cyrilzakka/clinical-trials huggingface dataset:
Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection

The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve.

The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediatric participants with RSV infection; b) To evaluate the efficacy of ODV on time to alleviation of targeted RSV symptoms in pediatric participants with RSV infection.

Pediatric participants will be enrolled as follows:

* Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to \< 40 kg
* Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to \< 6 kg

Eligibility Criteria:
Key Inclusion Criteria:

* Participants assigned male or female at birth, from birth to \< 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:

  * Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to \< 40 kg
  * Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to \< 6 kg
* RSV infection diagnosis ≤ 3 days prior to randomization.
* Negative test for influenza A/B, and SARS-CoV-2 infection ≤ 7 days prior to randomization.
* Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
* Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.

Key Exclusion Criteria:

* Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
* Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
* Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), ≤ 7 days prior to randomization.
* History of asthma or recurrent wheezing.
* Neuromuscular disease that affects swallowing.
* Cystic fibrosis.
* Participants who are immunocompromised.
* Alanine aminotransferase ≥ 5 × upper limit of normal (ULN).
* Abnormal renal function.
* Concurrent or previous treatment with other agents with actual or possible direct antiviral activity against RSV, received within 28 days or within 5 half-lives, whichever is longer, prior to randomization.
* Received palivizumab within 100 days, or nirsevimab within 1 year, or other RSV specific monoclonal antibody within 5 half-lives of the antibody, prior to randomization.
* Participant whose mother received RSV vaccination during pregnancy and who is \< 1 year old prior to randomization.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement

The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to Acryloc™ or Palacos® R and will be evaluated at regular intervals following hip surgery using patient, clinical, x-ray assessments and special x-rays which allow the stability of the hip implant to be determined


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects with non-inflammatory arthritis of the hip.

v) Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.

vi) Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other condition that would compromise their participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects undergoing corticosteroid treatment.

vii) Subjects with any condition for whom the use of conventional bone cement is contra-indicated.
Home-Based Exercise Training in Older Adults During the COVID-19 Pandemic

The physical fitness and functionality of older adults are affected during the COVID-19 Pandemic. Regular exercise programs are effective in physical fitness and functioning in older adults. Individualized and supervised exercise programs for older adults in a safe environment can improve physical fitness and functionality. This study aims to examine the effect of home-based and exercise training on physical fitness and functionality in sedentary older adults during the COVID-19 pandemic.

Purpose: This study aims to examine the effect of home-based supervised exercise programs on physical fitness and functionality in sedentary older adults during the Covid-19 pandemic.

Methods: The older adults participating in the study are divided into two groups as exercise group and the control group. Individual exercise training is applied to the exercise group for eight weeks, three days a week, and 45 minutes a day. This exercise training consists of a program that includes strengthening, flexibility, aerobic, and balance exercises. The control group is given only of stretching and breathing exercises. Individuals are evaluated using the Berg Balance Scale, Timed Up and Go Test, Senior Fitness Test, and Tinetti Falling Efficacy Scale before starting the study and at the end of the eight weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged between 65-85 years
2. Individuals have 24 points and above from the Standardized Mini-Mental State Examination
3. Sedentary individuals whose physical activity levels are inactive or minimally active group according to the Short form of International Physical Activity Questionnaire (IPAQ-SF).
4. Individuals who can stand for at least 90 seconds without assistance
5. Individuals who voluntarily agree to participate in the study
6. Individuals who have not suffered from COVID infection.

Exclusion Criteria:

1. Individuals who have malignancy
2. Individuals who are ambulatory with assistance
3. Individuals who have severe vision loss
4. Individuals who have a neurological disease (Stroke, Parkinson, Multiple Sclerosis)
5. Individuals who had surgery in the last six months
6. Individuals who have congestive heart failure
7. Individuals who have received exercise training in the last six months
Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section

To test the safety of high dose spinal in elective CS after prolonged sitting position.

