cyrilzakka/clinical-trials huggingface dataset:
A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD

The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of COPD
* Current or prior history of cigarette smoking

Exclusion Criteria:

* Medical diagnosis of asthma
* Significant condition or disease other than COPD
Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas

This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with DIPG who failed at least one line of prior therapy such as focal radiation therapy
2. Patient must be \> than 6 months and \< 18 years of age.
3. Confirmed evidence of disease progression from immediately prior therapy or refractory to the immediately prior treatment.
4. Karnofsky/Lansky performance status ≥ 50.
5. Adequate organ and marrow function as defined below:

   1. Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to treatment (cycle 1 day 1, C1D1)

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   2. Hemoglobin\>8.0 mg/dL without red blood cell transfusion ≤ 3 days prior to C1D1
   3. Total serum bilirubin\<1.5 X upper limit of normal (ULN)
   4. AST (SGOT)/ALT (SGPT)≤2 X ULN;; ≤ 5 X ULN if there is liver involvement secondary to tumor
   5. Serum creatinine≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2)
6. Ability to understand and the willingness to sign a written informed consent document by the patient or their legal guardian.
7. If patient is of child--bearing age, female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.
8. Patient must be able to swallow capsules and retain orally administered medication.

Exclusion Criteria:

1. Body weight \>10Kg.
2. Known active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV).
3. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)--related illness.
4. Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10\^9/L).
5. Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
6. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism.
7. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.
Comparison of Spencer Technique and Conventional Treatment in Adjuncts to Corticosteroid Injection in Frozen Shoulder

This study will compare the effectiveness of the Spencer Technique combined with intra-articular injection versus conventional therapy combined with intra-articular injection in managing frozen shoulder. The research problem addresses the need for optimal therapeutic approaches to improve pain relief, range of motion, and functional recovery in patients with frozen shoulder.

Utilizing a randomized controlled trial, the study will recruit 100 participants, divided into two groups: Group A receiving the Spencer Technique with intra-articular injection and Group B receiving conventional therapy with intra-articular injection. Outcome measures will include pain levels, range of motion, shoulder functional status and patient satisfaction, assessed through validated tools. The significance of this study lies in its potential to provide robust comparative data to guide clinical decisions and enhance patient outcomes, particularly in populations with a high prevalence of diabetes

Eligibility Criteria:
Inclusion Criteria:

* 30 years 60 years old.
* Diagnosed with unilateral adhesive capsulitis presenting symptoms of pain.
* restricted range of motion of frozen shoulder Stage 2 and 3

Exclusion Criteria:

* Rotator cuff injury
* Long-term Systemic Corticosteroid use
* Previous Ipsilateral shoulder CSI within 12 months.
Physiotherapy or Acupuncture for Lateral Epicondylitis

Work-related upper extremity disorders are common problems in working populations in western countries. Lateral epicondylitis (LE) or tennis elbow is the most frequent type of soft tissue syndrome of the elbow, with an annual incidence of four to seven cases per 1000 patients in general practice, and as high as 15 % of workers in highly repetitive hand task industries.

LE is a painful condition, leading to loss of function of the affected limb. Therefore it can have a major impact on the patient's work and personal life. If untreated, it persists for an average of six to 24 months and associated with significant sickness absence in 5 % of affected working-aged adults. The cost is therefore high, both in terms of loss of productivity and health care utilization.

Many treatments have been advocated in the management of LE, possibly implying that much is unknown about its etiology and how it best should be treated. Systematic reviews have failed to draw any firm conclusions as to what treatment is most effective in managing this condition.

Over the past 10 years acupuncture has gained wider acceptance for treating pain, by both clinicians and consumers of health, and there is some evidence suggesting that acupuncture treatment is effective in of acute symptoms in LE. A recent study supports that also elbow manipulation have a short-term relief of acute symptoms in LE, especially when combined with eccentric exercise. Our study will therefore explore the clinical effectiveness of physiotherapy versus acupuncture treatment of LE, compared with watchful waiting.

The study design is three armed and randomized, single blinded. The study aims, in a pilot stydy, to test if physiotherapy or acupuncture treatment of lateral epicondylitis, compared with watchful waiting, is useful means in pain relief for patients with lateral epicondylitis.

