cyrilzakka/clinical-trials huggingface dataset:
PEEK Retentive Elements Versus Conventional

comparing retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings

Background. Many patients suffer from lack of retention of conventional mandibular overdentures due to loss of clip retention over time. Computer-aided design-computer-aided manufacturing (CAD-CAM) milled polyetheretherketone PEEK materials may be used for construction of retentive housing and clip for improving retention of implant-supported overdentures.

Objective . To compare retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings.

Methods: Twenty-two participants were divided into 2 equal groups (n=11). The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements, while the PEEK group received implant-supported mandibular overdenture retained by PEEK retentive element and housings.The PEEK retentive elements were made by using computer-aided design and computer-aided manufacturing (CAD-CAM).Evaluation included measuring the retention by applying a gradual pulling up force by forcemeter and patient satisfaction with a 7-point visual analog scale (VAS) at overdenture insertion , 3,6, and 12 months subsequently by research interviewer.

Eligibility Criteria:
Inclusion Criteria:

* edentulous class I or II PDI classification no neuromuscular disordersand temporomandibular joint disorders

Exclusion Criteria:

* exposed to radiotherapy
Prevalence of Coronary Artery Disease in the Siblings of Premature Coronary Heart Disease

The aim of this prospective study is to investigate the prevalence of coronary artery disease using computed tomography with family history of premature coronary heart disease


Eligibility Criteria:
Inclusion Criteria:

* within 1 year
* the siblings of premature coronary heart disease (male\<55years old, female\<65yeasrs old: Framingham Heart Study) patients admitted relevant hospital

Exclusion Criteria:

* Documented coronary heart disease
* experienced adverse events with relevant treatment
* contraindicated with beta-blockers
* Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects
Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-65 years of age
* chronic hepatitis C , genotype 1
* serologic evidence of CHC infection by an antibody test
* chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months
* compensated liver disease
* use of 2 forms of contraception during the study in both men and women

Exclusion Criteria:

* previous interferon or ribavirin therapy
* systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
* medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
* decompensated liver disease
* women who are pregnant or breastfeeding
ASTERIX: Low Dose ASA and Nexium

The purpose of the study is to evaluate the effect of esomeprazole 20 mg od versus placebo for the prevention of gastric and/or duodenal ulcers in patients taking low-dose ASA.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of a condition (cardiovascular and/or cerebrovascular protection or other reasons) that requires daily intake of low-dose ASA, 75-325 mg, and is expected to continue for the duration of the study (daily is defined as at least 5 days per week).
* Age \>= 60 years.
* No gastric and/or duodenal ulcer at the baseline endoscopy.
* H. pylori negative by serology test at screening.

Exclusion Criteria:

* Upper GI symptoms
* Erosive oesophagitis
* Malignancy
The Safety, Tolerability, and Pharmacokinetics of Inhaled TLC19 in Healthy Volunteers

Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and PK of single ascending doses of inhaled TLC19 in healthy volunteer subjects.

A Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and PK of single ascending doses of inhaled TLC19 (Hydroxychloroquine Liposome Inhalation Suspension) in healthy volunteer subjects. Three dose levels will be assessed in sequential cohorts, with 2 mL, 4 mL, and 6 mL. Total of approximately 30 subjects will be randomized in the study in 3 cohorts. Subjects will be enrolled and randomized to receiving either TLC19 or TLC 19 Vehicle.

Drug Administration: Blinded study medication will be administered through inhalation via a portable vibration mesh nebulizer.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 to 65 years of age
2. Body mass index (BMI) 18.0 to 30.0 kg/m2.
3. Never-smoker

Exclusion Criteria:

1. Body weight \<50 kg
2. Donation of blood (450 mL) or blood loss within 3 months prior to study
3. Contraindication, allergy, or hypersensitivity to hydroxychloroquine or chloroquine or other 4 aminoquinolines
4. Use of any prescription or OTC medications or herbal supplements within 2 weeks (or 5half-lives if longer) prior to study
5. Use of any investigational product/medical device within 30 days or 5 half-lives prior to study, or participation in ≥4 investigational drug studies within 1 year prior to study
6. History or presence of any of the following conditions:

   * Autoimmune or rheumatoid inflammatory disease
   * Cardiac disorders
   * Lung disease, prior intubation, or requiring use of an inhaler
   * Liver cirrhosis or Child-Pugh class C
   * Retinopathy or maculopathy
   * Neuromuscular diseases
   * Glucose-6 phosphate dehydrogenase deficiency
   * Hematologic malignancy
   * Chronic kidney disease or renal failure
   * Psoriasis or porphyria
   * Diabetes mellitus
   * Severe allergic or anaphylactic reactions
   * Any other significant condition that would preclude participation
7. History of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years
8. Fever or symptomatic viral or bacterial infection within 2 weeks prior to study
9. Any clinically significant laboratory abnormality
Diet, Hepcidin, and Chemotherapy RDI

This prospective, observational cohort study will evaluate the extent of associations between self-reported pro- or anti- inflammatory dietary intake patterns for one month before induction chemotherapy for gynecological cancer or neo/adjuvant chemotherapy for breast cancer and baseline serum hepcidin concentrations. Associations between hepcidin concentration and relative dose intensity (RDI) of chemotherapy will also be evaluated.