This is a prospective double-blind randomized study, designed to include cases in two groups (using epical program for sample size calculation), one study groups and one control group (parallel). Each group should have at least 30 female patients scheduled for elective caesarean section with a total of 60 cases.

Eligibility Criteria:
Inclusion Criteria:

* Full term pregnant female indicated for the elective section under spinal anesthesia with no history of medical importance

Exclusion Criteria:

* Urgent cases, emergency cases, adverse medical history, anticoagulant treatment, associated pregnancy complication, failed spinal, surgical complication or refusal
Efficacy and Safety of Ginkgo Biloba Extract in Mild Cognitive Impairment and Cerebrovascular Insufficiency

The purpose of the study is to determine weather Ginkgo biloba standardized extract (24% ginkoflavonoglicozides and 6% terpenes) is effective in treatment of cognitive and concentration impairment

Inclusion criteria is cerebrovascular insufficiency MNSE\>20. 90 patients are divided into three groups randomly. First group is being administered 120 mg ginkgo biloba extract, second group 60 mg of the extract and the third group has being administered placebo during the period of 6 months. Methods used for evaluation are SCAG, MMSE, MDRS, VFT, CGI, TCD and color Doppler of carotid arteries. Methods used for follow up safety include: routine blood tests, biochemical tests, neurologic and physical examination, vital signs and ECG.

Eligibility Criteria:
Inclusion Criteria:

* cerebrovascular insufficiency and mild cognitive disorder (MMSE=20-28)

Exclusion Criteria:

* pregnancy
* cognitive disorder caused by psychological, metabolic endocrine nutritional and heart disorder
* alcohol or drug abuse
Diagnostic Value of Endoscopic Ultrasound Elastography and Contrast Enhanced Endoscopic Ultrasound for Differential Diagnosis of Gallbladder Polyp

Gallbladder polyps are often detected incidentally by ultrasonography. The most of gallbladder polyps are non-neoplastic such as cholesterol polyps and do not need further treatments. However, neoplastic polyps, which need additional treatments to prevent malignancy, show the same appearance on ultrasound. Clinically, the differential diagnosis between cholesterol polyps and adenomatous polyps is very important for patient follow-up and treatment. However, differential diagnosis between these two conditions is difficult using conventional trans-abdominal ultrasound.

Endoscopic ultrasound (EUS) is less affected and disturbed by subcutaneous fat or intraabdominal air, so a clearer image of pancreatobiliary system can be obtained. In addition, EUS elastography and contrast enhanced EUS are recently introduced. EUS elastography enables practitioners to evaluate the stiffness of a target lesion and compare it with surrounding tissues (strain ratio). Also, contrast enhanced EUS is used widely with additional information such as presence of vessels and enhancement pattern of soft tissues. Several studies have been published that EUS elastography can help in the differential diagnosis of pancreatic solid lesions.

Although studies have been conducted to confirm the usefulness of transabdomnial ultrasound with elastography or contrast enhancement at differentiating gallbladder polyps, no prospective studies have been conducted to evaluate the usefulness of EUS elastography or contrast enhanced EUS for gallbladder polyp. Therefore, with this prospective study, we would like to evaluate the diagnostic value of EUS elastography and contrast enhanced EUS for differential diagnosis of gallbladder polyps.


Eligibility Criteria:
1. Inclusion Criteria:

   1. Gallbladder polyp of 8-10mm or more in size confirmed by imaging tests
   2. Must be 19 years old or older
   3. With voluntary agreement to participate in the study after be informed about the necessity of EUS due to the clinical necessity
2. Exclusion Criteria:

   1. Unable to confirm histological diagnosis (ex. Patients did not underwent cholecystectomy)
   2. Younger than 18 year-old
   3. Without agreement with this study or informed consent
Biomarkers in Acute Abdomen

Background: In the emergency setting, acute abdominal pain is a diagnostic challenge, as pain is a subjective measure, and serious causes needing surgical intervention do not always meet the clinical picture. Biomarkers measuring the individual stress or pain level may aid in identifying surgical emergencies, but there are many influencing factors that have to be taken into account.