Eligibility Criteria:
Inclusion Criteria:

* Lateral epicondylitis LE (duration \> 2 weeks)
* Unilateral localization
* Individuals with average pain of NRS 4 or higher during the last week prior to screening
* Aged between 18 and 67 years
* Written informed consent

Exclusion Criteria:

* Corticosteroid injections during the last 4 weeks
* Diseases of the central or peripheral nervous system
* Inflammatory rheumatic diseases
* Radio-ulna or radio humeral osteoarthritis
* Unwilling to participate
Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer

This study is to evaluate the tolerability and safety of ONO-7475 in combination with osimertinib in the first-line treatment of patients with EGFR-mutated, stage IIIB/IIIC/IV or recurrent non-small cell lung cancer (NSCLC), which is unsuitable for radical irradiation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage IIIB/IIIC/IV or recurrent NSCLC, which is unsuitable for radical irradiation
2. Patients with confirmed EGFR gene exon 19 deletion or EGFR gene exon 21 mutation(L858R)and who are scheduled to receive osimertinib
3. Patient has an ECOG performance status of 0-1

Exclusion Criteria:

1. Patients with severe complication
2. Patients with multiple primary cancers
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology

The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.

The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.

The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.

The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.

Patients who are referred to the clinic will spend one night's sleep in the clinic. They will wear a polysomnography system (current goldstandard) and the novel device.

At the end of the trial, we will compare the diagnosis results from both systems.

Eligibility Criteria:
Inclusion Criteria:

* Children older than one year old
* Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.

Exclusion Criteria:

* Patients whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
* Known allergy to the adhesive dressing.
* Patients with physical or mental impairments who would be too distressed with additional sensors on themselves.
* Patients with not enough space on the neck area to fit the sensor.
* Clinical problem in the area in which the device will be attached, eg skin condition
Varicose Vein in Patients Under the Age of 40

Varicose veins are a result of valvular insufficiency and presented with twisted, enlarged veins. They not only cause cosmetic concerns but also lead to limb edema, skin pigmentation/lipodermatosclerosis, and even venous ulcers. This disease affects a large percentage of the population. Although there have been several researches on the risk factors for varicose veins and the outcomes of alternative therapies , there is currently limited data focusing on varicose veins in young patients. In this case-control study, we wanted to assess the risk factors for varicose veins in patients under the age of 40, as well as their long-term results of surgery.


Eligibility Criteria:
Inclusion Criteria:

1. great saphenous varicose veins (GSVV) with saphenous vein reflux \>0.5s.
2. lower extremity venography excluding iliac vein compression;
3. treated by great saphenous vein stripping and ambulatory phlebectomy.
4. the patient had a minimum follow-up of five years.

Exclusion Criteria:

1. secondary varicose veins (defined as varicose veins caused by deep vein thrombosis, iliac venous compression or venous injury etc.);
2. small saphenous veins;
3. treated by endovenous ablation/laser or sclerotherapy alone.
Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit

Acute Kidney Injury (AKI) is a common complication of severe trauma patients and is associated with increased morbidity and mortality.Trauma patients have many risk factors for AKI such as hypovolemic shock, rhabdomyolysis, massive transfusion, major surgeries and abdominal compartment syndrome.The primary outcome of the study is to correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS .The secondary outcomes are ;the length of ICU and hospital stay and 28 days mortality in AKI patients.

• Study Population: 60 cases of polytrauma patients who have ISS\>15.

* Inclusion Criteria:

  * Age from 18 to 70 years old males or females
  * Injury Sensitivity Score (ISS \>15 )
* Exclusion Criteria:

Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.

Sample size :the calculated sample size is 60 cases of trauma patients.

• All patients' data will be recorded on admission and daily for 7 days:

* Vital signs (blood pressure, heart rate, respiratory rate, body temperature).
* Lab investigations: complete blood count, international normalized ratio, prothrombin time, arterial blood gases, kidney function tests, liver function tests, creatine kinase, creatine kinase-muscle band, creatinine clearance, serum sodium, serum potassium and serum phosphorus will be requested for all patients at admission then daily follow up by creatine kinase, creatine kinase-muscle band, kidney function tests, serum sodium, serum potassium and serum phosphorus for 7 days. Glasgow Coma Scale (GCS), Injury Severity Score (ISS),Urine output (ml/kg/h),RIFLE criteria.,Length of ICU and hospital stay,28 days mortality.

