cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Echinacea for the Common Cold

The purpose of this study is to determine whether three Echinacea preparations with different chemical compositions are effective for prevention or treatment of the common cold.

Echinacea is a widely used herbal remedy for the common cold. Previous clinical trials designed to assess the efficacy of Echinacea for prevention or treatment of the common cold have produced inconsistent results. A variety of different Echinacea products have been used in these clinical trials. Recent studies indicate that different Echinacea preparations have dramatically different phytochemical profiles. The available clinical trial data provide no information about the potential role of the different constituents of Echinacea in common cold prevention or treatment. Our hypothesis is that the variation in reported clinical effectiveness may be due to differences in the phytochemical profile of the Echinacea preparations used. This study will address the following specific aims: 1) Evaluate the effectiveness of chemically defined extracts of E. angustifolia root which contain alkamides, echinacoside or polysaccharidelglycoprotein for common cold prevention or treatment; 2) Assess the correlation between specific Echinacea metabolites in serum and nasal secretions and efficacy for prevention and treatment of colds; and 3) Determine the effect of different Echinacea preparations on the host response to rhinovirus infection.

Eligibility Criteria:
The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block

The purpose of this study is to investigate the effect of ultrasound-guided thoracic paravertebral block (TPVB) when performing sympathetic block for upper limb pain control.

Well-trained pain physicians performs all US-guided stellate ganglion block(SGB)s or US-guided thoracic paravertebrl block(TPVB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure.

For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 5 ml of 1% mepivacaine is injected for the SGB group. Syringes are prepared by one nurse who do not involved in other steps of this study.

For US-guided TPVB, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at T2 paravertebral space. 10 ml of 1% mepivacaine is injected for the TPVB group. Syringes are prepared by one nurse who do not involved in other steps of this study.

Temperature measurement is conducted 2 times (before US-guided SGB or TPVB and after 20 minutes) at both hands by one person who's not involved in other measuring in the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of complex regional pain syndrome
* Clinical diagnosis of postherpetic neuralgia
* Clinical diagnosis of phantom limb pain
* Clinical diagnosis of chronic post-surgical pain
* Clinical diagnosis of post-traumatic pain syndrome
* Upper extremity pain lasting more than 3 months

Patients with a new or known diagnosis of chronic neuropathic pain lasting more than 3 months in the upper extremity

Exclusion Criteria:

* Refusal of a patient
* Any vascular disease in the upper extremities
* Previous history of thoracic sympathetic or stellate ganglion neurolysis (e.g. -thermocoagulation, radiofrequency neuromodulation, and/or chemical neurolysis)
* Coagulopathy
* Systemic infection or local infection at the needle injection site
* Major deformation at the level of the neck (radiotherapy, surgery, etc.)
* Known allergy to local anesthetics of amide type
* Inability to understand a numeric rating pain scale (cognitive dysfunction)
* Patients whose palm temperature on the ipsilateral side is ≥ 36.5℃ in the thermography before the procedure
The Heartflow Coronary Disease Progression Evaluation Study

Invasively measured fractional flow reserve (FFR) has proven to be useful in guiding coronary revascularization. Several studies have shown that it is justified to treat lesions with a value of 0.80 or lower and safe to defer from PCI in lesions with a value of \>0.80. Recently, computational fluid dynamics have allowed FFR measurement from coronary computed tomography angiography images (FFRCT) with excellent diagnostic accuracy compared to invasive FFR.

FFRCT can also effectively guide revascularization safely deferring patient with FFRCT \>0.80 from invasive angiography. In functionally non-significant lesions, computational fluid dynamic models in addition to CT plaque characteristics (low attenuation, positive remodelling, spotty calcification and napkin-ring sign) may be able to predict which lesions will become flow-limiting, causing clinical events in the future.

This study will evaluate disease progression in intermediate lesions (invasive FFR 0.81-0.90 at baseline) using FFRCT at 2 years and determine whether CT characteristics may help to identify lesions that are more susceptible for FFR decline. Additionally, we will correlate CT characteristics with coronary events (a composite endpoint consisting of all-cause mortality, target-vessel myocardial infarction and clinically driven target-vessel revascularization) up to 5 years after the baseline invasive FFR.


Eligibility Criteria:
Inclusion Criteria:

1. Patients (age ≥ 18 years) treated with PCI (for non-ST elevation myocardial infarction, unstable or stable angina and silent ischemia) or who undergo invasive FFR.
2. Minimum of one non-treated coronary artery with an intermediate lesion and invasive FFR 0.81-0.90 to serve as the target vessel for FFRCT.

