cyrilzakka/clinical-trials huggingface dataset:
A Single Research Site Bile Acid Sequestrant Acceptability (BASA) Scale Pilot Validation Study

The purpose of the research study is (1) to rate the taste, texture, appearance, and mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating cholestyramine and Tang to determine the accuracy and usefulness of a taste test questionnaire.

The primary objective of this study is to evaluate patient acceptability of 2 doses of orange-flavored generic Questran (cholestyramine) versus orange-flavored Tang Drink Mix (a commercial powdered orange drink without cholestyramine) via 2 BASA scales. A second objective is to assess the 2 different versions of the BASA scale. One version will be unweighted with the score based upon the aggregate score of each acceptability component. A second version will be weighted based upon subjectively-reported importance of the acceptability components. The one main study objective or focus is to determine which version of a BASA scale best differentiates patient acceptability of a bile acid sequestrant (cholestyramine) versus a placebo control powder (containing no bile acid sequestrant) thereby determining which BASA scale is the best validated instrument for future studies in assessing and comparing patient acceptability of bile acid sequestrants.

Eligibility Criteria:
Inclusion Criteria:

Subjects or generally healthy volunteers are eligible for inclusion if they meet the following inclusion criteria during the Screening Period:

* Men or women 18-70 years of age
* In general good health.
* Subjects are capable of giving informed consent, or if appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf.
* Subjects are willing and readily able to be contacted for post-study safety phone call assessments one to seven days after the single study visit.

Exclusion Criteria:

* Prior intolerance to bile acid sequestrants
* Women who are either pregnant, or who are not practicing any form of birth control.
* Prior gastrointestinal surgery
* History of ongoing gastrointestinal symptoms (indigestion, constipation, or diarrhea)
* History of bowel obstruction, malabsorption, or irritable bowel syndrome
* History of esophageal disease
* Current or past history of gall bladder disease
* Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to visit 1.
* Diagnosis of diabetes mellitus
* Known history of triglyceride levels \> 300 mg/dl.
* History of alcohol or drug abuse within 1 year of study entry
* Alcohol intake that exceeds more than 2 units of alcohol drinks per day
* Blood donation within 8 weeks of the study or anticipation of blood donation during the study.
* Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within 30 of visit 1).
* Any other situation in which the Investigator makes the judgment that participation in the study would not be in the best interest of the study participant, or in the best interest of providing reliable study data.
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Alzheimer's disease.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients age 18 and older
3. Diagnosis of Alzheimer's disease or dementia by a physician
4. Mini Mental Status Exam score less than 26

Exclusion Criteria:

1. Refusal to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 2 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease

Triptolide has been approve effective in animal model.

Randomized

Eligibility Criteria:
Inclusion Criteria:

* Clinically established ADPKD
* eGFR\>30ml/min.
* Chinese nationality

Exclusion Criteria:

* Uncontrolled infections
* Non-ADPKD complications
Remote Ischemic Postconditioning During Percutaneous Coronary Interventions

Angioplasty is a commonly performed procedure for treating blockage of the blood vessels in the heart. Although this procedure is usually successful, it is often accompanied by a small degree of damage to the heart (i.e., small heart attack).

The purpose of this study is to find out if inflating a blood pressure cuff on the arm or the leg at the time of angioplasty for several minutes has a beneficial effect.

Patients will be assigned to one of three treatment groups: inflating blood pressure cuff on the arm, inflating blood pressure cuff on the leg and a control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for PCI

Exclusion Criteria:

* Acute myocardial infarction
* Myocardial infarction or coronary bypass surgery during the last 4 weeks before PCI
* Use of Glyburide
* Heart failure (NYHA III/IV)
* Chronic inflammatory disease
* Severe renal impairment
* Significant peripheral vascular disease
* Unsuitable for use of an embolic protection device for PCI to SVG
Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases

Hematologic malignancies are heterogeneous groups of neoplasia, with frequent pulmonary complications. These complications may be secondary to the patient's comorbidities, to the hemopathy itself, or its treatments. Divided into infectious and non-infectious complications, the etiologies are numerous and varied. This makes the diagnostic approach complex for the clinicians

Although infectious processes of the lungs are common in these immunosuppressed patient collectives, non-infectious causes account for up to half of the pulmonary manifestations found in hematologic malignancies. Besides the frequent infections including opportunistic pathogens, a broad differential diagnosis including drug-induced lung injury by cytostatic substances, cytokines, and innovative immunotherapeutic agents, rarer transfusion of blood products, and intrathoracic manifestations of the hematologic malignancy itself, must be kept in mind. Finally, vascular complications can also lead to pulmonary reactions. Early and consistent diagnostics and treatment of bronchopulmonary, intrathoracic, and vascular complications within the framework of hematologic systemic diseases can be essential for the patient's prognosis. Up to 25% of patients with profound neutropenia lasting for \>10 days develop lung infiltrates, which frequently do not respond to broad-spectrum antibacterial therapy. While a causative pathogen remains undetected in most cases, Aspergillus spp., Pneumocystis jirovecii, multi-resistant Gram-negative pathogens, mycobacteria or respiratory viruses may be involved. In at-risk patients who have received trimethoprim-sulfamethoxazole (TMP/SMX) prophylaxis, filamentous fungal pathogens appear to be predominant, yet commonly not proven at the time of treatment initiation.

