cyrilzakka/clinical-trials huggingface dataset:
Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises

Objective:

A randomized clinical trial in order to evaluate the efficacy of structured eccentric exercises tutored by a physical therapist (PT) for patients with subacromial impingement.

Hypothesis:

H1 The exercises has a satisfactory effect and the need of an arthroscopic subacromial decompression can be reconsidered.

H0 No difference between the two exercises (experimental and active control) and the patients still need surgery

Further the study objective is to evaluate predictors for a positive or negative treatment response after three months of rehabilitation as well as after 12 months.

Method:

Patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are offered a three month rehabilitation program during the waiting time for surgery which is approximately 4-6 months. All patients must have tried conservative treatments for at least 6 months in primary care with unsatisfactory results. The patients will be randomized to either the structured eccentric exercises tutored by a physical therapist or control exercises with general movements for the neck and shoulders. All patients has an equal number of sessions with the PT to offer similar attention. After three months the following key-question has to be answered: due to your current experience of your shoulder problems do you still need this surgical intervention? A blinded orthopedic surgeon evaluates the following outcomes at baseline and after three and twelve months. Primary outcomes: Constant-Murley shoulder assessment, Disabilities of the Arm Shoulder and Hans and different aspects of pain. Secondary outcomes; EQ-5D, sick-leave and return to work. All patients are evaluated with a diagnostic ultrasound in order to reveal the condition of the rotator cuff. Also long-term results in those who go thorough with the surgery and those who decline will be assessed after 12 months.

Importance of the study results:

Since there is no consensus about which intervention that should be preferred for patients with subacromial impingement the results of the current study is warranted. If this exercise program is successful it can be implemented into clinical practice. Further, clinical characteristics of patients that really need an arthroscopic subacromial decompression can be identified.


Eligibility Criteria:
Inclusion Criteria:

* Subacromial impingement verified with Neer impingement injection test
* At least 6 months duration
* Treated in primary care without satisfactory result for at least 6 months

Three of these five must be positive:

* Neer impingement sign
* Hawkins-Kennedy impingement sign
* Jobe supraspinatus test
* Patte maneuver
* Typical history and pain location (C5 dermatome)

Exclusion Criteria:

* Radiological finding of malignancy, osteoarthritis, fractures
* Polyarthritis or fibromyalgia
* Pathological hyper-laxity or dislocation of the any of the shoulder joints
* Cervical spine pathology
* Lack of communication skills that prevent the use of outcome measures
Evaluation of Heparin Rebound in Cardiac Surgery

Recent work has shown that heparin rebound is common after cardiac surgery.

The exact doze of protamine required to neutralize heparin at the end of CPB is unknown. Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also unknown if precise titration of protamine perioperatively in cardiac surgery can influence transfusion requirements after cardiac surgery.

This study will assess how much protamine is required to neutralize residual heparin perioperatively in cardiac surgery through measurement of functional assays of heparin (anti-Xa and anti-IIa levels). In the first phase of this study, protamine titration assays will be carried out on normal pooled plasma incubated with heparin in the laboratory.

Once the correct dose of protamine required to neutralize the heparin is established in the laboratory, the second phase will begin. Herein, plasma samples from patients undergoing cardiac surgery (with anticoagulation with two different commercial preparations of heparin) will be evaluated for residual heparin (Anti-Xa and anti-IIa levels). Protamine titration assays wil then be carried out in vitro to assess neutralization of heparin.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Written consent
* Scheduled for cardiac surgery under CPB (cardiopulmonary bypass)--(elective or emergency)
* 10 patients undergoing cardiac surgery where CPB time is anticipated to be short (isolated primary CABG (coronary artery bypass graft);isolated mitral-valve repair or aortic-valve replacement)
* 10 patients undergoing cardiac surgery where CPB time is anticipated to be longer (CABG + valve surgery combined; reoperations)

Exclusion Criteria:

* Known coagulopathies
* Liver dysfunction
* Patients receiving unfractionated or low molecular weight heparin thrombin inhibitors, warfarin, antiplatelets within the past 7 days
* Patients expected to undergo hypothermic CPB or circulatory arrest
Nano Fat Injection With or Without Fractional Carbon Dioxide Laser in Acne Scars

Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars

Acne scars is a world wide problem .though lots of treatment exists still mo gold standard for treatment of acne scars in this study.

Assessment of nano fat grafting combined with carbon dioxide laser resurfacing versus nano fat grafting alone in treating facial atrophic acne scars

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years who attend the Outpatient Clinics of Dermatology and Plastic Surgery Departments, Assiut University Hospital, with moderate to severe atrophic facial acne scars on both cheeks, as assessed using the Goodman and Baron Qualitative scar grading system (12), will be enrolled in the study.

