cyrilzakka/clinical-trials huggingface dataset:
"resiLIR Basic": A Psychological Online Intervention to Enhance Resilience in the General Population

The goal of this clinical trial is to examine the developed online resilience intervention "resiLIR Basic" for the general population.

Participants will receive a 6-week online intervention addressing resilience and stress as well as different resilience factors. The main question is whether the intervention is effective in increasing psychological resilience.

Background: Acute and chronic stress in everyday life plays an essential role in the onset and development of several physical and mental health conditions. The ability to maintain or return to mental health during stress exposure is characterized as resilience. Especially the COVID-19 pandemic emphasized the role of resilience for mental health and pointed to the importance of easily accessible and flexible interventions to improve resilience in the general population.

Objectives: The aim of the study therefore is to examine the feasibility and efficacy of a newly developed online intervention to foster resilience in the general population.

Methods: In a waitlist control design, 240 adults will participate in the 6-week resilience intervention "resiLIR Basic". This online intervention consists of 8 modules of about 45-60 minutes length using psycho-educational elements and practical exercises to address evidence-based resilience factors, such as optimism or sense of coherence. Participants will complete online surveys on resilience, mental health, and several resilience factors pre-, during and post-intervention as well as 3, 6 and 12 months after completion as follow-up assessments.

Implications: The study will contribute to an evidence-based and easily accessible supply of resilience interventions supporting health promotion and stress prevention in the general population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Fluent in German language
* Have access to an internet-enabled device with a large screen (tablet / laptop / computer).
* as well as that they can use at least once a week for 45 min to 1.5 hours during the study period

Exclusion Criteria:

* Acute mental health crisis (e.g., suicidality)
* Psychiatric/psychotherapeutic treatment
* Neurodegenerative disease(s)
* Diagnosis of schizophrenia or other psychotic disorders, bipolar disorder, post-traumatic stress disorder
Fruquintinib in Patients With Metastatic Colorectal Cancer

FRUQUENT is an observational study in Germany. The goal of the study is to evaluate how well Fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies.

To this end, it will be analyzed how well patients respond to the therapy in the clinical routine. Further points of interest to the study are survival data, safety data, the use of medical care facilities, and the quality of life of patients treated with Fruquintinib.

Participants will be treated as decided by the treating physician and according to their routine practice.

FRUQUENT is a prospective, multicenter, observational study in Germany, collecting real-world data of patients with metastatic colorectal cancer (mCRC) who receive fruquintinib according to the SmPC. The goal of the study is to analyze the effectiveness of the monotherapy with fruquintinib in adult patients with mCRC that have previously been treated with available standard therapies, including fluoropyrimidine, oxaliplatin-, and irintecan-based chemotherapies, anti-VEGF agents, and, if RAS wild-type, anti-EGFR agents. Moreover, the patients must have progressed on or be intolerant to treatment with either trifluridine/tipiracil or regorafenib.

All data for FRUQUENT will be obtained in routine clinical practice, allowing for a representative evaluation of the effectiveness of fruquintinib in a real-world setting. The study aims to recruit 150 patients in 50 practices (office based, oncology outpatient-centers or hospitals) to facilitate robust data.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Indication and decision for therapy with fruquintinib in accordance with the current German SmPC of fruquintinib as monotherapy for patients with mCRC.
* Prior treatment with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF therapy, and if RAS wild-type, anti EGFR therapy.
* Progression on or intolerance to treatment with either trifluridine/tipiracil and/or regorafenib.
* Other criteria according to current SmPC.
* Signed written informed consent.\* \* Patients are allowed to be enrolled up to 6 weeks after their first dose of fruquintinib. These patients cannot participate in the PRO assessments.

Exclusion Criteria:

* Participation in an interventional clinical trial (except follow-up) within 30 days prior to enrollment or start of treatment with fruquintinib, whatever comes first.
* Contraindications according to current SmPC.
The Prevalence of Bone Degenerative Diseases in Beijing - a Cross-sectional Study

The purpose of this observational study is to investigate the prevalence and risk factors of bone degenerative diseases


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years， residents of Beijing city
2. Must demonstrate willingness to participate in the study by signing the written informed consent

Exclusion Criteria:

1. Subjects who had surgery on disc or knee
2. Pregnent women
First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age: 18 to 45 years (inclusive)
* Body mass index (BMI) : ≥18 and ≤30 kg/m²
* Race: White

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Relevant diseases within the last 4 weeks prior to the first drug administration
* Existing chronic diseases requiring medication
* Known or suspected malignant tumors or carcinoma in situ (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial until follow-up including drugs which might affect the pharmacokinetics
Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in G6PD Deficient Patients

A clinical study to assess the safety and efficacy of alternative regimens of primaquine for radical cure of vivax malaria in glucose 6-phosphate dehydrogenase (G6PD) deficient. G6PD deficient patients with P. vivax monoinfection will be treated with either weekly or delayed one-week course of primaquine, and the currently recommended by national guideline, 12-week chloroquine regimen to compare treatment safety among groups. All groups will be actively monitored for hemolysis during treatment and will have six-month follow-up period to assess treatment efficacy.

This is an open-label, randomized, phase II, clinical trial of safety and efficacy. Patients will be screened for eligibility and treated at the Fundação de Medicina Tropical Dr Heitor Vieira Dourado in Manaus and the Centro de Pesquisa em Medicina Tropical (Cepem) in Porto Velho, Brazil. A total of 104 vivax malaria patients will be recruited into the study, 52 G6PD deficient (Arm 1) and 52 G6PD normal (Arm 2). Patients with spectrophotometrically-confirmed G6PD deficiency (10-60% of adjusted mean male activity) will be divided into three subgroups of 10 patient each. All arms will receive standard 3-day chloroquine course. Additionally, Arm 1a will receive a delayed course of primaquine for 7 days, starting only at the fifth-day post-chloroquine initiation \[ARM HALTED DUE TO SAFETY CONCERNS\]. Arm 1b will receive weekly primaquine, once a week, for 8 weeks. Arm 1c will receive prophylactic 12-week course of chloroquine, as recommended by national guidelines for such patients (control group in terms of safety). Arm 2, the control group of efficacy, will receive standard regimen, comprised of 3-day chloroquine plus concomitant 7-day primaquine. All patients will receive directly observed therapy (DOT) and will be closely monitored for clinical parameters and laboratory markers of hemolysis including hemoglobin, methemoglobin, lactate dehydrogenase, haptoglobin, reticulocytes, indirect bilirubin, aspartate aminotransferase, and urinalysis. All groups will be followed for 6 months after treatment to assess relapse rate. Primary endpoint is the tolerability of the regimens defined by hemoglobin fall. Secondary endpoints include treatment failure (relapse during follow-up), frequency of adverse effects, and rate of hemoglobin fall during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated vivax malaria monoinfection
* G6PD deficiency ranging from 10%-60% of adjusted mean male activity
* Baseline hemoglobin \>9 g/dL
* Willing to comply with study requirements

Exclusion Criteria:

* Pregnancy or breastfeeding
* Comorbidities (hepatopathy and/or nephropathy)
* Use of antimalarials in the previous two weeks or current use of potentially hemolytic drugs
* Any condition which would place the subject at undue risk of hemolysis or interfere with the results of the study, as judged by investigator.
A PHASE I, SINGLE-CENTER, MIXED METHODS STUDY ON THE HEALTH OUTCOMES OF VISUAL SELF EXPRESSION

To gain understanding about the impact of visual art making on biomarkers, such as cortisol, alpha amylase, oxytocin, etc. to examine whether and to what extent there are changes in levels of stress and immune function in patients and caregivers adults (including family caregivers and medical professionals)


Eligibility Criteria:
Inclusion Criteria:

* Adults between the age of 18 - 70
* A healthcare professional, a patient or caregiver in the Radiation Oncology Department at the University of Pennsylvania
* Subjects must be capable of giving informed consent

Exclusion Criteria:

* Any healthcare professional or patient/caregiver not working in or being seen at Radiation Oncology Department at the University of Pennsylvania
Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway

The LMA Supreme is a new extraglottic airway device which brings together features of the LMA ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed anesthetized patients

The LMA Supreme is a new extraglottic airway device which brings together features of both the LMA ProSeal (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively), the LMA Fastrach (fixed cuve tube and guiding handle - to facilitate insertion and fixation) and the LMA Unique (single use - prevention of disease transmission). The new features are that the airway tube incorporates a drain tube within its lumen to shorten and straighten its path, it is oval-shaped to match the shape of the mouth and to reduce rotation in the pharynx, the inner cuff has been strengthened to prevent airway obstruction from infolding and epiglottic fins have been added to prevent airway obstruction from epiglottic downfolding. In the following randomized, crossover study, we test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed, anesthetized patients

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology physical status grade I-II
* Age 18-80 yr
* Elective gynecological surgery
* Supine position

Exclusion Criteria:

* Known or predicted difficult airway
* Body mass index \>35 kg m-2
* Risk of aspiration
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel

Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.


Eligibility Criteria:
Inclusion Criteria:

* HIV-negative
* Willing to participate and sign and informed consent form.
* Willing to be tested for HIV and to use an experimental vaginal gel.
* Willing to use a reliable form of contraception during the study.
* Willing to undergo pelvic examinations with colposcopy according to the protocol throughout the study.
* Normal cervical assessment.
* Willing to abstain from using any vaginal product (other than the study product).
* Willing to be sexually abstinent from Day 1 until completion of study product use on Day 10.

Exclusion Criteria:

* Currently pregnant or breast-feeding.
* Currently has any clinically detectable abnormality on the vulva, vaginal walls or cervix.
* Currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has Genital Ulcer Disease (GUD) or vaginal candidiasis symptoms; or has an HSV-2 lesion as indicated by clinical diagnosis or laboratory test.
* Symptomatic bacterial vaginosis (BV) and unwilling to undergo treatment.
* Current use of injection drugs.
The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.

This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.

This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy. The patients will be randomly divided into two groups. One group will undergo laparoscopic proximal gastrectomy with double-flap technique (DFT) anastomosis, while the other group will undergo laparoscopic proximal gastrectomy with double-tract reconstruction (DTR). The primary endpoint is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The secondary endpoints include postoperative complications, surgery-related indicators, and postoperative nutritional status.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 and 80 years, regardless of gender;
2. Patients diagnosed with gastric cancer through tissue biopsy;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
4. American Society of Anesthesiologists (ASA) classification of I to III;
5. Acceptable for laparoscopic proximal gastrectomy with preoperative examinations (based on endoscopic ultrasound and/or contrast-enhanced computed tomography of the thorax and abdomen) confirming the following oncological features:

   Primary tumor located in the upper part of the stomach (proximal 1/3 of the stomach) or gastroesophageal junction; Length of esophageal invasion ≤ 1 cm, tumor maximum diameter ≤ 4 cm; Preoperative staging T1-3N0M0 (based on AJCC 8th edition TNM clinical staging);
6. Voluntary signing of informed consent.

Exclusion Criteria:

1. Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
2. Presence of contraindications to surgery;
3. Multiple malignant lesions in the stomach;
4. Presence of other malignancies that may affect the preservation of stomach function;
5. Previous upper abdominal surgery (excluding cholecystectomy);
6. Preoperative examination reveals active peptic ulcer;
7. Patients who have received or are currently receiving treatment for systemic inflammatory diseases;
8. Pregnant or breastfeeding women;
9. Conditions deemed unsuitable for participation in this study by the investigator.
T Cell Repertoire Analysis of Immune Mediated Skin Diseases

This study is designed to identify the cells of the immune system that cause skin disease such as psoriasis and mycosis fungoides. Blood samples from many patients will be compared in hopes of finding common cells and molecules responsible for skin diseases. Results of this study will increase our knowledge about immune mediated skin disease.