This is a prospective, observational cohort of 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July 1, 2024 - approximately September 2025. At study baseline (after diagnosis, but prior to starting chemotherapy), participants will complete a \~30-minute food frequency questionnaire (FFQ) and demographic/food security survey using a preprogrammed iPad in the clinic. The clinical research nurse will obtain an additional research blood draw at the same time as the patient's routine clinical blood draw prior to chemotherapy initiation for serum hepcidin concentration measurement. Data on cancer type, premorbid medical conditions, and chemotherapy plans and administration will be collected from the electronic health record by study staff and the duration of data collection will be the length of chemotherapy plus 30 days. Data will be used to address the objectives below.

Among adult women scheduled to receive chemotherapy for breast or gynecological cancer treatment, the objectives/aims of this study will be to:

1. Determine the extent to which pretreatment, self-reported Dietary Inflammatory Index dietary pattern scores from dietary intake during the one month prior to chemotherapy initiation are associated with pretreatment serum hepcidin concentrations
2. Determine the extent to which pretreatment serum hepcidin concentrations are associated with chemotherapy RDI.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with invasive breast cancer, OR
* Have been diagnosed with epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, OR
* Have been diagnosed with endometrial cancer
* Are chemotherapy-naïve
* Are scheduled to receive neoadjuvant chemotherapy (or adjuvant chemotherapy following lumpectomy for breast cancer patients) or neoadjuvant/induction chemotherapy for gynecological cancer at GW Cancer Center

Exclusion Criteria:

* Prior primary hematological condition that would cause abnormal blood counts (e.g. leukemia)
* Pregnant at the time of potential enrollment
* Receipt of erythropoietin-stimulating agents or blood transfusion in the 6 weeks prior to initial testing
* Women who are cognitively unable to provide a diet history for the month prior to assessment.
Validation of a Scale to Evaluate the Perception of Oral Health in Patients With Schizophrenia

Apart from objective criteria for the evaluation of oral health (CAO, CPI...), there are no scales to evaluate the oral health of patients with schizophrenia. The only scales that do exist are for the population at large, children or the elderly. Given the severely deteriorated oral health in these schizophrenic populations, it is important to have a tool to evaluate their perception of the quality of their oral health so as to better orientate prevention programmes.

The aim of this study is to validate a tool to measure the perception of oral health in patients with schizophrenia.

To do this, patients will be invited to complete a series of self-questionnaires relative to the concept of oral health.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of schizophrenia according to DSM V
* Hospitalized patients or outpatients who have been taking an antipsychotic treatment for more than 2 years
* Patients older than 18 years
* Patients who have provided oral informed consent to take part in the study

Exclusion Criteria:

* Patients who are psychiatrically unstable or delusional
* Subjects on chemotherapy
* Adults under guardianship
* Patients without national health insurance cover
A Study of the Effectiveness of Electronic Interventions on the Standardized Prescription Benzodiazepines and Z-drugs

A retrospective surveys and group interviews focusing on the prescription and abuse of benzodiazepines will be carried out in China. Based the results of retrospective surveys and group interviews and guidelines of benzodiazepines and Z-drugs standardized use, a real-world randomized control trial of would be carried to evaluate the effectiveness of the intervention of using electronic content push in reducing the use rate of psychiatric BZDs and Z-drugs and improving clinical efficiency.

Benzodiazepines (BZDs) and Z-drugs are commonly used sedative and hypnotic drugs in psychiatry. A small number of studies have suggestted that there may be improper use or even abuse in recent years. Long-term use of BZDs and Z-drugs may have the risk of impairing memory, respiratory depression, and increasing accidents risk. At present, there is no risk investigation on psychiatric BZDs and Z-drugs abuse in China, and many psychiatric practitioners lack of knowledge on the standard use of BZDs and Z-drugs. The aim of this study was to understand the use of benzodiazepines in psychiatric outpatient clinics in China and to develop a BZDs and Z-drugs standardized use electronic intervention guidebook and to verify the effectiveness of this electronic intervention in reducing the use of BZDs and Z-drugs in psychiatric outpatient clinics and improving clinical efficiency. Through retrospective surveys and focus interview groups, the study was conducted to understand the use of BZDs and Z-drugs and related factors of abuse in psychiatric outpatient clinics in Shanghai, Hunan, Sichuan, Wuhan and Jiangsu provinces. Based on the consensus and guidelines of domestic experts, BZDs and Z-drugs standardized electronic intervention was used. The real-world randomized controlled research method was combined with electronic content push and periodic electronic evaluation to evaluate the effectiveness of the intervention in reducing the use rate of psychiatric BZDs and Z-drugs and improving clinical efficiency. The research can deeply understand the use of BZDs and Z-drugs in domestic psychiatry and form an effective BZDs and Z-drugs standardized electronic intervention manual, which will provide practical value for regulating domestic BZDs and Z-drugs in the future.