Eligibility Criteria:
Inclusion Criteria:

* • Age from 18 to 70 years old males or females

  * Injury Sensitivity Score (ISS \>15 )

Exclusion Criteria:

* Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.
Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery

Several regional anesthesia have been shown to improve postoperative outcomes in many studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane block (analogous to the TAP block but intended for the back) which targets the sensory component of the dorsal rami of the thoracolumbar nerves in patients undergoing back surgeries.


Eligibility Criteria:
Inclusion Criteria:

* patients with ASA 1 or 2 aged between 21years old up to 60 years old of both sex scheduled of back surgery

Exclusion Criteria:

* Exclusion criteria will be patients refusal or inability to give an informed consent , history of relevant allergy to any of the drugs used in the procedure , previous lumbar spine surgery or back surgery with planed spinal fixation.
Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer

The goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer.

This is a multicenter, prospective, single-arm open-label study designed to enhance surgical R0 resection rate, reduce residual lesions, decrease distant metastasis and disease recurrence rates, and prolong the survival of patients with advanced endometrial cancer (stage III-IVb FIGO 2023) by neoadjuvant chemotherapy combined with tislelizumab.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and signed informed consent form;
2. Age ≥18 years;
3. Eastern Cooperative Oncology Group performance status 0-1;
4. The International Federation of Gynecology and Obstetrics (FIGO 2023) stage III-IVb of endometrial cancer;
5. Has not received any systematic anti-tumor treatment for advanced diseases in the past;
6. Have measurable disease according to RECIST v1.1 criteria;
7. Patients must meet the following criteria for laboratory tests to ensure adequate organ function:

   * ANC ≥1,500/mm3, or ≥1.5×109/L
   * Platelet count≥75,000/mm3 or 75 x 109/L
   * Hemoglobin≥9 g/dL or ≥5.6 mmol/L
   * Glomerular filtration rate estimated（eGFR） according to the Chronic Kidney Disease Epidemiology Collaborative Group formula （CKD-EPI EQ6）was≥40 mL/ 1.73m2
   * Serum total bilirubin ≤ 1.5x upper limit of normal range（ULN）
   * Both AST and ALT were ≤3 x ULN
8. The expected lifespan exceeds 3 months.

Exclusion Criteria:

1. Received PD-1 target therapy other than tislelizumab or other antibody or drug therapy that specifically targets T-cell costimulation or checkpoint channels within 6 months before enrollment；
2. Has human immunodeficiency virus infection, active viral hepatitis, and active tuberculosis infection；
3. Active leptomeningeal disease or uncontrolled, untreated brain metastases resulting in elevated intracranial pressure;
4. Major surgical procedures had been performed within 4 weeks before consent was obtained；
5. Other conditions deemed by the investigator to be ineligible for enrollment.
Artificial Intelligence for Diminutive Polyp Characterization

Artificial intelligence is a promising tool that may have a role in characterizing colon epithelial lesions (CADx), helping to get a reliable optical diagnosis regardless of the endoscopist experience. Performances of the different CADx systems are variable but it seems that, in most cases, high accuracy and sensitivities are achieved. However, these CADx systems have been developed and validated using still pictures or videos, and a real-world accurate test is lacking. No clinical trials have tested this technology in clinical practice and, therefore, performance in real colonoscopies, practical problems, applicability, and cost are unknown.

The resect-and-discard (R\&D) and diagnose-and-leave (D\&L) strategies have been proposed as a means to reduce costs in the evaluation of colorectal polyps avoiding a substantial number of pathology evaluations. A pre-requisite for this paradigm shift is an accurate optical diagnosis (HOD). However, performance results for HOD have been highly variable among endoscopists representing a barrier for the adoption of the R\&D and the D\&L strategies.

