cyrilzakka/clinical-trials huggingface dataset:
Yoga for Anxiety in Adults

The purpose of this study is to investigate the effect of a telerehabilitation-yoga intervention delivered remotely via videoconferencing on adults with Parkinson's Disease and anxiety symptoms.

A single group intervention study of adults (18-80 years-old) with Parkinson's Disease and anxiety symptoms undergoing a 6-week intervention of 30-minute yoga classes delivered remotely through videoconferencing 2-3 times per week. Subjects with symptoms of anxiety as indicated by their score on the Parkinson's Anxiety Scale will complete yoga classes delivered at-home with videoconferencing, receiving one-on-one yoga instruction including breathing, postures, and meditation/relaxation for two-three times a week. Data collection will occur remotely via videoconferencing at 0-weeks, 6-weeks after a waiting period, 12-weeks after the intervention, and 6-weeks after the last lab visit. Data collection will include demographics, mental health questionnaires, motor assessments, enjoyment, usability, and follow-up yoga status. Each yoga session will be video recorded to aide in recording adherence, adverse events, and challenges.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Parkinson's Disease
* symptoms of anxiety as indicated by PAS (score ≥ 14)
* 18-80 years old
* ability to communicate verbally and follow directions
* English-speaking
* access to WiFi and applicable technological device (computer, laptop, tablet, smartphone etc.)
* willing to be video recorded during the yoga session
* willing to open Zoom on their technological device
* demonstrates self-reported technological literacy.

Exclusion Criteria:

* major depressive disorder (self-report medical history)
* injury or condition that could prevent engagement in yoga poses
* cognitive impairment or condition that would prevent the participant from understanding the tasks or communicating with the research team
* past yoga experience exceeding 5 or more times within the last 2 months
* pregnant women (self-report)
Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

This is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented N2 positive non-squamous NSCLC with resectable (Stage IIIA or T3-4N2 IIIB) disease (according to Version 8 of the IASLC Cancer Staging Manual \[IASLC Staging Manual in Thoracic Oncology 2016\]).
* Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures).
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
* A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).

Exclusion Criteria:

* Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
* History of another primary malignancy, except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease
* Patients who have pre-operative radiotherapy treatment as part of their care plan
* Mixed small cell and NSCLC histology
* T4 tumours infiltrating the aorta, the oesophagus and/or the heart; and/or any bulky N2 disease deemed unresectable
* Patients who are candidates to undergo only segmentectomies or wedge resections
* Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
* Prior treatment with EGFR-TKI therapy
* Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior)
Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL)

The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 and ≤75 years of age
* body mass index ≥18.5 and ≤45 kg/m2
* Weight stable (i.e., ≤3% change)
* ≤150 min of structured exercise/week for at least 2 months before entering the study
* Blood glucose: \< 126 mg/dl fasted, \< 200 mg/dl with 2 hour oral glucose tolerance testing
* Hemoglobin A1C (HbA1C) ≤6.5%
* Dyslipidemia triglycerides ≥125 mg/dL
* No chronic kidney disease
* Not vegan or vegetarian or on high protein diet (e.g. Atkins) or supplements that are not allowed
* No intolerance or allergies to study diet ingredients
* No excessive alcohol or tobacco consumption

Exclusion Criteria:

* \<18 and \>75 years of age
* body mass index \<18.5 or \>45 kg/m2
* history of or current significant organ system dysfunction (e.g., heart disease, stroke, diabetes, cancer in remission for \<5 years, dementia, chronic kidney disease)
* allergies or intolerances to meal ingredients, vegans or vegetarians
* use of medications that could confound the study outcomes (e.g., anti-inflammatories, immune modulators, etc)
* take dietary supplements (e.g., certain pre- and pro-biotics, fiber, fish oil supplements)
* engaged in regular structured exercise \>150 min per week
* alcohol use disorder as defined by the National Institute of Alcohol Abuse and Alcoholism or use of controlled substances
* pregnant women
* persons who use tobacco
* prisoners
* the inability to grant voluntary informed consent.
Effect of Semi-sitting Position on Mask Ventilation

