cyrilzakka/clinical-trials huggingface dataset:
Bowel Preparation for Inpatient Colonoscopy

This study will compare two strategies for bowel cleansing prior to inpatient colonoscopy: the entire preparation taken the night before the procedure versus half the preparation taken the night before the procedure, and the other half taken the morning of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* any diagnosis for which colonoscopy is indicated

Exclusion Criteria:

* ileus
* severe colitis/toxic megacolon
* gastric retention
* bowel perforation
* gastrointestinal obstruction
* gastroparesis that precludes oral bowel preparation
* pregnant or lactating women
* allergy to polyethylene glycol.
* unable to give consent
Automated Telephone Monitoring for Symptom Management

To improve the management of symptoms, patients with cancer undergoing chemotherapy will be monitored using an automated telephone system to record the severity of 15 prevalent symptoms for up to 8 consecutive weeks. Outcomes include; significant reduction in symptom severity and improvement in health states.

Overview: Prevalent symptoms among patients undergoing chemotherapy include: pain, fatigue, dry mouth, constipation, anorexia, nausea, sleep disturbance, shortness of breath or difficulty breathing, as well as psychological symptoms such as depression and anxiety. A survey of 1000 patients with cancer indicated that close to a quarter reported 10-12 symptoms. Given the impact of symptoms upon physical function, work, emotional distress, and hospitalizations, it is critical that strategies be developed and tested to improve symptom management.

This trial of a behavioural intervention for symptom management is significant because: 1) it contrasts a proactive approach, individualized to patients' symptom management needs, with a more conventional model that places responsibility on the patient for symptom management; 2) it controls for the method of delivery and the use of printed material; 3) it targets prevalent symptoms known to affect cancer patients undergoing chemotherapy; 4) it examines the relative effects of each arm, in terms of symptom severity (primary outcome), impact on patients' physical and social roles, and emotional distress; and 5) it explores these outcomes in terms of their impact on the use of services and costs of care.

Goal: The goal of this randomized trial is to determine if a nurse delivered Patient Assisted Management of Symptoms (PAMS) intervention individualized to patients' needs for symptom management, delivered by telephone, when compared to Telephone Information and Monitoring of Symptoms (TIMS) where symptoms are only monitored by telephone, with references to the symptom management toolkit will reduce symptom severity, improve physical function, and other outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* solid tumor cancer diagnosis
* receiving chemotherapy treatment

Exclusion Criteria:

* Emotional or psychology disorder for which patient is receiving treatment
* does not speak English
* does not have access to a telephone
* difficulty hearing on the telephone
Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin

This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Current treatment with human soluble insulin, insulin NPH or premixed human insulin
* The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

* Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
* Previous enrolment in this study
* Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir
Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma

This phase II trial studies how well intensity-modulated stereotactic radiation therapy works in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. To determine the effect of intensity-modulated (IM)-stereotactic radiotherapy (SRT) on the incidence of wound infection (requiring oral/intravenous \[IV\] antibiotics or surgery), or wound dehiscence.

SECONDARY OBJECTIVES:

I. To determine the effect of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning.

II. To determine the effect of IM-SRT on the incidence of hair loss and recovery rate.

III. To determine the effect on quality of life (QoL) using European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).

TERTIARY OBJECTIVES:

I. To determine if treatment of Intensity-modulated stereotactic radiotherapy (IM-SRT) in patients with newly diagnosed grade II-IV gliomas can decrease the loss of scalp thickness in the coronal plane in T-1W magnetic resonance (MR) images.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed low or high grade glioma (grade II-IV)
* Karnofsky performance status (KPS) \>= 60
* Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment
* Estimated survival \>= 3 months
* Labs considered acceptable per standard of care
* Patient must sign a study specific informed consent form
* Radiation treatment must begin \>= 3 weeks and =\< 8 weeks after surgery

Exclusion Criteria:

* Prior history of scalp radiation or intolerance to standard course of radiation treatment
* Co-morbidities that would influence wound healing including diabetes (insulin dependent) or smoking (current ongoing use)
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
* Karnofsky performance status (KPS) \< 60
* Patient can't have magnetic resonance imaging (MRI) scan
* Active collagen vascular disease
Neonatal Outcome by Reason for Delivery

To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal hospital discharge.

This is a prospective, observational study that will use information from the medical records of mothers and their newborns. This study seeks to determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal hospital discharge.

Secondary Objectives: 1) Difference in mortality between the PTL and PROM groups, composite morbidity differences for other reasons for premature delivery, and individual morbidities including IVH, PVL, RDS, sepsis, seizures, BPD and NEC

Study Population: All babies from singleton pregnancies delivering in each of the involved hospitals who deliver at less than 32 weeks of gestation who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.

