cyrilzakka/clinical-trials huggingface dataset:
RECHARGE: A Brief Psychological Intervention to Build Resilience in Healthcare Workers During COVID-19

The healthcare industry is inherently demanding, stressful, and, at times, emotionally draining. On a typical day, many workers must make rapid and critical decisions, manage numerous demands, team conflicts, and challenging situations with patients and their families. For some health care workers (HCW), the current pandemic - COVID-19 - has also exacerbated these challenges. Providing psychological support is key in alleviating stress among HCWs, yet the situation does not require therapy because HCWs do not principally suffer from a mental disorder. RECHARGE was specifically developed for HCWs and is an abbreviated online version of Problem Management Plus, an evidence-based intervention that helps to cope with stress in times of crisis. As a brief psychological intervention for adults affected by adversity emerging from stress exposure, RECHARGE teaches people three well-documented strategies to manage acute stress (a: managing stress, b: managing worry, c: meaningful activity). It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioral activation, and enhancement of meaningful activities, which are all based on the principles of cognitive-behavioral therapy. The aim of this study is to evaluate the efficacy of RECHARGE to reduce stress in HCWs and enhance their work performance. Participants in this randomized controlled trial (RCT) study are randomly assigned to either RECHARGE or the active control group. To this end, stress including symptoms of burnout, worries, anxiety, depression, PTSD, and work performance will be measured at baseline, post-intervention, and at a 2 and 6 month follow up.


Eligibility Criteria:
Inclusion Criteria:

* Anxiety and depression checklist (K10) score of 16 or higher
* Healthcare worker
* Sufficient German language comprehension
* Access to teleconferencing platform

Exclusion Criteria:

* Currently participating in a similar study
* Currently in psychotherapeutic treatment / coaching
* Currently on sick leave for more than 2 weeks
Evaluation of Postoperative Pain Control in Ear Surgery

Middle ear surgery is the most popular procedure in ear, nose and throat surgery. Increased sympathetic stimulation after surgery can activate the sympathetic system, causing hypertension and increased heart rate. As a result of these clinical conditions, hemorrhage can occur, which can impair the quality of the surgical field, which is undesirable in middle ear surgery.Clinical studies should be conducted with auricularis magnus nerve block applied in the perioperative period in middle ear surgery and postoperative pain scores.

Middle ear surgery is the most popular procedure in ear, nose and throat surgery. Increased sympathetic stimulation after surgery can activate the sympathetic system, causing hypertension and increased heart rate. As a result of these clinical conditions, hemorrhage can occur, which can impair the quality of the surgical field, which is undesirable in middle ear surgery.Ultrasound-guided auricularis magnus nerve block can be used as a potential solution to these problems. Ultrasound-guided peripheral nerve block can be visualized. It is appropriate and applicable to block a single distal nerve with a small dose of local anesthetic under ultrasound guidance. Ultrasound-guided blocking of the blocked area has reduced side effects with increased accuracy and accurate analgesic effect.

In middle ear microsurgery, the nerve innervation of the postauricular incision area may not primarily originate from the auricularis magnus. Therefore, clinical studies should be conducted with auricularis magnus nerve block applied in the perioperative period in middle ear surgery and postoperative pain scores.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing CWD and Mastodectom
* Patients undergoing elective surgery
* ASA (American Society of Anesthesiologists) physical status classification I-II
* Patients over 18 years of age

Exclusion Criteria:

* Anticoagulant use
* Allergy to the drugs to be used
* ASA (American Society of Anesthesiologists) physical status classification IV-V
* Presence of infection in the area where the block will be applied
* Patient's refusal to accept the block application or inability to cooperate with the patient
A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo

The object of this study is to assess the long-term safety and efficacy of cervical disc replacement with the ProDisc-C vivo Cervical Disc in a prospective, randomized, multi-center trial with 7 years of follow-up.

This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing ProDisc-C vivo artificial cervical disc replacement and ACDF (Anterior cervical discectomy fusion) to treat degenerative disc disease (DDD). 648 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (324 patients in each group). One group will be treated with ProDisc-C vivo disc replacement. The other group will be treated with ACDF. The clinical outcomes and radiographic measurements will be compared between two groups at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.

Eligibility Criteria:
Inclusion Criteria:

* Single-level cervical disc disease.
* At least one additional confirmatory neuroradiographic study, such as MRI or CT- enhanced myelography that showed findings consistent with clinical findings and complaints.