Eligibility Criteria:
Inclusion Criteria:

1. at least 3-year working experience as a psychiatrist;
2. provide outpatient services for at least 1 year with the frequency of more than once a week;
3. willingness to receive standardized electronic interventions on BZDs and Z-drugs prescription.

Exclusion Criteria:

1. will retire within six months;
2. refuse to extract their prescription information from the outpatient database.
Using CPAP to Improve Menstruation in Women With Polycystic Ovarian Syndrome and Obstructive Sleep Apnea

The purpose of this study is to determine if treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure in women with both OSA and polycystic ovarian syndrome will improve the regularity of the women's menstrual cycles.

Women seeking fertility treatment at the University of Louisville will be screened for polycystic ovarian syndrome (PCOS) based on history and then blood work if history suggests PCOS. After establishing a diagnosis of PCOS based on the National Institute of Health criteria, they will be screened for impaired glucose tolerance, Class III obesity, and obstructive sleep apnea \[using the Epworth Sleepiness Scale (ESS) as the initial screen\]. For those women that screen positive on the ESS, they will be referred to the University of Louisville Physicians Sleep Center for a formal sleep study. Only patients with PCOS, severe obstructive sleep apnea, impaired glucose tolerance, and Class III obesity will qualify for enrollment in the study. Once enrolled, patients will be encouraged to use continuous positive airway pressure (CPAP, standard of care for treatment of obstructive sleep apnea) for at least six months. During those six months, patients will be asked to track their menstrual cycles and whether they took progesterone to induce a withdrawal bleed during that time period. The use of ovulation predictor kits to help determine ovulation status will be encouraged, but not required for the study.

During initial evaluation, patients seeking fertility care having a clinical presentation concerning for PCOS have their blood drawn for evaluation of thyroid stimulating hormone, free and total testosterone, antimullerian hormone, and 2 hour glucose tolerance test. At the conclusion of six months of CPAP therapy, patients will be asked to repeat the above blood tests for comparison to baseline values.

Women can continue to attempt pregnancy during the study time period if they desire.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* English speakers
* Polycystic ovarian syndrome by NIH criteria
* Abnormal 2 hour glucose tolerance test
* Body mass index \>/= 40 kg/m2
* Severe obstructive sleep apnea diagnosed with either a home or in-house sleep study

Exclusion Criteria:

* Age \<18 or \>35
* Non English speakers
* No diagnosis of PCOS
* Normal glucose tolerance test
* No diagnosis of obstructive sleep apnea
* Body mass index \< 40 kg/m2
* Using any form of hormonal contraception
RescuE pLAsma eXchange in Severe COVID-19

The spectrum of coronavirus disease 2019 (COVID-19) ranges from asymptomatic infection to acute respiratory distress syndrome ("ARDS") and patient death. Severely affected patients may develop a cytokine storm-like clinical syndrome with high mortality. Laboratory tests in these patients show an excessive and uncontrolled immune response with consecutive multi-organ failure. In addition, there is evidence for the development of prothrombotic autoantibodies as an epiphenomenon of "Severe Acute Respiratory Syndrome Coronavirus 2" (SARS-CoV-2) infection. Therapeutic plasma exchange ("TPE") is being discussed as a therapeutic alternative in patients with severe, refractory COVID-19. The idea is that plasma exchange eliminates both endogenous and exogenous inducers of an exuberant inflammatory response as well as prothrombotic factors, thus breaking the secondary vicious circle of SARS-CoV-2 infection. In general, TPE is a safe procedure with known efficacy in other severe viral diseases as well as in cytokine storm-like diseases and ARDS of other geneses. Moreover, initial data, mostly derived from case studies, demonstrate promising therapeutic efficacy of TPE in severe COVID-19 courses with previously lacking treatment options. To further evaluate the therapeutic efficacy of TPE in severe COVID-19, a prospective randomized controlled trial of TPE in severe SARS-CoV-2 infection is being conducted at our center. Patients will be randomized to a control group (standard therapy according to center standards) and a therapy/intervention group (standard therapy + TPE).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent by the study participant or their legally appointed representative.
* Age ≥ 18 years
* Evidence of acute SARS-CoV-2 infection, confirmed by PCR testing
* Invasive ventilation
* Fever ≥ 38.5°C, confirmed by a total of 3 consecutive measurements or ongoing renal replacement therapy and temperature ≥ 37.5°C
* D-dimers ≥ 2mg/L
* Dexamethasone ≥ 6mg/day or equivalent dose on at least 2 days