Exclusion Criteria:

1. ST elevation myocardial infarction.
2. Previous CABG.
3. Target vessel for FFR measurement \< 2.0 mm in diameter.
4. Contraindications to contrast agents, beta-blocking agents, nitroglycerin or adenosine.
5. Life expectancy less than 3 years.
6. Creatinine clearance \< 30 ml/min\*1.73m2.
Effect of Oral Helicobacter Pylori Infection on the Efficacy of Gastroluminal Helicobacter Pylori Eradication Therapy

The aim of this study is to assess the effect of oral Helicobacter pylori infection on the efficacy of gastric Helicobacter pylori infection eradication. Patients diagnosed with gastric Helicobacter pylori infection are tested for oral Helicobacter pylori and given standard bismuth quadruple therapy, with a urea breath test, a rapid urease test, or a Helicobacter pylori stool antigen test to confirm gastric Helicobacter pylori eradication at week 6 follow-up, and an oral Helicobacter pylori test kit to confirm oral Helicobacter pylori eradication.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18\~70 ,both gender.
2. Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection.
3. Have not received dental care or systemic periodontal basic treatment in the past 1 year.

Exclusion Criteria:

1. Those who have contraindications to the drugs used in this institute or are allergic to the drugs used.
2. There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
3. Ongoing use of antiulcer medications (including PPIs taken within 2 weeks before Helicobacter pylori infection testing), antibiotics, or bismuth complexes (more than 3 times/week before screening).
4. Those with severe oral diseases and malignant tumors of the mouth.
5. Women planning pregnancy, pregnancy and breastfeeding.
6. Previously had upper gastrointestinal surgery.
7. Those who do not take their medication on time.
8. Refusal to sign informed consent.
Clinical Trial Navigation to Increase Participation and Diversity in Cancer Clinical Trials

This clinical trial evaluates a clinical trial navigation intervention to help increase participation and diversity in cancer clinical trials. Cancer clinical trials are an important part of the development of treatments, and improved patient care and outcomes. Despite this, only a small number of cancer patients participate in clinical trials. There are many different items that contribute to low clinical trial participation, including health-related social needs (HRSN) and financial burden. Guiding participation toward understanding, inclusion, diversity, and equity for cancer clinical trials (GUIDE), is a program that uses a trained clinical trial navigator, or "Guide", to work with identified potential cancer clinical trial patients to help them recognize and remove HRSN and financial barriers preventing clinical trial participation. A clinical trial navigation intervention, like GUIDE, may help increase participation and diversity in cancer clinical trials.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients meet with a clinical trial navigator to understand activities involved with clinical trials, identify financial barriers to clinical trial participation, and review available financial resources. Patients receive ongoing access to the Guide for up to 6 months. Patients also receive standard of care (SOC) supportive care services.

ARM II: Patients receive SOC supportive care services.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Identified as potentially eligible for an open clinical trial by clinical trial pre-screening (operating in breast, gastrointestinal \[GI\], and genitourinary \[GU\] clinics)
* Have ≥ 1 health related social need, defined by

  * Food insecurity, housing instability, transportation challenges, or financial instability documented in the Supportive Cancer Care Questionnaire in Epic Electronic Medical Record (EPIC), OR
  * Concerns about insurance, cost of trial, additional trial visits, travel, transportation, childcare, OR unable to take time off work documented by clinical trial pre-screening (CTPS), OR
  * Medicaid insurance documented in EPIC
* Able to speak English

Exclusion Criteria:

* Unable to speak English
* Children, adolescents, and teens under the age of 18 years
* Patients participating on clinical trials providing financial navigation, such as clinicaltrials.gov identifier (CT ID): NCT04960787
* Patients refusing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization
Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee

The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral above the knee amputees of non-dysvascular etiology
* 100-275 lbs
* ≥ 1 yr. of prosthetic experience
* Independent community ambulator
* Self-reported ability to walk for 20min consecutively

Exclusion Criteria:

* Above the knee amputees of dysvascular etiologies
* Body weight \<100 or \>275 lbs
* Does not speak English or Spanish
* Use of an assistive device (i.e. canes, walkers)
* Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees
* Known skin issues
* Known cognitive impairment
Laparoscopic Sacropexy: Comparison of Mesh Attachment

The purpose of this study is to compare postoperative complications and outcome two different attachment sites of the dorsal mesh support in laparoscopic sacropexy.