The aim of the study is to characterized the T cell repertoire of individuals with immune mediated skin disease (e.g. psoriasis and mycosis fungoides). Peripheral blood with be collected from volunteers with psoriasis, mycosis fungoides and age matched controls. Fifteen tablespoons of blood will be collected prior to the initiation of treatment and again after the patient shows a clinical response to treatment. The time between blood draws will be no less than 3 months. There will be no more than two blood draws per patient. Blood samples will be used to determine the patient's HLA haplotype via PCR and DNA sequencing. After the patient's haplotype has been established the activated T cell repertoire will be analyzed for clonal expansions. Clonal expansions in the T cell repertoire will be determined by immunoscope analysis, which is a PCR based technique.

Eligibility Criteria:
Inclusion Criteria:

* Have an immune mediated skin disease, such as psoriasis or mycosis fungoides
* Are not taking immunosuppressive medications, which may interfere with T cell analysis.

Exclusion Criteria:

* are taking immunosuppressive medications, which may interfere with T cell analysis
MHNA-001 for Young Adults With IBS

The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ IBS together with care as usual in approximately 100 young adults with Irritable Bowel Syndrome.

Following informed consent, all participants will complete a series of screening questionnaires to determine eligibility for study entry. Eligible participants will be enrolled, and will receive access to MHNA-001 (Mahana™ for IBS). Participants will use MHNA-001 for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participant meets IBS diagnostic criteria via Rome IV questionnaire.
* Participant has IBS, based on IBS-SSS score of ≥125 at time of screening (corresponding to mild, moderate, or severe IBS).
* Participant is 18-21 years of age at the time of consent.
* Participant is able to speak, read, and understand English.
* Participant is capable and willing to complete questionnaires, track symptoms, and complete exercises associated with use of Mahana™ IBS.
* Participant has unrestricted access to an iOS (running iOS 13 or later) or Android smartphone with internet connectivity and sufficient space for Mahana™ IBS to be installed.
* If participant is taking any prescription IBS-related concomitant medications, he/she must have been on a stable dose/regimen for at least 30 days prior to the date of Screening/Enrollment and is not intended to make changes to dose or regimen during the treatment period (i.e., through Week 12 of the study).

Exclusion Criteria:

* Participant has a medical or psychiatric comorbidity that might account for GI symptoms, confound the measurement of IBS symptoms, or compromise the participant's ability to complete the study (ex. inflammatory bowel disease, chronic liver disease, substance abuse disorder, etc.) in the opinion of the investigator.
* Participant is currently using opioids or plans to use for chronic pain management and/or recreation.
* Participant has been hospitalized for psychiatric reasons within 12 months prior to screening.
* Participant is currently experiencing high depression symptom severity as indicated by a score \>14 on the PHQ-8.
* Participant is currently experiencing suicidal ideation as indicated by a score of 2 or 3 on item 9 of the Beck Depression Index (BDI). \*
* Participant is currently using any prescription digital therapeutic that delivers components of cognitive-behavioral therapies.
* Participant has undergone CBT, any other skills-based, or GI-specific psychological therapy (e.g. Dialectical Behavioral Therapy, Acceptance and Commitment Therapy, Behavioral Activation, Problem-solving Therapy, Gut-Directed Hypnotherapy, etc.) within 2 years of study entry.
* Participant has participated in any investigational trial within 30 days prior to Screening or plans to participate in another clinical trial during the study period.
* Participant is currently pregnant or nursing.
Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension

To evaluate the effects of two different antihypertensive medications in the drug class of beta-blockers on control of glucose in Type II diabetic patients with high blood pressure.


Eligibility Criteria:
Inclusion criteria:

* Patients at screening must be insulin producing Type II diabetics (C peptide positive).
* Must have a history of mild to moderate hypertension (140-179 systolic; 90-1-9 diastolic).
* Must be on stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
* Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).
* Must be on a stable antidiabetic regimen (drug treated or diet alone).

Exclusion criteria:

* Patients using beta-blocker therapy.