cyrilzakka/clinical-trials huggingface dataset:
Post-Approval Clinical Trial of the PCM® Cervical Disc

On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.

The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.

A prospective, multi-center, post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the PCM Cervical Disc IDE clinical study and will to give consent to participate.

All of the PCM IDE investigational sites who have active patients will be chosen to participate in this study. All patients who are actively participating in the pivotal IDE study will be asked to participate in this study.

The study consists of follow-up periods only. The follow-up period will last for seven years from each patient's surgery date.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in the PCM Cervical Disc IDE clinical study
* Patients willing and able to give informed consent

Exclusion Criteria:

* Patients considered failure during the PCM Cervical Disc IDE clinical study
* Patients who were withdrawn during the PCM Cervical Disc IDE clinical study
Acute Plasma Abeta Responses to Stress

Research has shown that activation of the sympathetic nervous system for extended periods or during certain times in life can increase the risk for Alzheimer's disease. Some research in animal models show that acute activation of the sympathetic nervous system through stress exposure can increase certain Alzheimer's disease-related biomarkers, such as amyloid-beta, within hours of exposure. However, how acute sympathetic nervous system activation via stress exposure affects amyloid-beta levels in humans has yet to be examined.

In this study, the investigators will examine whether brief increases in sympathetic activation result in immediate changes in plasma amyloid-beta levels in the five hours after exposure.

Aim 1: determine whether acute exposure to stress (increasing sympathetic nervous system activation) increases plasma amyloid-beta-40 and amyloid-beta-42 in the five hours following exposure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult weighing at least 110 pounds
* No chronic conditions or illness
* Taking no medications or drugs that might alter the stress response (e.g., corticosteroids, beta-blockers, and others)
* Not using any hormone-containing medication (e.g., hormonal contraceptives, hormone replacement, etc.)
* No contraindications for cold pressor test exposure (high blood pressure, heart disease, dysrhythmia, peripheral vascular disease, any other cardiovascular disorder, diabetes, vasculitis, lupus, tingling or numbness in the hands and/or feet, cryoglobulinemia, and Reynaud's phenomenon)
* No history of fainting during blood draws
* No phobia of having their blood drawn
* No general history of fainting or seizures
* Not currently diagnosed with a mood disorder (e.g., major depressive disorder)
* Not pregnant in the past 12 months
* Not lactating in the past 12 months
* Not trying to become pregnant if premenopausal
* Experienced natural menopause if postmenopausal
* Be non-smokers
* Be fluent in English

Exclusion Criteria:

- Unwilling to be filmed during the stress task OR unwilling to sign the waiver allowing their filmed responses to be used in scientific presentations
Assessing a Medicaid Randomized Insurance Experiment Within Community Clinics

This study examines the impact of a randomized insurance experiment on preventive services receipt and healthcare utilization in safety net patients using linked public insurance claims and safety net clinics' electronic health record (EHR) data.

In 2008, the Oregon Medicaid program used a "lottery" (Oregon Experiment) to allocate limited insurance resources to low income adults who did not categorically qualify for traditional Medicaid coverage. Thousands were randomly selected to apply for Medicaid; many others were not selected. This "natural policy experiment" is the first population-level randomization of insurance coverage since Rand's 1971-1982 experiment. We will use data from safety net clinics that share a common electronic health record (EHR) operated by OCHIN, a non-profit organization in Portland, Oregon. As one of the nation's largest linked community health center networks, the OCHIN EHR database records nearly all visits to safety net clinics in Oregon with one patient chart linked across \>100 community health centers. We will link Medicaid claims data and the OCHIN database to determine patients that had applied to participate in the Oregon Experiment, as well as to determine those that gained insurance via this experiment. We will test the hypothesis that public insurance coverage is associated with higher rates of receiving preventive care services and increased healthcare utilization among persons with a usual source of primary care. To that end, we will analyze preventive care and utilization patterns among the OCHIN clinic patients affected by Oregon's Medicaid Experiment. This study capitalizes on two unique opportunities: an EHR database linking \>100 community health centers, and the quasi-experimental design of Oregon's randomized Medicaid experiment.

The specific aims related to the Oregon Experiment are:

1) To compare post-intervention rates of preventive services receipt among OCHIN patients randomized to the Oregon Experiment group (intervention group), compared to those not in the coverage group (comparison group); and 3) To compare post-intervention rates of ambulatory healthcare utilization among OCHIN patients randomized to the Oregon Experiment group (intervention group), compared to those not in the coverage group (comparison group).

