cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae

This is a randomized, double-blind, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive GEN-004 with adjuvant or placebo. Each subject will receive up to 3 doses at 4 week intervals.

Following the third dose, subjects will be inoculated intranasally with S. pneumoniae serotype 6B. Nasal washes to identify S. pneumoniae colonization will be obtained pre-inoculation, and then 2, 7 and 14 days after inoculation.

Subjects will also be monitored for safety and tolerability throughout the dosing period, and then for 12 months after their last dose.

The purpose of this study is to evaluate the effectiveness of GEN-004 in reducing colonization rates and magnitude of colonization following the S. pneumoniae challenge.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant females, ages 18 to 55 years inclusive.
* Willing and able to provide written informed consent.
* Fluent English speakers only (for safety reasons)
* Willing to perform and comply with all study procedures including attending clinic visits as scheduled.

Exclusion Criteria:

* Prior vaccination with pneumococcal vaccine.
* History of invasive pneumococcal disease (i.e., sepsis, meningitis or pneumonia with bacteremia).
* Close contact with at risk individuals (young children \[under 5years\], immunosuppressed adults, elderly, chronic ill health).
* Current smoker or significant smoking history (\>10 pack years).
* Pregnant or breast-feeding woman.
* Women of child-bearing potential (WOCBP) who are deemed not to have sufficient, effective birth control in place for 1 month prior to vaccination and 1 month after the final vaccination.
* Allergy to penicillin or amoxicillin.
* Any screening laboratory value \> Grade 1
* Positive serologic test for HIV-1 or hepatitis C infection; positive hepatitis B surface antigen (HBsAg).
* Asthma (on regular medication) or other respiratory disease.
* Immunocompromised individuals, including those receiving corticosteroids or other immunosuppressive agents.
* Presence or history of auto-immune disease (refer to Appendix 4) regardless of current treatment.
* No antibiotic treatment within 1 week of inoculation
* Previous involvement in EHPC study inoculated with pneumococcal bacteria
* In any other clinical trial unless in observational stage or follow-up
* Diabetes, type 1 or type 2.
* Other active, uncontrolled co-morbidities that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements.

NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to first dose of Study Drug.
Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations

This study will enroll 30 adolescents with bipolar disorder (BD) who are suffering from symptoms of depression despite already taking a traditional mood-stabilizing medication. Curcumin will be added to their current medications for 8 weeks. During these 8 weeks, their mood symptoms will be assessed regularly. Height, weight, and blood pressure will also be measured repeatedly. Blood tests will be completed before treatment, after 4 weeks of treatment, and at the end of the study. Blood tests will allow us to determine whether changes in inflammation and oxidative stress explain curcumin's effect on mood. Finally, we will use sophisticated technology to measure blood vessel functioning. We have three main predictions: 1. Curcumin will improve mood symptoms without causing physical problems; 2. Curcumin will reduce inflammation and oxidative stress, and these reductions will be linked to improvements in mood; 3. Curcumin will improve blood vessel functioning, and these improvements will be linked to improved inflammation and oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* all races and ethnicities
* bipolar disorder I or II
* currently treated with lithium, divalproex, lamotrigine, and/or second generation antipsychotic
* doses stable for greater than or equal to 4 weeks
* current CGI BP score of moderate or greater
* current CDRS-R severity of greater than or equal to 35

Exclusion Criteria:

* If female, pregnant or sexually active without reliable contraception
* significant suicidal ideations (as determined by clinical interview or CDRS-R \> 3) and/or any suicidal intent, even if fleeting or non-recurrent, in the preceding 2 weeks
* substance dependence within the past 2 months
* daily antidepressant, glucocorticoid, nonsteroidal anti-inflammatory, anti-platelet, anti-coagulant, antacid, or oral hypoglycemic medication or insulin; high-dose antioxidant vitamin supplements or other natural health products that may function as an antidepressant within 30 days of baseline
* IQ\<80 or autistic disorder
* full threshold mania and/or YMRS \> 20 and/or psychosis
* hypersensitivity to curcumin/turmeric, gelatin
* dietary consumption of curcumin/turmeric \> 3 times/week
* clinically significant or unstable medical disorder; known gallstones and/or bile duct obstruction, stomach ulcers, excessive stomach acid/heartburn/gastroesophageal reflux disease (GERD); or clinically significant baseline laboratory abnormalities; or ALT and /or AST above the upper limit of normal on repeat examination at baseline
* severe depression (CDRS-R \> 98) and/or severely ill (CGI BP \>5)
The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery

The goal of this clinical trial is to compare the effect of high-calorie density formula (HDF) and standard formula (SF) in infants with congenital heart surgery. The main questions it aims to answer are:

1. Is there any difference in nutritional status between both groups after 3 months?
2. Is there any difference in calorie intake per day between both groups during hospitalization?
3. Is there any difference in clinical outcomes (mortality, duration of using mechanical ventilation, length of stay, and events of side effects) between both groups?

