cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years

The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In addition the antibody response to the four dengue virus serotypes will be evaluated.

The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to assess safety and immunogenicity in healthy adults and children living in dengue endemic countries.

The study enrolled 360 healthy participants. The study was conducted in 2 parts, Part 1 - age descending and and Part 2 - expansion - ages 1.5-11 years. Participants were allocated to one of the four age cohorts in Part 1 (21 to 45 years, 12 to 20 years, 6 to 11 years, and 1.5 to 5 years) and expansion age cohort 1.5-11 years in Part 2. Participants were randomized in 2:1 ratio and in 3: 1 ratio in Part 1 and 2 respectively to receive:

* TDV 0.5 mL SC injection
* Placebo (inactive solution) - this is a solution that looks like the study drug but has no active ingredient

This multi-center trial was conducted worldwide. The overall time to participate in this study was up to 37 months (including screening period). Participants made multiple visits to the clinic including a final visit at Day 1080.

Eligibility Criteria:
Inclusion Criteria:

* In good health as determined by medical history, physical examination including height and weight
* Normal safety laboratory values at screening
* Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies \& Hepatitis B surface antigen
* Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception
* Weight: Within 1.3 times of the upper limit of local normal age-adjusted body mass index (BMI)

Exclusion Criteria:

* For participants ≥12 years, clinically significant electrocardiogram (ECG) findings
* History of significant dermatologic (skin) disease within last 6 months
* History of diabetes mellitus
* History of thymic pathology, thymectomy, myasthenia or any immunodeficiency
* History of recurring headaches or migraines
* Hypersensitivity to any vaccine
* For participants ≥12 years, positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
* History of alcohol abuse
* Pregnant or lactating female
Differences in Brain Derived Neurotrophic Factor Levels Between Chronic and Asymptomatic Pain Patients

A case-control study will be conducted to analyze the differences in BDNF levels between patients with chronic pain and asymptomatic people.

Brain-derived neurotrophic factor (BDNF) is considered a biomarker of brain plasticity. Since different alterations in brain plasticity have been found in chronic pain patients, the investigators want to study whether there are differences at the molecular level in this population compared to an asymptomatic population in order to be able to accurately measure the impact of different physiotherapy interventions in an objective way.

Eligibility Criteria:
Inclusion Criteria:

* males and females aged 18 to 65 years with musculoskeletal pain for a minimum of 3 months
* patients recruited by information pamphlets from the university clinic of the Rey Juan Carlos University, and CSEU La Salle
* not having received physiotherapy treatment for this same process in the last 3 months.
* ability to perform all the clinical tests and to understand the study process, as well as to obtain informed consent.

Exclusion Criteria:

* Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.
Communication Intervention for Fecal Ostomy Surgery

In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention.

In this study the investigators are trying to understand the feasibility and acceptability of a psychologically informed communication guide for fecal ostomy Surgery with the overall goal of improving biopsychosocial outcomes of patients undergoing fecal ostomy surgery.

An estimated 100,000 people in the US undergo fecal ostomy surgery (colostomy or ileostomy) each year, frequently to address severe symptoms (i.e., obstruction, perforation, and incontinence) due to colorectal cancer, diverticulitis, and pelvic floor dysfunction. Complication rates after fecal ostomy surgery are high (up to 37%) with negative effects on patient and family quality of life. Surgeons do not traditionally identify and address health outcomes patients with serious illness prioritize when making treatment decisions, such as caregiver burden, loss of independence and psychosocial function. Communicating this information is key to address patient anxiety when facing major surgery and ensure caregiver preparedness among patients and families considering fecal ostomy surgery.

Current surgical guidelines support the use of preoperative communication and education interventions to improve psychosocial adjustment after fecal ostomy surgery based on expert opinion. However, little evidence exists evaluating the impact of communication interventions or content needs of patients undergoing fecal ostomy surgery or their family. Despite these guidelines, a recent study notes that inadequate ostomy education remains a frequent concern among patients undergoing fecal ostomy surgery. Furthermore, patients' perception of inadequate education is associated with poor emotional, social, and marital outcomes after surgery. There is a critical need to address this deficit in communication quality between patients undergoing fecal ostomy surgery, their family, and surgical care providers. Our guiding hypothesis is that development of a Communication Intervention for fecal ostomy Surgery (CI-oSurg) is acceptable to patients and clinicians, and will ultimately reduce patient distress and improve quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. English fluency and literacy
3. Patient planned to undergo elective fecal ostomy surgery

Exclusion Criteria:

1. Deemed inappropriate by the surgery team
2. Unable to provide consent due to severe cognitive impairment or physiologic status (septic shock/intubated)
Hardware Removal After ORIF of Ankle Fractures

Ankle fractures account for 10 % of fractures in the adult population. A part of patients (40%) is treated surgically. After healing of the fractures, about one year after the operation, a surgery is often performed to remove the hardware in order to diminish pain. If this surgery is necessary is debated in the literature.

The aim of our study is to evaluate the outcome of hardware removal surgery after a surgery of the ankle for a fracture. For that, we will perform do a controlled randomized trial with two arms: one arm includes the participants who will have a hardware removal and the other arm will not have a surgery.

Outcome parameters are the patients reported outcome and pain related disability. They will be assessed by the questionnaires FAAM score (Foot and Ankle Ability Measure) and PDI (Pain Disability Index) at the beginning and at the end of the study, at six months. The third outcome parameter will be the complication rate after an anklehardware removal surgery, which will be assessed through the Ernst-Ssink classification.

The study consists of a prospective multicentric parallel two-arm randomised non-blinded study, conducted at the HFR and RHNe (level of evidence II).

The planned intervention is the following: after an ORIF of the ankle, patients have a follow-up. At the 12- month control, we ask eligible patients if they want to participate to the study. If they agree, they are randomised to treatment recommendations in one of two groups: conservative or surgical. The patients may follow or not the recommendations; not following the recommendations does not exclude them from the study. Patients of both groups will fill out FAAM and PDI questionnaires at 12 and 18 months after the 1st operation. Patients in the surgical group will have a hardware removal surgery. It is a very common operation consisting of hardware removal that is done ambulatory by the orthopaedic surgeons specialized in foot and ankle surgery. Operated patients will have the usual postoperative follow-up (6 weeks, 3 months and 6 months postoperative) and all complications will be recorded and classified according to the Ernst-sink classification

Eligibility Criteria:
Inclusion Criteria:

* \>18 y.o
* Operative treatment of ankle/foot fractures at HFR or RHNe:
* Ankle fractures: bi-malleolar and tri-malleolar fractures or equivalent
* FAAM score \>5%, \<95%
* Patient expected to complete length of study
* Patient with sufficient cognitive and linguistic ability in order to participate in the study.
* Operable patients (ASA score ≤3)

Exclusion Criteria:

* Absolute indications for HR: infection/malunion/allergy to metal/refracture
* Ankle fractures that are not listed in the criteria above
* Patient treated for a fracture at the same foot/ ankle before
* Patient with fracture of two different regions of the foot/ankle
* Patient treated for the fracture outside of HFR and RHNe
* Patient non ambulating before time of injury
* Patients having diabete,
* immunocompromised under chemotherapy,
* Peripheral artery disease stade IV
* Pregnant patients
Fosamax Bone Loss Study: Alendronate to Prevent Bone Loss

This is a study to determine if Fosamax (alendronate), a medication approved by the Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in postmenopausal women, is effective in decreasing the rate of bone loss which often begins to increase in the three to five years preceding the menopause (perimenopausal transition).

