cyrilzakka/clinical-trials huggingface dataset:
Real-Time Instrument for Acetabular Shell Positioning

The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty.

The investigators will enroll 44 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of real-time instrument from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments.

The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.


Eligibility Criteria:
Inclusion Criteria:

Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:

* Primary, unilateral anterior or posterior total hip arthroplasty
* 18 to 85 years old at time of surgery
* Able to get a pre- and post-operative CT scan at the Cleveland Clinic

Exclusion Criteria:

* Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
* Pregnancy
* Incarceration
* Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19

This study is a combined Phase 1 and Phase 2 study with IV infusion of NGM621 to evaluate the safety, tolerability, and PK in healthy volunteers (Part 1), and safety, tolerability, PK and efficacy in subjects with confirmed SARS-CoV-2 infection (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result prior to dosing.
* Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must use an effective method of contraception during the study, for at least 1 month following study completion, and must not plan to become pregnant for at least 1 month after her last study medication dose.
* BMI 18-32 kg/m2 inclusive
* Ability to understand and provide informed consent
* Subjects confirmed with SARS-CoV-2 infection by PCR and hospitalized
* If on mechanical support, less or equal than 2 days on mechanical ventilation or oxygenation

Exclusion Criteria:

* Currently enrolled in another investigational protocol to treat SARS-CoV-2 infection
* Known history of complement deficiency
* Active infection with, or history of, compllicated pneumococcal or Neisseria meningitis infection or history of unexplained, recurrent infection, within the last 60 days prior to dosing.
An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly

The present study is planned as an expanded treatment protocol to provide acromegalic patients for whom medical therapy is appropriate access to pasireotide LAR while regulatory approval for pasireotide is sought.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of active acromegaly with elevated IGF-1 (\>ULN) and random GH (\>1 μg/L) within 30 days of screening.
* Patients who are not controlled by pituitary surgery or who are not eligible for or refuse surgery.
* For patients on medical treatment for acromegaly the following washout periods must be completed before screening assessments are performed:

  * Dopamine agonists (bromocriptine, cabergoline): 4 weeks
  * GH-receptor antagonists (pegvisomant): 8 weeks
  * Somatostatin analogues: no washout period required
* Karnofsky performance status ≥ 60.

Exclusion Criteria:

* Concomitant treatment with somatostatin analogues unless concomitant treatment was discontinued 28 days before first pasireotide LAR injection is administrated.
* Concomitant treatment with growth hormone receptor (GHR)-antagonists or dopamine agonists unless concomitant treatment was discontinued and the washout period was completed before the screening assessments are performed.
* Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.
* Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression.
* Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks of screening.
* Patients who have received radiotherapy of the pituitary within 4 weeks prior to screening or have not recovered from side effects of radiotherapy.
* Patients who have a history of hypothyroidism and who are not adequately treated with stable doses of thyroid hormone replacement therapy.
* Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix).
* Diabetic patients whose blood glucose is poorly controlled.

Other protocol-defined inclusion/exclusion criteria may apply.
Retrospective Observational Study to Define HBsAg Loss With or Without Seroconversion to antiHBs in Patients With Chronic Hepatitis by B Virus Treated With Nucleoside/Nucleotide Analogs

Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Chronic hepatitis B (HBeAg+ or HBeAg-)
* HBsAg loss
* Treated with nucleoside/nucleotide analogues
* With or without previous interferon (IFN/PEG-IFN)
* Patients with HBsAg loss after 2006
* Immunocompetent patients

Exclusion Criteria:

* Spontaneous HBsAg loss
* HBsAg loss while treatment in monotherapy or combinated with IFN or PEG-IFN.
* Patients with hepatitis delta virus (HDV) coinfection.
* Patients with hepatitis C virus (HCV) coinfection.
* Patients with HIV coinfection.
* Patients with liver transplant.
* Patients with reactivated hepatitis B virus (HBV) by immuno-suppressive treatment.
Biofeedback and Hydrogen Water as Treatments for Chronic Fatigue Syndrome

The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.

The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and over the counter (OTC) supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.

Participants will be randomized to one of the three study condition, HRV-BF alone, hydrogen water alone or combined HRV-BF and hydrogen water. All interventions are home-based with no in person visits. All communications with participants will be via virtual call, phone call, email and land mail.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-65. - BMI\>30.