A group of participants will be given HDF (1 kcal/ml) from enrollment until three months. Researchers will compare them to the group of participants who are given SF (0.67 kcal/ml) to see if there is any difference in nutritional status, calorie intake, and other clinical outcomes between the two groups.

The study is a randomized, double-blind controlled trial to compare the efficacy of HDF formula compared to SF in nutritional and clinical outcomes among infants who had congenital heart surgery in Harapan Kita National Cardiovascular Centre (HKNCC), Jakarta, Indonesia.

The researchers use consecutive sampling to include eligible infants and obtain informed consent from the parent or legal guardian of infants who fulfilled the eligibility criteria. Block randomization is done by a research assistant, and then the allocation is prepared using a sealed envelope to assign infants into HDF and SF groups.

Participants are then assessed by a multi-professional team and given enteral feeds based on local guidelines. Routine follow-up is done at 2 weeks, 1 month, 2 months, and 3 months after the intervention to record weight, length, and any episode of complication or adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patient of less than 1 year of age who underwent congenital heart surgery procedure in Harapan Kita National Cardiovascular Center
* Risk adjustment for congenital heart surgery (RACHS) score 2-4
* Patients who do not get exclusive breastfeeding due to any cause

Exclusion Criteria:

* History of prematurity (\<37 weeks gestational age)
* Formula intolerance or cow milk protein allergy
* Lethal chromosome abnormality
* Galactosemia
* Gastrointestinal malformation or obstruction
* Renal failure
* Liver disease
* Metabolic abnormalities
* Need for extracorporeal membrane oxygenation

Drop-out

* Patients who develop diarrhea for more than 5 days during the study period despite getting adequate therapy
* Patients who need prolonged total parenteral nutrition (e.g., gastrointestinal bleeding due to any cause, chylothorax, etc.)
* Patients with necrotizing enterocolitis during the study period
Sensor Augmented Pump (SAP) Therapy for Inpatient CFRD Management

This research proposes a pilot study using the combination of continuous glucose monitor (CGM) and insulin pump therapy, also known as sensor augmented pump (SAP) therapy, for cystic fibrosis related diabetes (CFRD) management in the inpatient setting, with the aim of improving glycemic control.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥8 years
2. Confirmed diagnosis of CF by consensus guidelines \[50\]
3. Diagnosis of CFRD based on American Diabetes Association and CFF criteria \[51\]
4. Admission for pulmonary exacerbation

Exclusion Criteria:

1. Known type 1 or type 2 diabetes, monogenic diabetes (MODY)
2. Critical illness requiring admission to the intensive care unit
3. Admission for indications other than pulmonary exacerbation (ex. Distal intestinal obstructive syndrome, surgery)
4. Pregnancy
SAPT Versus DAPT in Incomplete Revascularization After CABG

The study aims to compare the efficacy of dual antiplatelet therapy (DAPT) over single antiplatelet therapy (SAPT) in patients with incomplete revascularization after coronary artery bypass graft surgery (CABG).

Before hospital discharge, patients will be 1:1 randomized to SAPT (acetylsalicylic acid 100 mg/die) or DAPT (acetylsalicylic acid 100 mg/die + ticagrelor 90 mg bis in die). DAPT will be continued for 12 months, and ticagrelor will be withdrawn thereafter. Primary endpoint is the evaluation of cardiac-related mortality at 5 years from hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing CABG, ± cardiopulmonary bypass, ± any associated cardiac procedures (valve replacement,...)
* incomplete myocardial revascularization, defined by anatomic or functional criteria
* obtained informed consent

Exclusion Criteria:

* acute coronary syndrome \< 12 months from surgery
* dual antiplatelet therapy at hospital admission
* planned procedure to complete myocardial revascularization (e.g. hybrid approach)
* intolerance / unable to take acetylsalicylic acid or ticagrelor
* preoperative atrial fibrillation
* impaired compliance
* planned pregnancy
* history of gastrointestinal bleeding
* chronic kidney disease (eGFR \< 30 mL/min/1.73 m2)
* chronic liver disease
* severe heart failure at hospital admission
* active malignancy
* alcohol abuse
* any clinical condition not compatible with the treatment

Exit Criteria:

* postoperative atrial fibrillation requiring anticoagulation
* postoperative hemorrhagic events (stroke, GI bleeding)
* occurrence of contraindications to acetylsalicylic acid or ticagrelor
* surgical treatment requiring DAPT withdrawn
* patient decision
Pediatric SARS-CoV-2 Infections: Course of COVID-19, Immune Responses, Complications and Long-term Consequences

Longitudinal study of 56 households with at least one member who had COVID-19 to compare the course of illness, immune responses, and long-term consequences of SARS-CoV-2 infection in HED patients with those of control subjects of the same age group. Complete households are investigated, including women who are pregnant when exposed to the virus and their newborn child(ren).


Eligibility Criteria:
Inclusion Criteria:

* household with one or more members registered as patient(s) in the University Hospital Erlangen
* at least one person \<18 years of age
* at least one household member who has or had a SARS-CoV-2 infection confirmed by a positive PCR test, detection of specific antibodies against this virus, or by development of COVID-19 symptoms after being in close contact with a person known to be infected with SARS-CoV-2
* informed consent

Exclusion Criteria:

* missing informed consent of one or more household members
* language barriers to communication that would prevent informed consent
Extended High-frequency Hearing and Speech Perception

This study examines the effects of low-pass filtering speech on speech perception.


Eligibility Criteria:
Inclusion Criteria:

* native speakers of American English
* normal hearing 250-8000 Hz

Exclusion Criteria:

* non-native speakers of American English
* hearing loss
A Phase 1 Dose Escalation Study of VX-993 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-993 at different doses in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Participants of non-childbearing potential
* Nonsmoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

* History of febrile illness or other acute illness within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

This is an open-label prospective community intervention trial to assess the impact of community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws bacterial skin infections.

Communities will be randomised to receive standard treatment for both yaws and scabies either in parallel (site 1) or in sequence (site 2).

Treatment of yaws:

Single dose of Azithromycin (30mg/kg, max 2G).

Treatment of scabies:

Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a contraindication to Ivermectin (WT\<15kg, pregnant or breastfeeding women) given in 2 doses 7-14 days apart.

Investigators will complete a clinical and microbiological assessment of bacterial skin disease at baseline and at 12 months to assess the impact of treatment on the prevalence of bacterial infection and the emergence of antimicrobial resistance.

Primary Outcome

1. Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms.

   Secondary Outcomes
2. Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms
3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms


Eligibility Criteria:
Inclusion Criteria:

* All community members are able to be included in the study.

Exclusion Criteria:

* Allergy to any of the components of the allocated drug regimen
Nursing Home Pain Management Algorithm Clinical Trial

Pain assessment and management deficiencies in nursing homes (NHs) are well documented. Unrelieved pain in this setting results in poorer resident outcomes, including depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm coupled with intense diffusion strategies in improving pain, physical function and depression among NH residents. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in resident outcomes and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain in severely cognitively impaired residents who are unable to provide self-report.

Inadequate pain management in nursing homes (NHs) is well documented. Unrelieved pain in this setting results in depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm delivered using intense diffusion strategies. Outcomes are facility pain practices and residents' pain, physical function and depression. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in resident outcomes and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain in severely cognitively impaired residents who are unable to provide self-report.

Eligibility Criteria:
Inclusion Criteria:

* long-term nursing home residents,
* 65 years and older,
* with moderate or greater pain in the week prior to screening,
* residing in a participating facility,
* who consent to participate (or whose surrogate decisionmaker consents to participation)

Exclusion Criteria:

* short-term stay patients,
* persons less than 65 years,
* residents on hospice
Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation.

The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with short-term persistent AF.


