cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Innate Immunity and Aging Study

This study plans to examine biological bases of cognitive aging. The goals of the study are to better understand how immune system markers, measured in the blood and in the spinal fluid, are related to clinical features of aging over time. The study also aims to better understand how different types of biomarkers may relate to immune health and the aging process. This research may ultimately help us better understand what puts individuals at risk for cognitive decline and for Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

1. Between ages of 60-89
2. Have a reliable study partner who has frequent contact with the subject (i.e., at least twice per month) and is able to provide information about functional abilities
3. Mini Mental State Examination (MMSE) \>23
4. Clinical Dementia Rating (CDR) global score of 0
5. No informant report of significant cognitive decline in prior year
6. No evidence from the screening visit suggesting a neurodegenerative disorder (per team neurologist)
7. Willingness to complete both baseline and 2-year follow-up procedures

Exclusion Criteria:

1. Major psychiatric disorder (e.g. schizophrenia, bipolar disorder, untreated major depression within past year)
2. Neurological conditions affecting cognition (e.g. Parkinson's disease, epilepsy (onset prior than 2 years ago), head trauma with loss of consciousness \>5 min within past two years, large vessel infarct, mild cognitive impairment, or dementia)
3. CNS immune conditions and other conditions affecting cognition (e.g., multiple sclerosis, paraneoplastic encephalitides; Hashimoto's encephalopathy; systematic lupus erythematosus)
4. Systematic illness (e.g.,current cancer, renal failure, respiratory failure)
5. Substance abuse/dependence (DSM-V criteria)
6. Current medication use likely to affect CNS (e.g., long-acting benzodiazepines, neuroleptics in the phenothiazine and haloperidol families)
7. Current medication use that precludes lumbar punctures (e.g. anticoagulants, antiplatelets, heparin shots, or some other blood thinner medications: Warfarin \[coumadin\], Pradaxa \[dabigatran\], Xarelto \[rivaroxaban\]. Eliquis \[apixaban\], or Plavix \[clopidogrel\].
8. Significant sensory or motor deficits that would interfere with cognitive testing
9. Factors that preclude MR imaging (e.g., pacemaker)
10. Factors that preclude lumbar puncture
Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A

This study is to generate qualitative data to evaluate the impact of frequency of FVIII infusions on patients' satisfaction with treatment and their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient is enrolled in the BAY94-9027 extension studies or is within 3 months of having completed participation in the BAY94-9027 extension studies;
* Patient allocated to Arm 2, Arm 3 or Arm 4 of BAY94-9027 extension studies.

  * Arm 2 Prophylaxis treatment of BAY94-9027; 2 infusions per week during the extension study
  * Arm 3 Prophylaxis treatment of BAY94-9027; infusion every 5 days during the extension study
  * Arm 4 Prophylaxis treatment of BAY94-9027; every 7 days during the extension study
* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
* Patient must be willing and able to participate in a telephone interview lasting up to 30 minutes;
* Patient must have sufficient cognitive and linguistic capacities to allow them to actively participate in an interview lasting 30 minutes.

Exclusion Criteria:

* Patient is part of Arm 1: On-demand treatment of BAY94-9027 at individual dose and number of infusions based upon location and severity of bleeds;
* Patient is unlikely to comply with the study protocol (e.g. uncooperative attitude) or unlikely to complete the study for any reason in the opinion of the recruiter;
* Patient has great difficulty hearing or reading;
* Patient has any significant comorbid condition (including uncontrolled psychiatric conditions) that might limit or interfere with their ability to talk about their Hemophilia A and participate in the study;
* Patient has severe neurological or cognitive deficits that might affect their ability to participate in an interview.
Inspiratory Training in Children After Fontan

This study will assess physical and respiratory capacity, diaphragmatic mobility and quality of life. Healthy children and children who have undergone Fontan surgery will participate. Some children in the late postoperative period of Fontan surgery will be randomized to a group of inspiratory muscle training that will last for 2 months. Children after Fontan surgery will be evaluated twice, once at the beginning and again after two months of follow-up.

