cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

Curcumin is shown to impact several different pathways of neuroprotection, however clinical trials have not shown positive results, due to the poor bioavailability of curcumin. This study is designed to determine efficacy and safety of high-bioavailability curcumin formulation (Longvida) in subjects with Alzheimer's disease.

Curcumin is a polyphenolic molecule that comprises approximately 3-5% of turmeric (Curcuma longa) root, giving the spice its characteristic yellow color. Because of its anti-inflammatory, anti-amyloid, and antioxidant properties, curcumin has shown positive effects in animal models of Alzheimer's disease (AD). However, a six month human study was conducted with unformulated curcumin showing insignificant trends, due to limited bioavailability and brain permeability of unformulated curcumin. In animal models of AD, oral dosing of solid-lipid curcumin particle (SLCP or Longvida) significantly reduced memory deficit and impacted biomarkers better than unformulated curcumin. This study is to determine the potential efficacy and safety of highly absorbed SLCP curcumin in subjects with AD.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female age ≥ 50.
* Diagnosed with probable AD using NINDS-ADRDA research criteria. MMSE score ≥5 and ≤20.
* No history of significant psychiatric or non-AD neurological disease.
* An available caregiver to monitor and administer medication and to accompany the subject to every clinical visit.
* On stable doses of concomitant medications for at least one month prior to starting study medication.

Exclusion Criteria:

* Current or recent major psychiatric illness that meets DSM-IV criteria (i.e. bipolar disorder, schizophrenia).
* Significant uncontrolled systemic illness (i.e. chronic renal failure, chronic liver disease, poorly controlled diabetes, or poorly controlled congestive heart failure).
* Recent history of gastrointestinal bleeding or ulceration.
* Alcoholism or substance abuse within the past year per DSM-IV criteria.
* Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein).
Rehabilitation to Patients Over 65 Years Undergoing THA

Patients over 65 years do not have a self care ability the surgery benefits them.

The aim of this study is development of a rehabilitation program based on patients' self-rated health.

1. A cross section study including 600 patients
2. RCT including 160 patients

Fase 1: 600 patients waiting for or already having received total hip-/knee-replacement participated in a questionnaire study using SF- 36. The aim was to document self-rated health among this population.

Fase 2: Results from the cross section study form the base for the RCT, where 160 patients over 65 years undergoing THR, 80 patients are in an intervention group and 80 patients in a control group. A nurse intervention program is tested, and results from the study will form the base for a structured rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:patients over 65 years undergoing total hip replacement

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Exclusion Criteria:

* patients dropping out
Study in Japan of the Safety And Antiviral Activity in Adults With Chronic Hepatitis B Current Lamivudine Therapy

The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete response to current lamivudine therapy


Eligibility Criteria:
Inclusion Criteria:

* Documentation of chronic hepatitis B infection by ALL of the following:

  1. Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy
  2. Patient who have received lamivudine therapy for 24 weeks or more, or patient who have documented YMDD mutation or other lamivudine-resistant mutation while on lamivudine
  3. Documented HBV Viremia ≥ 10\*5: copies/mL
* ALT in the range of 1.3 to 10 x ULN
* Subjects must have well-compensated liver disease a) value

Exclusion Criteria:

-
Bacteriological Link Between Upper and Lower Airways in Cystic Fibrosis and Primary Ciliary Dyskinesia

Cytobacteriological examination of sputum and bacteriological sampling in the middle meatus.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 6 years old
* Patients with cystic fibrosis or primary ciliary dyskinesia.
* Patients capable of performing an expectorations
* Patients having been informed of the research, having received the information note and not having opposed the research

Exclusion Criteria:

- Refusal to participate in the study
Study of the Composition and Bacterial Diversity of the Vaginal Microbiota in Healthy Versus Pathological Conditions (Bacterial Vaginosis) Using a Targeted Metagenomic Approach (RNA 16s)

It aims to determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).