We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients


Eligibility Criteria:
Inclusion Criteria:

* Obese patients undergoing general anesthesia

Exclusion Criteria:

* diseases or structural abnormalities in the upper airway
* those who were at risk of aspiration
* cardiovascular or respiratory diseases
* pregnancy
Laparoscopic Hartmann's Reversal Procedure: In the Absence of Standardized Guidelines, we Started a Database of Patient Submitted Reversal Hartman With Standard Technique and Laparoscopic Technique, Prospectively for One Year and a Follow-up Period of 6 Months

Several studies have shown laparoscopic technique's advantages, including more rapid post-operative recovery, less post-operative pain, earlier restoration of bowel function, more rapid return to normal diet, and reduced morbidity but it could still remain a complicated operation due to adhesions and difficulty in identifying the rectal stump. Nevertheless, nowadays laparoscopic technique has largely become part of clinical practice even for younger surgeons. Assumed this, and in the lack of prospective studies, we aimed to confirm the advantages of laparoscopic Hartmann reversal (LHR) by confirming the difference in peri-operative outcomes and postoperative complications.

In clinical practice, the first question to be asked is whether there is a right timing for a patient to undergo Hartmann's reversal procedure and whether timing influences the incidence of complications (short-terms and long-terms outcomes). Another aim of the study is to investigate if the length of rectal stump influences the outcome of Hartmann's reversal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes, ≥ 18 years old.
2. Patients who underwent Hartmann procedure for diverticulitis, intestinal ischemia or trauma
3. Patients who may face a one-year follow-up.
4. Patients fit for surgery.

Exclusion Criteria:

1. age \< 18.
2. patients that have undergone Hartmann's procedure for cancer and also post-Hartmann adjuvant radiotherapy or residual neoplastic disease.
3. immunodepression condition (patients undergoing chemo-radiotherapy and/or immunotherapy, patients undergoing immunosuppressive therapy for autoimmune diseases or transplants, cirrhotic class C and D patients, patients with chronic renal failure undergoing dialysis treatment.)
4. patients with missing data
5. Pregnancy or lactation
Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy

This is a randomized controlled trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) in comparison with TAU (at the VA) in a 2:1 ratio in 75 Veterans with PTSD who have not responded to standard treatment at the VA.

Veterans with PTSD are a highly vulnerable population with tremendous disability and unmet needs. Few VA patients with PTSD now actually receive evidence-based psychotherapy because current exposure-based treatments have low uptake. The project goal is to expand the range of PTSD psychotherapy treatments available at Veterans Administration Medical Centers. This pilot trauma recovery proposal takes the next step in translating a brief efficacious psychotherapy developed and tested for panic disorder, Panic Focused Psychodynamic Psychotherapy (PFPP) for Veterans with PTSD at the VA New York Harbor Healthcare System (VA NYHHCS). PFPP was developed, manualized, and studied in RCTs over the past two decades. We hope that Trauma-Focused Psychodynamic Psychotherapy (TFPP), an adaptation of PFPP, with its high response rates in panic disorder with/without agoraphobia, and non-exposure protocol, will fill crucial gaps in Veteran care. A major challenge facing psychotherapy research is translating and implementing efficacious therapies to the community. No psychodynamic psychotherapy for anxiety or PTSD has achieved this in the US. This pilot RCT represents a paradigm shift in its approach to trauma. TFPP will be the only PTSD treatment for Veterans to incorporate Veterans' input into refinement of the treatment as this project progresses. TFPP targets aspects of traumatic experience and approaches Veterans' lives more broadly than the symptom-focused treatments the VA currently offers our traumatized Veterans.