In patients who do not improve rapidly with first-line therapy with broad spectrum antibiotics, cross-sectional thoracic CT imaging is essential. It provides much better definition of the pattern of radiological changes that includes three main groups: consolidation, nodules (micro- and macro-), and diffuse changes, as ground glass pattern. Discuss these radiological patterns and how this guides the appropriate initial investigations and treatment options will be of a great value to be followed.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years or older diagnosed with hematological diseases and documented pulmonary manifestations during their disease course

Exclusion Criteria:

1. Patients aged under 18 years.
2. Patients without demonstrable evidence of lung involvement.
3. Patients with incomplete medical records or insufficient data to analyze.
Measures of Obesity and Co-Morbid Conditions in Maori

It has been proposed that a higher cut off for BMI (body mass index) is to be used in Maori to define overweight and obesity. However, no one has assessed the prevalence of co-morbid conditions associated with BMI. It is well known that Maori are at greater risk of diabetes and cardiovascular disease compared to non-Maori and a delay in the identification of those who are overweight and obese may be detrimental for Maori. We will assess BMI, other measures of adiposity and prevalence of co-morbid conditions with a comparison with a similar matched non-Maori population.

This is a body composition analysis study of people self-identifying Maori and non-Maori participants from both Dunedin and Invercargill. The study consists of a clinical visit for anthropometry and oral glucose tolerance test (OGTT), followed by a single Dexa Scan visit. Participants meeting all the inclusion criteria were invited to participate in the study.

Outcome will be determined by examining Dexa Scan data and surrogate clinical endpoints. The clinical endpoints include: anthropometric measurements, Dexa analysis, bioelectric impedance, and BP measurements, and the biochemical measures of: lipid profile, fasting insulin and glucose, liver functions and uric acid levels.

Eligibility Criteria:
Inclusion Criteria:

* Self identify as Maori and non-Maori aged between 18-68 years
* Male and female
* Non-diabetic
* Resident of Dunedin and Invercargill

Exclusion Criteria:

* The presence of diabetes, renal or liver failure, or any other medical condition which is unstable and for which they are currently having active treatment
Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

Main objective of the trial:

The main objective of the trial is to evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy.

Eligibility Criteria:
Inclusion Criteria:

* Has histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx, and larynx
* Has or be willing to provide tumor tissue for testing
* Has measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
* Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Has adequate hematological function per protocol
* Has adequate renal function per protocol
* Has adequate hepatic function per protocol
* Agrees to use effective contraception while on the study and for 6-months after the end of the study
* Provides written informed consent(s)

Exclusion Criteria:

* Has left ventricular ejection fraction (LVEF) \<50%
* Had prior epidermal growth factor receptor (EGFR) targeted regimen
* Had prior anti-human epidermal growth factor receptor 3 (anti-HER3) therapy
* Had prior chemotherapy for recurrent/metastatic disease
* Had anti-cancer therapy between biopsy and submission of sample
* Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
* Has known history of brain metastases or active brain metastases
* Has uncontrolled hypertension
* Has clinically significant electrocardiograph (ECG) findings
* Had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or arrhythmia requiring medication
* Had platinum-containing drug therapy with radiotherapy less than 6 months before study drug treatment
* Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment
Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy

This study is an extended follow-up of the study (ClinicalTrials.gov ID: NCT01758120)-Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* biopsy-proven primary IgA nephropathy
* 18-70 years old
* elevated serum Creatinine and less than 3.0mg/dl
* with a written consent from participants to receive prednisone and/or cyclophosphamide

Exclusion Criteria:

* diabetes;
* contraindications for the treatment of prednisone and/or cyclophosphamide
* any treatment with steroids or immunosuppressive drugs prior to this study
* acute deterioration of renal function(including those of glomerular origin)
Clinical Effect of Allogeneic Meniscus Transplantation

In this study, patients who underwent allogeneic meniscus transplantation and meniscus resection were followed up for more than 10years to evaluate the long-term efficacy and explore the cartilage protective role of meniscus transplantation.

To investigate the long-term clinical effect of allogeneic meniscus transplantation, IKDC score, Lysholom score, Tegner score, VAS score, etc. were used to compare the clinical effects of allogeneic meniscus transplantation, and the progress of knee joint degeneration and cartilage injury was evaluated through X-ray and MRI.

Eligibility Criteria:
Inclusion Criteria:

The age is less than 50 years; the force line is basically normal (≤ ± 3°); the joint is stable or the joint stability is corrected at the same time during the operation; the joint degeneration or large area cartilage damage. In the transplantation group, 10 patients experienced pain or swelling in the joint space of the affected side for an average of 35 months after meniscus resection, and then received meniscus transplantation. The other 8 patients underwent meniscus transplantation at the same time as meniscus resection. Patients in the resection group received meniscus transplantation at the same time. Symptoms, signs, and magnetic resonance imaging (MRI) were diagnosed as a meniscus tear and the judgment during the operation could not be preserved, so a total meniscus was performed.