Laparoscopic sacropexy has become a well established treatment option for vaginal vault prolapse with excellent outcome and low rates of recurrence. Compared to the similar vaginal sacropexy procedure a significant rate of postoperative constipation is reported. As the surgical technique is very similar for both procedures it could be possible that the exposure of the lower vaginal wall and placement and of the dorsal mesh and closer proximity to the colon in laparoscopic sacropexy might cause this. In this randomized controlled clinical trial we compare two different attachment sites for the dorsal mesh during laparoscopic sacropexy. One group is randomized for attachment in the middle of the dorsal wall of the vaginal stump and for the other group preparation and attachment for the dorsal mesh is performed deeper in the lower pelvis for an attachment at the distal part of the dorsal vaginal wall.

Peri-operative data, intra- and postoperative complications and results of short-term (constipation) and long-term( recurrences rate) outcome are recorded.

Eligibility Criteria:
Inclusion Criteria:

* vaginal vault prolapse
* recurrence of vaginal vault prolapse
* signed consent

Exclusion Criteria:

* rectocele
* BMI\>40
Silastic Sheet Usefulness Following Septoplasty

This study aimed to evaluate the effectiveness of silastic septal splint in reducing the rates of complications, decreasing the post-operative pain, and improving satisfaction in comparison to quilting suturing technique.

Methods:

A single center randomized controlled trial, including adult above the age of 18. A total of 50 participants who underwent septoplasty were enrolled and randomly assigned into two groups, Silastic group (n=25), and quilting group (n=25). Nasal obstruction severity was assessed by using an Arabic validated version of NOSE score, preoperatively then 3 days, one week and one month postoperatively. Post-operative complications were assessed at outpatient clinic 1 week and 1 month postoperatively. Pain was assessed by a 10-point numerical scales via phone call on the 3rd day postoperative.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years) healthy individuals of both genders with deviated nasal septum and no other concomitant procedures.

Exclusion Criteria:

* 1. Concomitant procedure other than septoplasty. 2. Previous history of septal or nasal surgery. 3. Presence of nasal polyps, chronic sinusitis or other regional pathology. 4. Bleeding disorders or anticoagulation therapy.
Pharmacological Treatment of Rett Syndrome With Glatiramer Acetate (Copaxone)

A phase 2 open label trial to test a potential drug treatment for Rett syndrome, the leading known genetic cause of severe neurological impairment in girls. The drug, Copaxone (generic name - Glatiramer acetate) is medication FDA approved for the treatment of multiple sclerosis. Copaxone's high safety profile has been documented in large cohorts of patients for more than 12 years.

Background/rationale for the study:

In Rett syndrome brain cells aren't actually lost, instead poor maturation of connections between brain cells (synapses) prevents effective neurological functioning, and is the main morphological feature of the disease. The MeCP2 gene plays a major role in transcriptional regulation of other genes, one of which is the gene encoding brain-derived neurotrophic factor (BDNF).

The disease progression and severity of symptoms is directly affected by the level of BDNF expression. An increase of BDNF levels (by genetic manipulations or pharmacological agents) leads to delayed onset of Rett syndrome-like symptoms in experimental models; rescued gait/mobility, improved quality of life and increased survival rates.

Copaxone treatment by subcutaneous injection caused elevation of BDNF levels. Quantitative immunofluorescence assays showed about a twofold increase in neuronal expression of BDNF following Copaxone treatment.

We expect that an increase in BDNF levels with Copaxone administration will stimulate communication between brain cells (synaptic maturation), which will lead to amelioration of symptoms (motor functions/gait, cognitive functions, breathing, encephalopathy and improve quality of life) for girls with Rett syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with genetically confirmed Rett Syndrome (RTT)
* Age: 10 or more years old. Selection of the age is based on the available evidence of the safety of Glatiramer Acetate (GA) in this group, and the relative homogeneity/stability of the phenotype, which is not expected to spontaneously change within a 6 month period at this age
* Ambulatory (with our without support)

Exclusion Criteria:

* Prolonged Qtc (obtained within 30 days prior to enrollment)
* Presence of co morbid non-Rett related disease
* Presence of immunodeficiency requiring intravenous immunoglobulin 3 (IVIG 3) months prior to enrollment
* Allergy/sensitivity to GA or mannitol
* Inability or unwillingness of legal guardians to give written informed consent
A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

This is a phase I/II clinical research study with BGT226, an inhibitor of phosphatidylinositol 3'-kinase (PI3K). The study consists of a Phase I dose escalation part followed by a safety expansion part and a Phase II expansion part.