This study aims to evaluate physical capacity through cardiopulmonary testing, submaximal physical capacity testing by the 6-minute walk test, respiratory capacity by spirometry, respiratory muscle strength by manovacuometry, diaphragmatic mobility by ultrasound, quality of life by the AUQEI questionnaire. There are three groups, a healthy control group, a Fontan control group and a Fontan intervention group. The intervention will be done by respiratory muscle training using the Power Breath device.

Eligibility Criteria:
Inclusion Criteria:

* Age 8 to 12 years;
* Both sexes;
* No history of other heart disease;
* No history of lung and musculoskeletal diseases;
* \&gt;1 year post-operative Fontan Surgery;
* Clinically stable;
* Absence of serious arrhythmias;
* Medical clearance to participate in the study; The legal guardian has agreed to participate in the research and the child has consented

Exclusion Criteria:

* Musculoskeletal alterations;
* Patients with neurological sequelae;
* Patients with genetic syndromes associated with cognitive or psychiatric disorders;
* History of perioperative arrhythmias;
* Patients with uncontrolled heart failure;
* Recent angina;
* Severe arrhythmia;
* Hemoptysis;
* Pulmonary hypertension;
* Diaphragmatic plication;
* Moderate to severe asthma.
Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee

The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria

* Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.
* \>40 years
* Radiographic evidence of at least one osteophyte in either knee at screening

Exclusion Criteria

* Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)
* Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.
* Received arthroscopic or open surgery to the index knee within 6 months of screening
* History of joint replacement surgery (index knee).
* Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening
* Long acting hyaluronic acid injection of the index knee within 6 months of screening
* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
* History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
* Female subject with reproductive capability.
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

This study has the purpose to answer how the Lipoprotein(a) (Lp(a)) level is distributed among Atherosclerotic cardiovascular disease (ASCVD) patients in Russia, and what is the connection between elevated levels of this parameter and the cardiovascular disease (CVD) risk.

This study will consist of several phases (consecutive stages):

Phase I: a cross-sectional study of Lp(a) level with ASCVD patients

Phase II:

* A non-interventional, prospective, cohort study with the phase I patients
* A cross-sectional study of Lp(a) levels with relatives of phase I patients
* A non-interventional, prospective, cohort study with patients' relatives

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent (signed and dated).
2. Males and females aged ≥18 years.
3. Presence of one of the following ASCVDs for at least 3 months within the 2 years prior to signing the informed consent to participate in this study:

   * history of MI;
   * history of IS and/or TIA;
   * IHD confirmed by coronary angiography (stenosis ≥50%);
   * any revascularization surgery (emergency or planned), including CABG, PCI, carotid endarterectomy or carotid/intracranial stenting;
   * peripheral artery disease (intermittent claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or revascularization in case of lower limb ischemia).

Exclusion Criteria:

1. Acute infectious and inflammatory diseases, such as COVID-19, in the month leading up to the Screening visit.
2. Lp(a)-lowering therapy/methods (Lp(a) apheresis with PCSK9 inhibitors, inclisiran prior to the Screening visit) in the medical history before the Screening visit.
3. Participation in any interventional clinical study with investigational or marketed medicinal products at the time of enrollment.
4. Participation in other real-world clinical studies.
5. Stages 4 and 5 of chronic kidney disease (glomerular filtration rate CKD-EPI \<30 mL/min/1.73 m2) and/or hepatic disease (total bilirubin: 2 × ULN).

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.

The purpose of this study is to investigate the efficacy of three different modalities of post-operative pain control in parturient with opioid use disorders. The investigators aim to determine whether the different approach utilized show better outcomes with pain management and if there are any association with reduction of symptoms of anxiety, depression, and overall well-being.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include being a parturient with Substance use disorder (SUD) and age 18-35

Exclusion Criteria:

* Exclusion criteria include having a diagnosed medical condition(allergies to medication, pathology such as severe aortic stenosis excluding patients from receiving an epidural etc) that will exempt patient from intervention arm of the study.
Segmental Epidural Anesthesia (SEA) V/S General Anesthesia for PCNL

Management of nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive endoscopic technique and is used for the fragmentation and removal of stones of size more than 20 to 30 mm, staghorn stones or multiple stones resistant to ESWL. Anaesthesia for PCNL is a challenge because of the disease, surgical procedure, positioning, hypothermia,and the possibility of fluid absorption, dilutional anaemia and blood loss. General anaesthesia is the gold standard for this surgery.The advent of new drugs has refined the technique of general anaesthesia. However there are several issues related to prone position still to be addressed like accidental extubation and difficult reintubation, nerve injuries and post operative respiratory complications.