Exclusion Criteria:

* Patients have cervical spinal conditions other than single-level symptomatic degenerative disc disease or evidence of instability.
* Symptomatic disc disease at level C2 -3 or C7-T1.
* A history of discitis.
* A medical condition that required medication,such as steroids or nonsteroidal antiinflammatory medications that could interfere with fusion.
Olanzapine for Cancer Related Anorexia-cachexia Syndrome

Cancer anorexia-cachexia syndrome is one of the common conditions in cancer patients. Olanzapine has been demonstrated to reduce chemotherapy-induced anorexia. However, there is scarce information regarding olanzapine as a treatment of cancer anorexia among patients who does not receive chemotherapy. Therefore, this randomized controlled trial aims to evaluate the efficacy of olanzapine to lessen cancer cachexia-anorexia syndrome.


Eligibility Criteria:
Inclusion Criteria:

* pathologically or cytologically metastatic or locally advanced cancer
* anorexia and \>=5% weight loss during the past 6 months or anorexia with numerical scale of anorexia \>=5
* ECOG performance status 0-3
* able to complete questionaire and able to swallow pills

Exclusion Criteria:

* receiving chemotherapy or anti-cancer systemic therapy
* life expectancy longer than 1 month
* received radiotherapy at head/neck or thoracic or upper abdomen in the past 2 weeks
* surgery within 4 weeks
* pregnancy
* serum bilirubin \> 2 mg/dl or serum Cr \> 2 mg/dl
* current use of olanzapine or other antipsychotic drug
* known cardiac arrhythmia, uncontrolled brain metastasis, history of seizure or acute coronary event in the past 6 months
A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer

The overall objective of this Phase 1 study is to evaluate the safety, PK, and anti-tumor activity of 12 weeks of daily oral dosing with HP518 after selecting the RP2D of HP518 based on assessments of multiple dose escalation in patients with progressive mCRPC.

This First in Human dose escalation and expansion study of HP518 in patients with mCRPC is being conducted not only to evaluate the safety and tolerability of orally administered HP518, but also to provide necessary information for efficacy analysis in future studies.

Eligibility Criteria:
Inclusion Criteria:

1. Has histologically confirmed adenocarcinoma of the prostate.
2. Has metastatic disease at study entry documented by 2 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
3. Has disease progression while receiving any ADT, androgen biosynthesis inhibitors, or second-generation AR inhibitors.
4. Must have recovered from toxicities related to any prior treatments
5. Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy.
6. ECOG performance status score of 0 to 1.

Exclusion Criteria:

1. Has received more than 1 line of chemotherapy for prostate cancer.
2. Use of enzalutamide, and/or other second-generation AR inhibitors and/or abiraterone as follows:

   * Received any agent within 4 weeks prior to the start of study drug.
   * Discontinued agent without evidence of radiographic or PSA progression.
3. Has had any anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177Lu-PSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518.
4. Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).
5. Has significant cardiovascular disease.
6. Use of an investigational agent, without evidence of radiographic or PSA progression, within 4 weeks prior to the first dose of HP518 or a period required by local regulation, whichever is longer.
A Comparative Prospective Study of the Arthroscopic Meniscus Repair Methods

Performing arthroscopic meniscus repair following a traumatic meniscus tear as an alternative to a meniscectomy is now an acceptable choice. Preserving meniscus tissues is crucial due to the significant role they play as an essential part of the knee joint. It is essential to comprehend the additional tools that can impact the recovery of the meniscus after suturing. Patients have been randomly assigned into two groups using the computerised application "randomizer for clinical trial lite," and the treatment outcomes were compared after one year. One group of patients has received a standard meniscus suturing technique, whereas another group has experienced the meniscus suturing treatment with an additional fibrin clot approach. Data pertaining to demographics, clinical characteristics, radiological findings, and survey responses have been carefully collected prospectively.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who provide consent to participate in the study, including patients and their care providers. The inclusion criteria for this study are as follows: being under the age of 19, having a traumatic isolated full-thickness meniscal tear longer than 1cm that has been confirmed by both preoperative MRI and arthroscopy, and not having undergone any previous surgery on the affected knee.

Exclusion Criteria:

* This investigation excludes patients with developmental disabilities who are unable to read or interpret in their native language.
Air Optix Extended Wear Contact Lenses

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as extended (overnight) wear.

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.