Eligibility Criteria:
Inclusion Criteria:

* must have applied for the Oregon Experiment in 2006
* must have been a patient in an Oregon safety net clinic that is part of the OCHIN, Inc network
* for preventive services outcomes only, matched patients had to have been at a clinic with an electronic health record system by 3/11/08

Exclusion Criteria:

* under 19 years of age
* over 64 years of age
* not alive at the end of the 36 month post-period
* unknown/missing gender
"The Effects of Oxytocin on Patients With Borderline Personality Disorder"

RCT. Two substudies (clinical and experimental). Main objective of the trial is to examine if oxytocin, compared to placebo shows any additional effect on the therapy achievements (outcome) of patients with borderline personality disorder, who receive an in-patient standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).

Secondary objectives :

Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in patients with borderline personality disorder. Comparison of the effects of Oxytocin on patients with BPD and major depression.


Eligibility Criteria:
Inclusion Criteria:

* Gender: Both, male and female
* Minimum Age: 18 Years
* Maximum Age: 50 Years
* Borderline personality disorder or major depression (clinical control group)
* Mini Mental Status Test \> 27 (capacity to consent)

Exclusion Criteria:

* chronic or acute somatic health problems
* Schizophrenia
* Bipolar affective disorder
* pregnancy
* breast feeding
* neurological disorder
* allergy to antidegradants
Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

The goal of this clinical trial is to learn about the efficacy of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE. The main question it aims to answer is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VENETOCLAX-AZACITIDINE therapy.

Participants will be given DASATINIB treatment up to 3 months. Response will be assessed by a myelogram and a complete blood count at the end of every cycle. Follow up will last 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of AML except Philadelphia chromosome-positive AML (Ph+) and acute promyelocytic leukemia (AML M3)
* Age ≥ 18 years
* ECOG ≤3
* VEN-AZA refractory defined as no response after two cycles of VEN-AZA whatever the dose and the treatment duration
* Signed informed consent form
* Affiliation to a social security system, or beneficiary of such a system

Exclusion Criteria:

* Patient eligible to a targeted therapy having a market authorization
* Central nervous system involvement
* Heart failure
* Liver failure
* Kidney failure
* Contraindication to DASATINIB
* Positive for HIV (detectable viral load), Hepatitis B or C
* Pregnant or breastfeeding woman
* No efficient contraception for the women of childbearing age
* Emergency situation person or not able to express his/her informed consent
* Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice)
* Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons
Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer

This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V).


Eligibility Criteria:
Main Inclusion Criteria:

* Biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis by standard CT imaging and bone scintigraphy, or locoregional recurrence (including lymph nodes) assessed by CT or multi-parametric magnetic resonance imaging (MRI) and confirmed with negative biopsy in case of prior RT.
* In case of BCR after RP all the following criteria should apply: a. PSA ≥0.2 ng/mL, b. PSA Doubling Time (PSADT) \>3 months and \<12 months
* In case of BCR after RT all the following criteria should apply: a. PSA \>nadir + 2 ng/mL, b. PSADT \>3 months and \<12 months
* ECOG performance status ≤2.
* Laboratory values obtained ≤30 days prior to first vaccination: Hemoglobin ≥5.6 mmol/L; Absolute granulocyte count ≥1.5 x 109 /L, Platelets ≥100 x 109 /L., Total bilirubin ≤1.5 x upper limit of normal (ULN).
* Creatinine ≤1.5 x ULN.
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5 x ULN.

Main Exclusion Criteria:

* Patients who are receiving androgen-deprivation therapy or considered a candidate for immediate anti-androgen deprivation therapy (ADT) as judged by the investigator.
* Patients who have received prior ADT are not eligible with the exception of those that received ADT ≤36 months in duration and ≥9 months before randomization and administered only in the neoadjuvant/adjuvant setting.
* Patient is planned for salvage therapy with RT or radical prostatectomy.
* Castrate level of serum testosterone \<50 ng/dL at screening.
* PSA \>10 ng/mL
Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD): a Prospective Randomized Controlled Study

This study plans to enroll 148 patients undergoing upper gastrointestinal endoscopic submucosal dissection (ESD). Patients will be randomly divided into a control group (conventional tracheal intubation) and an experimental group (endoscopy-assisted tracheal intubation). Patients meeting the inclusion criteria and not falling under the exclusion criteria will be invited to participate in the study. Upon providing voluntary consent, the research physician will arrange for the patient's inclusion in the study. After signing the informed consent form, the research physician will collect the patient's basic information, medical history, and other details, followed by timing the preoperative preparation period and evaluating postoperative discomfort