Exclusion Criteria:

* Other major medical condition or regular medication that produces fatigue. No home computer or internet access. No smart phone.
Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

The purpose of this preliminary report is to retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18years of age at the time of procedure

  * patients with localized lipodystrophy in the medial or lateral thigh, and visible cellulite of laxity in the lower extremity or buttocks
  * BodyTite treatments performed from January 2018 - May 2019 for Cellulite indication

Exclusion Criteria:

* active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scaring. o BodyTite treatments performed from March 2018 - May 2019 for lipodystrophy and cellulite of laxity
A Bioequivalence Study of APX001 High-load and Low-load Tablets

A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
* Minimum body weight of 50 kg.
* Screening hematology, clinical chemistry, coagulation, and urinalysis consistent with overall good health and having an estimated glomerular filtration rate (eGFR) \>80 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula.

Exclusion Criteria:

* Having any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.
* History or presence of neurological disorders including abnormal movements or seizures.
* History or presence of malignancy within the past year. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
* Significant and/or acute illness or chronic infection, as judged by the investigator, including, but not limited to: upper airway infection, urinary tract infection, or skin infection within 30 days prior to the first study drug administration.
* Taking any drug or herbal CYP3A modulator (e.g., erythromycin; St. John's Wort) within 4 weeks (or 5 half-lives, whichever is longer) or any other nutrients known to modulate CYP3A activity (e.g., grapefruit juice; Seville orange) within 2 weeks prior to the first admission.
A Study to Measure Relationship Between Antimüllerian Hormone and Initial Dose of Menopur®

AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first IVF/ICSI cycle in the current practice.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between \[18-42\] years.
* Both ovaries present.
* Regular menstrual cycles presumed to be ovulatory.
* Primary or secondary infertility of any origin for more than 12 months.
* Patient with at least one result of antimüllerian hormone (AMH) measured by a fully automated assay available before inclusion, and performed in the past 12 months before inclusion.
* Candidates eligible to a first IVF/ICSI cycle and for whom Menopur® HP-hMG 600 IU/mL has been prescribed.
* Having received oral and written information on the study, without any objections for the use of his/her anonymized data, and having signed a written Informed Consent Form.

Exclusion Criteria:

* Major uterine or ovarian morphological abnormalities or past ovarian surgery.
* Endometriosis stage III/IV.
* Polycystic ovarian syndrome.
* Major endocrine or metabolic abnormalities without treatment.
* Patient included in an interventional study assessing treatment for infertility.
Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.

Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 4(RI4) developed by Real Imaging. This technology generates 3D metabolic maps and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor. The procedure is non-invasive, comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.

The purpose of this clinical study is to assess the ability of this novel technology to detect clinically occult breast cancer in a cohort of women that are at high risk for breast cancer.

We hypothesize that the combination of screening mammography and metabolic screening (3D MIRA) will result in significantly higher breast cancer detection rates.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Woman has read, understood and signed the inform consent form
* Age: 20 years and older
* Women who are asymptomatic for breast cancer
* Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models
* Women scheduled to undergo routine mammography and/or US or MRI screening

Exclusion Criteria:

* Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan
* Women who had a lumpectomy surgery
* Women who had undergone mastectomy and/or reconstruction
* Women who have undergone any type of breast surgery throughout the 6 months preceding the study
* Women who have had a breast biopsy performed throughout the 10 weeks preceding the study.
* Women who have a fever on the day of the MIRA imaging
* Women who are pregnant
* Women who are breast-feeding
* Women who had undergone breast reduction/augmentation
Green Coffee Effect on Metabolic Syndrome

The present study aimed to investigate the effect of green coffee bean extract (GCBE) on the inflammatory biomarkers in obese patients with a metabolic syndrome via analyzing some inflammatory biomarkers as resistin, TNF-α, total sialic acid, homocysteine, high sensitivity C-reactive protein (hs-CRP) and anti-inflammatory cytokine, adiponectin

160 obese patients supplemented with either GCBE capsules (800 mg) daily or placebo for 6 months and advised to take a balanced diet. Blood samples were collected at baseline and after three months of supplementation

Eligibility Criteria:
Inclusion Criteria:

Participants were enrolled if they were

* aged 20-60y
* waist circumference \>102 cm in male; 88 cm in female
* triglycerides ≥150 mg/dL (1.7 mmol/L)
* HDL-C\<40 mg/dL (1.03 mmol/L) in males \& \<50 mg/dL (1.29 mmol/L) in females
* systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg.

Exclusion Criteria:

* liver, kidney, coronary artery disease, type I diabetes, autoimmune diseases, cancer, infection, smoking, recent major surgery, routine coffee consumption, pregnancy or breast-feeding, use of anti-inflammatory drugs, corticosteroids, hormone replacement therapy, weight-loss and anti-hypercholesterolemic medications three months or less prior to enrolment
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura

The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with Henoch-schönlein purpura.