Eligibility Criteria:
Inclusion Criteria:

* Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only);
* Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
* Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for at least 3 years in an extended wear modality, as determined by the Investigator;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline;
* Use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection;
* Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear;
* Other protocol-defined exclusion criteria may apply.
Aspirin in the Prevention of Cardiovascular Events in Hemodialysis Patients

The study is prospectively initiated to: (1) evaluate the alterations in platelet function to aspirin therapy and the prevalence of aspirin resistance in patients with chronic kidney disease undergoing hemodialysis, and (2) compare the incidence of vascular events (myocardial infarction, cardiac death, stroke, vascular access thrombosis, or revascularization procedure) and the safety profile among placebo-treated, aspirin-resistant and aspirin-sensitive patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with end-stage renal disease who are undergoing long-term hemodialysis.

Exclusion Criteria:

Patients will be excluded if there is evidence of

* a recent history of acute uremia,
* previous adverse reaction to a aspirin or history of aspirin hypersensitivity (eg, aspirin-induced asthma or angioedema),
* concurrent treatment with other antiplatelet agent (clopidogrel or ticlopidine), steroidal drugs, or nonsteroidal anti-inflammatory drugs,
* high immediate risk for bleeding (eg, active peptic ulceration, recent injury, or hemophilia), or
* life-threatening condition other than end-stage renal disease or vascular disease (eg, non-skin cancer).
Assessment of Inspiratory Profiles Through Airflow Resistances Designed to Mimic Inhalers

It is hypothesized that different inhalation profiles (inhalation flow rate versus time curves) result from different forms of patient training. Furthermore, significant inter-subject variability in these profiles should exist that can, under some circumstances, depend on the design of different inhalation devices; this is because dry powder inhalers have different airflow resistances. The investigators also hypothesize that the spread of flow rate versus time profiles for inhalation can be collected. Finally, these profiles can be analyzed from a group of human subjects and used to define a mean and statistical range of inhalation flow rate versus time curves.

The investigators propose to collect the inhalation profiles from 20 'inhaler naïve' healthy volunteers after they have (a) read a typical inhaler package insert and (b) been formally trained in inhaler use by a pharmacist. No drug exposure will occur. The data will be used from this pilot study to (a) show the inter-subject variability in the inhalation profiles used by adults inhaling through realistic airflow resistances (like those in inhalers) following different types of training (b) show how formal training changes inhalation technique and (c) provide a database of typical inspiratory profiles for use and improvement of realistic tests of inhalers in the laboratory. Since pulmonary deposition from inhalers greatly depends upon the way patients inhale through them, this research will result in a database to improve the design and in vitro characterization of inhalers.


Eligibility Criteria:
* Must be healthy as determined by a health questionnaire
* Must not be currently pregnant (self reported)
* Must not have symptoms of an obstructive or restrictive lung disease or be suffering from allergies or congestion at the time of testing
* Must have Forced 'Expiratory Volume in one second' \>'Lower Limit of Normal' predicted
* Must be medically stable with no evidence of acute medical or psychiatric illness,
* Must have never used or been trained to use a dry powder inhaler,
* Must not be currently using any inhaler, nasal spray or drug known to affect lung function, Bronchodilators and decongestants in any form are excluded
* Must be at least 4 feet 10 inch tall,
* Must weigh at least 110 pounds (50 kilograms) and be no more than 264 pounds (120 kilograms)
* Must not currently, or in the past year, have used tobacco products
Patient Preferences for Breast Reconstruction After Mastectomy

Deciding whether or not to have breast reconstruction after mastectomy is highly challenging for many patients. This study will examine patients' decisions about reconstruction and the effects of reconstruction on quality of life and body image.

Breast reconstruction after mastectomy is an important treatment option for the many thousands of women who undergo mastectomy each year. Its insurance coverage is mandated by federal law. Many women who want reconstruction, particularly women from racial and ethnic minorities, never receive it, and some women who undergo reconstruction regret having it, raising concern about the quality of decisions about the procedure. Little is known about the quality of breast reconstruction decisions, defined as the extent to which decisions are informed and concordant with patients' preferences. A lack of reliable methods for evaluating preference concordance has resulted in a paucity of research in this area. Deciding about breast reconstruction requires a patient to predict how she would feel after the procedure, a process called affective forecasting. Extensive psychological research has shown that people have difficulty making accurate predictions about how they will feel, tending to overestimate the effects of disease and treatments on their well-being and to underestimate their ability to adapt to change and the effects of other aspects of their lives. Despite the importance of affective forecasting to decisions about breast reconstruction, no research has examined this aspect of those decisions. The investigator proposes to conduct a pilot cohort study of breast cancer patients undergoing mastectomy, with or without reconstruction with the following specific aims: Aim 1: to evaluate whether patients make informed decisions about breast reconstruction that are concordant with their preferences; Aim 2: to assess the accuracy of patients' preoperative predictions about their post-operative body image and well-being; and Aim 3: to assess the effects of breast reconstruction on quality of life and body image and the potential modification of those effects by preference concordance.

