cyrilzakka/clinical-trials huggingface dataset:
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)

The study consists in evaluating the analgesic efficacy of Gabapentin versus Placebo in the short term (72h) acute lumbosacral radiculalgia due to disc herniation.

In addition to the usual analgesic treatment, the patient will receive gabapentin or placebo.

During the three days of treatment, an evaluation of the pain and the tolerance will be performed within the two groups: experimental and control.

The objective of the study is to evaluate the analgesic efficacy of GABAPENTIN versus Placebo in 72h for hospitalised patients suffering from acute lumbosacral radiculalgia due to disc herniation.

After signing the consent form, patient's clinical data will be collected and the patient will be allocated to one treatment arm by the randomisation process (ratio 1:1 and stratified on the strong opioid intake).

Two treatment arms are possible :

* Experimental group: GABAPENTINE per os
* DAY1:300 mg
* DAY 2: 600 mg
* DAY3 : 900 mg
* Control group: placebo (same dosage per day as GABAPENTINE).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years,
* Radiculalgia or lumboradiculalgia less than 3 months (pain of a lower limb systematized to a radicular territory, possibly associated with lumbar pain),
* Inpatient management for a minimum of 72 hours after inclusion,
* Initial radiculalgia VAS ≥ 4 (moderate to severe pain),
* Concordant disc herniation between clinical symptomatology and imaging (CT or MRI) less than 3 months,
* Written consent signed by the patient,
* Affiliation to a social security system
* For women of childbearing age, use of effective contraception

Exclusion Criteria:

* Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications),
* Chronic neuropathic pain in the lower limb affected by radiculalgia,
* Lumbar infiltration performed within 72 hours prior to inclusion or unable to be performed after 72 hours,
* Patient already on Gabapentin or Pregabalin, or having taken these treatments in the 7 days prior to inclusion
* Contraindication to Gabapentin (Hypersensitivity to the active substance or to any of the excipients: corn starch, talc, yellow iron oxide, titanium dioxide, sodium lauryl sulfate, gelatin, shellac, propylene glycol, black iron oxide and potassium hydroxide)
* Creatinine clearance \< 30ml/min,
* Hemodialysis patient,
* Body weight \< 50kgs,
* Transplant patient
* Patient under guardianship or curatorship
* Pregnant or breastfeeding woman
Study of Reminding to Improve Medication Adherence in Heart Failure

This study is being done to look at how people manage their heart failure. The investigators are testing two medication reminder systems and the investigators want to know which one people like better. The investigators also want to see if they have any effect on ease of managing medication in individuals with heart failure.

A pilot and feasibility randomized trial of two medication reminder systems for patients with heart failure (HF). The investigators believe that medication reminder systems will improve adherence and will reduce the effects of cognitive impairment on medication adherence. The investigators believe that patients will accept and use a medication reminder system, but the investigators cannot specify which system will be preferred. Each has different features which may be perceived as more or less desirable.

The investigators will enroll 60 patients with HF and randomize them to four conditions in a 2 (device 1 versus device 2) by 2 (Active versus Passive) design. After enrollment in the trial, patients will be consented and will complete pretesting at Summa Health System in the Center for Clinical Trials. They will primarily undergo brief computerized cognitive testing, complete self-report measures (e.g., quality of life, depression, self-management related social support), and will give consent for medical information to be collected from their electronic medical record. They will then be randomized to condition. In-home training will be provided regarding how to use the equipment. Medication adherence will be monitored for 28 days, followed by an in-home post-test (all pre-test measures) during which the equipment is returned.

Eligibility Criteria:
Inclusion Criteria:

* 45-90 years of age
* documented systolic or diastolic heart failure

Exclusion Criteria:

* History of neurological disorder
* moderate or severe head injury with greater than 10 min loss of consciousness
* Past or current history of severe psychiatric illness. Specifically, psychotic disorders (e.g. schizophrenia) and bipolar disorder. Potential study participants will not be excluded on the basis of managed depressive or anxiety disorder. These conditions are common in HF patients and their exclusion may limit generalizability of findings.
* 5 year past or current history of alcohol or drug abuse (defined by DSM-IV criteria)
* History of learning disorder or developmental disability (defined by DSM-IV criteria)
* Renal failure requiring dialysis
* Current home telemonitoring program to assist with HF self-management
* They do not have a land-line telephone
* Cardiac surgery \< 3 months
Sedation Strategies for Therapeutic Bronchoscopy

Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for flexible therapeutic bronchoscopy
* Adult patients aged 18 to 65 years
* American Society of Anesthesiologists (ASA) Physical Status Classification I-II
* BMI 18.5-25kg/m2
* Subjects provide informed consent

Exclusion Criteria:

* Severe airway obstruction
* Coagulation disorder
* Repeat bronchoscopy (more than 3 times)
* Severe liver and renal dysfunction
* Cardiovascular and cerebrovascular diseases
* Pregnancy
* Chronic opioid user
* Drug abusers or addicts
Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)

This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, and/or fallopian tube cancer that is platinum-resistant or refractory
* Low Human epidermal growth factor receptor (HER) 3 messenger ribonucleic acid (mRNA) expression
* At least one measurable and/or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 50 percent (%)
* Negative serum pregnancy test in women of childbearing potential
* Women of childbearing potential must agree to use effective contraception as defined by protocol during and for at least 6 months post study treatment

Exclusion Criteria:

* Non-epithelial tumors
* Ovarian tumors with low malignant potential (borderline tumors)
* History of other malignancy of prognostic relevance within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma, or tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the breast
* Previous treatment with more than 2 chemotherapy regimens
* Any prior radiotherapy to the pelvis or abdomen
* History or evidence on physical/neurological examination of central nervous system disease unrelated to cancer (uncontrolled seizures), unless adequately treated with standard medical therapy
* Pre-existing peripheral neuropathy \>/= common toxicity criteria (CTC) grade 2 (applicable for paclitaxel cohort only)
* Inadequate organ function
* Uncontrolled hypertension or clinically significant cardiovascular disease
* Current known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Current chronic daily treatment with corticosteroids (\>/= 10 mg per day of methylprednisolone or equivalent), excluding inhaled steroids
* History of receiving any investigational treatment within 28 days prior to first study drug administration
* For Part 2 of the trial: prior enrollment into Part 1 of the trial
* Concurrent participation in any therapeutic clinical trial
Brain Lesions After Transcatheter Aortic Valve Replacement

The Brain lEsions after TrAnscatheter aorTic ValvE Replacement (BETTER) registry is a prospective, observational, multi-center registry aiming to assess the presence of new brain microbleeds assessed on susceptibility-weighted imaging at 3 enrolling sites, in China (West China Hospital, Sichuan University), UK (St Thomas' Hospital) and Denmark (Rigshospitalet, University of Copenhagen). The main study arm is planned to include 100 patients with symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices and 50 isolated bioprosthetic SAVR patients treated during the enrollment period as a control arm.

"Silent" stroke post-TAVR presents as asymptomatic brain ischemic lesions detected on diffusion-weighted magnetic resonance imaging (DW-MRI), with an incidence ranging from 60% to 100% in different studies. On the contrary, hemorrhagic lesions are not systematically studied given the poor visualization of small hemorrhage (i.e. microbleeds) on traditional T1, T2 or DW-MRI sequences. We have previously identified an incidence of new brain microbleeds early after TAVR of 100% with the routine use of susceptibility-weighted imaging (SWI). We hypothesize that new brain microbleeds are prevalent in patients with aortic stenosis after either TAVR or SAVR. The key objective of this registry is to evaluate the incidence, distribution and clinical impact of new brain microbleeds after transfemoral TAVR in patients with symptomatic severe aortic stenosis, in comparison with SAVR.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic severe aortic stenosis (\>60 years old) being scheduled for either transfemoral TAVR or isolated SAVR

Exclusion Criteria:

* Patients who have been diagnosed with brain cancer, brain haemorrhage, brain abscess, aneurysm, cerebral palsy, encephalitis, nervous system infection, head or neurological injury, or trauma, stroke
* Contraindications for a magnetic resonance imaging (MRI) scan (i.e. metallic implants, claustrophobia, MR-incompatible pacemakers or prosthetic heart valves)
* Unremovable dental prostheses that are deemed to affect MRI quality
* Severe coronary artery disease that is unrevascularized
* Prior stroke within the last 12 months
* Expected non-compliance concerning follow-up examinations
* Have participated in other clinical trials
ARMA for Postoperative GERD After Sleeve Gastrectomy