Eligibility Criteria:
Inclusion Criteria:

1. Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
2. Patients presenting with Persistent AF with AF duration \< 2 years scheduled to undergo a PVAI procedure
3. Age range of 18 - 85 years
4. Patients with already implanted devices with AF detection capabilities (for clinical indications): ILR implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber PM, ICD or CRTD and an existing functional atrial lead.
5. Patients must be able and willing to provide written informed consent to participate in the clinical trial.

Exclusion Criteria:

* Congenital heart disease, age younger than 18 years, significant valve disease, LA size \>55 mm, and severe heart failure (ejection fraction \< 30% and/or New York Heart Association class IV).
* Presence of a mechanical prosthetic valve.
* Secondary causes of atrial fibrillation
* Documented intra-atrial thrombus or another abnormality which precludes catheter introduction.
* Social factors that would preclude follow up or make compliance difficult.-
* Patients who are or may potentially be pregnant Previous left atrial catheter ablation or MAZE procedure.
Left Cardiac Chambers Size in Obese Individuals and Its Relation to BMI and Waist Circumference

Aim of study:

To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals.

1. Primary outcomes:

   -To determine if there is relation between left cardiac chambers size ,BMI and waist circumference in obese individuals.
2. Secondary outcomes:

   * To determine the effect of obesity on heart health in obese individuals.

Body mass index and waist circumference are important measurements of our bodies as they can affect our health.The person is obese if he has BMI equal 30 or higher.Increased risk of obesity related disease occurs in men with waist circumference equal 102 cm or more and woman with waist circumference equals 88 cm or more. increasing BMI and waist circumference can increase risk of type 2 diabetes mellitus ,hypertension ,cardiovascular disease and cerebrovascular accidents.There are many diseases that can affect left cardiac chambers size like aortic, mitral valvediseases,hypertension and atherosclerosis.Screening of patients heart by echocardiography allow us to detect changes in the muscle of heart and this allow doctors to put treatment plan to patient to prevent heart health from deterioration. In this study the investigators want to know if there an association between left cardiac chambers size ,BMI and waist circumference in obese individuals.

Eligibility Criteria:
Inclusion Criteria:

* 1-Patient age 18 years old or above. 2-Patient BMI 30kg/m2 or higher . 3-Patient waist circumference in men 102cm or more and in women 88cm or more. 4-Obese patient with comorbidities (e.g DM,HTN).

Exclusion Criteria:

* 1-Patient age 18 years old. 2-Patient BMI less than 30 kg/m2. 3-Patient waist circumference in men less than 102cm and in women less than 88cm.
Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression

Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions


Eligibility Criteria:
Inclusion Criteria:

* any patient with large cystic lesion

Exclusion Criteria:

* any patient can't follow home instructions
Arthroscopic Repair Of Partial Thickness Articular Side Rotator Cuff Tears Using Transtendon Versus Conversion Repair Techniques

This study aims to compare the functional results of patients who underwent two different arthroscopic methods for the management of articular-sided partial-thickness rotator cuff tears (PT-RCTs).

The present study aims to compare the functional results following the repair of PT-RCTs using the conversion versus the trastendon techniques

This is a prospective randomized study carried out at a tertiary trauma center between October 2022 and June 2023. The research ethical Committee authorized this study protocol \[(Institutional Review Board (IRB) number: N-383-2023)\], and all participants signed an informed consent prior to joining the study. This study included 50 patients with PT-RCTs who underwent arthroscopic repair using either the conversion technique (25 patients) in group A or the transtendon technique (25 patients) in group B. The random assignment of all patients to enter either group was computerized using simple randomization.

Eligibility Criteria:
The inclusion criteria were:

* Patients suffering symptomatic PT-RCTs exceeding 50% of the tendon thickness, documented by preoperative magnetic resonance imaging (MRI) and confirmed by arthroscopy intraoperative.
* Failure of nonoperative management for at least 3 months.

The exclusion criteria were:

* Prior shoulder surgery.
* Severe concomitant pathologies including glenohumeral arthritis, advanced subscapularis tear, and biceps tendon rupture.
* Associated Bankart lesion.
* Patients with uncontrolled Diabetes mellites.
Clinical Effect of a Nasal Former in Nasal Deformities

Investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Healthy adults with skewed, humped or broad nose, who are able to attend all follow-ups

Exclusion criteria:

* Inability to keep the research plan
* Allergies to components of the nasal brace
* Diseases of the bone metabolism
* Medication affecting bone metabolism
* Drugs or alcohol abuse