Eligibility Criteria:
Inclusion Criteria:

* Women 21 years of age or older
* Having a mastectomy at UNC for treatment of Stage I, II, or III breast cancer, ductal carcinoma in situ (DCIS) or for prophylaxis

Exclusion Criteria:

* Stage IV breast cancer
* Women who do not speak English
* Severe psychiatric illness
Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.

The purpose of this study is to determine if Ticagrelor increases the Adenosin induced coronary blood flow velocity.


Eligibility Criteria:
Inclusion Criteria:

* Suitable for ECG recording of CBFV and have no adverse reaction to adenosine challenge
* Have a body mass index between 18 and 30 kg/m2

Exclusion Criteria:

* History of clinically significant disease or disorder.
* Abnormal vital signs
A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus

This study was a multicenter, randomized, parallel and controlled study in adult patients with T2DM to evaluate the efficacy, safety (including immunogenicity) and pharmacokinetics of GZR18 injection in adult patients with T2DM.


Eligibility Criteria:
Inclusion Criteria:

* (1) Chinese adults, male or female aged between 18 and 75 (including both ends).

  (2) According to the diagnostic and classification criteria of diabetes issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria of WHO in 2011, type 2 diabetes was diagnosed for more than 3 months.

  (3) Lifestyle intervention and / or unregulated use of antidiabetic drugs within 3 months before screening, or stable use of less than 3 oral hypoglycemic drugs within 3 months before screening.

  (4) HbA1c (HbA1c) ≥ 7.0% and ≤ 11% during screening.

  (5) Body mass index (BMI) ≥ 18.5 kg/m2.

  (6) There is no birth plan within 6 months from the signing of informed consent to the last administration, and those who voluntarily take effective contraceptive measures and have no sperm donation plan. Fertile women are not breastfeeding, and the screening and baseline pregnancy tests must be negative.

  (7) Patients fully understand the purpose, nature, methods and possible adverse reactions of the trial, can communicate well with researchers, and can understand and comply with the requirements of this study. During the study, they can maintain a stable diet and exercise lifestyle, and voluntarily sign an informed consent form to enter this study.

Exclusion Criteria:

* (1) Known or suspected to be allergic to GLP-1 drugs or their excipients, or have contraindications to their use.

  (2) Those who participated in clinical trials of other drugs or devices within 3 months before were screened and given treatment.

  (3) Surgery that can lead to weight instability was performed within 2 months before screening, or non-diabetic drugs that affect weight are currently being used or are in the weight loss program and are not in the maintenance stage.

  (4) History of alcohol or drug abuse, or positive results of pre-random drug abuse screening (urine screening).

  (5) Continuous use of insulin for more than 14 days in one year before screening (the time for gestational diabetes to receive insulin treatment is not within this limit); GLP-1RA drugs were used in the first 6 months; dipeptidyl peptidase-4 (DPP-4) inhibitors were used in the first month.

  (6) Growth hormone and other drug treatments determined by researchers to affect insulin levels were performed within 3 months before screening.

  (7) Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmotic nonketotic diabetic coma within 6 months before screening.
24 Month Follow-up of Patients With Osgood Schlatter (OSD)

Osgood Schlatter is a common knee condition, affecting approximately 10% of adolescents. OSD is thought to be a growth related pain conditon, and thus resolve after maturation. Despite this, there a lack of prospective data investigating whether this is in fact the case.

This is a prospective cohort study of 51 adolescents (aged 10-14 at baseline) with Osgood schlatter. Participants are followed for two years.

Eligibility Criteria:
Inclusion Criteria:

* 10-14 years of age
* Pain at tibial tuberosity during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation
* Pain during palpation of tibial tuberosity
* Knee pain for 6 weeks or more

Exclusion Criteria:

* Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).
* Previous surgery
* Pain from the hip or back that interferes with activities of daily living.
* Habitual patella luxations
* Clinical suspicion of meniscal lesion