cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Alveogyl and Cutanplast Dressing on Postoperative Pain Following Tooth Extraction: A Clinical Trial

This study aims to assess the post-dental extraction pain following the application of two different dressing materials.

Alvogyl® and Absorbable gelatin sponges

Effective postoperative pain relief improves the quality of recovery and the resumption of normal activities. Many options are available for postoperative pain relief following tooth extraction including systemic analgesic, intra-alveolar socket dressing medicaments, and follow the postoperative instructions; the choice of the medication determined by drug availability, chance of side effect of some drugs and financial considerations. The use of intra-alveolar dressing materials is widely suggested in the literature such as Alvogyl® that used as palliative treatment which includes eugenol (analgesic, anti-inflammatory), iodoform (antimicrobial), and butamen (anesthetic). Absorbable gelatin sponges contain haemostatic material and may be used for local application in surgical procedures where traditional haemostasis is difficult. In addition to its haemostatic effect, an absorbable gelatin sponge can be used as a drug reservoir to provide sustained release of drugs

The aim of this study is to measure the pain intensity after using socket dressing materials following tooth extraction.

Eligibility Criteria:
Inclusion Criteria:

* Single tooth extraction
* Upper and lower teeth

Exclusion Criteria:

* Surgical extraction
* Medically compromised patients
* Presence of active infection
* Presence of pathology
Gleevec in Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma

The purpose of this research study is to evaluate the overall response rate to imatinib mesylate in participants with relapsed or refractory T cell non-Hodgkin's lymphoma. This drug has been used in chronic myeloid leukemia and information from those other research studies suggests that it may help to treat T cell non-Hodgkin's lymphoma.

OBJECTIVES:

Primary Objective To evaluate the overall response rate

Secondary Objectives To assess the safety and tolerability To assess the duration of response To assess the progression free survival and overall survival

STATISTICAL DESIGN:

This trial will use a single stage design to differentiate a \>/= 25% response rate from a \</= 5% rate. If observed data is consistent with the alternative response rate of 25%, imatinib would be deemed clinically interesting and worthy of a larger phase II study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed T NHL, excluding T prolymphocytic leukemia, T lymphoblastic lymphoma, and T/NK large granular lymphocytic leukemia.
* Measurable disease, defined as at least one bidimensionally measurable site of disease measuring at least 1.5cm in greatest diameter.
* Failed at least one systemic chemotherapy or biologic therapy for T cell lymphoma unless it can be clearly documented that the patient can not tolerate such therapy.
* 18 years of age or older
* Life expectancy of greater than 3 months
* ECOG Performance Status of lesser then or equal to 2
* Normal organ and marrow function as outlined in the protocol
* Agree to the use of adequate contraception prior to study entry and for the duration of the study

Exclusion Criteria:

* Chemotherapy or radiotherapy within 4 weeks prior to entering the study
* Receiving any other study agents
* CNS lymphoma requiring active therapy
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to imatinib mesylate
* Participants requiring concomitant administration of any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible
* Patient previously received radiotherapy to 25% or greater of the bone marrow
* Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or lactating women
* History of a different malignancy except for individuals who have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy
* HIV-positive individuals on combination antiretroviral therapy
* Known chronic liver disease
* Major surgery within 2 weeks prior to study entry
A Case Management Intervention to Prevent ER Visits in HIV-infected Persons

Case management has become an integral part of HIV care. There is little science however demonstrating its effectiveness. This is a randomized, controlled trial of a phone call intervention after an ER visit to see if this can reduce further ER visits, hospitalizations, deaths, and cost.

One year retrospective look at outcome measures followed by a one year trial of a phone call after each ER visit in half of the group. Outcomes measured are cost, ER visits, hospitalizations, death, length of stay. Adults only, English or Spanish, questionnaire on depression, appointments, drug use with referral to case management services, drug rehab services, or followup appointments. Time for intervention is recorded to estimate cost.

Eligibility Criteria:
Inclusion Criteria:

* Patient in our clinic as of 4-1-04

Exclusion Criteria:

* \<18 years old
Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure

This study will test the effects of valsartan versus placebo on exercise tolerance in patients with symptoms of heart failure


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic diastolic heart failure
* Breathlessness with physical exertion

Exclusion Criteria:

* Uncontrolled hypertension
* Asthma, COPD, or abnormal lung function
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Allergy to valsartan

Other protocol-defined exclusion criteria may apply
Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge

Alveolar bone atrophy post-extraction has been well documented in the past years. normal healing event results in a minimal loss of vertical height (around 1 mm), but a substantial loss of width in the buccal-lingual plane (4-6 mm). Alveolar socket preservation is thought to deal with this issue as to prevent the loss of alveolar bone dimensions post extraction in the case of delayed implant placement


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to a history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
* Patients that refuse to be called back for implant placement post extraction.
* Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.
* Pregnant Females.
A Study in Erectile Dysfunction

The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.