Exclusion Criteria:

* include: pregnancy or lactation; active acne, history of deep chemical peeling or filler injection in the previous 6 months, history of keloid or hypertrophic scar formation; use of isotretinoin in the previous 6 months; active infection in the treatment area; bleeding tendencies; history of herpes simplex or herpes zoster infection on the face; and patients with unrealistic expectations.
Novel Exhaled Breath Aerosol Collection Devices in Patients with Lower Respiratory Tract Infection - a Performance and Acceptability Study

This study will assess the performance of two novel breath collection devices and their subsequent detection of respiratory pathogens compared to sputum samples in patients with lower respiratory tract infections.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the scope of the study and provide written informed consent
* Age \>18 years
* Speaking German
* Health status (assessed by study personnel at local site) well enough to use the breath collection devices
* Willing to provide all three study samples (sputum and two breath samples) required for the study
* Clinical diagnosis of a lower respiratory tract infection (LRTI) defined as:

  (i) New infiltrate (chest X-ray, ultrasound, or CT scan), and (ii) at least one clinical symptom suggestive of LRTI (fever ≥38°C, chills, new or worsening cough, new or worsening sputum production, new or worsening dyspnea, tachypnoea, chest pain)

Exclusion Criteria:

* Patients for whom the collection of all three study specimens within 24 hours of initiating antibiotic treatment is not feasible
* Patients with known cystic fibrosis or bronchiectasis
* Critically ill patients at the discretion of the investigator
* Patients on oxygen supplementation with a face mask, high-flow-oxygen, non-invasive or mechanical ventilation; oxygen supplementation via nasal cannula will be permitted.
* Patients with proven acute pulmonary embolism
* Patients with best supportive care
* Patients with severe hypoxemia (SpO2 \<88%) despite oxygen supplementation
* Hospitalization within the last 14 days prior to admission
Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as docetaxel, epirubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy when given together with docetaxel followed by standard therapy in treating women with breast cancer.

OBJECTIVES:

Primary

* Evaluate the tolerance to concurrent neoadjuvant docetaxel and cyberknife hypofractionated radiotherapy followed by standard treatment in women with breast cancer in order to find the maximum-tolerated dose of radiotherapy.

Secondary

* Evaluate the efficacy of the combination chemoradiotherapy.
* Evaluate breast-conserving surgery.
* Evaluate the quality of life.

OUTLINE: This is a dose-escalation study of cyberknife hypofractionated radiotherapy.

Patients receive neoadjuvant docetaxel IV on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Beginning during the first or second course of neoadjuvant chemotherapy, patients undergo hypofractionated radiotherapy. Patients then receive standard chemotherapy comprising epirubicin hydrochloride IV, cyclophosphamide IV, and fluorouracil IV on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo surgery 4-8 weeks after the last course of chemotherapy, and then undergo standard radiotherapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of breast cancer

  * Unifocal disease
  * Non-metastatic disease
  * Not a candidate for breast-conserving surgery
* No superficial breast cancer (defined as the distance between tumor and skin ≤ 1 cm)
* Undergone MRI of the breast to define the macroscopic tumor volume
* Undergone scanning of the breast to mark the location for radiotherapy

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No counter-indications to surgery, standard neoadjuvant chemotherapy, or insertion of an implantable venous device
* No patient for whom clinical follow up is impossible for psychological, familial, social, or geographical reasons
* No patients deprived of liberty or under trusteeship

PRIOR CONCURRENT THERAPY:

* No prior ipsilateral breast irradiation
Screening for Liver Fibrosis by Using Non-invasive Methods in Patients With Diabetes. A Prospective Study

The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients with diabetes.

Patients with diabetes are at risk for nonalcoholic fatty liver disease (NAFLD) leading to advanced fibrosis, cirrhosis, and liver cancer. However, liver fibrosis screening in this large population needs non-invasive methods. Recently, FibroScan was shown to be a good method for the diagnosis of advanced fibrosis in NAFLD patients. We examined the efficacy of a screening strategy with a noninvasive fibrosis biomarker (FibroTest) and transient elastography (FibroScan) in patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects
* More than 18 years of age
* Patients with Diabetes
* Written informed consent

Exclusion Criteria:

* Patients refusing to participate to the study and to provide written informed consent
Metal or Plastic Stents to Relieve Obstruction of Obstructive Jaundice Prior to Resection of Periampullary Tumors.

Patients with obstructive jaundice due to periampullary tumor can temporarily be relieved of their jaundice with transpapillary stenting at endoscopic retrograde cholangio-pancreatography (ERCP) prior to operation. Usually plastic stents are used.

Hypothesis: Self expanding metallic stents offer a be a better alternative for preoperative stenting in patients with obstructive jaundice due to periampullary tumour obstruction.

