cyrilzakka/clinical-trials huggingface dataset:
Dependence on Analgesics in Chronic Non-cancer Pain

The identification of an addiction to opioid analgesics has become strong recommendation for the purpose of improving the clinical management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself. The main objective of this study is to evaluate the factors associated to the discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception that the patient with non-cancer chronic pain has of this dependence.

The long-term use of opioid analgesics for the treatment of chronic non-cancer pain exposes patients to the risk of developing drug dependence on these psychoactive drugs with loss of control of their use. In general medicine as well as in algology consultation, the identification of an addiction to opioid analgesics (and even misuse as a gateway to addiction) have thus become strong recommendations for the purpose of improving the management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself.

The discrepancy between the assessment of drug dependence on analgesic drugs by the algologist and the perception that the patient has of this dependence will be investigated through a multicentre cross-sectional descriptive survey performed in pain treatment centres in France.

In addition to opioid analgesics, other pharmacological classes used for analgesic use will be investigated as they are concerned with the development of drug dependence. This is particularly the case for gabapentins.

Eligibility Criteria:
Inclusion Criteria:

* suffering from chronic non-cancer pain,
* taking at least one analgesic medication

Exclusion Criteria:

* Patient minor or major protected by the law (under tutelage),
* Patient with chronic pain of cancerous origin,
* Opposition of the patient to be included in the study,
* Patient not having the overall skills to complete a self-questionnaire: major difficulties in understanding the French language and / or reading / writing difficulties.
Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects

This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-03463275 oral controlled release formulation in Japanese and Western male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).
* Japanese subjects must have four Japanese grandparents who were born in Japan.

Exclusion Criteria:

* Subjects that are genotyped to be PM (poor metabolizer), UM (ultrarapid metabolizer), IM/EM and EM/UM for CYP2D6 status.
* Evidence or history of clinically significant hematological (including anemia), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia

The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.

The study is a prospective, consecutive, multi-center, 1:1 randomized study (UroLift System:TURP). The study is intended to be conducted at up to 20 different centers in Europe and Canada to enroll up to 100 subjects.

Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.

Eligibility Criteria:
Inclusion Criteria:

• Men \>50 years old with moderate-severe BPH

Exclusion Criteria:

* Size, width of prostate
* Other medical condition or co-morbidity contraindicative for TURP or UroLift
Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion Criteria:

* Any serious disease
Long-Term Experience and Health Effects of COVID-19

The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission. Data will be deidentified and consolidated to create a large national longitudinal database.

Ths is a longitudinal, observational, descriptive study to gather data needed to support a better understanding of COVID-19 from the perspective of a diverse national population.

This multi-phase study will use an action research approach to identify specific ways that physician groups, federally qualified health centers (FQHCs), public health departments, and other health and social services systems in the United States can address healthcare needs and mitigate the transmission of COVID-19. Email surveys will be used to assess the historical and current status of participants by medical condition, geography, and demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever, loss of sense of taste or smell, etc.) and their current psychosocial needs.

The study will provide the structure for an iterative exploration of trends over time (up to 24 months). The opt-in survey will be posted and available to individuals 18 and older who choose to participate. Survey frequency will be every two weeks.

To analyze broader trends, all survey responses will be de-identified and aggregated. Overall general findings will not be linked to individuals or physician groups when reporting and publishing study results.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Any gender specification
* Has consented to proceed with survey
* Is able to complete the survey via email on a regular basis

Exclusion Criteria:

* none
The Effect of Cycling Off Criteria During Pressure Support Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients

The investigators' aim is to study the effect of cycling off criteria during pressure support ventilation in COPD patients at two levels of PEEP and PSV.

In this study two levels of cycling off criteria at two levels of PEEP and PSV were tested in term of gas exchange, respiratory mechanics, work of breathing and patient comfort.

Eligibility Criteria:
Inclusion Criteria:

* Stable COPD patients during invasive mechanical ventilation

Exclusion Criteria:

* Hemodynamic instability,
* Paralysis
Effectiveness of the Education Support Program Provided Via Text Message

Information will be provided to first year midwifery students via text message within the scope of the 'Basic Principles and Practice in Midwifery Education' support programme. This information is planned to last approximately 4 weeks. The study will be conducted to evaluate the effect of the information provided on the knowledge levels of the students.


Eligibility Criteria:
Inclusion Criteria:

* In 2023-2024 Spring Term, with the success of the Basic Principles and Practices Course in Midwifery to have completed the programme,
* Having a mobile phone,
* Accepting to participate in the research is one of the inclusion criteria of this studyc

Exclusion Criteria:

* Students who incompletely completed the post-test and first test scales will be excluded from the study.
Giving Resources to LOw-income Children to Enhance RecoverY

The goal of this clinical trial is to learn if an intervention to provide food support to families who are part of a Medicaid Accountable Care Organization will provide benefits. The main question it aims to answer:

Does this monthly food support intervention reduce food insecurity and healthcare utilization in these patients.

Participants will complete surveys in the hospital, 14-days after discharge, and then quarterly for up to 18 months. Families randomized to the intervention group will receive monthly grocery gift cards for one year.


Eligibility Criteria:
Inclusion Criteria:

* Parent of a pediatric patient admitted to one of two units at our hospital with HealthVine insurance

Exclusion Criteria:

* Previous study participation
Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]

The purpose of this survey is to evaluate the safety (i.e., frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg) to a large number of patients in daily medical practice.

This survey was designed to evaluate the safety (i.e., frequency of adverse events) and efficacy (i.e., hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 mg (Takepron Intravenous 30 mg) to a large number of participants in daily medical practice.

For adults, 30 mg of lansoprazole is typically mixed in physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 mL of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the following diseases for whom oral administration is not feasible:

Gastric ulcer, duodenal ulcer, acute stress gastritis, and acute gastric mucosal lesion (all of which should be accompanied by bleeding).

Exclusion Criteria:

-
Crossmodal Learning in Therapeutic Processes (Task 2-2)

Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with sensory ataxia.


Eligibility Criteria:
Inclusion Criteria:

* Electrophysiological diagnosis of sensory ataxia
* Age \>= 18, \<=80
* Existing declaration of consent

Exclusion Criteria:

* Pregnancy
* Lacking capacity for consent
Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients

This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.

A dose-escalation part will first determine the maximum tolerated dose (MTD) and/or recomended dose for expansion (RDE) of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.

Subsequently, the MTD and/or RDE of each combination will be investigated in two expansion treatment groups of CRPC patients who have failed abiraterone acetate therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult males ≥ 18 years old
* Eastern Cooperative Oncology Group Performance Status ≤ 2
* Patient must have a castrate level of testosterone (\<= 50 ng/dL or 1.7 nmol/L). ( Castrate status must be maintained by continued GnRH analogues unless patient has undergone surgical orchiectomy).
* Histologically or cytologically confirmed diagnosis of advanced or metastatic prostate cancer.
* Advanced or metastatic castration-resistant prostate cancer progression after abiraterone acetate failure
* Patients should have no more than 2 lines of prior chemotherapies including cytotoxic agents
* Discontinuation of all anti-androgen, anti-neoplastic or investigational treatment \>= 4 weeks (6 weeks for bicalutamide).

Exclusion Criteria:

* Previous treatment with PI3K pathway inhibitors (e.g. PI3K, AKT, mTOR inhibitor), ketoconazole, CYP17 inhibitors (exception of AA), or enzalutamide.
* Patient has active uncontrolled or symptomatic CNS metastases
* Inadequately controlled hypertension (e.g. systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=95 mmHg)
* Patient has a QTcF \> 480 msec on the screening ECG (using the QTcF formula), has a short/long QT syndrome, or history of QT prolongation/Torsades de Pointes
* Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs
* Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others)
* Patients who experienced dose reductions and/or treatment interruptions due to abiraterone acetate related toxicities (i.e. serious AEs, AEs, liver toxicities during abiraterone acetate treatment
Assessing Mental Health Providers' Clinical Knowledge and Skills Via an Online Training on LGBTQ-affirmative Cognitive-behavioral Therapy

The purpose of the proposed study is to train mental health providers (MHPs) at lesbian, gay, bisexual, transgender, and queer (LGBTQ) community centers across the United States in evidence-based, LGBTQ-affirmative cognitive-behavioral therapy (CBT).