Artificial intelligence is a promising tool that may have a role in characterizing colon epithelial lesions (CADx), helping to get a reliable optical diagnosis regardless of the endoscopist experience. Performances of the different CADx systems are variable but it seems that, in most cases, high accuracy and sensitivities are achieved. However, these CADx systems have been developed and validated using still pictures or videos, and a real-world accurate test is lacking. No clinical trials have tested this technology in clinical practice and, therefore, performance in real colonoscopies, practical problems, applicability, and cost are unknown.

Methods and analysis: The ODDITY trial is a European multicenter randomized, parallel-group superiority trial comparing GI-Genius artificial intelligence optical diagnosis (AIOD) to human optical diagnosis (HOD) of colon lesions ≤ 5 mm performed by endoscopists, using histopathology as the gold standard. A total of 643 patients attending a colonoscopy within a CRC screening program (either FIT- or colonoscopy-based) or because of post-polypectomy surveillance will be randomized to the ADI group or the HOD (control) group. A computer-generated 1:1 blocking randomization scheme stratified for center and endoscopist will be used.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending a colonoscopy within a population-based CRC screening program (FIT- or colonoscopy-based) or because of post-polypectomy surveillance,
* Written informed consent before the colonoscopy,

Exclusion Criteria:

* None, patient included
* Previous history of inflammatory bowel disease.
* Previous history of CRC
* Previous CR resection
* Polyposis or hereditary CRC syndrome
* Coagulopathy/Anticoagulants
* Unwillingness to participate
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke

The purpose of this clinical trial is to investigate the efficacy of a hybrid-based rehabilitation program for the upper extremity(UE) combining the interventions- Functional Electrical Stimulation (FES) and Robotic rehabilitation in individuals with chronic stroke. The main question it aims to answer is if the Hybrid multi-muscle FES+Robot upper extremity rehabilitation is more effective in improving the upper extremity motor impairments and function as compared to robotic upper extremity training alone.

Individuals with chronic stroke(\> 6months after stroke) will be recruited. All participants will complete clinical and kinematic assessments at 2 time points(baseline and after 6 weeks training). Each participant will receive 18 sessions of 60 minute upper extremity training over 6 weeks.

Study participants will be randomly assigned to receive either of the following upper extremity training- 1. Hybrid multi-muscle FES+Robot training group or 2.Robot only training group.

The following clinical assessments to measure the motor impairments and functional recovery will be performed: Fugl-Meyer Upper Extremity, Modified Ashworth Scale, and Wolf Motor Function Test.

Kinematic assessments will be conducted using the REACH robotic device and the Kinereach/trakStar system. The following kinematic parameters will be collected: Smoothness, Range of Motion, and Speed.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with chronic stroke(\>6months post stroke)
2. Age-22-85 years old
3. Ability to perform a Upper Extremity forward reach of about 3 inches

Exclusion Criteria:

1. Upper Extremity co-morbidities-pain, arthritis, and other neurological disorders
2. Unable to tolerate electrical stimulation
3. Have implants such as pacemaker, spinal cord or deep brain stimulator
4. Have an elbow contracture of greater than 150 degrees
5. Receiving Botox injections within 3 months
Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.

OBJECTIVES:

Primary

* Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite\^® Radiation Therapy System.

Secondary

* Determine the early and late complication rates and cosmetic outcome in these patients after treatment.

OUTLINE: Patients undergo lumpectomy. Patients with negative tumor margins\* (no ink on tumor) undergo placement of the MammoSite\^® Radiation Therapy System at the time of lumpectomy or within 4 weeks after surgery.

NOTE: \*If positive margins are present, the surgeon may elect to resect the positive margins and then insert a new MammoSite® device if all other eligibility criteria are met.

Beginning 2-5 days after placement of the MammoSite\^®, patients undergo brachytherapy through the MammoSite\^® twice daily for 5 days (a total of 10 fractions).

After completion of study treatment, patients are followed periodically for ≥ 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy
* Size: \< 3 cm on mammogram
* Unicentric disease
* Ability to place MammoSite device at time of lumpectomy or within 4 weeks of lumpectomy
* Patient Age: ≥ 18 years, no upper limit
* Life expectancy \> 5 years

Exclusion Criteria:

* Prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix
* Pregnant or breast feeding
* Multicentric disease
* Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis