cyrilzakka/clinical-trials huggingface dataset:
Treatment of Lateral Epicondylitis With a Percussive Therapy Device

The purpose of this study is to assess the efficacy of using a percussive therapy device in addition to physical therapy to treat acute tennis elbow

The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be "subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act" (ref: FDAAA Checklist)

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 years old or older are included
* Patients with atraumatic lateral epicondylitis symptoms
* Symptoms persistent and present for at least 2 weeks
* Presence of 2 of the following on clinical examination: +tenderness to palpation common extensor tendons and/or lateral epicondyle origin, pain over the lateral elbow with passive flexion of the wrist in an extended position, +pain with resisted supination, +pain with resisted middle finger extension.

Exclusion Criteria:

* Any records flagged "break the glass" or "research opt out."
* Patients with elbow osteoarthritis,
* Patients with a history of traumatic injury to the elbow
* Patients with workers compensation
* Patients who received cortisol injection in the elbow
* MRI evidence of common extensor tear
* A history of surgery on the affected elbow,
* Cognitive or behavioral problems which would preclude informed consent.
* Patients with coagulopathies
* Patients who are pregnant
* Patients who had a cortisone injection within 3 months
Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers

To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
2. Age ≥65 and ≤85 years
3. BMI ≥18.5 and BMI ≤32.0 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria:

1. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Clinically relevant surgery of gastrointestinal tract
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. Any relevant bleeding history
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
8. Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
10. Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
11. Alcohol abuse (more than 60 g/day)
12. Drug abuse
13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
14. Excessive physical activities (within one week prior to administration or during the trial)
15. Any laboratory value outside the reference range that is of clinical relevance
16. Inability to comply with dietary regimen of study centre
Perceived Stress Among ICU Medical Staff During COVID-19 Crisis

The objective of this study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.

Well-being of caregivers and stress management in intensive care units are essential keys to an adequate quality of care, especially during the anxious context of coronavirus pandemic. Taking care of numerous patients, the increasing work and mental charges, facing death, the need of material and changes in work organization are all elements that can influence stress among medical workers. Considering real causes of stress and what are the needs of the medical team is fundamental for developing concrete actions to ease the workloads. A few studies were conducted in China on psychological distress of medical staff during COVID-19. According to these few studies about psychological distress in ICU, investigators think that stress scores during COVID-19 could be increased among nurses during pandemic. The second hypothesis is that causes of stress would be not so different from normal care but could be amplified by the actual situation. One point to take into consideration is that most of the studies were conducted in China and medical policy and hospital organization are different in Belgium. The objective of the study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years old
* working in ICU for at least November 2019
* working in ICU regularly since March 2020
* Medical and paramedical professionals
* Working in direct contact with COVID patients

Exclusion Criteria:

* Medical professionals from others departments
* Internship students
* External volunteers for COVID
* Non front-line nurses
A Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.

The goal of this prospective observational study is to learn about the treatment decisions in advanced colorectal cancer treated with oxaliplatin and irinotecan. The main questions:1. learn about the efficacy and safety of immunotherapy or targeted drugs or other chemotherapy for patients treated with oxaliplatin and irinotecan（non-retreatment/rechallenge group，NR group）. 2. learn about the efficacy and safety of oxaliplatin or irinotecan for patients treated with oxaliplatin and irinotecan (retreatment/rechallenge group, RT/RC group). 3. compare the efficacy and safety of various treatment regimens for patients treated with oxaliplatin and irinotecan. This study will only collect the clinical data of patients, without any intervention, in the treatment services. All participants will be provided written informed consent as per the Declaration of Helsinki principles.


Eligibility Criteria:
Inclusion Criteria:

1. Phologically confirmed colorectal adenocarcinoma
2. Treated by oxaliplatin and irinotecan and discontinued due to progression or intolerable drug toxicity
3. ECOG 0-2
4. Predicted survival more than 3 months
5. Estimated by investigators that the main organ function is enough good to tolerate the next treatment plan.
6. Sign informed consent.
7. Agree to receive survival follow-up

Exclusion Criteria:

1. Previously exposed to regorafenib, furoquintinib, TAS-102, PD-1 inhibitors, or targeted drugs or immunotherapy for HER2 amplification, BRAF V600E mutation, and NTRK gene fusion.
2. Previously rechallenged or retreated by oxaliplatin or irinotecan after progression from chemotherapy regimens including oxaliplatin and irinotecan.
3. Participate in another interventional clinical study at the same time, unless in the follow-up stage of intervention study.
4. Proposed to use a treatment regimen containing regorafenib, furquintinib, and trifluridine, but has any problems obstacling oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction et al.
5. Disagree to take contraceptive measures during the study treatment period or within 6 months after the end of the study treatment period.
6. Has other primary malignant tumor history, unless non-melanoma skin cancer or lentigo maligna or carcinoma in situ with sufficient treatment and no disease recurrence.
7. Has the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
8. Has concomitant diseases that seriously endanger patient safety or affect patient completion of the study.
9. Has other problems that is not suitable for clinical research.
Warm Water for Unsedated Colonoscopy

Unsedated colonoscopy is characterized by lower costs, recovery time and incidence of drug-related side effects, although it may be painful for the patient. Based on recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation.


Eligibility Criteria:
Inclusion Criteria:

* adult outpatients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

* refuse to initiate colonoscopy without routine sedation
* inadequate bowel preparation
* incapacity to give informed consent
Pharmacogenetics for Pain Management in Joint Replacement Patients

The purpose of this study is to determine the ability to use pharmacogenetic testing in a joint replacement practice to prescribe the most effective pain medicine for a specific patient.


Eligibility Criteria:
Inclusion Criteria:

* Primary total hip or total knee arthroplasty cases

Exclusion Criteria:

* History of narcotic dependence
Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

Diagnostic accuracy of biomarker testing (galactomannan (GM), (1

A multicentre, open, prospective diagnostic study on the diagnostic accuracy of biomarker testing (galactomannan (GM), (1

Eligibility Criteria:
Inclusion Criteria:

* prolonged neutropenia \> 10 d, patients
* after allogeneic stem cell transplantation or solid organ transplantation,
* Patients wth acute leukemia in induction treatment,
* patients witrh graft-versus-host-disease,
* patients under chronic immunusuppressive therapy such as ciclosporin,
* patients with HIV,
* patients with chronic steroid treatment

Exclusion Criteria:

* Age \< 18 years
* missing informed consent
* contraindication for pleural centesis
Electromyographic Calibration Guided by Depth of Anesthesia

The goal of the CELESTE study is to evaluate whether calibration of EMG is needed for reliable interpretation of neuromuscular function and if so, to identify the minimal necessary depth of anesthesia.

Neuromuscular monitoring is used to document neuromuscular function intra-operatively. Failure to restore neuromuscular function prior to extubation results in residual neuromuscular blockade which is associated with increased postoperative morbidity and mortality. It is essential to document baseline neuromuscular function before administration of the neuromuscular blocking agent. However, during anesthesia induction, neuromuscular monitoring is rarely calibrated due to its time-consuming nature coinciding with the patients' loss of consciousness.

The CELESTE trial is a randomized, prospective, observational proof-of-concept study. We plan to enroll sixty adult participants scheduled for elective non-cardiac surgery requiring general anesthesia with moderate neuromuscular blockade. Participants will be randomized into three electromyography (EMG) calibration groups: based on state entropy ("depth of anesthesia"), group 1 will receive "analgesic calibration", group 2 "sedated calibration", and group 3 "no calibration". Participants will be randomly allocated to receive calibration at a certain depth of anesthesia. All participants will receive a standard EMG performed on the contralateral arm. Standard EMG will be calibrated at state entropy of 50.

Eligibility Criteria:
Inclusion Criteria:

* signed informed written consent
* BMI 17.5-30 kg/m\^2
* ASA \<= 3
* supine positioning during surgery with intraoperative access to both arms
* absence of allergy to muscle relaxants and reversal agents
* absence of neuromuscular disease

Exclusion Criteria:

* ambulatory patients for whom discharge is planned within 12 hours of anaesthesia
* patients undergoing minor surgical
* procedures scheduled outside the operating room
* patients who are endotracheally intubated prior to surgery
* pregnancy
* indication for rapid sequence induction
* patients undergoing arm surgery
* patients with preceding injuries impairing muscle or nerve function of the arm (e.g., finger amputation)
Effects of a Telephone Based Peer Support to Reduce Depressive Symptoms and Improve Social Support in Women With CHD

In a randomized controlled trial the investigators intended to evaluate the effect of a telephone based peer support intervention on depressed or anxious women with coronary heart disease (CHD). The investigators intended to include 198 depressed or anxious women aged over 18 years with CHD. Participants were randomized to intervention (IG) or waiting list (WL). IG was offered immediate telephone-based contact to peer counselors while WL received the offer with a 6-month delay. All participants got at least one telephone call by a clinical psychologist (study information, feedback about the individual level of distress, proposal to get help). Main outcome variables were depressive symptoms (PHQ-9) and perceived social support (F-SozU K-14). In an additional quasi-experimental trial, the investigators included 11 peer counselors and 11 matched controls not taking part in the intervention. Main outcome variables were mood states (POMS) and perceived social support (F-SozU K-14).


Eligibility Criteria:
Inclusion Criteria:

* coronary heart disease
* depressive symptoms (HADS \>7)
* insurants of former Kaufmännische Krankenkasse (KKH)-Allianz
* German speaking
* at least 18 years old
* written informed consent

Exclusion Criteria:

* hardness of hearing
* severe somatic illness
* current severe depressive episode or current suicidal tendency
* severe mental illness (dementia, psychosis)
Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations

The present study aims to examine the efficacy of transcranial direct current stimulation on the severity of auditory hallucinations.

Rationale: Auditory hallucinations (AH) are a symptom of several psychiatric disorders, such as schizophrenia. In the majority of patients, these AH respond well to antipsychotic medication. Yet, a significant minority continues to experience frequent AH despite optimal pharmacotherapy and AH severely decrease quality of life in these patients. The number of alternative treatment options for this medication resistant group is currently low and most of them focus on coping with the hallucinations. Transcranial direct current stimulation (tDCS), in contrast, is a safe, non-invasive technique that is able to directly influence cortical excitability through the application of very low electric currents. This technique has only a few transient side-effects and is cheap and portable. To date, only one randomized controlled trial has been published, suggesting high efficacy of tDCS for the treatment of medication-resistant AH in a relatively small sample. We aim to replicate and extend these findings by investigating the efficacy of this technique in a larger sample.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18.
* Frequent auditory hallucinations (at least 5 times a week).
* Patients are on a stable dose of antipsychotic medication (which can also be zero) for at least 2 weeks
* Mentally competent for informed consent.
* Provided informed consent.

Exclusion Criteria:

* Metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing)
* History of seizures, or a history of seizures in first-degree relatives.
* History of eye trauma with a metal object or professional metal workers
* History of brain surgery, brain infarction, head trauma, cerebrovascular accident, broken skull, brain tumour, heart disease, cardiac pacemaker.
* Skin disease on the scalp on the position of the tDCS electrodes
* Coercive treatment based on a judicial ruling
* Pregnancy in female patients
Measuring Synovial Fluid Components

Participants with grade 3 and 4 knee osteoarthritis will recieve aspiration of synoivial fluid, and then receive either dextrose, hemaotopoietic stem cell, or platelet rich plasma, or no injection. The synovial fluid will be analyzed for changes in components.

80 participants with grade 3 and 4 symptomatic knee osteoarthritis, with a visable effusion, will receive aspiration of 3 ml of synovial fluid from the suprapatellar pouch, followed by either injection with 10 mL of 12.5% dextrose, 10 cc hematopoietic stem cells, 10cc PRP, or no injection into the suprapatellar pouch. They will then receive aspiration of 3 ml of synovial fluid at 2 days and either 7 days (for dextrose injected or no injection) or 14 days (stem cell and PRP injected) days post injection. These synovial samples will be analyzed for a change in components.

Eligibility Criteria:
Inclusion Criteria:≥ 6 months of knee pain with walking

* ≥ 6/10 on a 0-10 point numerical rating scale
* High grade medial compartment cartilage loss ( Kellgren-Lawrence grade 3 or 4) on plain weight bearing X-ray
* Exposed subchondral bone at 110 degrees of flexion by ultrasound examination
* Easily visible suprapatellar pouch with quads conttraction.

Exclusion Criteria

* Current intake of NSAIDs or steroids
* Current anticoagulation therapy
* Inflammatory or post-infectious knee arthritis
* Systemic inflammatory conditions
* Knee flexion less than 100 degrees
* Knee extension less than 165 degrees
* Valgus or varus more than 15 degrees
* Any knee injection in the precedign 3 months
* BMI more than 50 kg/ meter squared
* Gross synovial folds on ultrasound.
SLC13A5 Deficiency Natural History Study - Remote Only

SLC13A5 deficiency (Citrate Transporter Disorder, EIEE 25) is a rare genetic disorder with neurodevelopmental delays and seizure onset in the first few days of life. This natural history study is designed to address the lack of understanding of disease progression and genotype-phenotype correlation. Additionally it will help in identifying clinical endpoints for use in future clinical trials.

This is a longitudinal observational study for the natural history of SLC13A5 deficiency for up to 2 years. This study does not involve any therapeutic intervention. The study includes remote visits which will be done via telephone or remote video conferencing. Translators will be available during these remote visits for non-english speaking caregivers. The initial visit will consist of collecting a detailed medical history and medical records. Prior brain imaging and available EEGs will be collected and reviewed by the study neurologist. Neuropsychological assessments will be made using Vineland Adaptive Behavior Scale version 3. Brief standardized videos recorded by the caregiver will be reviewed and scored by study personnel for movement assessment. Caregiver of ages 2 and up will be asked to complete the QOL Family Impact Module and the QOL epilepsy module. In addition to the initial visit, assessments in 1st year (every 3 months) and 2nd year (every 4 months) of enrollment will be made through remote interviews. Caregiver will be asked to maintain a seizure diary for the duration of the study to assess seizure burden. Personnel having expertise to comprehensively evaluate biological pathways that are perturbed by SLC13A5 deficiency will analyze the collected data. Improved understanding of disease pathogenesis will guide therapeutics and reveal clinical endpoints for use in future clinical trials. Identifying genotype-phenotype correlations can guide prognostication, clinical management, and genetic counseling.

Eligibility Criteria:
Inclusion Criteria:

1. Parent(s)/legal representative and/or patient must be willing and able to give informed consent/assent for participation in the study.
2. Males and females of any age are eligible for this study
3. Suspected or confirmed diagnosis of SLC13A5 deficiency with genetic variants in both SLC13A5 alleles and consistent clinical characteristics. Variants of uncertain significance in one or both alleles are acceptable if deemed good candidates by participant's primary geneticist or neurologist and study personnel.
4. Participant and caregiver must be willing to provide clinical data and participate in standardized assessments.

Exclusion Criteria:

1. The presence of a second, confirmed disorder, genetic or otherwise, affecting neurodevelopment or with other overlapping symptoms of SLC13A5 deficiency.

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Effects of Preservation Rhinoplasty Nasal Valve Angle and Area

The study planned to compare the internal nasal valve angle measurements of patients who underwent preservation rhinoplasty before and after surgery.

Nasal congestion is one of the most common complaints in Otorhinolaryngology medicine. One of the most common causes of this is the collapse or blockage of the Internal Nasal Valve (INV). The internal nasal valve is the narrowest part of the airway and creates the greatest resistance to airflow. Its most important function is to regulate the inspiratory airflow. It is determined by the angle formed between the caudal part of the upper lateral cartilage and the nasal septal cartilage. This angle normally varies between 9-15 degrees. The tip of the inferior turbinate and the tissues surrounding the piriform aperture may affect this area. When this angle is less than 9 degrees, the valve collapses in inspiration. The internal nasal valve region should be evaluated in every patient complaining of nasal congestion. the investigators planned to radiologically examine the improvement in the internal nasal valve angle of the patients we operated on.

Eligibility Criteria:
Inclusion Criteria:

* Preservation rhinoseptoplasty

Exclusion Criteria:

* Absence of nasal obstruction
* Previous nasosinusal surgery
* Cranio-facial anomalies
* Presence of nasosinusal tumors
A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.

100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).

Patients will be treated for 48 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 cell count of 200 - 700 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

AIDS defining condition within 1 month of study entry.

Prior Medication:

Excluded:

Patients with any history of antiretroviral therapy treatment.