Objective: To evaluate defined stress biomarkers for their diagnostic and prognostic utility in measuring pain, and to evaluate potential influencing or confounding factors.

Design: Prospective observational study in 200 patients presenting to the emergency department with acute abdominal pain.

Estimated duration: May 2015 - May 2016 Location Setting: Emergency Department (ED) of the Hôpital Universitaire Pitié-Salpétrière, Paris, France.

Study population: 200 patients presenting to the ED with acute abdomen

Eligibility criteria:

* Inclusion criteria: Presentation at ED with acute abdominal pain, aged at least 18 years
* Exclusion criteria: no informed consent, pregnancy, homeless, no social assurance

Procedure:

Patients presenting to the ED with acute abdominal pain will be included after informed consent is given. Blood and saliva samples will be drawn initially and after 4 hours, and baseline data assessed. All diagnostic procedures results and diagnosis made by the treating physicians as well as initiated treatment will be recorded Final diagnosis and outcome will be assessed by 2-week-telephone interview.

Measurement of candidate biomarkers will be performed in collected material. Copeptin and SAA will be measured as potential biomarkers, as a control value, cortisol will be obtained. Other biomarkers will be in consideration, depending upon availability and financial aspects.

Safety evaluations: All recommendations outlined in the ICH Guidelines for Good Clinical Practice will be adhered to throughout this trial.

Sample size considerations: The number of patients of this pilote study is based on the estimate of 25 % or 50 of acute abdomen patients to have a surgical emergency.

Significance of the study: If a biomarker is found that safely discriminates between surgical urgency and harmless abdominal pain, this will spare radiologic exposure in often young patients and will aid in optimized allocation of health care resources.


Eligibility Criteria:
Inclusion Criteria:

* Presentation at ED with acute abdominal pain, aged at least 18 years

Exclusion Criteria:

* No informed consent, pregnancy, homeless, no social assurance
To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)

This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate) in participants with a urea cycle disorder (UCD) who completed the safety extensions of HPN-100-005 (NCT00947544; HPN-100-005SE), HPN-100-006 (NCT00947297; HPN-100-007), or HPN-100-012 (NCT01347073; HPN-100-012SE). The initial studies were 1- to 2-week crossover studies, and their associated safety extensions were 12-month, open-label studies. All participants who completed the initial studies were eligible to enroll in the associated safety extension studies, and new participants were also permitted to enroll directly into the safety extension studies.

The duration of treatment in this study was open-ended. Participants were to return for clinic visits as prescribed by the investigator, and were to be seen at a minimum of every 6 months. At each clinic visit, participants were queried about any adverse events (AEs) or hyperammonemic crises (HACs) that occurred since the last visit. Physical and neurological examinations were performed, and blood samples were collected for the analysis of ammonia, amino acid panels, and routine clinical laboratory safety tests. Participants underwent neuropsychological testing at baseline, every 12 months thereafter, and at the final study visit.

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects who completed Studies HPN-100-005SE, HPN-100-007, or HPN-100-012SE
* Signed informed consent by participant and/or participant's legally authorized representative
* Negative pregnancy test for all females of childbearing potential

Exclusion Criteria:

* Any clinical or laboratory abnormality or medical condition that, at the discretion of the investigator, may have put the participant at increased risk when participating
* Known hypersensitivity to PAA (phenylacetate) or PBA (phenylbutyrate).
* Liver transplant, including hepatocellular transplant
* Pregnant, breastfeeding or lactating females
The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery

Background: Breast cancer is one of the most prevalent cancers worldwide. Fortunately, survival has improved in recent years thanks to its early detection and curative treatments such as mastectomy. However, this medical procedure is associated with a range of unwanted effects such as postoperative pain and anxiety. Some studies have reported that acupuncture could be an effective treatment to control these types of symptoms, although only few studies have been conducted on women undergoing mastectomy.