Combined spinal epidural(CSE) and only epidural anaesthesia (EA) is a well established technique of anaesthesia for upper abdomen and lower thoracic surgeries. It use has also been reported in PCNL surgeries.Segmental epidural can selectively blocks pain fibres from the surgical site. This not only allows to limit the dose of the local anaesthetics, but also limit motor and sympathetic blockade. Selective sympathetic block is associated with respiratory, cardiac, gastrointestinal and metabolic benefits. This formed the basis of our current study. In the present study the investigators aimed to evaluate the efficacy of segmental epidural for PCNL and compared it with standard technique i.e. GA.

To evaluate efficacy the investigators compared intraoperative haemodynamics, surgical clearance of stones, post operative pain, surgeon's and Patient's satisfaction scores and postoperative complications and side effects in 60 ASA I and II patients undergoing PCNL surgery who received either General anesthesia or Segmental epidural Anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA I/II
* Age - 18 years to 60 years
* Either sex
* BMI \< 30

Exclusion Criteria:

* Unwilling for consent
* ASA 3
* Obesity with BMI \> 30.
* Contraindications for Epidural Anaesthesia
* Undilated pelvicalyceal system
Effectiveness of Nefopam for Thermoregulation During Surgery

Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia

Hypothermia, whether therapeutically induced or unintentional, triggers thermoregulatory defenses including vasoconstriction and shivering. Nefopam, a non-opioid, nonsteroidal centrally acting analgesic, has an opioid-sparing effect and anti-shivering potency without sedation, making it an ideal candidate to counteract thermoregulatory shivering.

Since complete compartmental pharmacokinetics (PK) are lacking this prospective, randomized, double-blind study in 8 volunteers was set to investigate the PK of arterial nefopam samples with non-linear mixed effect modelling. A two compartment mammillary model independent of covariates was found to describe the data best and could be implemented to drive automated pumps, achieving and maintaining a desired plasma concentration.

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteers ages 18-40

Exclusion Criteria:

* history of alcohol or drug abuse
A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients, \>=18 years of age;
* HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
* candidates for chemotherapy.

Exclusion Criteria:

* previous chemotherapy for metastatic or locally recurrent breast cancer;
* concomitant hormonal therapy for metastatic or locally recurrent disease;
* concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
* previous radiotherapy for treatment of metastatic disease;
* evidence of CNS metastases.
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom

This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject has a diagnosis of definite unilateral Meniere's disease.
* Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has a history of previous endolymphatic sac surgery.
* Subject has a history of previous use of intratympanic gentamicin in the affected ear.
* Subject has a history of drop attacks.
* Subject has experienced an adverse reaction to intratympanic injection of steroids.
Effect of Portion Size Over 5 Days in Preschool Children

In this study, the investigators varied the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. The primary aim of the study is to determine the effect of varying the portion size of foods and beverages served over 5 days on energy intake in preschool children.


Eligibility Criteria:
Inclusion Criteria:

* Attending one of the designated childcare centers

Exclusion Criteria:

* Food Allergies
* Food Restrictions
* Health Issues that Preclude Participation
* Not available for duration of the study
Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women

Sacroiliac joint pain is the most causes of back pain In pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal Shock wave is new conservative treatment used in physical therapy Shock wave is most effective for sacroiliac joint pain Low level laser is a most effective pain relive and effective on sacroiliac joint pain

The study is to determine if there is any difference between the effect of shockwave and low level laser therapy on sacroiliac joint pain in postnatal women This study will be randomly distributed into two equal group Group A consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive shockwave therapy 2 session per week for 6 weeks Group B consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive low level laser therapy 2 session per week for 6 weeks

Evaluation procedures History taking recording in recording data sheet Weight and height measurement by calculate BMI Disability assessment by OWDI Pain assessment by VAS scale Assessment of pressure of pain threshold by pressure algometry

Eligibility Criteria:
Inclusion Criteria:

* postnatal women suffering from sacroiliac joint pain for at least 3 months.
* They should have moderate to severe pain .
* They should have positive findings in at least 3 of 5 provocation sacroiliac joint tests

Exclusion Criteria:

* lumber or hip joint pathology
* Acute pelvic bacterial or viral infection .
* Receiving corticosteroid injections within the previous 6 weeks
A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3

This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and effective for patients who are current injection drug users or receiving opiate substitution therapy and who are responding well to treatment early on.