The purpose of the proposed study is to train mental health providers (MHPs) at LGBTQ community centers across the United States in evidence-based, LGBTQ-affirmative cognitive-behavioral therapy (CBT).

The primary objective of this study is to determine whether the LGBTQ-affirmative CBT training increases LGBTQ and CBT knowledge, clinical skills, and cultural humility among a sample of MHPs from LGBTQ community centers in the U.S. The proposed prospective study will follow a 2-arm waitlist randomized-controlled trial design where one group of MHPs will be randomized to receive the intervention training (i.e., the immediate training group) in LGBTQ-affirmative CBT, and the second group of MHPs will be randomized to a waitlist control group.

The proposed mixed-methods study will consist of predominantly quantitative self-report measures, as well as a qualitative self-assessment of participants' LGBTQ-affirmative CBT clinical skills. All study measures will be administered online at three time points-- baseline, 4-months post-baseline, and 8-months post-baseline (changed prior to randomization from 3-months and 6-months, respectively)-- via the secure Yale Qualtrics survey software.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* Fluent in English
* Mental health provider (including, but not limited to licensed practicing counselors, licensed clinical social workers, licensed marital and family therapists, clinical/counseling psychologists, pre-doctoral psychology interns, third-year or greater graduate practicum students/externs)
* Currently practicing in an LGBTQ community center that is coordinated by CenterLink, the coordinating hub for LGBTQ community centers in the U.S.

Exclusion Criteria:

* • Individuals unwilling or unable to give informed consent at the time of participation and/or not fitting the eligibility criteria outlined above
Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer

A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The study included 6 months baseline measurement, and 12 months intervention. Patients will be assigned to high adherence or low adherence group. Then, through randomization, low adherence patients will be assigned to the intervention or control group. Study Coordinator delivers the intervention using the WALKON mobile application. Control participants receive usual care with continuous monitoring using Medication Event Monitoring System (MEMS) device.

* Baseline measurement (n=200): screening and enrollment
* 3-month visit: collecting MEMS data
* 6-month visit: collecting MEMS data and assigned to the high adherence (n=70) or low adherence group (n=75). The low adherence intervention group (n=75) will be educated about the WALKON mobile application.
* 12-month visit: Control group: collecting MEMS data intervention group: monthly calls + collecting MEMS data
* 18-month visit: collecting MEMS data and interview

Eligibility Criteria:
Inclusion Criteria:

* Stage 0-III breast cancer
* Treated with Adjuvant hormonal therapy

Exclusion Criteria:

* Stage IV breast cancer
* Breast cancer recurrence or metastasis
* Severe medical illness
PheCheck Feasibility Study

The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino acid analyzer), in patients with PKU.

The main aims are:

* Evaluate the accuracy of PheCheck as compared to the gold standard
* Evaluate ease of use by lay participants

The primary objective of this feasibility study is to evaluate the accuracy of the analyte concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from capillary blood compared to the gold standard (HPLC amino acid analyzer) which quantitatively measures Phe in venous blood.

The study will enroll subjects into one study cohort. It will include patients 10 years or older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* 10 years of age or older
* Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent

Exclusion Criteria:

* Younger than 10 years of age
* Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy
* Lack of signed informed consent
* Previous enrollment in the study and has completed study visit 1 and 2
Effectiveness of Trephination With Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment

This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Results of this study will help ascertain whether platelet rich plasma may improve meniscal healing rates.

