cyrilzakka/clinical-trials huggingface dataset:
Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction

Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive. Despite the great demand for more in-depth, long-term studies of both techniques, current evidence is low or moderate and there are only few studies focusing on both health-related quality of life and complication rates in the same patient collective.

This study aims at investigating the complex relationship between the occurrence of complications and patient-reported long-time satisfaction in autologous and alloplastic breast reconstruction.

The study is conducted at the Medical University of Graz and has been approved by the responsible ethics' committee (EK: 32-235 ex 19/20). The study includes female breast cancer patients who underwent elective breast reconstruction at one of the participating departments between April 2020 and April 2023. Written informed consent was obtained from all individual study participants enrolled.

Exclusion criteria is defined as:

* Missing or insufficient information
* combination of reconstruction techniques on the same breast
* reconstruction procedures with insufficient number of cases
* inability to fully understand study procedures and to provide informed consent

Data were first collected retrospectively from the clinical data management programs using surgical reports, outpatient charts, and physicians' letters. Personal data such as patient age, concomitant diseases, nicotine abuse, anticoagulation status, previous oncological therapy and surgery, etc. were acquired. Furthermore, surgery-related data (site and type of reconstruction, size and location of implant/tissue expander, intraoperative complications) and data on the postoperative course (early and late complications, revision surgeries, number of total surgeries required, etc.) were acquired.

The five-level modified Clavien-Dindo classification is used to objectively classify postoperative complications, to allow further comparisons between treatment options, different time periods and correlations to health-related quality of life. Postoperative changes in health-related quality of life are measured using the BREAST-Q questionnaire, an effective and reliable patient-reported outcome measure in breast reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* female breast cancer patient undergoing autologous or alloplastic breast reconstruction willing to participate in this study
* age between 18 and 80 years (upper limit due to indication for breast reconstruction)
* written informed consent

Exclusion Criteria:

* Missing or insufficient information
* combination of reconstruction techniques on the same breast
* reconstruction procedures with insufficient number of cases
* inability to fully understand study procedures and to provide informed consent
Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

Oxaliplatin is a platinum analogue that has significant antitumor activity with better tolerability than cisplatin. The objective of the study is to evaluate the safety and activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or older
* Histologically confirmed squamous cell carcinoma of esophagus
* Curatively (R0) resected, lymph node positive
* ECOG performance status of 0 or 1
* Restoration of oral intake \>1500 kcal/d
* No prior chemotherapy except for neoadjuvant ones
* No prior radiotherapy within 1 month before registration
* Adequate marrow, hepatic, renal and cardiac functions
* Provision of a signed written informed consent

Exclusion Criteria:

* Severe co-morbid illness and/or active infections
* Prior treatment with oxaliplatin
* Pregnant or lactating women
* Active CNS metastases not controllable with radiotherapy or corticosteroids
* Known history of hypersensitivity to study drugs
Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial Hypertension

The objective of this observational study is to gain clinical insight on the actual use of sildenafil citrate (Revatio™) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of sildenafil at doses ≥20mg three times daily for the treatment of PAH.

The study design proposed is a retrospective chart review going back five years (01 April 2006 estimate) from the time of study initiation (31 March 2011 estimate). Within this five-year period, study index will occur the first time an adult patient begins sildenafil for the treatment of PAH for a period of at least three months. The patient has to be taking sildenafil at doses ≥ 20mg tid for the treatment of PAH.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age at study index;
* Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of \> 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization;
* Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation

Exclusion Criteria:

* Patient has known contraindications to sildenafil at study index;
* Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index
Effectiveness of Pain Neuroscience Education Compared to a Conventional Education for Patients With Chronic Low Back Pain

The hypothesis is that pain biology education, combined with a rehabilitation program, reduces disability to 3 months, compared to conventional spinal physiology education.