Eligibility Criteria:
Inclusion Criteria:

* Male and at least 18 years old, with at least a 3-month history of erectile dysfunction (ED).
* Anticipate having same adult female sexual partner during the study.
* Agree to make at least 4 sexual intercourse attempts with the female partner during the 4-week run-in phase without medication.
* Agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of three attempts required during that period). Also agree to make at least 3 intercourse attempts during days 5-14 following randomization.
* Agree not to use any other ED treatment during the study and for 24 hours after the final study visit.

Partner Inclusion Criteria:

* Female and at least 18 years old.
* Agree to make at least 4 sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase without medication.
* Agree to make at least 1 sexual intercourse attempt per day with the male partner during days 1-4 following randomization
* Agree to make at least 3 intercourse attempts during days 5-14 following randomization.

Exclusion Criteria:

* Previous or current treatment with tadalafil or any phosphodiesterase type 5 (PDE5) inhibitor on a daily basis for once daily use.
* ED caused by other primary sexual disorders, or untreated or inadequately treated endocrine disease.
* History of radical prostatectomy, other pelvic surgery or penile implant.
* Clinically significant penile deformity in the opinion of the investigator.
* Clinically significant renal insufficiency, or hepatobiliary disease as determined by the investigator.
* Glycosylated hemoglobin of \>11%.
* Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months.
* Have any significant cardiac conditions as described in the protocol exclusion criteria.
* Have a history of significant central nervous system injuries within the last 6 months.
* Have a history of Human Immunodeficiency Virus infection.
* Have any condition that would interfere with the subject's ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results.
* Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar, or Avodart \[dutasteride\]).
* History of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
* Previously completed or withdrawn from any other study investigating tadalafil for once daily use.
* Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Prior ineffective treatment with any PDE5 inhibitor in the opinion of the investigator.
Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System

The Yale HF Registry is a live EHR based registry that allows for retrospective and real-time monitoring of Heart Failure case across the Yale New Haven Health System.

Electronic Health Records based registries can be an important resource for precision medicine delivery by understanding the population burden of chronic diseases such as heart failure. These registries can allow for a deeper understanding of gaps in guideline recommended therapies among patients who are under the purview of large, integrated Therefore, we have created a live registry within the integrated Yale New Haven Health System-the Yale Heart Failure Registry-that includes all patients with a diagnosis of HF and has detailed information about demographics, comorbidities, laboratories, imaging, medications, and clinical outcomes (including hospital readmissions). The registry is updated daily and can be queried for clinically relevant questions aimed at quality improvement.

Eligibility Criteria:
Inclusion Criteria:

* Seen within the Yale New Haven Health System
* Diagnosis of heart failure

Exclusion Criteria:

* Age\<18
The Study of Different Dose Rituximab in the Treatment of ITP

The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).

62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Male or female, between the ages of 10 \~ 70 years.
3. Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is large, without immunosuppressive therapy or immunosuppressive treatment ineffective
4. To show a platelet count \< 30×10\^9/L, or with bleeding manifestations.
5. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2

Exclusion Criteria:

1. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
2. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
3. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
4. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
5. Patients who are deemed unsuitable for the study by the investigator.
Studying Non-motor Symptoms in HSP

Comparing the non-motor symptoms of patients with hereditary spastic paraplegia (HSP) to healthy controls (spouses, relatives or other healthy controls) by using the a number of specific questionaires

https://lamapoll.de/NMS_in_HSP

Eligibility Criteria:
Inclusion Criteria:

* Group 1: Patients with HSP (hereditary spastic paraplegia)
* Group 2: Healthy controls
* Age 18 to 70 years
* Written, informed consent

Exclusion Criteria:

* Lack of ability for a written, informed consent
* Presence of spastic gait disorder or other neurological condition (Group 2)
The Predictors and Patient Versus Parental Perceptions of Health-Related Quality of Life in Pediatric Chronic Pain

This study is intended to provide additional insight into the factors affecting health-related quality of life with pediatric chronic pain as perceived by the patient versus his or her parents.In doing so, additional insight into the subjective interpretation the pediatric chronic pain experience will be gained. The four objectives of this study will be (a) to examine further the relationship between patient self-reported health-related quality of life and parent proxy-reported health-related quality; (b) to identify what biological, psychological, and/or social factors are the strongest predictors of a pediatric chronic pain patient's self-reported pain intensity and self-reported health-related quality of life, in a diverse cohort of patients referred to and subsequently treated by an anesthesiology-based yet interdisciplinary pediatric chronic pain medicine program; (c) to assess the effect of patient-specific, pain-focused biopsychosocial treatment regimen on pain intensity and health-related quality of life; and (d) to determine the effect of patient/parental satisfaction with on-going health care on their compliance with and uptake of the pain treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