The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. The investigators believe that augmentation with platelet rich plasma as prolotherapy ill induce healing without the need for arthroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Complete horizontal 10 mm in length
* Tear located in the vascular/avascular portion of the meniscus (chronic horizontal tear on MR)
* Single tear of the medial and/or lateral meniscus
* Skeletally mature patients 18-70 years of age

Exclusion Criteria:

* discoid meniscus
* arthritic changes (Kellgren Lawrence scale \>2) or axial leg deformity (valgus \> 6 deg)
* inflammatory diseases (i.e. rheumatoid arthritis)
* concominant chondral defects (\> 2 ICRS)
A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation

This will be a single-center, randomized, parallel group, multiple dose administration, double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation. Four groups including a placebo group will be enrolled and will receive multiple oral doses of YKP10811 or matching placebo.

If the participant fulfills the initial eligibility criteria, the patient will be randomized to 1 of the active treatment groups or placebo. During the treatment period, patients will receive study medication once daily for 8 days. Patients will undergo scintigraphic assessment of gastric, small bowel and colonic transit of solids over the 48-hour period.

Patients will be males or females, 18 through 65 years of age with a body mass index (BMI) of 19 through 40 kg/m2, with Chronic Constipation or Functional Constipation and no evidence of evacuation disorder as assessed by the Investigator and meet all the inclusion criteria and none of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Non-smokers (refrained from any tobacco or nicotine usage, including smokeless tobacco, nicotine patches, etc.) for at least 6 months prior to Day 1 of the study
2. Body Mass Index of 19 through 40 kg/m2
3. Participants must be willing to follow dietary restrictions
4. Females of childbearing potential (ie, not menopausal, no hysterectomy, no bilateral oophorectomy) must complete a negative pregnancy test (urine) prior to receiving any radioisotopes
5. No evidence of pelvic floor dysfunction
6. If clinically indicated, absence of an evacuation disorder should be confirmed within 30 days prior to the first dose of study medication
7. At Screening, patients must meet ROME III Criteria for FC, which assumes an absence of a structural or biochemical explanation
8. The patient's screening (baseline) colonic transit test must show a GC ≤ 2.4 at 24 hours; and
9. Baseline EKG shows QTc interval ≤ 450mSec

Exclusion Criteria:

1. History of clinically-significant manifestations or current abnormality of any organ system
2. History of inflammatory bowel disease
3. Any history of GI surgery within 6 months prior to the first dose of study medication
4. History of clinically-significant prolonged diarrhea, in the absence of a laxative
5. Patients who have started a special dietary habit and/or an intense physical workout program within 4 weeks prior to the first dose of study medication
6. Any clinically-significant surgical procedure within 30 days prior to the first dose of study medication
7. History of alcoholism or drug addiction within 12 months prior to the first dose of study medication
8. Any patient who has had an acute illness within 5 days prior to the first dose of study medication, eg, flu syndrome, GI virus, indigestion
9. Patients who are breastfeeding
E-Polycaprolactone-Containing Membrane in Alveolar Bone Regeneration

This study aimed to evaluate the effectiveness of synthetic polycaprolactone (PCL) bioscaffold membranes used for alveolar augmentation in maxillofacial surgery for increasing the amount of newly formed bone after three-dimensional application.


Eligibility Criteria:
Inclusion Criteria:

* (1) patients aged \>18 years without any systemic disease or with an established systemic disease that precluded the surgical procedure; (2) patients whose bone deficiency was augmented with PCL scaffolds; (3) patients with an indication for dental implant-supported prosthesis who lacked sufficient bone for dental implants according to cone beam computed tomography (CBCT) evaluation and, therefore, needed bone augmentation; and (4) patients with preoperative and postoperative images.

Exclusion Criteria:

* patients (1) with uncontrolled systemic diseases, (2) who had undergone radiation therapy, (3) who were female and pregnant, (4) who had previously undergone any surgical procedure related to augmentation in the area of the defect, (5) who had incomplete files or lacked pre- and post-treatment radiologic records, or (6) who had psychological problems.