Eligibility Criteria:
Inclusion Criteria:

* Low Back Pain since more than 1 year
* Affiliated to Social Security Scheme
* Rolland Moris ≥ 8
* Start Back ≥ 4

Exclusion Criteria:

* Suspicion or proven case of serious pathology such as recent vertebral fracture (less than 6 months), infection, malignant tumors and / or radiculopathy.
* Have a history of rheumatic inflammatory disease
* Have a true radiculalgia (with or without radiculopathy)
* Have a scoliosis \> 30° (if it is considered as a predominant contributor of pain's persistence).
* Rating of pain \> 8/10
* Have had lumbar surgery in the past 12 months
* Have had an injection in the past 3 months
* Patients under legal protection (guardianship, curatorship)
* Pregnant patients
* Patients who are not able to understand, read or speak french
* Inability to receive informed information
Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease

This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* Are outpatients, male or female, 30 through 75 years of age
* Meet diagnostic criteria for major depression episode and a clinical diagnosis of idiopathic Parkinson's disease
* Have a clinician-rated 17-item Hamilton Depression Rating Scale (HAMD17) total score greater than or equal to 15, a Beck Depression Inventory (BDI) total score greater than or equal to 13 and a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 3 at both Visit 1 and Visit 2
* Have satisfactory cognitive function
* Have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to Visit 1

Exclusion Criteria:

* Any current primary psychiatric diagnosis other than Major depressive episode, and any personality disorder that could interfere with the compliance with the study protocol
* Atypical or secondary parkinsonism due to drugs or diseases with features of Parkinson's disease
* Motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study
* Clinically significant laboratory abnormalities or serious, unstable medical illness
* Lack of response of current episode to two or more adequate courses of antidepressant therapy
Apatinib Treatment for Advanced Esophagus Cancer

Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age: 18 to 75 years old, men and women;
* 2. After histopathological and immunohistochemical examination diagnosis of esophageal squamous cell carcinomas. At least one measurable lesion after the treatment (the length to diameter of CT scan≥10 mm , accord with the requirement of RESCIST 1.1);the lesions of whom had not received radiotherapy.
* 3. Advanced esophageal squamous cell carcinoma without molecular targeted drug therapy;
* 4. ECOG PS:0-1;
* 5. Life expectancy≥12 weeks;
* 6. Patients who have disease progressed or relapsed after standard chemotherapy, or who have been unable to tolerate chemotherapy;
* 7. The main organs function properly, that is, meet the following criteria:

  1. blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L;
  2. biochemical examination: ALB≥30g / L; (without infusion of albumin during 14 days) ALT and AST\<2ULN; TBIL≤1.5ULN; Plasma Cr≤1.5ULN;
* 8. The results of the serum pregnancy test of women in childbearing age must be negative in the 7 days prior to treatment; all patients (both male and female) should take adequate barrier contraception within the entire treatment and 4 weeks after treatment.
* 9. Subject should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up;
* 10. Investigator believe that subject who can benefit.

Exclusion Criteria:

* 1. In the past or at the same time with suffered from other malignancies;
* 2. Pregnant or lactating women;
* 3. Patients with high blood pressure and can't get a good control after antihypertensive drug therapy (systolic blood pressure\>150mmHg, diastolic blood pressure\>100mmHg); patients with grade Ⅱ or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval≥450ms) and Ⅲ\~Ⅳ grade cardiac insufficiency according to NYHA; cardiac color Doppler ultrasonography: LVEF \<50%;
* 4. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the drug taking and absorption;
* 5. With a clear risk of gastrointestinal bleeding (such as locally active ulcer lesions, fecal occult blood above + +), history of gastrointestinal bleeding within 6 months, and unhealed wounds;
* 6. Central nervous system metastasis has occurred;
* 7. With abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
* 8. With mental illness, or mental history of drug abuse;
* 9. With anastomotic recurrence;
* 10. Patients who have participated in other drug clinical trials in 4 weeks;
* 11. Patients who have concomitant diseases that are seriously compromise the patient's safety or affect the patient to complete the study according to the researcher's judgment;
* 12. Patients those researchers believe not suitable for the inclusion.
A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin

Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Women must not be of childbearing potential (WNOCBP)
* Women and men must agree to follow instructions for methods of contraception

Exclusion Criteria:

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study.
* Any major surgery within 4 weeks of study drug administration
* Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration
* Previous treatment with BMS-963272
* Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1

Other protocol-defined inclusion/exclusion criteria could apply
Anti-Stress Intervention Among Physicians Study

Medical practice often comes with high stress. Stress negatively affects our health and well-being and is linked to doctors making mistakes, some of which can be deadly.