Eligibility Criteria:
Inclusion Criteria:

* Reporting moderate PTSD, as defined by a CAPS score of \>40
* Have at least one of the following history with CPT and/or PE:

  * offered and declined
  * dropped out of treatment
  * been determined unsuitable by their treatment team
  * received treatment but continue to experience symptoms meeting entrance criteria.
* Require stabilization on psychiatric medication for 2 month period prior to entry into study to avoid confounding treatments

Exclusion Criteria:

* Presence of SCID-5 assessed psychotic disorder, bipolar disorder, or substance use that would interfere with trial demands
* Severe suicidality that would require immediate crisis management
* Organic mental syndromes, delirium, or unstable medical conditions that would interfere with trial demands
* Inability to meet trial demands.
Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population

Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects a ratio of up to 20-30% of infants prematurely born before 30rd week. Delay of starting to speak, cerebral palsy and cognitive disorders may be seen in infants suffering from this disease. Although all the evidence found on the specific mediators and pathways that regulate the mechanism by studies made to understand the pathophysiologic mechanism, there hasn't been any remarkable progress on preventing the development of BPD in new-born infants born below 1500gr body weight. BPD is still one of the most important morbidity and mortality reasons in premature infants. There is a need of further studies to understand the genetic background of BPD specific to different populations, to identify polymorphisms related with the disease and for developing genetic methods for early the diagnose of the disease.

With this purpose, first of all polymorphisms related with BPD and those which are related with similar other lung diseases will be investigated. DNA samples derived from blood samples of 200 patients (100 BPD infant and 100 control) will be examined for polymorphisms in specific genes that are chosen in the light of the prior literature scanning. To the investigators' knowledge, this will be the first study of a broad scanning of polymorphisms related with BPD in Turkish population.

Bronchopulmonary dysplasia is a chronic lung disease that affects a ratio of up to 20-30% of infants prematurely born before 30rd week. Delay of starting to speak, cerebral palsy and cognitive disorders may be seen in infants suffering from this disease. Although all the evidence found on the specific mediators and pathways that regulate the mechanism by studies made to understand the pathophysiologic mechanism, there hasn't been any remarkable progress on preventing the development of BPD in new-born infants born below 1500gr body weight. BPD is still one of the most important morbidity and mortality reasons in premature infants. There is a need of further studies to understand the genetic background of BPD specific to different populations, to identify polymorphisms related with the disease and for developing genetic methods for early the diagnose of the disease.

With this purpose, first of all polymorphisms related with BPD and those which are related with similar other lung diseases will be investigated. DNA samples derived from blood samples of 200 patients (100 BPD infant and 100 control) will be examined for polymorphisms in specific genes that are chosen in the light of the prior literature scanning. To the investigators' knowledge, this will be the first study of a broad scanning of polymorphisms related with BPD in Turkish population.

Eligibility Criteria:
Inclusion Criteria:

* infants born under 30 gestational week
* infants with bronchopulmonary displasia

Exclusion Criteria:

* major congenital abnormalities
* lack of data
* parents don't agree with informed consent
Smartphone App-assisted PPI

Proton pump inhibitors (PPIs) are frequently prescribed for 30 days but taken infinitely. PPIs belong to the most often inappropriate medicines (PIMs). Correct intake of medicines (named adherence) can be supported by digital devices such as smartphone applications. The goal of this interventional study is to test the feasibility of an app-based treatment support provided by community pharmacists in patients prescribed a short-term PPI (30 days). The intervention consists in tracking medication intake, symptom course and well-being over the treatment duration of 30 days with the mednet app on patients' personal smartphones.

This is an exploratory study in a primary care setting with community pharmacists recruiting patients who are newly prescribed a PPI for a short-term treatment (30 days). There is no control group and no randomization. After informed consent and installing the app on their personal smartphones, patients will answer three questions from the app once daily. The questions address medication intake (yes/no), symptom course (better, worse, identical, no symptoms) and well-being (satisfactory/needs improvement). Worsening of symptoms will trigger an alarm (via email) at the pharmacy. The pharmacist will call the patients and use information from adherence and well-being to consolidate a supporting counseling.

Feasibility and a frequency estimation of the interventions will be the focus of the study in view of a larger implementation study with community pharmacies. Further implementation outcomes will be assessed through interviews and surveys (satisfaction, interprofessional work).

Eligibility Criteria:
Inclusion Criteria:

* is ≥18 years old;
* has symptoms that suggest or correspond to gastroesophageal reflux disease (GERD);
* is newly prescribed a short-term PPI treatment;
* accepts to use of the smartphone app mednet during the study period;
* signs the informed consent form;
* understands and speaks (Swiss) German.