Planned Sample Size: We plan a two year study and estimate based on historical data for the institutions to be included in the study, which should yield approximately 6000 babies less than (\<) 32w0d gestation. For a 10% difference in composite morbidity (assuming 90% power and two-sided alpha=0.05) assuming a rate of 60% at least 661 patients are needed in each of the 3 groups (PTL, PROM, and other).

Eligibility Criteria:
Inclusion Criteria:

* Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating
* Singleton pregnancy
* Delivery where the baby is:

  1. Stillborn OR
  2. Born alive and:
* expires before it leaves the delivery room OR
* is cared for in the Neonatal Intensive Care Unit or an Intermediate Care Nursery

Exclusion Criteria:

* Patient less than 18 years of age
* Pregnancies that had previously been multiple gestations but where one or more fetuses had died after 12weeks of gestation
* Deliveries where the baby is born alive, does not expire in the delivery room but the baby does not get admitted to the NICU.
Does Follow-up With Serum Beta Human Chorionic Gonadotropin (BhCG) Simplify Medical Abortion?

The purpose of this study is to evaluate if BhCG testing to determine the completion of medical abortion simplifies the medical abortion protocol. Investigators hypothesize that women randomized to ultrasonographic determination of completion of medical abortion will have MORE follow-up visits/interventions beyond standard protocol than those randomized to medical abortion follow-up with serum BhCG.

The investigators also hope to explore satisfaction with BhCG based follow-up among women seeking medical abortion. Investigators hypothesize that the majority of women who choose to follow-up with serum BhCG will be satisfied with this method of medical abortion follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergoing medical abortion
* Proficiency in English
* Working phone and willingness to be contacted by phone
* Agreeing to surveys regarding demographics, follow-up preferences, and satisfaction with chosen follow-up method

Exclusion Criteria:

* Concern for ectopic pregnancy or unable to document intrauterine pregnancy
* Clinical instability or signs of pelvic infection
* Medical conditions that contraindicate medical abortion
* Unwilling or unable to comply with study follow-up procedures
* Being in a situation where receiving phone calls or additional contact with research staff may endanger the privacy or safety of the subject (e.g., situations of domestic violence)
* Inability to give informed consent
* Previous participation in this study
Hayman's Haemostatic Suture to Treat Severe Post-partum Haemorrhage

Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage.

Considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.

Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage.

The Hayman suture offers the potential advantages that can be applied fast and easy, a key point in an emergency situation, and avoids having to perform a lower segment hysterotomy when post-partum haemorrhage follows a vaginal delivery, therefore minimising the trauma to the atonic bleeding uterus.

Considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.

Eligibility Criteria:
Inclusion Criteria:

* Women that had major Post-partum Haemorrhage, resistant to pharmacologic therapy, treated with Hayman's Haemostatic Suture.

Exclusion Criteria:

* None.
Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy

Children with focal refractory epilepsy will be routinely included in the collection of history, blood routine, biochemistry, EEG, MRI and 18F-FDG PET to determine the location of the epileptogenic focus and to assess the severity of the disease. This international multicenter clinical trial uses a double-blind, randomized, controlled study to evaluate the safety and efficacy of LCM in clinical applications in children with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of focal epilepsy with or without generalized seizures according to the 2017 International Association of Anti-Epilepsy (ILAE) classification criteria.
* Stable taking 1 or 2 other first-line anti-epileptic drugs for at least 10 weeks before screening visits.
* Seizure occurred during the 8-week retrospective baseline period with a complete medical record diary.

Exclusion Criteria:

* A history of status epilepticus within 3 months prior to screening visits.
* Poor adherence to previous treatment.
* Other serious organic diseases, mental illnesses and neurological diseases.
* Abnormal liver and kidney function and blood routine results.
VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection

This is a post-marketing study to verify the clinical benefits of VIGIV \[CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution\] in the resolution of complications resulting from smallpox vaccination in eligible patients treated with VIGIV.

This is an open-label Phase 4 study designed to collect additional data to assess the safety and efficacy of VIGIV \[CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution\] in the first 100 consented patients treated with VIGIV.

Eligibility Criteria:
Inclusion Criteria:

Subjects treated with VIGIV deployed from the US Strategic National Stockpile for any of the following conditions:

* Eczema vaccinatum.
* Progressive vaccinia.
* Severe generalized vaccinia.
* Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy, or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions.
* Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.
* Informed consent voluntarily signed by subject, legal guardian or representative to participate in the study. For minors, the informed consent form must be signed by a legally acceptable representative and when appropriate, informed consent/assent must also be obtained from the minor.