In this study, the effect of two quick stress-relief methods on daily stress levels is estimated. The two anti-stress exercises are designed to easily fit into daily routines:

1. Box breathing (6 minutes) is known to reduce stress and lower the heart rate. It is used by the military and law enforcement, among others, to manage stress.
2. Breathing and mindfulness exercise (10 minutes): This guided breathing and mindfulness intervention combines mindful breathing with simple body movements, developed to reduce the perceived level of stress.

The effectiveness of these interventions is being examined in a series of N-of-1 trials. Each participant can choose between the interventions. After being randomly allocated to an individual sequence of one-week intervention and control phases, the study begins. Participants record their stress levels daily over the four-week study period. The intervention is only performed in the intervention phases. Upon completing the study, the stress levels during the intervention phases are compared to those in the control phases. Each participant will receive an individual analysis based on the collected data. In addition, the investigators will estimate the effects at the population level.

Three months after the study, a survey will be sent to the participants to check if the benefits have persisted.


Eligibility Criteria:
Inclusion criteria

* Physicians in training in Germany
* Weekly working time in medical activity of at least 9 hours
* Regular access to a mobile phone on which the "StudyU"-App can be installed
* Informed consent

Exclusion criteria

* Age \<18 years
* Specialist training already completed
* No clinical activity during the study period or part of the study period (e.g. vacation, research activity, etc.)
* Participation in another intervention study during the study period
* Does not speak German
* Does yoga more than 4 times a month
* Meditates or performs breathing exercises on average more than 4 days per month
* Confirmed or suspected pregnancy
* Presence of a psychiatric disorder
* Presence of cardiovascular disease
* Presence of respiratory or pulmonary disease
* Presence of a neurological disease
* Substance abuse (for example, alcohol, drugs, or other)
* Planned surgery within the next 6 months
* Doctor's recommendation (or self-assessment) not to perform mindfulness or breathing exercises
* Lack of informed consent
* Employee of the Charité - Universitätsmedizin Berlin (due to data protection reasons, employees of the Charité - Universitätsmedizin Berlin will not be included in this study)
A Standardized Nursing Intervention Protocol for HCT Patients

RATIONALE: Visiting patients at home to teach them about self care after a stem cell transplant may be more effective than standard therapy in improving quality of life.

PURPOSE: This clinical trial is studying home visits to see how well they work compared with standard therapy in treating patients undergoing donor stem cell transplant for hematologic cancer.

OBJECTIVES:

Primary

* Test the effects of a Standardized Nursing Intervention Protocol (SNIP) on overall quality of life (QOL); physical, psychological, social, and spiritual well-being subscales; and functional status of patients undergoing allogeneic hematopoietic stem cell transplantation (AHSCT) at discharge, 3, 6, and 12 months post-hospitalization as compared to AHSCT patients who receive the usual care and attention control.

Secondary

* Test the effects of SNIP-AHSCT on time-to-first complication, total number of complications, and mortality across these groups of patients.
* Identify subgroups of patients who benefit most from the SNIP-AHSCT in relation to sociodemographic characteristics, disease and clinical factors, and transplant factors.
* Decompose the effect of the SNIP-AHSCT on QOL into direct and indirect effects.

OUTLINE: Patients are randomized to 1 of 2 treatment groups.

* Group 1: Patients receive home teaching visits on medical aspects of self care, monitor and respond to signs and symptoms of infections, recommended exercise and nutrition program, relevant literature on bone marrow transplantation, diet, nutrition, and a variety of resources at 1, 2, and 3 months after hospital discharge. Patients also receive telephone-reinforcement calls monthly in months 4-12, and have a 24-hour telephone availability throughout the study. Patients complete the City of Hope quality of life questionnaires on physical, psychological, social, and spiritual well-being, and physical functional status at discharge, and then at 3, 6, and 12 months after hospitalization.
* Group 2: Patients receive usual medical care and attention at discharge, and then at 3, 6, and 12 months after hospitalization. Patients also have a hot-line availability throughout the study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a hematologic cancer (e.g., leukemia or lymphoma)
* Scheduled for a single allogeneic bone marrow or peripheral blood stem cell transplantation

PATIENT CHARACTERISTICS:

* Living within a 50-mile radius of the City of Hope National Medical Center
* English-speaking

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior hematopoietic stem cell transplantation
Group Training for Social Skills in Psychosis

The purpose of this study is to assess the feasibility of a social skills training group for people with psychosis.