* outpatients ranging between 8 years and 18 years of age directly referral from either their primary care physician or another specialist physician

Exclusion Criteria:

* patients in whose biologic families English is not the primary, native language
* patients suffering from severe cognitive dysfunction (i.e., mental retardation)
* patients with a life-expectancy of less than three months at the time of initial clinical evaluation
Identification of Predictive Factors for Survival of Patients With Recurrent Prostate Cancer From Clinical Features, Tissue Image Features and Molecular Biomarker Data

We seek to improve the predictive accuracy of the nomogram to predict survival for patients with castrate mets disease through the addition of pathological data, the results of automated machine vision based image analysis of H\&E stained tumor tissue developed at Aureon Biosciences,and molecular biomarker studies (25 markers) determined by immunohistochemistry on tissue microarrays prepared from paraffin-embedded tumor.


Eligibility Criteria:
Inclusion Criteria:

Patients in the first retrospective study (Stage 1) must be part of the 409 patient strong MSKCC cohort with progressive metastatic prostate cancer which was used for the generation of the original nomogram.

For details please see original publication by Smaletz et al. Patients involved in the second retrospective study (Stage 2) must be part of the 223 patients with a rising PSA after surgery or radiation therapy who were treated on conjugate vaccine trials at MSKCC..

Exclusion Criteria:

For details of excluded patients on the clinical metastases castrate disease study, please see original publication by Smaletz et al.4

• (MSKCC - add reference if publication available for rising PSA patients)
TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA

The purpose of this study is to evaluate the superiority of CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronum bromide) versus CHF 1535 100/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate), in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.


Eligibility Criteria:
Inclusion Criteria:

* History of asthma ≥ 1 year and diagnosed before 40 years old
* Uncontrolled asthma with double therapy only on medium doses of Inhaled CorticoSteroid (ICS) in combination with Long-acting beta2 Agonist (LABA) with ACQ-7 (Asthma Control Questionnaire) ≥1.5
* Pre-bronchodilator FEV1 \<80% of the predicted normal value
* Positive reversibility test
* At least 1 documented asthma exacerbation in the previous year

Exclusion Criteria:

* Pregnant or lactating women
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior screening
* Current or ex-smokers (\>= 10 packs year)
* Any change in dose, schedule or formulation of ICS + LABA combination in the 4 weeks prior screening
Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer

To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone

The study is a double-blind, randomized Phase 2 trial of Exemestane +/- MM-121. The trial is designed to demonstrate whether MM-121 + Exemestane is more effective than Exemestane alone in ER+ and/or PR+ and Her2 negative breast cancer patients that have failed first-line anti-estrogen therapy in the locally advanced or metastatic setting and patients that have progressed during (or within 6 months of completing) adjuvant treatment with a non-steroidal aromatase inhibitor (AI)and/or tamoxifen. Patients will be treated until radiologic or clinical progression of their disease is documented. Local radiologist and/or PI assessment is accepted.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic breast cancer
* Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast cancer
* ≥ 18 years of age

Exclusion Criteria:

* Received prior treatment with exemestane
* Extensive visceral disease (rapidly progressive, life-threatening metastases, including symptomatic lymphangitic metastases)
* Symptomatic CNS disease
HALO Patient Registry: Ablation of Barrett's Esophagus

The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems.

Summary The HALO Patient Registry provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD). The primary objective is to provide a tool for participating physician investigators to collect outcomes data related to the use of the HALO Ablation Systems.

Protocol Design:

This is a prospective, multi-center patient Registry. Sites may choose to also retrospectively enroll previously treated patients (after obtaining informed consent) and enter retrospective data into case report forms on-line. "Retrospective data collection" is defined as any data other than patient history collected prior to signing of the informed consent. A set of case report forms (CRFs) is provided along with this protocol to track outcomes. The CRFs may be completed and retained on site, but the site is recommended to utilize the internet-based data entry system.

Eligibility Criteria:
Inclusion Criteria:

* Must be a candidate for ablation of Barrett's esophagus with the HALO Ablation System.
* Must agree to the proposed follow-up schedule and provide informed consent for participation.

Exclusion Criteria:

* Pregnancy
* Prior radiation therapy to the esophagus
* Esophageal varices at risk for bleeding
* Prior Heller Myotomy
Short-term Air Pollution Exposure and In-hospital Outcomes in Patients With Acute Myocardial Infraction

The aim of this study is to investigate whether or not short-term expose to air pollution is associated with in-hospital outcomes, such as mortality and morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Less than 12 hours after the onset of myocardial infarction symptoms
* Documented acute ST (S- and T-wave)-segment elevation myocardial infarction
* Received emergent percutaneous coronary intervention

Exclusion Criteria:

* Age under 18-year old