Exclusion Criteria:

Severe knee synovial disease; severe joint degeneration or extensive cartilage damage; improper force lines; severely unstable joints that cannot be corrected; both meniscuses are removed; the other knee joint has a history of severe trauma or surgery.
The EASE-IT CT Registry

ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.

Patients undergoing TAVI require routine pre-procedural assessment of CAD (coronary artery disease).

ICA (invasive coronary angiography) is the gold standard in patients with high pre-test probability. It is associated, however, with procedural risk, radiation and cost.

CTA (computed tomography angiography) currently has limited use for the evaluation of CAD in pts with severe symptomatic AS (aortic stenosis) - medications required such as beta blockers and nitroglycerine, are frequently not well tolerated by pts.

But as TAVI is increasingly being performed in patients with modest pre-test probabilities for obstructive CAD or a lack of implications thereof (pts. ≥75 yrs), the use of CTA may become more appealing.

Eligibility Criteria:
Inclusion Criteria:

Investigational CTA-only Cohort

* Consecutive adult patients ≥ 75 years
* Consecutive patients with severe AS (symptomatic or asymptomatic) with a guideline-based indication to undergo implantation of a transcatheter heart valve of the SAPIEN family
* Ability to undergo CTA
* Patient is scheduled to undergo a 30 Day and 3 Months follow-up

CTA+ICA control Cohort

* Consecutive adult patients ≥ 75 years
* Consecutive patients underwent implantation of a transcatheter heart valve of the SAPIEN family because of severe aortic stenosis
* Ability to undergo CTA and ICA

Exclusion Criteria:

investigational CTA-only Cohort

* Patients with already diagnosed proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50%
* Any prior coronary revascularization / prior aortic valve replacement
* Life expectancy below 12 months
* Lack of informed consent / data protection statement

CTA+ICA control Cohort

* Patients diagnosed with proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% already at baseline
* Any prior coronary revascularization / prior aortic valve replacement
* Life expectancy below 12 months
* Lack of informed consent / data protection statement
Solriamfetol and CBT-I in Patients With Insomnia Disorder

Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia \[CBT-I\]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will consolidate sleep and improve sleep continuity.

The current proposal is for a one-year study to investigate whether solriamfetol can improve sleep continuity and daytime performance, alone and in combination with Cognitive Behavioral Therapy for Insomnia. It is expected (given a common mechanism \[wake extension\]) that both Cognitive Behavioral Therapy for Insomnia and treatment with solriamfetol will improve sleep continuity, and that such effects will potentially be additive.

Eligibility Criteria:
Inclusion Criteria:

• Participants will meet the diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

In addition, the complaint of disturbed sleep will meet the following criteria:

* ≥ 30 minutes to fall asleep (SL) and/or ≥ 2 awakenings per night of ≥ 15 minutes duration and/or wake after sleep onset (WASO) time of ≥ 30 minutes where total sleep time (TST) did not exceed 6 hours (unless sleep efficiency \[SE\] is ≤ 80%).
* The problem is present for \> 3 nights per week.
* The problem duration exceeds ≥ 6 months.
* The complaint of impaired daytime function must include, although not limited to, the report of daytime fatigue, sleepiness, or both.
* Preferred regular sleep phase between 10:00 PM and 8:00 AM
* Must garner physician's assent from their primary care clinician

Exclusion Criteria:

* Use of medication expressly for the purpose of falling or staying asleep (e.g., trazodone/ desyrel, melatonin, Tylenol PM, Nyquil, Benadryl).
* Night shift work
* Compromised renal function
* Major Coronary Artery Disease and/or uncontrolled (with meds) Hypertension
* Planning to become pregnant, pregnant, and/or breastfeeding
* Unstable medical or psychiatric illness
* Symptoms suggestive of sleep disorders other than insomnia
* Polysomnographic data indicating sleep disorders other than insomnia
* Evidence of active illicit substance use, abuse, or dependence
* Use of CNS active medications that are for treatment of insomnia or are thought to have caused insomnia as a side effect
* Inadequate language comprehension
* Current or past experience with CBT-I
* No access to the computers, I-Pads, or the internet
Endometriosis and Brominated Flame Retardant (ENDOTOX Study)

The investigators wish to highlight, in a Case-Control design, if there is an increased concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis with surgical indication ) versus bioaccumulation recorded in a control cohort ( women recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis ) . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes described by the HAS) and previous breastfeeding experience (yes / no , opposite the release expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .


Eligibility Criteria:
Inclusion criterion for de cases :

* Age : 18-45 years old
* Deep endometriosis with or without endometriomas that need surgery (clinical examination, MRI, surgery)
* Accessing to the omental and/or parietal adipose tissue
* Non opposition of the patients for the samples collection and consent for the present study.

Inclusion criterion for the controls :

* Patients without any history of endometriosis and without suggestive symptomatology. Often patients operated for cesarean section.
* Possible access to the adipose tissue of the omentum or abdominal wall

Exclusion criterion for the cases :

* Pregnancy
* Death

Exclusion criterion for controls :

* Pregnancy
* Death