This study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy


Eligibility Criteria:
Inclusion Criteria:

* Patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to PPI treatment
* Pathological esophageal acid exposure, defined by DeMeester score \>14.7 or acid exposure time (AET) \>4.2% on pH study

Exclusion Criteria:

* Primary esophageal motility disorders
* Sliding hiatal hernia \>3cm
* Narrow gastric sleeve that precludes retroflexion of scope
* Gastric sleeve stricture
* Malignancy
* Pregnancy
* Patients not fit for general anesthesia
* Other cases deemed by the examining physician as unsuitable for safe treatment
* Refusal to participate
A Study Comparing Time to Intubate With and Without a Barrier Box

This study is for patients who will be having surgery and will have a breathing tube placed during intubation. The purpose of the research is to study the time it takes to use a barrier box for placement of a breathing tube. A barrier box is a clear box that sits over the head and shoulders of a patient as a breathing tube is placed. The box is used to protect the healthcare provider's exposure to coronavirus in patients who have COVID-19. The study will not include patients who test positive for COVID-19 or who are sick with COVID-19 symptoms. The researchers want to learn how long it takes to use the barrier box before it is used routinely in COVID-19 patients.

The study will have two groups of 39 patients in each group. Some patients will have a barrier box and some patients will not have a barrier box. Patients will be randomly assigned to the barrier box or no barrier box group. The study will measure the time it takes to place the breathing tube.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting for surgery needing general anesthesia with endotracheal intubation
* pre-operatively tested negative for SARS- CoV-2 virus

Exclusion Criteria:

* inability to consent or cooperate,
* children
* pregnant women
* patients with severe cardiopulmonary compromise
* American Society Anesthesiologists' (ASA) physical status 4 and 5
* Body Mass Index (BMI) \>35
* known or anticipated difficult airway
* patients with positive COVID status or unknown COVID status
* patients who reported claustrophobia in the pre-operative area
Effectiveness of Targeting Food Aid to Malnourished Children Compared to Targeting All Children Under Two Years

The objective of this study is to compare two approaches to targeting donated supplementary food to young children. The study compares the effectiveness of the widely-used curative approach where targeting is based on the child's poor nutritional status to a preventive approach which targets children in poor communities solely on the basis of age and provides supplementary food to all children aged 6-23 months. Cost-effectiveness of the two targeting approaches will also be assessed.

Under-nutrition is widespread among young children in poor countries. In many countries one of the programmatic responses has been distribution of supplementary food to under-nourished children and, often, their families. Traditionally, children under five years have been identified based on low weight-for-age or other anthropometric indicators, and those below a certain cut-off have received supplements. Typically this results in supplementation of many children in the 3-5 year age range, since they are most likely to display cumulative deficits in height and weight, and thus fall below the chosen cut-off.

However, there has been increasing evidence that the most effective period to ensure benefit from supplementary food is when children are 6 to 24 months of age. This is the period of highest growth velocity among humans and thus a period when most growth faltering occurs.

Based on this evidence, the current study aims to assess the effectiveness and cost-effectiveness of a preventive approach that targets children under 24 months as compared to the traditional "curative" approach that targets malnourished (and usually older) children under the age of 5 years.

The comparison is made in the programmatic context of a US Title II food aid distribution program implemented by an international non-governmental organization in rural Haiti. This programmatic context is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study has also involved development of new nutrition education materials and tools, aimed at enabling caregivers to prevent malnutrition. In addition, a range of program operational issues will be studied in order to yield results useful to other implementers of similar interventions.

Comparison: Comparisons will be made at the level of the program site, with service delivery points randomized either to target food supplements as in the past, based on the child's nutritional status, or to target preventively based on age. Pregnant women and lactating women with infants under 6 months of age will receive supplements under both targeting models. Effectiveness will be assessed based on two cross-sectional surveys, at baseline and two years after full implementation of the program.

Eligibility Criteria:
Inclusion Criteria:

* Family resides in community served by World-Vision Haiti's Maternal and Child Health and Nutrition Program

Exclusion Criteria:

* None
Research Report: CERITER Clinical Study - Stride One

The goal of this clinical study is to investigate the short-term impact of the use of Ceriter Stride One on the quality of gait in patients rehabilitating after a cerebrovascular accident (CVA). Stride One is a smart insole that provides real-time audio feedback (cues) to the patient when performing a certain exercise.