Exclusion Criteria:

* in the opinion of the pharmacist or physician, unlikely to comply with the study schedule or are unsuitable for any other reason.
AZA Combined with R-GemOx for Elderly DLBCL Patients

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of AZA（azacytidine）combined with the R-GemOx (rituximab, gemcitabine and oxaliplatin) regimen as first-line treatment in elderly diffuse large B-cell lymphoma (DLBCL) patients.

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of AZA in combination with R-GemOx for untreated elderly DLBCL patients.

The induction phase consisted of 8 cycles of AZA in combination with R-GemOx for a total of 8 treatment cycles. The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.

The primary endpoint is the overall response rate (ORR).Secondary efficacy measures included CR and PR,SD, progression-free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Aged ≥60 years, both male and female.
3. Pathologically confirmed DLBCL
4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
5. No previous chemotherapy or radiotherapy for DLBCL has been received.
6. Expected survival ≥3 months.

Key Exclusion Criteria:

1. DLBCL combined with other types of lymphoma. Transformed DLBCL.
2. DLBCL with central nervous system invasion.
3. The patients have contraindications to any drug in the combined treatment.
4. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
5. Mentally ill persons or persons unable to obtain informed consent.
6. The investigators think that the patient is not suitable for the study.
The Effective Effect-Site Propofol Concentration for Induction and Intubation for Schnider Model in Parturients

The aim of this study was to determine the target propofol concentration needed to provide adequate hypnosis for induction and tracheal intubation for Schnider model using total body weight (TBW) in parturients. In addition, investigators wanted to define the hemodynamic adverse effects associated with these propofol target concentrations.

The temperature was maintained at 22˚ C in the operating room. Patients were placed supine with 15°left lateral tilt achieved using a wedge under the right buttock. Electrocardiograph (ECG), pulse oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) were monitored by one anesthesiologist (S/5 Anesthesia Monitor, GE Healthcare, Helsinki, Finland), and Bispectral Index (BIS) values (A2000 BIS® XP monitor, version 3.2; Aspect Medical Systems Inc., Newton, MA) were obtained and recorded. The BIS smoothing time period was set at 15 seconds. The mean values of the above-mentioned parameters were recorded at 3-min intervals for three consecutive times to determine baseline values. Peripheral vein catheterization on the right hand was then performed but no prehydration was given. A fixed volume of 500 mL hydroxyethyl starch solution was infused at the rate of 0.2 ml.kg-1.min-1, then Lactated Ringer's solution was infused at the same rate until the end of surgery.

Using a computer-generated random-number sequence, patients were allocated to 1 of 6 groups of predefined propofol target Ce for induction, namely, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 µg.mL-1. General anesthesia was induced with fentanyl 3 µg.kg-1. Propofol was administered by the TCI device to achieve the predetermined target propofol Ce. Loss of consciousness was defined by the disappearance of the eyelash reflex that was assessed every 5 seconds after patients spontaneously closed their eyes. After loss of consciousness, succinylcholine 1.5 mg.kg-1 was administered and tracheal intubation was performed 1 minutes later only if the BIS value was \<60 and target propofol Ce had been reached. After intubation, patients were connected to mechanical ventilation adjusted to obtain an end-tidal CO2 of 30 to 35 mm Hg and the propofol target concentration was reduced to 3µg.mL-1. Anesthesiologists performing loss of consciousness assessment and intubation were blinded to the target propofol Ce. SpO2, SBP, DBP, MAP and HR were recorded once a minute for 10 min until 5 minutes after tracheal intubation when the study finished.

Eligibility Criteria:
Inclusion Criteria:

* Thirty-six women undergoing elective cesarean section under general anesthesia were enrolled in this prospective observational study.

Exclusion Criteria:

* Diabetes controlled by insulin
* Preeclampsia
* Heart diseases
* History of taking drugs potentially affecting cardiovascular system.
* Patients fasted for at least 8 hours before surgery and no premedication was given