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing endoscopic submucosal dissection (ESD) at Ningbo University Affiliated First Hospital from December 2024 to December 2026.
* Aged between 18 and 75 years.
* Patients who voluntarily agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Individuals under 18 years of age.
* Patinents unwilling or unable to provide informed consent.
* Patients with severe chronic cardiac or pulmonary disease, or those who have required hospitalization for coronary or cerebrovascular events or radiotherapy within the past 3 months.
* Patients with severe abdominal symptoms such as severe pain, bloating, or nausea.
* Patients with inadequate preoperative preparation.
* Individuals requiring lifelong anticoagulant therapy, those with severe bleeding disorders, or those who have recently taken anticoagulant or antiplatelet medications.
* Pregnant or breastfeeding individuals.
Evaluation of the Efficacy of Compression With Tight Surgical Gloves in Patients With Taxane-based Therapy

In this study, the effect of compression therapy of the hands with tight surgical gloves to reduce peripheral neuropathy in adult patients during the application of taxanes will be evaluated.

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of treatment with taxanes. The damage to peripheral nerves leads to pain, numbness, and motor dysfunction, which is very distressing for patients and often results in the reduction of the therapeutic dose of taxanes. Preventive measures are limited, but recent studies show that compression of the hands with tight surgical gloves can significantly reduce the incidence of CIPN. The aim of this randomized controlled trial is to investigate the efficacy of compression therapy in reducing CIPN during taxane-based chemotherapy. The randomized controlled and double-blind study will be conducted at the Comprehensive Cancer Center Zurich (CCCZ) of the University Hospital Zurich from 07/24 to 06/25. Participants will be recruited if they have breast cancer or a urogenital carcinoma and are receiving nab-paclitaxel, paclitaxel, or docetaxel. Exclusion criteria include previous neurotoxic treatment, existing neuropathy, peripheral vascular disease, or the use of medications that affect polyneuropathy. The intervention group will wear surgical gloves with a compression pressure of 23-32 mmHg (equivalent to compression class II) for 30 minutes before, during, and 30 minutes after the infusion. The control group will wear non-compressing gloves with a pressure of less than 3 mmHg. The primary endpoint is the occurrence of moderate to severe CIPN within four therapy cycles, measured according to NCI-CTCAE criteria. Secondary endpoints include patient-reported symptoms and quality of life, assessed by the FACT/COG-NTX questionnaire. Comfort and adherence to the compression therapy will also be evaluated. Participants will be randomized into two groups of 57 each. Data collection and analysis will be conducted according to standardized procedures, and the data will be securely and confidentially stored and managed.

Eligibility Criteria:
Inclusion Criteria:

* Mamma or Urogenital carcinoma
* first treatment with Taxanes (nab-Paclitaxel, Paclitaxel, Docetaxel)
* signed informed consent
* sufficient proficiency in German or English

Exclusion Criteria:

* other therapy that could have caused peripheral neuropathy within the last 24 months (Taxane, Platin, Vincaalkaloids, etc.)
* History of neuropathy such as Raynaud's phenomenon, fibromyalgia and diabetic polyneuropathy
* Use of polyneuropathy medications including duloxetine; gabapentin/pregabalin; topical amitriptyline, ketamine, baclofen; oral cannabinoids; tricyclic antidepressants; and ganglioside monosialic acid
* such impaired cognition that prevents participation in the study according to the assessment of the caregivers
A Study of Trastuzumab Subcutaneous in Participants With Human Epidermal Growth Factor Receptor-2 (HER2) Positive Early Breast Cancer

This observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in routine clinical practice. Data from eligible participants will be collected for the duration of their treatment (approximately 1 year) and for 1-2 years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the breast
* HER2-positive tumor
* Eligible for neo-adjuvant or adjuvant treatment with trastuzumab SC according to the judgement of the physician Note: As of participant recruitment (date of participant informed consent), retrospective documentation is allowed but limited to up to 9 weeks after initial start of therapy with trastuzumab SC

Exclusion Criteria:

* Contraindications according to the Summary of Product Characteristics of Herceptin SC
* Pregnant and breastfeeding women
Perioperative Parameter and Treatment Outcomes of ECIRS in Asia

This is an observational, international, multicenter, cohort study, prospectively collecting clinical data registry on consecutive patients with urinary stone undergoing ECIRS.