The main questions it aims to answer are:

* Will patients with a CVA show a qualitatively better gait pattern after training with a Stride One insole?
* Can patients maintain this improvement in gait pattern without audio feedback at the end of the training?

Participants will

* Receive daily gait rehabilitation using Stride One for 1 week
* The quality of the gait pattern was evaluated at the beginning and at the end of the week, with and without the use of Stride One
* An additional evaluation was performed three to four days after the end of therapy without the use of Stride One
* Immediately after the end of the intervention week, the patient and the treating therapist were asked about their findings regarding the use of Stride One while walking

Both therapist and patient reported an improvement in the quality of the foot roll-off pattern in 100% of cases. This improvement was also objectively determined in the data measured by Stride One, with an average of 8% improvement on Stride One general quality parameter, and an average of 25% improvement on Stride One specific quality parameter for the specific patient. Furthermore, 89% of patients indicate that using Stride One helps them to understand their physiotherapist better, and 67% of patients indicate that they can practice more and better with Stride One.

Practicing one week with Stride One generates a positive clinical impact on the gait pattern. A lasting improvement in the gait pattern without using Stride One, three to four days after the intervention, could not be demonstrated in this short time period. Further research is needed to evaluate the effect of Stride One after more long-term use.

Additional research questions are suggested.

Eligibility Criteria:
Inclusion Criteria:

* CVA, residentially admitted to the rehabilitation center in Herk-de-Stad, Belgium
* Older than 18 years of age
* Gait problems as a result of the CVA
* Able to walk safely and independently (possibly with a walking aid)
* Able to understand and sign an information and consent form

Exclusion Criteria:

* Severe cognitive problems (attention) that make it difficult to understand instructions or follow feedback
* Hearing problem
VTX-2337 in Combination With Radiotherapy in Patients Low-Grade B-cell Lymphomas

This study is to determine the safety and effectiveness of VTX-2337 (an investigational drug that stimulates the immune system) in combination with radiation therapy in treating patients with low-grade B-cell lymphoma. Patients will receive 2 low doses of radiotherapy, and 9 intratumoral injections of VTX-2337 over the course of 3 months.


Eligibility Criteria:
Major Inclusion Criteria:

* low grade B cell lymphoma
* 1 or more sites of disease appropriate for intratumoral injection
* measurable disease other than the injection site
* Performance Status of 1 or better
* Adequate bone marrow, renal and hepatic function
* No active autoimmune disease or systemic immunosuppressive drugs
* Life expectancy \> 4 months

Exclusion Criteria:

* Known HIV
* Known brain metastases
* Malignancy within last 5 yrs (basal cell or non-invasive squamous cell carcinoma OK)
* Anticoagulation therapy other than 325mg QD ASA
* Significant cardiovascular disease
* Pregnant or nursing
Nonpharmacological Methods for Children in Procedural Pain

The aim of this study was to determine the effect of the distraction cards, virtual reality and Buzzy® methods on venipuncture pain and anxiety in children aged 7-12 years.

The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. For pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. Studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. However, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable nonpharmacological methods, such as distraction cards, virtual reality and Buzzy®, can be used especially in acute settings.

Eligibility Criteria:
Inclusion Criteria:

* Due to undergo venipuncture for blood testing
* Suitable for venipuncture at antecubital location using a 21 Gauge X 1.5 inch needle
* Due to undergo venipuncture under the same environmental conditions (phlebotomy seat, heat, light, noise, etc.)
* Due to undergo venipuncture at the first attempt

Exclusion Criteria:

Children;

* had chronic diseases
* had neuro-developmentally delayed
* had visual, audio, or speech impairments
* were hospital stay for treatment
* had a history of sedative, analgesic or narcotic use within 24 hours before admission
The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis

This randomized controlled study will be conducted to examine the effects of Yoga on Sleep, Fatigue and Physical Activity in Individuals Diagnosed with Relapsing-Remitting Multiple Sclerosis.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with Relapsing-Remitting Multiple Sclerosis Being an adult between the ages of 18-65

Exclusion Criteria:

* Those who have communication problems Those with psychiatric problems Having a condition that prevents you from doing yoga