The study will evaluate the feasibility, safety and effectiveness of shortened treatment for hepatitis C genotypes 2/3 in current injection drug users or receiving opiate substitution therapy. Treatment will be with pegylated interferon alfa 2b (directly observed) and ribavirin for 12 weeks in those that have non-quantifiable (\<15 IU/ml detected and \<15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 and 24 weeks in those that have quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* chronic HCV infection
* HCV genotype 2/3 infection
* active injection drug use (within 24 weeks prior to consent) or currently receiving opiate substitution therapy
* compensated liver disease
* negative pregnancy test (within 24 hours of first dose of study medication)
* effective contraception for the duration of the study
* written informed consent

Exclusion Criteria:

* previous interferon or ribavirin therapy
* investigation drug use in the 6 weeks prior to first dose of study medication
* infection with HCV genotypes other than 2/3
* HIV infection
* HBV infection
* ongoing severe psychiatric disease
* frequent drug use that is judged by the treating physician to compromise treatment safety
* standard clinical and medical exclusions for treatment with pegylated interferon alfa 2b and ribavirin
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Erythropoietin is made by the kidneys to stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood that help clot blood in case of injury. Platelets also sometimes form blood clots in blood vessels that may cause heart attacks. This study is trying to determine whether erythropoietin increases the clotting action of platelets. Information on erythropoietin in healthy subjects may eventually help in the treatment of patients with heart attacks.

Anti-apoptotic effects of erythropoietin in experimental myocardial infarction and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of rHuEpo in acute MI can be tested in large clinical trials, more information on the effects of short-term rHuEpo on platelet function are needed. Accordingly, the current proposal aims to determine the effects of 3 doses of rHuEpo (100U/kg, 200U/kg and 400U/kg daily for 3 days) on platelet function and other safety measures in healthy subjects.

Specific Aim: To determine the effects of three ascending doses of rHuEpo vs. placebo on in vivo and in vitro platelet function in healthy subjects treated with aspirin and clopidogrel.

Hypotheses to be tested: 1) 1) Short-term administration of rHuEpo does not alter bleeding time responses to aspirin and clopidogrel when compared with placebo. 2) Short-term administration does not alter in vitro platelet aggregation responses to aspirin and clopidogrel when compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-40 years
* Able and willing to provide written informed consent
* Bleeding time \<10 minutes

Exclusion Criteria:

* Any chronic medical disease
* Chronic or frequent over-the-counter or prescription medication use
* Hemoglobin \>15 gm/dl for both genders or \<13 gm/dl (men) or \<12 gm/dl (women)
* Platelet count \>400,000/µl or \<150,000/µl
* Blood pressure \> 140/90 mmHg
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters

The aim of this study is to look at the long-term safety and clinical parameters of somapacitan in paediatric participants with growth hormone deficiency under routine clinical practice conditions. The study population will include 400 paediatric growth hormone deficient participants from the Global Registry for Novel Therapies in Rare Bone and Endocrine Conditions (GloBE-Reg) treated with once-weekly somapacitan and fulfilling the eligibility criteria of the study. The total duration of the study is planned to 10 years consisting of a 5-year recruitment period in the GLoBE-Reg followed by a 5-year follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Treated with commercially available somapacitan according to local practice at the discretion of the physician.
* Primary confirmed diagnosis of growth hormone deficiency as per local practice.
* Male or female below 18 years of age at the time of signing informed consent in the GLoBE-Reg.

Exclusion Criteria:

* Participants with active malignancy or in treatment for active pre-existing malignancy.