inclusive)
* Mild to moderate active disease, 10\<PUCAI\<45
* Stable medication (IMM/5ASA) use or no medication use for the past 6 weeks.
* Participant has agreed to follow the UCD for 12 weeks

Exclusion Criteria:

* Any proven current infection such as positive stool culture, parasite or C. difficile within the past 4 weeks
* Antibiotic or corticosteroid use in the past 2 weeks
* Use of biologics in present or in the past
* PUCAI\>45
* Acute severe UC in the previous 12 months
* Current extra intestinal manifestation of UC
* Primary Sclerosing Cholangitis (PSC) or liver disease
* Pregnancy
* Known food allergy to mandatory foods in the UCD