Exclusion Criteria:

None.
Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)

In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients

In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients.

The aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Dafilon suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place 10 ± 5 days post-operatively (and post-operatively depending on routine clinical practice of each hospital).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing mucosal wound closure using Dafilon as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be included).
* Written informed consent regarding the data collection for the PMCF.

Exclusion Criteria:

* Emergency surgery.
* Oral surgery procedures requiring bone regeneration.
* Pregnancy.
* Patients taking medication that might affect wound healing.
* Patients with hypersensitivity or allergy to the suture material.
Safety Study of Bevacizumab Plus Chemotherapy To Treat Metastatic Colorectal Cancer

To assess the safety profile of bevacizumab in combination with chemotherapy for the treatment of metastatic colorectal cancer

This is a multi-centre, observational, non-interventional study. Patients with metastatic colorectal cancer eligible for Bevacizumab in combination with chemotherapy treatment will be enrolled in this trial.

Eligibility Criteria:
Inclusion Criteria:

* with histologically confirmed metastatic colorectal cancer
* patients with metastatic colorectal cancer who are eligible for Bevacizumab in combination with chemotherapy treatment
* Written informed consent
* Unlimited line of treatment (first-line or second line is not limited)

Exclusion Criteria:

Patients who are not eligible for Bevacizumab treatment according to locally approved Bevacizumab China package insert will be excluded. The following patients are not eligible for Bevacizumab treatment according to local Bevacizumab China package insert:

* Recent history of serious hemorrhage or hemoptysis of ≥1/2 teaspoon of red blood
* Proteinuria at baseline: Patients discovered to have ≥ 2 grams of proteinuria/24 hours \*

  * The measurement of 24-hour proteinuria level is recommended for patients with moderate to high proteinuria risk indicated by clinical judgement. The treatment with bevacizumab should be delayed when proteinuria is ≥2g/24 hours.
* Major surgical procedure within 28 days prior to treatment initiation, or not fully healed wounds
* Pregnant or lactating women
* Excluding patients known to be allergic to bevacizumab or any of the excipients
Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.

The purpose of this study is to determine how an important weight loss after bariatric surgery affects obese patients ' spine, and the effects it has on low back pain, sagittal alignment and lipomatosis .

Obesity and back pain are massive public health problems, and the relationship between the two has not been described and studied. However, the investigators have also observed that many ex-obese patients still suffer from back and leg pain after an important weight loss.

The aim of this study is to measure the effect of weight loss on back pain, and to find out what parameters can explain such modifications (increasing or decreasing back pain).

The investigators will study clinical parameters, as well as radiological (to measure the effect of weight loss on spine sagittal alignment) and MRI (to measure lipomatosis, which is a fat epidural accumulation, responsible for nerve compression and therefore back and leg pain).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* BMI \> 40 or BMI \> 35 with comorbidities due to obesity ( criteria for bariatric surgery)
* Follow up in Pompidou's Hospital Nutrition service
* Bariatric surgery intervention ( Sleeve gastrectomy or By pass)
* Follow up possible for one year or more
* Being covered by French social insurance
* Consent to participate in the study

Exclusion Criteria:

* History of spine surgery
* Bariatric surgery postoperative complication
* Non mastering of french language
* MRI contraindication
* Patient under legal protection ( e.g. guardianship)
A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium

The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD with symptoms over 1 year
* Smokers or ex-smokers
* Males or post-menopausal females between 40 and 80 years old
* Able to use electronic devices

Exclusion Criteria:

* Past history or current evidence of clinically significant heart disease
* Current diagnosis of asthma
* Patients who require long term oxygen therapy
* Treatment with antibiotics within 4 weeks of study visit 1b
Pyruvic Acid Versus Salicylic Acid Preparation in Treatment of Plantar Warts

Plantar warts can be bothersome and painful requiring treatment. The investigators will compare the efficacy of pyruvic acid and salicylic acid in treating multiple plantar warts. Patients with multiple plantar warts will be randomized to receive either pyruvic acid 70% or compound salicylic acid solution (salicylic acid 16.7%, lactic acid 16.7%, and collodion 100%) applying topically twice a day for 4 weeks. Patients will be visited every 2 weeks for one month after starting treatment and then every one month for up to 3 months. The number and size of warts will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* aged 12 years and above
* multiple warts (at least 2)

Exclusion Criteria:

* mosaic warts
* already under any treatment for warts
* pregnant or lactating women