This study is assessing the feasibility of a psychological intervention targeting social cognition problems in people with psychosis. The intervention is a group psychological treatment facilitated by a clinical psychologist. The group therapy takes advantage of audiovisual material and practical exercises to illustrate strategies and thinking styles that may help participants overcome difficulties in social settings.

A second objective of this study is to test a new method to measure social cognition by using portable devices. These devices will be carried by participants in their everyday life and will ask about their social activity levels at random times and record activity levels.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis part of the psychosis spectrum (according to DSM-IV or DSM-V or ICD-10)
* Good command of the English language
* Social engagement problems as evidenced by care coordinator report and number of hours spent in social activities per week lower than 10.

Exclusion Criteria:

* Primary diagnosis of substance abuse disorder
* Change in antipsychotic medication in the last six weeks
* Significant learning difficulties (premorbid IQ lower than 70)
Absorption and Tolerability of Injectable Administration of Niagen®+, as Compared to NAD+

This study evaluates the subjective effects of injection administration of NR on healthy adult populations.

The purpose of this work is to explore the tolerability of Niagen®, nicotinamide riboside chloride, a specialized form of vitamin B3, via intramuscular (IM), subcutaneous (SQ), and intravenous-push (IVP) administration, in comparison to NAD+, an active comparator, administered through the same routes.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
* Lives within 100 miles of the NRI study site
* Any gender, aged 40-65, inclusive
* Good general health as evidenced by medical history
* BMI 25-34.9 kg/m2
* Sedentary behavior (defined as \<20 minutes per day or 100 minutes per week of moderate to vigorous exercise)
* Demonstrated fatigue (Fatigue Assessment Scale) defined as a below-average score
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
* Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

* Current diagnosis of any seizure disorder, diabetes or insulin resistance, any kidney or liver disorder, heart disease, anemia, cancer, or Parkinson's disease
* ANY chronic illness (pre-disease state acceptable)
* Out of range phosphate levels at baseline
* BMI less than 25 or greater than or equal to 35
* Pregnancy, trying to conceive, or breastfeeding
* Known allergic reactions to any components of the intervention or related compounds, including any form of B3
* Positive COVID-19 test within 30 days of the study period
* Recent dramatic weight changes (10% change in body weight in the last 6 months)
* Existing usage of a NAD+ or NAD precursor supplement in any form (oral, nasal, patch, or injection/IV administration), including a B-complex supplement, within 60 days of the study, not including multivitamins.
* Introducing a new medication, supplement, investigational drug, or other intervention (including lifestyle changes) within 60 days of the start of the study.
Treatment of IL-6 and Its Receptor Antagonists in Children's Severe Sepsis.

In severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. However, the role of IL-6 and its receptor antagonists in patients with severe sepsis and septic shock is discussed controversially. To date, the efficacy and safety of IL-6 and its receptor antagonists in children with severe infection is not fully evaluated.

The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit of Children's Hospital of Fudan University from January 2022 to December 2023. Children with a PICU length of day less than 48h will be excluded. Patients who met the inclusion criteria will be divided into trial group and control group. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record.

Eligibility Criteria:
Inclusion Criteria:

* 1.Children between 29 days and 18 years old. 2.Severe pneumonia and/or sepsis.Patients were included who meet the guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019) issued by the National Health Commission of the people's Republic of China and/or who meet the International Guide to the 2020 campaign to Save sepsis: management of septic shock and sepsis-related organ dysfunction in children.

Exclusion Criteria:

* 1.notifiable infectious diseases. 2.The researcher believes that he is not suitable to participate in other situations in this study. 3.Participants in other clinical trials in the same period. 4. discharge within 48 hours.