Eligibility Criteria:
Inclusion Criteria:

* Woman aged between ≥ 18 and ≤ 45 years old,
* In good general health (outside the gynaecological sphere), i.e. no chronic pathology and not taking medication at the time of inclusion and/or long-term,
* Woman with a healthy or pathological vaginal flora according to Amsel's clinical diagnosis and Nugent's score :

Population with bacterial vaginosis (verification of at least the following 3 criteria + Nugent score):

* Vaginal pH \> 4.5
* greyish, homogenous vaginal secretions adhering to the vaginal wall
* characteristic vaginal odour of "rotten fish" after contact of the vaginal discharge with a few drops of 10% potash ("sniff test")
* Presence of "Clue Cells" in the microscopic examination of fresh vaginal secretions. Clue cells are cells of the ectocervix lined with gram-negative bacilli.

  * Nugent Score ≥ 7

Healthy population (Verification of at least 3 following criteria + Nugent score) :

* Absence of vaginal pH \> 4.5
* No greyish, homogenous vaginal secretions adhering to the vaginal wall
* No characteristic vaginal odour of "rotten fish" after contact of the vaginal discharge with a few drops of 10% potash ("sniff test").
* Absence of "Clue Cells" on microscopic examination of fresh vaginal secretions. Clue cells" are cells of the ectocervix lined with gram-negative bacilli.

  * Nugent Score ≤3

    * Able and willing to participate in the research by complying with the procedures of the protocol, especially regarding vaginal sampling,
    * Having given its free, informed and written consent.

Exclusion Criteria:

* Patient during menstruation,
* Patient who has had vaginal sex within 48 hours,
* Patient with irregular menstrual cycles,
* Patient undergoing preventive or curative treatment for vaginal infections,
* Patients suffering from other diseases of the vagina (herpes, chlamydia, syphillis),
* Patients undergoing antibiotic or antifungal treatments or taken less than 3 months ago,
* Patient under probiotic or prebiotic complementation or taken less than a month ago,
* Patient with systemic or immunodeficient disease,
* Patient with an alcohol consumption of more than 2 glasses per day,
* Pregnant or breastfeeding woman, or woman planning to become pregnant within the next 8 weeks, or woman in the post-partum period,
* Patient unable to understand information related to the study (mental or linguistic disability),
* Patient participating or having participated within the previous 3 months in another clinical trial, or in a period of exclusion from a clinical trial,
* Patient not affiliated to a social security scheme.
Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis

The purpose of this proof of concept study was to determine whether CMK389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.

This was a subject and investigator blinded, randomized, placebo-controlled, parallel-group, repeat-dose, multicenter, non-confirmatory study of CMK389 in chronic pulmonary sarcoidosis. This study investigated the safety and efficacy of 10 mg/kg CMK389 administered intravenously (i.v.) every 4 weeks for a total of 4 doses, versus placebo

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a body mass index (BMI) at screening within the range of 18 - 46 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
* Biopsy proven pulmonary sarcoidosis diagnosed \> 1 year prior to screening
* Scadding stage II, III or IV as determined by the most recent chest x-ray obtained within 12 months prior to screening or at screening (confirmed by the Investigator)
* HRCT extent of fibrosis \<20% (confirmed by the central imaging reader) at screening
* Treatment with 5-15 mg/day prednisone (or prednisone oral equivalents) for ≥ 6 months prior to screening.
* Co-medication with methotrexate or azathioprine for ≥ 6 months prior to screening (Note: hydroxychloroquine is allowed as background therapy but not required)
* Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines

Exclusion Criteria:

* Diagnosis of significant pulmonary hypertension (WHO group 5) requiring pharmacological treatment
* Active cardiac sarcoidosis requiring treatment. Inactive cardiac sarcoidosis or stable cardiac sarcoidosis not requiring treatment are permissible.
* A known diagnosis of neurosarcoidosis
* Forced vital capacity (FVC) \<50% of predicted at screening (central read)
* Modified British Medical Research Council (mMRC) dyspnea scale ≥ 3 at screening
* Concomitant treatment with leflunomide, cyclophosphamide, mycophenolate, infliximab, etanercept, adalimumab, golimumab, ustekinumab, roflumilast, pentoxifylline, and abatacept within 12 weeks of screening
* Prior treatment with rituximab, canakinumab, anakinra, and tocilizumab
* Current use of any inhaled substance, including but not limited to tobacco, marijuana products and use of electronic cigarette or vaping device, and excluding inhalers or nebulizers prescribed for pulmonary sarcoidosis
* Any conditions or significant medical problems which in the opinion of the investigator and in consultation with the sponsor, immunocompromises the patient and/or places the patient at unacceptable risk for immunomodulatory therapy
* Contraindication to FDG-PET scan investigations such as severe claustrophobia or uncontrolled diabetes
* History or current diagnosis of ECG abnormalities not due to Cardiac Sarcoidosis and indicating significant risk of safety for patients participating in the study
* A diagnosis of Lofgren's syndrome
* A history of pancreatitis
High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome

To compare the primary outcome, failure of extubation defined by the need for re-intubation and mechanical ventilation within 5 days of initial extubation and secondary outcomes, morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC) and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation period for preterm infants between 24 and 28 weeks gestation with respiratory distress syndrome.

Inclusion criteria were: 1) Preterm neonates with gestational age of 24 to 28 completed weeks. 2) In the case of twins, both neonates were included in the same treatment arm. 3) Success to wean with 24 hours to extubate. 4) Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.

Exclusion criteria were: 1) Evidence of severe birth asphyxia. 2) Known genetic or chromosomal disorders. 3) Infants delivered to mothers with ruptured membranes of more than three weeks duration. 4) Potentially life-threatening conditions unrelated to prematurity. 5) Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

Randomization A computer-generated block-randomization sequence with random block sizes was used. Infants who were part of multiple births underwent individual randomization. Clinicians opened consecutively numbered, sealed, brown envelopes immediately before extubation to determine the study-group assignment.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm neonates with gestational age of 24 to 28 completed weeks.
2. In the case of twins, both neonates were included in the same treatment arm.
3. Success to wean with 24 hours to extubate.
4. Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.

Exclusion Criteria:

1. Evidence of severe birth asphyxia.
2. Known genetic or chromosomal disorders.
3. Infants delivered to mothers with ruptured membranes of more than three weeks duration.
4. Potentially life-threatening conditions unrelated to prematurity.
5. Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.
Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines

An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe glabellar lines at maximum frown
* Understands the study requirements and signs an informed consent form

Exclusion Criteria:

* Botulinum toxin treatment in the face within 6 months prior to study treatment
Contemporary Characteristics of Penile Cancer

This study develops a prospective database of patients who are evaluated and treated for penile cancer. This will facilitate analyzing trends in cancer incidence, risk factors, treatment, complications, and tumor progression. It will also prospectively validate the importance of pathological prognostic factors previously reported and outcome related to contemporary treatment.

PRIMARY OBJECTIVE:

I. To prospectively collect data on the presenting features, management and outcome of penile carcinoma at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, The Woodlands and Bay Area Regional Care Centers.

OUTLINE:

Patients undergo data collection every 6 months for up to 15 years.

Eligibility Criteria:
Inclusion Criteria:

* All diagnosed patients with a primary penile malignancy, including those with squamous carcinoma

Exclusion Criteria:

* No patient meeting the above criteria will be excluded
Isocapnic Hyperventilation - an Alternative Method

Isocapnic hyperventilation (IHV) is a method that shortens time to extubation after inhalation anaesthesia by increasing airway carbon dioxide (CO2) during hyperventilation (HV). In two experimental studies (mechanical lung model and porcine model) and in a pilot study on patients undergoing sevoflurane anaesthesia for major ear-nose-throat (ENT) surgery, the investigators evaluated the feasibility of an alternative technique of IHV. By performing a prospective, randomised controlled study, the investigators want to further test this alternative method for IHV.