Patients diagnosed with urinary stones and planned for ECIRS in different centres will be recruited for the study. This registry collects clinical data on patients with ECIRS performed, includes baseline information on demography, symptoms, risk factors, and laboratory variables. Treatment information, perioperative outcomes, and follow-up details (up to 3 months after surgery) will also be collected. In summary, it captures patterns of presentation and treatment parameters, as well as perioperative and short-term outcomes of patients managed by ECIRS.

Eligibility Criteria:
Inclusion Criteria:

* Patients with urinary calculi
* Undergoing Endoscopic Combined Intrarenal Surgery (ECIRS)
* Agreed to consent for the study

Exclusion Criteria:

* Patients who have ECIRS for other conditions, such as urothelial cancer etc.
* Patients who intraoperative record was incomplete.
* Patients only have either PCNL or ureteroscopy done (not both)
A 24-month Clinical Evaluation of Different Bulk-fill Restorative Resins in Class II Restorations

The aim of this study is to evaluate the clinical performance of three different bulk-fill restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin composite and a fiber-reinforced resin in Class II restorations over a period of 24 months.

The objective of this study is to evaluate the 24-month clinical performance of three different bulk-fill restorative resin materials in Class II restorations. Forty patients with at least three approximal lesions in premolar and molar teeth will be participated in the study. A total of 120 Class II cavities will be restored using Tetric EvoCeram Bulk Fill (n=40), SureFil SDR flow + Ceram X mono (n=40), and everX Posterior + G-aenial Posterior (n=40) with their respective adhesives according to the manufacturers' instructions. All restorations will be placed by one operator. The restorations will be evaluated at baseline and at 6, 12, 18, and 24 months using modified USPHS criteria by one examiner. The restoration groups for each category will be compared using Pearson's chi-square test, while Cochran's Q test will be used to compare the changes across different time points within each restorative material (p\<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Patients who accept to participate and sign the informed consent
* Patients who have at least three similar-sized approximal primary caries lesions in premolar and molar teeth.
* The teeth to be restored had a normal occlusal relationship with natural dentition and had adjacent tooth contact and had a normal response to a vitality test with no periapical pathology

Exclusion Criteria:

* Patients who don't accept to participate and sign the informed consent
* Patients who have a history of adverse reaction to the test materials
* Patients who are pregnant or lactating, have fewer than 20 teeth
* Patients who have poor oral hygiene, have severe or chronic periodontal disease, have heavy bruxism
"L-Sandwich" Strategy in the True Coronary Bifurcation Lesions

The treatment of coronary bifurcation lesions continue to remain challenges. Due to the complexity of the anatomical structure and the limitations of imaging, there are poor attachment and under-expansion of the stent at the branch ostium, which causes in-stent thrombosis and restenosis. The delayed re-endothelialization arise from multi-layer stents. The one-stent strategy causes the displacement of the plaques and ridges of the branch ostium, and thus insufficient blood flow to the branches. The "L-sandwich" strategy, stents were implanted in the main vessel(MV) and the shaft of side branch(SB) respectively, then a drug-coated balloon(DCB) was applied to the ostium of the SB, to improve the tedious operation process in true bifurcation lesions and reduce postoperative complications. The purpose of this study was to explore the feasibility, safety, and efficacy of the "sandwich" strategy.

This is a study to evaluate the application of L-Sandwich in true bifurcation coronary artery disease.All eligible patients were randomly divided into three groups: experimental group 1: dual stent group: both main vessel(MV) and side branch(SB) were stented, and DK-Crush or Culotte were performed according to different pathological characteristics. Experimental group 2: single stent + drug-coated balloon（DCB）: stent was implanted in the MV, and only drug balloon was used in the SB.Experimental group 3: L-Sandwich : stent was implanted in the MV, and the branch was implanted 3-5mm away from the ostium，and the DCB was implanted in the ostium of the branch.IVUS+ angiography was used to guide the operation and evaluate the outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with true bifurcation disease with SB lesion length\>25mm

Exclusion Criteria:

* SB diameter\<2.5mm
* presence of cardiogenic shock or cardiopulmonary resuscitation
* Expected survival \<1 year
* Allergy to indexed medications
* Intolerable to dual antiplatelet therapy
* pregnant
* Severe calcification needing rotational atherectomy