During the three to five years prior to the menopause, the rate of bone loss increases. One way that physicians treat this is with oral contraceptive medication. However, the incidence of complications from oral contraceptives after the age of 40 increases. Therefore, a non-hormonal means of preventing bone loss should be useful. Fosamax (alendronate) is in a class of compounds called bisphosphonates. This study is being done to determine whether Fosamax can be used to prevent the increased rate of bone loss during the perimenopausal transition.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 40-54 with symptomology of perimenopause including hot flashes, irregular periods and vaginal dryness.

Exclusion Criteria:

* Women should not be on hormone replacements, oral contraceptives, or bone mineral enhancing medications (bisphosphonates, selective estrogen receptor modulators \[SERM's\], parathyroid hormone \[PTH\], calcitriol, fluorides)
* They should not have any abnormalities of the esophagus which delay esophageal emptying
* They should not have hypocalcemia or severe kidney disease
* Their bone mineral density (T-score) should not be greater than 2 standard deviations.
Non-invasive Monitoring of Miscarriage

cfDNA is extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.

Pregnancies achieved by assisted reproductive technologies (ART) are closely monitored, therefore miscarriages that occur very early in the pregnancy are frequently meticulously recorded and reported. On the other hand, spontaneous abortion rates among naturally occurring conceptions are notoriously hard to quantify and are often overstated when using criteria from assisted reproductive technologies. Additionally, women who have undergone treatment with ART are a particular population with traits that can make them more vulnerable to spontaneous abortions.

cfDNA would be extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-45 years.
2. Women who attend the early pregnancy loss clinic or Patients who receive ART
3. Their partner, the biological father of the pregnancy

Exclusion Criteria:

* History of psychological/ psychiatric problem
* Patient refusal
European Multi-center Post Market Study of the IBV Valve System

The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.

The IBV Valve System (Spiration Inc. Redmond, WA) has CE Mark approval for the treatment of diseased and damaged lung. The devices are one-way valves that can be placed in the airways via flexible bronchoscopy limiting airflow distally. For the treatment of emphysema, valves are placed in airways communicating to the most diseased areas of lung tissue to re-direct airflow to less diseased areas. A multicenter, blinded and randomized study of these valves is being conducted in 7 centers in 6 European countries. The study is evaluating the effectiveness of this therapy for the treatment of upper lobe predominant emphysema in patients with severe to very severe emphysema (GOLD classification 3 to 4) that despite best medical management continue having poor quality of life, severe symptoms and physical limitations. The primary endpoints are to measure and compare responses using the St. George's Respiratory Questionnaire and lung volume changes as measured by CT-scans. Consented patients that meet the strict inclusion criteria have a bronchoscopic procedure and are randomized into treatment or control (no valves) groups. After the procedure, all patients stay blinded to their group assignment and have follow-up evaluations at 1 and 3 months. After the 3-month evaluation, each patient is un-blinded. The treatment group is then scheduled for an additional follow-up at 6 months and the control group is offered valve treatment (rollover) and evaluated approximately 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* Between 40 and 74 years of age
* Predominantly upper lobe emphysema and severe dyspnea
* Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
* Physical ability to participate in the study by performing a 6-minute walk distance of \> 140m
* No cigarette smoking for 4 months and willing to abstain throughout the study
* Severe airflow obstruction defined by FEV1 45% of predicted
* Severe hyperinflation defined by: TLC \> 100% of predicted and RV \> 150% of predicted

Exclusion Criteria:

* Between 70 and 74 years of age and an FEV1 or DLCO \< 20% of predicted
* Severe gas exchange abnormalities
* Major medical disease that will limit evaluation, participation or follow-up
* Active asthma component to their disease
* Giant bulla (\> 1/3 volume of lung)
* Severe pulmonary hypertension
* Requirement for \> 6L02 to keep saturation \> 90% with exercise
* Evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period
Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease

The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics as well as Clostridium difficile Diarrhea.