Exclusion Criteria:

* Age \> 85 years
* Pre-existing treatment limitations
* Pregnancy
* Confirmed pulmonary arterial embolism with hemodynamically relevant right heart strain
* ST-segment elevation myocardial infarction (STEMI)
* Participation in an intervention study elsewhere
Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™

The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 70 years of age (inclusive) at the time of randomization
* Willing and able to provide written informed consent and HIPAA Waiver
* An appropriate candidate for participation with unbroken non-irritated abdominal skin
* Willing to adhere to the study procedures and to attend the scheduled study visits according to the requirements of the study protocol
* Willing to adhere to the scheduled study visits
* Good manual dexterity and be able to take care of their abdominal area independently
* Be willing and able to record the required study data in a specified format

Exclusion Criteria:

* A history of a known sensitivity or allergy to System 3+ adhesive (modified Stomahesive® technology), Stomahesive®, Durahesive®, Polyethylene Film, or polyester fiber,or to any adhesive components in general as listed in the Investigators Brochure.
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
* Subjects with any chronic allergies requiring the use of prescription medication
* History of skin disease affecting abdominal area
* Currently uses topical ointments in the area of the abdomen or is unwilling/unable to terminate over the counter use of topical ointments in the area of the abdomen
* Active case of eczema, dermatitis, psoriasis
* Pregnant or lactating females.
* Subject currently enrolled in another investigational study
* Possesses extensive knowledge about either product (ie employees that re members or extended members of the Core Team work in ostomy research and development, or ostomy division sales and marketing )
Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

Compared to the knee and shoulder, the hip joint leaves relatively little space to maneuver arthroscopic instruments and camera. To expand the potential space in the hip joint, traction is commonly applied to the operative leg through a perineal post. This is an effective technique to improve the working space for arthroscopy, however it has been associated with complications, including perineal numbness. Traction pads, used alone or with a perineal post, can reduce pressure on the perineal area, thus reducing numbness. The investigators hypothesize that positioning hip arthroscopy patients using a traction pad on a standard traction table with a perineal post will reduce the incidence and duration of postoperative perineal numbness.


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy
* Ability to read and speak English

Exclusion Criteria:

* Revision surgery
* Oncologic surgery
* Use of regional anesthesia
* Arthroscopic hip surgery that involves procedures other than labral repair, acetabuloplasty, CAM-plasty, IT band windowing, Iliopsoas lengthening
Observational Study of Double Cord Blood Transplant

The efficacy and safety of non-myeloablative and myeloablative preconditioning followed by dual-unit umbilical cord blood transplantation from unrelated donors in adult patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation are evaluated through prospective observation and analysis of actual clinical data collection


Eligibility Criteria:
Inclusion Criteria:

* (1) Aged 19 and older (2) Patients scheduled for umbilical cord blood transplantation as a primary allogeneic hematopoietic stem cell transplantation for the treatment of the following hematologic diseases:

  * Acute leukemia (myeloid/lymphoid/mixed lineage) planned for transplantation for treatment purposes

    * Myelodysplastic syndromes planned for transplantation for treatment purposes ③ Chronic leukemia (myeloid/lymphoid/monocytic) and myeloproliferative neoplasms planned for transplantation for treatment purposes ④ Malignant lymphomas, multiple myeloma planned for transplantation for treatment purposes ⑤ Other malignant hematologic malignancies planned for transplantation for treatment purposes ⑥ Planned for transplantation for the treatment of bone marrow failure diseases, including aplastic anemia (3) If all contents of the consent form are understood and consented to in writing.

Exclusion Criteria:

* (1) Patients with a history of allogeneic hematopoietic stem cell transplantation or those undergoing transplantation for the treatment of engraftment failure (secondary allogeneic hematopoietic stem cell transplantation is an exclusion criterion; however, patients eligible for registration include those undergoing their first allogeneic stem cell transplantation following an autologous stem cell transplantation).

  (2) Patients with severe, uncontrolled infections or severe cardiopulmonary dysfunction, as judged by the investigator.

  (3) Patients with an ECOG Performance Status (PS) greater than 3 or those receiving mechanical ventilation in the intensive care unit.

  (4) Patients who do not consent to participate in the study or those deemed unsuitable for sincere participation by the attending physician.