Patients who present with obstructive jaundice and have a periampullary tumor and where the patient seems to be in good condition for surgical resection are offered the opportunity to become randomized to either endoscopic drainage with self expanding metallic or plastic stents. Before randomization they are informed about the study details and have to give their consent to participate. The metallic as well as plastic stents are standard commercially available stents. Within four weeks after stent placement the patient will be operated and the following parameters will be evaluated: quality of life, clinical symptoms and lab tests. At the operation the surgeon will make an evaluation of the inflammatory reaction in the area of the bile ducts. A culture from the bile is sampled close to the area where the anastomosis will be sutured. A tissue sample is also taken from the bile ducts to evaluate inflammation. A Lymph node is also sampled for the same reason. The surgeon also evaluates the difficulty with which the stent had to be removed. Postoperative complications are monitored in line with the regular routines at the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive jaundice in periampullary tumor.

Exclusion Criteria:

* Not willing to participate.
* Not a resectable tumor.
Hemostasis During Hypospadias Surgery

A comparison between the two hemostatic methods of hypospadias repairing operation, in terms of early and mid-term (up to 6 months) failure rate (wound dehiscence and urethral stricture needing reoperation) between the two groups: Group A) diluted Epinephrine injection, Group B) tourniquet application in children


Eligibility Criteria:
Inclusion Criteria:

- age under 15 Hypospadiasis ( Distal, Midshaft, Proximal)

Exclusion Criteria:

- Bleeding tendency Penoscrotal Hypospadiasis Other method
Effects of Breathing Exercises With and Without Inspiratory Muscle Training in COPD Patients

Chronic Obstructive Pulmonary Disease (COPD) is a major health issue that affects a large proportion of the population, especially those over 50 years old. It is characterized by breathlessness and reduced lung function. It has been hypothesized that practicing specific breathing exercises could potentially alleviate these symptoms and enhance lung volumes and capacities. In addition, there is a lack of clarity on the effects of inspiratory muscle training along with these breathing exercises, warranting further investigation. To determine the effects of breathing exercises with and without inspiratory muscle training on dyspnea, lung volumes and lung capacities in COPD patients. A total of 46 patients, aged over 50, will be enrolled from National Hospital and medical center, Lahore and Ittefaq Hospital, Lahore. These patients will be randomly divided into two groups A and B: the first group will be assigned to perform only diaphragmatic and pursed lip breathing exercises daily for 2 months. In contrast, the second group will also receive breather, which will involve inhaling through a mouthpiece with variable resistance and using breath-holding techniques. The trial will follow strict ethical guidelines, with all participants providing informed consent. Outcomes will be measured through pulmonary function tests and the Modified Borg Dyspnea Scale. The study will also obtain the necessary approval from the respective ethical committees of the participating institutions. The data will be analyzed in SPSS 26.0.


Eligibility Criteria:
Inclusion Criteria:

* Be aged between 35 and 50 years (23).
* Be of any gender.
* Have a clinical diagnosis of COPD, severity ranging according to GOLD stages of COPD II to III stages (24).
* Have the functional ability to perform the prescribed breathing exercises and inspiratory muscle training (25).
* Demonstrate a willingness to participate in the study by providing informed consent

Exclusion Criteria:

* Diagnosed musculoskeletal disorders that could potentially interfere with the e execution of the exercises.
* Recent chest injuries that might complicate the respiratory function.
* Pregnancy, given the potential for altered respiratory mechanics and concerns for f fetal safety.
* Prior history of abdominal or pelvic surgeries, as these could affect diaphragmatic movement and overall respiratory function.
* A history of malignancy, due to the potential for compromised overall health status and related complications.
* Active or latent tuberculosis, to prevent exacerbating the condition and potentially spreading the infection.
Transcutaneous Spinal Cord Stimulation for Parkinson Disease

Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn.

Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn. In this pilot trial, the investigators recruit participants with Parkinson' disease and freezing of gait. The aim of the study is to explore the safety along the non-invasive magnetic thoracic spinal cord stimulation as well the effect on gait problems, especially freezing of gait, prospectively, in an open-label fashion.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of advanced idiopathic Parkinson's disease
* significant freezing of gait despite optimized treatment with medications and rehabilitation program

Exclusion Criteria:

* psychiatric symptoms
* dementia
* cardiac pacemaker
Paraneural Sheath & Fascial Compartments Surround Brachial Plexus at Supraclavicular Fossa During Selective Trunk Block

The aim of this retrospective study is to define the paraneural (fascial) sheath and fascial compartments that surround the brachial plexus at the supraclavicular fossa by reviewing previous ultrasound images from cases that have undergone ultrasound guided selective trunk brachial plexus block.