The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.For all patients,rhIL-2(500,000 unit per square meter) infusions seven days;recurrent patients were applied again for 7 days;patients who were diagnosed HSPN were treated on a routine basis for 7 consecutive days, and then once every two week for 3months.

Eligibility Criteria:
Inclusion Criteria:

1. age \<18 years old
2. meet the EULAR/PRINTO/PRES for the diagnosis of HSP
3. HIV negative;Negative for HBV and HCV.

Exclusion Criteria:

1. heart failure (cardiac function ≥ grade III NYHA)
2. liver insufficiency (upper limit of normal range of transaminase \> 2 times)
3. renal insufficiency (creatinine clearance ≤30ml/min)
4. acute or severe infections such as bacteremia and sepsis
5. malignant tumor
6. high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month
7. mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
8. Intestinal ischemia or perforated gastrointestinal bleeding requires surgery
9. Inability to comply with IL-2 treatment regimen.
The Association of Pelvic Organ Prolapse Severity and Urinary Symptoms and Sexual Function

Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.

Women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. Therefore, the aim of this study is to identify the above associations by perineal sonography.

Eligibility Criteria:
Inclusion Criteria:

* all patients with lower urinary tract symptoms and will undergo urodynamic studies

Exclusion Criteria:

* none
Virtual Reality-based Exercise in Older Adults

The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in older adults.

We hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in older adults compared to a control group receiving usual care only.


Eligibility Criteria:
Inclusion Criteria:

* ability to ambulate without assistance
* willingness to provide informed consent

Exclusion Criteria:

* severe neurologic, cardiovascular, metabolic, or psychiatric disorders
* severe visual impairment
* cognitive impairment
Hearing Impairment as a Risk Factor for Dementia in Older Adults

This Doctor of Philosophy (PhD) project is part of a larger project on potentially modifiable risk factors for dementia in a life course perspective, with an overarching aim to improve prevention of dementia and thereby potentially relieve patient and caregiver distress and decrease societal load. The present PhD project will concentrate on confirming knowledge of HI as an independent risk factor for dementia and exploring potentially causative factors to explain this relationship.

Despite a huge increase in the knowledge about disease mechanisms in various types of dementia in recent years, no curative treatment exists at present. Results from research on disease-modifying agents have been disappointing. This has led to an increased interest in other ways to reduce the prevalence of dementia. A recent report estimated that up to one third of dementia cases could be delayed or prevented by interventions directed at the most common risk factors. In the "Lancet commission on dementia prevention, treatment, and care", hearing impairment (HI) was identified as the potentially most important modifiable risk factor. Even though HI is considered an important modifiable risk factor, the evidence regarding the association between HI and dementia risk is still limited.

Eligibility Criteria:
Inclusion Criteria:

* Living in designated area

Exclusion Criteria:

* None
Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection

Because the potential benefit of standard intravenous immunoglobulins (IVIG) - obtained from unselected donor pools including a varying proportion of donors previously exposed to CMV - has not yet been explored in pregnant women, the investigators performed a longitudinal prospective study on the possible efficacy of IVIG for prevention or therapy of fetal CMV infection.

Human IVIG are offered monthly to consecutive enrolled pregnant women with confirmed primary CMV infection at any stage, for the prevention and treatment of fetal CMV infection. Primary infection is defined by positive CMV IgM antibodies with absent or low titres of CMV IgG antibodies, and either low (\<40%) CMV IgG avidity indexes with positive CMV IgM AND IgG antibodies. In addition women with indefinite avidity index and positive CMV DNA detection in urine and/or blood samples are also considered for treatment. Standard human intravenous immunoglobulins were chosen for their safety and efficacy, well documented in other settings. IVIGs were used to perform all of the infusions in the study, undiluted after reconstitution, in accordance with instructions of the manufacturer. We chose to perform IVIG infusions using 0.5 g/Kg of body weight, to make sure that a dose of specific CMV IgG at least comparable with that carried by HIG were infused at each time point. Infusions last 4 to 5 hours, using a double lumen line to infuse approximately 1500 mL of either 5% glucose or saline solution in parallel with the undiluted IVIG preparation, to reduce the risk of infusion reactions.

CMV IgG and IgM antibodies and IgG avidity indexes are assayed before and after each IVIG infusion, within 15 minutes. Quantitative CMV DNA is amplified from whole blood and urine samples from pregnant women and neonates, using the Real-Time PCR, and on samples of amniotic fluid from women who required amniocentesis. The newborns will be followed for five years after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with confirmed primary CMV infection at any stage of gestation.

Exclusion Criteria:

* Pregnant women with falsely positive CMV IgM antibodies or high (\>40%) CMV IgG avidity indexes