Inpatient adult males and females who are at least 18 years of age or older, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics. The setting is an academic hospital.The patients are screened and potentially recruited upon initiation of antibiotic treatment regardless of indication for antibiotic prescription. The participants are patients being admitted to any inpatient units of the hospital for treatment with antibiotics. Exclusion criteria is:

* Diarrhea on admission or within the preceding week
* Reported recurrent diarrhea
* Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
* Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
* Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
* Bowel surgery causing liquid stools
* Regular probiotic intake before admission
* Lactose intolerance or intolerance to dairy products.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient adult males and females who are at least 18-89 years of age, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics.

Exclusion Criteria:

* Diarrhea on admission or within the preceding week
* Reported recurrent diarrhea
* Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
* Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
* Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
* Bowel surgery causing liquid stools
* Regular probiotic intake before admission
* Lactose intolerance or intolerance to dairy products
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

This is a multicenter, parallel multicohort, phase 2, single-arm study for adjunctive treatment in participants with high-risk myeloid malignancies undergoing allogeneic HSCT. The purpose of this study is to assess the safety and preliminary efficacy of off-the-shelf (OTS) ex vivo expanded NK cells (SAR445419) in improving relapse free survival (RFS).

The expected duration of the study for a participant is about 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 (Cohort A - MAC) or 18-75 (Cohort B - RIC)
* Participants with high-risk AML/MDS who are scheduled to undergo stem cell transplantation with matched sibling donor (MSD), matched unrelated donor (MUD) or haploidentical donor sourced HSCT
* Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) ≤ 3 (cohort A / MAC participants only)
* Adequate major non-hematopoietic organ system function
* Karnofsky performance score ≥70%
* Body weight ≥45 kg

Exclusion Criteria:

* AML beyond CR1
* Presence of FLT3 mutations
* Uncontrolled bacterial, viral, or fungal infections at time of enrollment
* Positive test for human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)
* Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or chronic infection
* Diagnosis of prior immunodeficiency or organ transplantation requiring immunosuppressive therapy
* Active or chronic autoimmune condition requiring systemic immunosuppressive or immunomodulatory therapy
* Prior allogeneic transplantation
* HSCT graft DSA ≥3000 MFI
* Current use of systemic corticosteroids at physiologic doses ≤ 0.2 mg/kg/day of prednisone or equivalent
* Use of checkpoint inhibitor therapy within 4 weeks prior to the start of HSCT conditioning regimen The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Felodipine Extended-Release Tablets Under Fasting Condition

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Felodipine Extended-Release Tablets USP 10 mg and Innovator's (Mylan Pharmaceuticals Inc., USA) Felodipine Extended-Release Tablets USP 10 mg. Dosing periods were separated by a washout period of 17 days during fasting study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

* Healthy males within the age range of 18 to 50 years.
* A body mass index within 18-25 Kg/m2.
* Given written informed consent to participate in the study.
* Absence of diseases markers of HIV 1 \& 2, Hepatitis B \& C virus and RPR.
* Absence of significant disease or clinically significant abnormal laboratory
* values on laboratory evaluation, medical history and physical examination during the screening.
* A normal 12-lead ECG.
* A normal chest X-Ray.
* Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol.
* No history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.
* No history of allergic rash.
* No history of significant systemic diseases.
* No history of psychiatric disorders or addiction to any recreational drug or drug dependence.
* No donation of blood within 56 days prior to study check-in.
* No participation in any clinical study within the past 56 days.
* No receipt of any prescription drugs or OTC products, with in two weeks prior to study check-in.
* No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in.
* No family history of neurological disorders.
* Not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in.
* Negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period.
* Not consumed grape fruit juice within the 48 hours prior to study check-in.

Exclusion Criteria:

* Blood pressure Systolic\> 140 mm Hg and \< 110 mm Hg Diastolic\< 70 mm Hg \> 90 mm Hg
* History of seizures
* History of alcohol consumption for more than 2 units/day.
* High caffeine or tobacco consumption
* History of difficulty with donating blood or difficulty in accessibility of veins.
* Any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons.
* Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study