The optimal anatomical plane (relative to the nerve) or the "goal" for local anesthetic (LA) injection during an ultrasound guided (USG) brachial plexus blockade (BPB) at the supraclavicular fossa is currently not known. USG BPB is often described as a "subfascial", "extra fascial", "intracluster", "interfascial", sub-perineural", "intraneural", "corner pocket" or "periplexus" injection. Although this suggests that the local anesthetic is injected into different tissue planes or fascial compartments, even if such planes do exist, as seen in other regions such as popliteal sciatic nerve are not clearly defined at the supraclavicular fossa. However, recently with the use of high definition ultrasound imaging for USG Selective trunk block (SeTB) and principal investigator has often observed distinct paraneural (fascial) sheath and fascial compartments surrounding the brachial plexus at the supraclavicular fossa. These connective tissue layers are also better delineated after the local anesthetic injection. The principal investigator believes these may be the connective tissue layers that previous researchers have referred to in different reports. Currently there are no published data demonstrating the paraneural sheath and fascial compartment surrounding the brachial plexus in-vivo. Principal investigator believes that this fascial layer and compartment influence the spread of LA during USG BPB around the individual elements of the brachial plexus at the supraclavicular fossa and therefore, these anatomical structures have to be delineated so as to improve the safety, success and quality of USG BPB. This study will involve reviewing archived high definition ultrasound images in audio video interleave format from all adult patients who had undergone USG SeTB for surgical anesthesia during upper extremity surgery from January 1, 2020 to June 30, 2021 to define the paraneural sheath and fascial compartments that surround the brachial plexus at the supraclavicular fossa.

Eligibility Criteria:
Inclusion Criteria:

* Archived high definition ultrasound images (datasets) in audio video interleave (AVI) format from all adult patients who had undergone ultrasound guided selective trunk block for surgical anesthesia during upper extremity surgery since the year 2020 (from 01/01/2020 to 30/06/2021).

Exclusion Criteria:

* patients \> 75 years old
* American Society of Anesthesiologists (ASA) physical status \> Ⅲ
* previous history of surgery at ipsilateral neck.
Evaluation of Liposomal Curcumin in Healthy Volunteers

Aim of the present study is:

* To evaluate the safety and tolerability of increasing doses of intravenous liposomal Curcumin in healthy subjects by means of adverse events, vital signs and safety laboratory assessments.
* To investigate the pharmacokinetics of increasing doses of intravenous liposomal Curcumin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects.
* Age between 18-45 years.
* Body mass index between 18-27 kg/m2
* Vital signs within the normal range after 5 minutes in supine position (SBP: ≥90 mmHg and ≤140 mmHg, DBP: ≥45 mmHg and ≤90 mmHg, Heart rate: ≥45 bpm and ≤90 bpm).
* Normal ECG (PR-interval ≤ 210 ms, QRS duration ≤ 140 ms, QTc ≤ 450 ms).
* Adequate bone marrow function as evidenced by an absolute neutrophil count ≥1500 cells/µl, all normal red blood cell indices, hemoglobin greater than 11 g/dl and a platelet count greater than 150,000/µl.
* Normal renal function.
* Normal hepatic function as evidenced by serum total bilirubin ≤1.2 mg/dl, or less than or equal to the upper limit of normal, and alkaline phosphatase less than or equal to the upper limits of normal, and ASAT and ALAT less than or equal to the upper limits of normal.
* Normal coagulation profile, and activated partial thromboplastin time (aPTT).
* Normal urine analysis.
* Signed informed consent.

Exclusion Criteria:

* Intake of steroids within 2 weeks prior to the first dose of study drug.
* Concomitant medications (especially anticoagulants and aspirin) or herbal supplements.
* Active infection, or a fever \> 38.5°C within three days prior to the first scheduled day of study drug dosing.
* Current or past history evidence of disease (e.g. hemolytic diathesis, anemia requiring substitution therapy, hemochromatosis) that could be exacerbated by administration of liposomal curcumin.
* History of prior malignancy within the past five years except for curatively treated non-melanoma skin cancer or cervical intraepithelial neoplasia.
* Allergy requiring medical treatment within the last four weeks.
* Known hypersensitivity to any of the components of turmeric.
* Participation in another clinical trial within 4 weeks before study initiation.
* NYHA Class 2 or congestive heart failure, uncontrolled hypertension, or arrhythmias.
* Positive HIV serology or evidence of active hepatitis.
* Unstable medical condition or any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with the patient's ability to sign the informed consent form, or his ability to cooperate and participate in the study, or to interfere with the interpretation of the results.
* History of treated or active seizure disorder or any CNS or PNS neurological disorder.
* Subjects who are pregnant or breast feeding