cyrilzakka/clinical-trials huggingface dataset:
PCT of Pharmacopuncture for Chronic Neck Pain

A pragmatic clinical study to compare the effectiveness of pharmacopuncture and acupuncture treatment strategies in patients with chronic neck pain

This study aims to confirm the comparative effectiveness of pharmacopuncture by conducting a pragmatic randomized controlled clinical trial with 128 patients suffering from chronic neck pain. The trial will compare patients treated with a pharmacopuncture-based strategy (64 patients) to those treated with an acupuncture-based strategy (64 patients). As this is a pragmatic clinical trial, participants will be randomly assigned to either the pharmacopuncture or acupuncture groups. However, the specific methods of pharmacopuncture and acupuncture to be used will not be predetermined. Instead, they will be determined based on the clinical judgment of the traditional Korean medicine doctor according to the patient's condition. All methods used will be recorded in the CRF (Case Report Form).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with neck pain persisting for more than 3 months
2. Patients with a Numeric Rating Scale (NRS) score of 5 or higher for neck pain
3. Patients aged between 19 and 70 years
4. Patients who agree to participate in the clinical study and provide a written informed consent form

Exclusion Criteria:

1. Patients diagnosed with serious specific diseases that could be the cause of neck pain (e.g., spinal metastasis of tumors, acute fractures, and spinal dislocations)
2. Patients exhibiting progressive neurological deficits or severe neurological symptoms
3. Patients whose pain originates from soft tissue disorders rather than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout)
4. Patients with other chronic diseases that could interfere with the interpretation of treatment effects or outcomes (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy)
5. Patients currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that could affect the study results
6. Patients for whom pharmacopuncture treatment is inappropriate or unsafe: those with bleeding disorders, those undergoing anticoagulant therapy, and severe diabetic patients with infection risks
7. Patients who have taken medications that could affect pain (e.g., Non-Steroidal Anti-Inflammatory Drugs, NSAIDs) or received pharmacopuncture, acupuncture, or physical therapy within the past week
8. Pregnant women, those planning to become pregnant, or those currently breastfeeding
9. Patients who have undergone cervical spine surgery within the past 3 months
10. Patients who have not completed participation in another clinical study within the past month or plan to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection
11. Patients who find it difficult to provide informed consent for participation
12. Other cases where the researcher deems participation in the clinical study to be difficult
Effect of Aerobic Exercise on Learning Outcomes

Most studies have reported that physical activity positively affects memory, observation, problem-solving, decision-making, and specific skills (e.g., reading and mathematics). From an acute perspective, a single exercise session performed before, during, and after a learning task has been shown to improve various memory and executive functions (e.g., decision-making, goal planning, task switching). A meta-analysis indicated that exercise performed close to learning tasks enhances short-term memory (e.g., information that disappears within a few seconds) and long-term memory (e.g., information recalled after long time delays). Practical training is necessary in physiotherapy education programs. Practical training includes laboratory work at school, profession-related projects, and clinical internships. Practical work learning prepares students for their profession, job roles, and professional identity. Furthermore, increasing practical applications, such as assessment and practice on models, will also enhance problem-based learning. Therefore, new approaches that enhance learning in practical training in the field of physiotherapy and rehabilitation may contribute to the development of knowledgeable and qualified physiotherapists.

In this context, this study was designed to evaluate the effect of a single session of aerobic exercise before a lecture on pelvic floor rehabilitation, which includes practical methods, on the learning outcomes of the course.


Eligibility Criteria:
Inclusion Criteria:

* Being a Physiotherapy and Rehabilitation student
* Not having taken a course/training on pelvic floor rehabilitation,
* Being between the ages of 18-22,
* Being a volunteer,
* Being literate in Turkish.

Exclusion criteria:

* Those with a high metabolic aerobic threshold according to the International Physical Activity Questionnaire (3000 METs and above),
* Students who answered "Yes" to any of the 7 questions in the General Health Questions section of the Exercise Readiness for All Questionnaire,
* Those with a history of neurological disease or epilepsy,
* Those with problems that prevent participation in exercise such as hypertension or other cardiovascular diseases.
A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer

The purpose of this study is to evaluate the safety and preliminary efficacy of four doses of SGX201 in subjects with rectal cancer treated with concurrent radiation and chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Primary rectal cancer
* Planned course of conventional neoadjuvant radiation therapy before surgery
* Scheduled to receive chemotherapy
* \>/= 18 years of age
* Negative pregnancy test

Exclusion Criteria:

* History of acute or chronic regional enteritis or inflammatory bowel disease
* Stool incontinence
* Uncontrollable diarrhea
* Abdominal-perineal resection or other surgery leaving patient without a functioning rectum
* Patients using colostomy or ileostomy
* Liver function tests \> 3x upper limit of normal, or bilirubin test result \> 1.5 the upper limit of normal
* Calculated creatinine clearance \<60 mL/minute
* Planned hyperfractionated or split course radiation
* Planned brachytherapy prior to completion of all external beam radiation therapy
* Prior pelvic RT
* An on-going infection
* ECOG score \>/= 3
* Leukopenia \<2,000 WBC/mm3 or Hg \<10.5 g/dL
* Participation in an investigational drug trial within the previous 30 days
* Patients with a medical condition that would interfere with study compliance
* Known hypersensitivity to 5-FU or capecitabine
* Anticipated inability to tolerate oral administration of SGX201
* Pregnant or breastfeeding
Perform Humeral System Study

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation.

Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be collected for the commercially available PERFORM™ Humeral System. The objective of this study is to demonstrate the safety and performance of the PERFORM™ Humeral System devices after implantation over a standard follow-up period using Patient Reported Outcome Measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. Safety and performance measures will be evaluated throughout the patient's participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of the informed consent or non-opposition (when applicable).
* Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
* Willing and able to comply with the requirements of the study protocol.
* Considered a candidate for shoulder arthroplasty using a study device.
* Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements

Exclusion Criteria:

* Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
* Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
* Active local or systemic infection, sepsis, or osteomyelitis
* Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
* Significant injury to the brachial plexus
* Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
* Neuromuscular disease (e.g., joint neuropathy)
* Patient with known allergy to one of the product materials
* Metabolic disorders which may impair bone formation
* Patient pregnancy
* Planned for two-stage surgery
An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols

This is an extension study that will allow participants to continue to receive study therapy when the original studies into which they were enrolled have reached their designated end-dates. This extension study is designed to further evaluate the safety and tolerability of tivantinib (ARQ 197) monotherapy or in combination with other drug(s) when given to participants who tolerated previous treatment well and may benefit from the continuing treatment.

This open label extension protocol enrolls participants who were treated in previous phase 1 (NCT01149720, NCT01517399, NCT01699061, NCT00612703, NCT00827177, and NCT00874042) and phase 2 (NCT00777309, NCT00557609, NCT00988741, NCT01395758 , and NCT01055067) tivantinib studies that have reached their designated end-dates. Participants enrolled in this extension protocol will provide further safety and tolerability information about tivantinib monotherapy or in combination with other drug(s) at the same dose(s), and same schedule(s) in which they were originally enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent to participate in clinical study of tivantinib
* Male or female participants of the age defined in the original protocol they were enrolled.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤3 (or ≤2 for tivantinib-naive participants)
* Adequate bone marrow function:

  * Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
  * Hemoglobin ≥8.0 g/dL (or ≥ 9.0 g/dL for tivantinib-naïve participants)
* Enrollment within 14 days of the completion of End of Treatment Visit of the original study
* Participants, who participated in previous ARQ 197 studies that have reached their designated end-dates, who did not meet discontinuation criteria in their original study, and who may, in the opinion of the Investigator and the Sponsor, benefit from treatment
* Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of study drug. Both men and women enrolled in this study must agree to use adequate birth control measures while on study

Exclusion Criteria:

* Known or suspected allergy to ARQ 197
* Substance abuse, medical, psychological or social conditions that may interfere with the participant's participation in the study or evaluation of the study results
* Any condition that is unstable or which could jeopardize the safety of the participant and his/her compliance in the study
* A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the participant to receive protocol therapy
* Requirement to receive other concurrent chemotherapy (excluding combination therapy defined in original protocol), immunotherapy, radiotherapy, or any other investigational drug while on study. Palliative radiotherapy is allowed provided that:

  * in the opinion of the Investigator, the participant does not have progressive disease
  * the radiation field does not encompass a target lesion
  * no more than 10% of the participant's bone marrow is irradiated
Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath

This is a pilot observational feasibility study of the ability of paramedics to assess thoracic ultrasound findings in the prehospital environment. The primary goal of the study is to determine whether paramedics are able to accurately assess for sonographic B-lines in patients with undifferentiated shortness of breath at least 80% of the time in the prehospital environment using a portable ultrasound (U/S) device.

In the first phase of the study, a cohort of senior and supervisory paramedics will be recruited into the study. These paramedics would undergo didactic and hands-on training to learn how to operate the U/S machine, and obtain and interpret basic U/S images. The paramedics will then participate in video review sessions and spend time in the emergency department (ED) with the U/S team to get hands-on experience with patients. In the second phase of the study, paramedics will be staffing ambulances or fly cars in and around the greater New Haven region and will respond to dyspnea calls. At each call, the paramedic will initially evaluate the patient clinically conducting a standard history and physical exam. The paramedic will then use the portable U/S machine to look for the presence of either unilateral or bilateral B-lines indicating possible pneumonia (in the case of unilateral B-lines) or pulmonary edema (in the case of bilateral B-lines). The paramedic will then document the presence or absence of B-lines for each lung on the prehospital study sheet. The paramedic will then use the U/S to evaluate for the presence of pleural effusions, lung sliding and pericardial effusion.

Eligibility Criteria:
Inclusion Criteria:

- Dyspnea and any of the following:

* Respiratory rate \> 20
* Room air oxygen saturation \< 92%
* Accessory muscle use, tripod position, nasal flaring
* Exam with evidence of rales/rhonchi or wheezing
* In acute respiratory distress on paramedic evaluation
* Any patient in acute respiratory distress with

Exclusion Criteria:

* Trauma
* Burns
* Pregnancy
* Kussmaul respirations from metabolic acidosis
* Cheyne-stokes from increased ICP (intracranial pressure), heart failure or CVA
* Drowning
Does Heart Rate Variance (HRV) Biofeedback Help Regulate Emotions and Improve Mindfulness in Mentally Unwell Offenders?

14 participants residing in a forensic psychiatric hospital completed 15 Heart Rate Variance (HRV) biofeedback sessions. They completed 4 psychometric questionnaires, pre, during and post biofeedback training.

This study aimed to establish whether Heart Rate Variance (HRV) biofeedback improved HRV coherence as well as psychological well-being (depression, anxiety, emotion regulation, and mindfulness) over the course of 15 biofeedback sessions in a sample of 14 patients with varying diagnoses; Paranoid Schizophrenia, Schizoaffective Disorder, Personality Disorder or Mixed Diagnosis. All 14 participants (n=10 male, n=4 female) participated in 15 biofeedback sessions. The study was researched and treatment was facilitated by a trainee forensic psychologist working with both male and female offenders residing within a Forensic Psychiatric Hospital, on both low and medium secure wards. An average coherence percentage was captured using the Wild Devine Programme® Relaxing Rhythms software for each session. Quantitative data were collected and analysed before, during and after biofeedback treatment to assess whether there was improvement in psychometric measures of depression, anxiety, emotion regulation and facets of mindfulness. A quasi experimental 'A-B-A design' was employed to assess the research questions.

Eligibility Criteria:
Inclusion Criteria:

* Male and female offenders aged 18 and above.
* Male and female offenders who reside in a medium and low Forensic Psychiatric Hospital.
* Individuals who have the capacity to consent to take part in the research
* Individuals deemed mentally stable and were found to have capacity to consent by their Multi-Disciplinary Team (MDT).

Exclusion Criteria:

* Individuals under the age of 18.
* Individuals who are not detained in a Forensic Psychiatric Hospital.
* Individuals deemed not well enough to consent by their Multi-Disciplinary Team (MDT).
* A level of cognitive impairment determined by diagnosis that would prevent individuals from understanding the feedback obtained. via pictorial or verbal prompts
* Individuals with specific breathing difficulties (e.g., chronic obstructive pulmonary disease) that would restrict them from being able to practice the breathing techniques.
Zeiss® IOLMaster 700 Corneal Topography Module Comparison With Schwind's Sirius Corneal Topography®

In order to determine the intraocular lens to be implanted during cataract surgery, keratometry and axial length must be measured in preoperative. The axial length is obtained by ocular ultrasound mode B. Keratometry is obtained by means of an automatic refractometer or corneal topography. Currently, ultrasound scanners are being developed with a topography module to combine axial length and keratometry measurement. The investigators want to evaluate the corneal topography module of the Zeiss® IOL Master 700 biometer.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women Requiring CHV Cataract Surgery
* Aged 18 or over
* Insured under a social security scheme
* Having been informed of the clinical study and having given oral express consent

Exclusion Criteria:

* Person unable to express consent
* Patient with a history of corneal dystrophy, corneal refractive surgery or keratoconus.
* History of chronic corneal disease
A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)

A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.


Eligibility Criteria:
Inclusion Criteria:

* Obese patients with a body mass index between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia, and sleep apnea

Exclusion Criteria:

* Patients with serious or unstable current or past medical conditions
CAR-T Cells in Treating Patients With Relapsed or Refractory NHL

This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet;
2. Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology.

   To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment;
3. There should be at least one measurable tumor focal point;
4. Karnofsky \[2\] score 50 or more;
5. Tumor cells were CD19 positive by immunohistochemistry or flow cytometry;
6. The expected survival time is greater than 3 months;
7. Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year;

Exclusion Criteria:

1. Serious cardiac insufficiency, left ventricular ejection fraction\<50;
2. Has a history of severe pulmonary function damaging;
3. Merging other malignant tumor;
4. Merging uncontrolled infection;
5. Merging the metabolic diseases (except diabetes);
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. patients with active hepatitis B or hepatitis C;
8. patients with HIV infection;
9. Has a history of serious allergies on Biological products (including antibiotics);
10. Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients;
11. Pregnancy or lactation women;
12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Reinforcing Exercise in Substance Abusing Patients

This study will evaluate the efficacy of an exercise-based contingency management (CM) intervention. A total of 120 substance abusing patients in intensive outpatient treatment will be randomly assigned to one of two conditions: (a) standard care plus CM for completing goal-related activities not related to exercising (e.g., improving work, family, or transportation issues), or (b) standard care plus CM for completing exercise-related activities. Compared to those receiving goal-related CM activity contracting, it is expected that those in the exercise CM condition will participate in more physical activities and develop greater strength and flexibility, decrease drug use, reduce HIV risk behaviors, lessen depressive symptoms, and improve health indices.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* English speaking
* in substance abuse treatment
* written permission from a physician (or their designated health care professional, e.g., nurse, physicians assistant) to participate in the study and an exercise program.

Exclusion Criteria:

* inability to comprehend the study
* in recovery for pathological gambling
* contraindication for exercising