Methods: This is a pragmatic randomized controlled trial with blind assessors. The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona (Spain). A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures, or standard care procedures alone. The main outcome, pain, will be assessed after the surgical intervention and 4, 10 and 30 days later using the numerical rating scale. Secondary outcomes include anxiety, use of analgesics, nausea, adverse effects, and surgical complications.

Discussion: Acupuncture is a low-cost non-pharmacological strategy. This study will help to clarify its possible role in controlling post-mastectomy adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer
* Primary breast cancer patient
* Candidate for breast cancer surgery (mastectomy)
* Aged between 20 and 70 years old
* Consenting to participate in the study and signing the informed consent form.

Exclusion Criteria:

* Have a previous history of breast cancer
* Have a previous diagnosis of a severe psychiatric disorder
* Present risk factors associated with breast cancer
* Do not speak Spanish or Catalan
* Are currently participating in another trial.
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca

This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.


Eligibility Criteria:
Inclusion Criteria:

* History of artificial tear use
* Moderate to severe signs of dry eye
* Moderate to severe ocular discomfort

Exclusion Criteria:

* Patients with uncontrolled systemic or ocular diseases.
* Have any history of refractive surgery
* Use any topical ocular medications other than those dispensed for the study, during the study

Other protocol-defined exclusion criteria may apply.
Drug-Drug Interaction Study With Aricept® (Donepezil)

The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and postmenopausal women

Exclusion Criteria:

* Medical History and Concurrent Diseases
* Gastrointestinal disease
* Gastrointestinal bleeding disorders
* History of peptic ulcer disease
* History of cholecystectomy
* History of seizure disorder
* History of asthma
* History of Chronic Obstructive Pulmonary Disease
* History of cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access
Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya

This study seeks to determine the most effective way to reach and provide pregnant women with accessible, comprehensive, and high quality HIV care and treatment.

This study uses a prospective cluster randomized design. Twelve clinics similar in size, population, and services in Migori district, Kenya that provide ANC have been randomly assigned to receive "integrated ANC, PMTCT \& HIV services" (intervention arm) or "non-integrated services" (control arm). At the intervention clinics, pregnant women will receive ANC, PMTCT and HIV care and treatment (including HAART if required) at the same clinic visit from the ANC provider. At the control clinics, women will receive antenatal care and PMTCT services with referral to the HIV care and treatment department located in the same facility. The control sites more closely resemble the current approach followed for care and treatment of HIV-infected pregnant women in Kenya. The content of ANC, PMTCT, and HIV care will be the same in the two study arms and will follow current Kenyan national guidelines. The only difference between the two arms will be the provider/location of HIV care and treatment.

Outcomes will be compared for HIV-positive pregnant women who attend intervention versus control facilities. In addition we will conduct qualitative research with health care providers at the study health facilities in order to learn provider perspectives on the two service models and to explore the effects of integration on provider job satisfaction (including work load).

Eligibility Criteria:
Inclusion Criteria:

* FOR SITE INCLUSION:

  * Each site must provide ANC services
  * Each site must provide HIV testing services for pregnant women
  * Each site must have an average of at least 20 new ANC clients per month
* FOR ENROLLMENT OF HIV-POSITIVE WOMEN:

  * All women testing HIV-positive at one of the 12 ANC clinics included in the study will be asked to participate in the study
* FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:

  * Health care staff must work within the ANC clinic at selected facilities
  * Staff must be able to read and speak English well enough to complete the informed consent process, participate in a one-on-one in-depth interview in English and complete a brief self-administered questionnaire

Exclusion Criteria:

* FOR SITE EXCLUSION:

  * If all of inclusion criteria are not met the site will be excluded
  * If site is already providing integrated ANC/HIV care services
* FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:

  * If all of inclusion criteria are not met the site will be excluded