Once the MTD has been defined, the safety expansion and efficacy expansion parts of the trial will be opened for enrollment.

Phase I safety expansion part will enroll advanced solid tumors. Phase II expansion part will enroll advanced breast cancer. An effort will be made to enrich the trial population with Cowden Syndrome patients with advanced solid malignancies.


Eligibility Criteria:
Inclusion criteria:

All patients

* Histologically-confirmed, advanced solid tumors
* Progressive, recurrent unresectable disease

Phase II expansion part (advanced breast cancer)

* Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression status
* Disease progression/recurrence following hormonal or anti-HER-2 treatment for advanced disease
* At least one but not more than two prior chemotherapy regimens for the unresectable tumor
* Measurable disease by MRI or CT scan

Cowden Syndrome patients with an advanced malignancy Genetic confirmation of Cowden Syndrome

* Age ≥ 18
* World Health Organization (WHO) Performance Status of ≤ 2

Exclusion criteria:

* Hematopoietic:
* No diabetes mellitus or history of gestational diabetes mellitus
* No acute or chronic renal disease
* No acute or chronic liver disease
* No acute or chronic pancreatitis
* No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
* No acute myocardial infarction or unstable angina pectoris within the past 3 months
* Not pregnant or nursing and fertile patients must use barrier contraceptives

Other protocol-defined inclusion/exclusion criteria may apply.
PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer

Predict and follow thanks to imaging the response to neoadjuvant chemotherapy in locally advanced breast carcinoma. Hypothesis : FLT-(18F)PET will be a predictor superior to both FDG-(18F) PET and MRI

PET/CT with FDG-(18F) and FLT-(18F) and MRI are performed at the initial staging, 3 times during sequential adjuvant chemotherapy and prior to surgery, aiming to find the most efficient modality to predict the response to neoadjuvant chemotherapy of the primary breast cancer and its possible lymph node metastases. Post-surgical histology and a 6 month follow-up (to detect occult metastases) will constitute the standard of truth for determination and comparison of diagnostic performances.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer scheduled for neoadjuvant chemotherapy followed by surgery

Exclusion criteria:

* Indicated chemotherapy without that a curative tumorectomies is foreseen(planned)
* Patient presenting an evolutionary infectious or inflammatory pathology, including an inflammatory breast cancer, being able to be source(spring) of false-positive results(profits) in TEP-FDG
* Patient in the course of radiotherapy or of chemotherapy or operated at the level of the thorax in 4 weeks preceding the date foreseen(planned) by the examination TEP (pose(installation) of implantable room(chamber) excludes)
* Diabetic waits
* Patient already includes in the other protocols of search(research) for Nuclear Medicine or for imaging using ionization radiations
* Patient not having given her lit(enlightened) assent
* Wait among which the surveillance TEP or the MRI during the chemotherapy will be impossible (that is by geographical or professional imperative, or if contraindication in the MRI, ex: port(bearing) of a pacemaker, cochlear magnetic implants, metal foreign bodies cf protocol)
* Of less than 18 years old or pregnant patient.
* Breast cancer stage(stadium) IV
* Biopsy on the already realized mammary tumor, for the period(delay) lower than 15 j.
* In case of alcoholic poisoning or of antecedents of reaction to the injection of ethanol: not inclusion to be discussed.
Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Disorders

Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common natural evolution: a chronic phase, characterized by a major risk of vascular events, followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer entities. During the past years, CML became a paradigm for targeted therapy and personalized cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many other mutations, opened similar perspectives. However, several questions remain to be answered in MPNs regarding the clinical implication of these major scientific discoveries: what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of complications and progression? Can these new biomarkers be used in the perspective of a personalized therapy of MPNs? his project will focus on the qualification of a series of known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with well-annotated samples


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Myeloproliferative neoplasms (MPN) diagnosed between 2005 and 2013
* Sample DNA diagnostics available: 500 mcg
* Untreated or treated with hydroxyurea, ruxolitinib, alpha interferon,
* Patient has given his(her) own consent for the use of the sample for research on the pathology and genetic analyzes

Exclusion Criteria:

* Refused to participate
* Patient treated with another molecule that hydroxyurea, ruxolitinib, or alpha interferon