Isocapnic hyperventilation (IHV) provides an alternative method for weaning from inhalation anaesthesia which decreases the time to eye-opening, extubation and time spent in the PACU. The method is well known since at least 40-50 years and involves the maintenance of a stable CO2 level during hyperventilation, which increases the elimination of anaesthetic gas without producing hypocapnia. Studies have declared that the reduction in time to eye-opening is 50-60 % compared to a standard weaning procedure after inhalation anaesthesia.

There are several principally different ways to maintain the CO2 level during hyperventilation, where a number of technical solutions that add dead-space to the anaesthesia circuit and thereby produce rebreathing of CO2 during hyperventilation are the most studied methods so far. However, the original method of directly adding CO2 to the breathing circuit during hyperventilation could be considered in need of a re-evaluation, as modern anaesthesia delivery units and monitoring equipment to a great extent can eliminate the risk of hypercapnia, that was described with this procedure in the 1980ies.

An alternative IHV method is to directly infuse CO2 to the inspiratory limb of the breathing circuit through a mixing box while using mechanical hyperventilation by a standardised protocol. This technique was recently evaluated by the investigators, in a bench test, and in an in vivo model. Based on these studies, the CO2 dosage needed to achieve isocapnia during HV at various levels of alveolar ventilation, CO2 production and dead space was estimated and a gender- and weight-based nomogram for CO2 delivery during IHV was constructed. Furthermore, the investigators could show, in vivo, that the washout time of sevoflurane anaesthesia was one-third compared to normal ventilation. The feasibility of this IHV method was evaluated in a pilot study in humans, based on the results of our two previous experimental studies. To finalize the project the investigators now conduct a prospective randomized trial to evaluate the efficacy of the method, compared to a standard weaning procedure, after long-term sevoflurane anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for major elective ear-nose-throat (ENT) surgery after informed consent was obtained during the pre-operative evaluation.

Exclusion Criteria:

* Patients with severe pulmonary or circulatory disease
A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia

This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient
* Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis
Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism

Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.

Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.


Eligibility Criteria:
Inclusion Criteria:

* 40\~75 years old
* Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months

Exclusion Criteria:

* Pregnant or lactating women
* Severe hepatic or renal dysfunction
* Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism
* Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism
* Obviously poor compliance.
Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer

This randomized clinical trial studies a geriatric assessment intervention in predicting chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer. Assessing patients' functional status, comorbidities, psychological state, social support, nutritional status, and cognitive function before treatment may help identify vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with cancer.

PRIMARY OBJECTIVES:

I. To identify areas of vulnerability in older adults with cancer through the use of a geriatric assessment, and to identify the potential referrals to an interdisciplinary team based on geriatric assessment results.

II. To determine whether the geriatric assessment driven interventions will lead to decrease in grade 3-5 toxicity.

SECONDARY OBJECTIVES:

I. To determine whether the geriatric assessment driven interventions will lead to improvement in the following outcomes: unplanned hospitalization, average length of stay (ALOS), emergency visits, unplanned readmission rates, and advance directive completion.

II. To determine whether there is significantly better quality of life (QOL) and function in the geriatric assessment intervention group compared to the standard of care group from start of treatment to the follow-up timepoint.

III. To determine the feasibility of delivering geriatric assessment driven interventions in a community setting using telemedicine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients follow an intervention plan created by the nurse practitioner (NP) using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.

ARM II: Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a solid tumor malignancy (any stage)
* Scheduled to start a new chemotherapy regimen (any line, combination cytotoxic chemotherapy with targeted agents are allowed)
* English, Spanish, and/or Chinese speaking
* Able to provide written informed consent

Exclusion Criteria:

* Not fluent in English, Spanish and/or Chinese (because not all questionnaires have been validated in other languages)