cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair

Blood supply to the sigmoid colon during open abdominal aortic aneurysm (AAA) repair is at risk. Ischemia of the sigmoid colon after AAA repair is potentially devastative. No reliable measures to prevent it are available and the underlying mechanisms are poorly understood. The aim of this study is to describe intraoperative perfusion patterns of the sigmoid colon during open AAA repair and their potential impact on postoperative outcome.


Eligibility Criteria:
Inclusion Criteria:

* undergoing elective open AAA repair between 2013 and 2016 were eligible for this study

Exclusion Criteria:

* No informed consent
* emergency cases
Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma

This trial intends: 1.To evaluate the concentration of Chidamide in the serum and cerebral-spinal fluid of PTCL patients at certain time points after taking the medicine, to evaluate the pharmacokinetics of Chidamide in these patients and its CNS (central nervous system) distribution.

2. To evaluate the efficiency and safety of Chidamide in PTCL patients.


Eligibility Criteria:
Inclusion Criteria:

1. PTCL patients confirmed by histopathology examination.
2. Did not accept radiotherapy, chemotherapy, targeted-therapy or hematopoietic stem cell transplantation within 4 weeks prior to inclusion;
3. Age 18-75 years old, male or female;
4. ECOG: 0-1 point;
5. Body weight: male 67±20 kilograms (47-87 kg), female 55±20 kilograms (35-75 kg);
6. Blood-routine test should satisfy (except lymphoma-related abnormalities): Hb≥90g/L，ANC≥1.5×109/L，PLT≥90×109/L；
7. Estimated survival ≥ 3 months;
8. Willing to sign the written consent before the trial.

Exclusion Criteria:

1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
2. QTc elongation with clinical significance (˃ 480ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment.
3. Cardiac B ultrasound show end-diastolic pericardial dark zone≥ 10mm
4. Patients who have received organ transplantation.
5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
6. Patients with active hemorrhage.
7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
8. Patients with active infection, or with continuous fever within 14 days prior to enrollment.
9. Had major organ surgery within 6 weeks prior to enrollment.
10. Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
11. Patients with mental disorders or those do not have the ability to consent;
12. Patients with drug abuse, long term alcoholism that may impact the results of the trial.
Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships

The goal of this study is to learn if Media Aware Parent - Tween, an online program for parents of children ages 9-12, helps parents have effective conversations with their child about health and media.

Parent-child pairs (N=300 pairs) will be recruited to participate in a randomized controlled trial. Parent consent and parent permission and youth assent will be sought. Participant pairs will be randomized into one of two study arms: intervention and active control. All participants will complete a web-based pre-test questionnaire. Youth and parents will then receive access to their randomly assigned resource. Approximately four weeks after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* The adult must be the legal guardian of a child ages 9 to 12 years old.
* The parent must be able and willing to receive email and text communication as part of the study.
* The parent-child pair must have access to a smartphone with internet connection as the resource review will be completed online in a format that is best viewed on a smartphone.
* The parent-child pair must be fluent in English as the study materials are written in English.
* The parent must indicate that they will give the child participant privacy to complete the questionnaires.
* Both the adult and child must agree to participate.

Exclusion Criteria:

* Only one parent-child pair per family may participate in the study. If the parent has more than one child aged 9 to 12 that is willing to participate, the parent will be prompted to select the child participant based on the following: if the parent's last name begins with a letter from A to M, select the youngest eligible child willing to participate or if the parent's last name begins with a letter from N to Z, select the oldest eligible child willing to participate.
* In an effort to ensure diversity in parent gender and race/ethnicity, not all eligible pairs who are interested in participating will be enrolled in the study.
The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO

This is a retrospective, observational study and will investigate the clinical predictive value of and change in muscle quantity and quality in critically ill patients with severe respiratory failure requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO).

The use of veno-venous extra-corporeal membrane oxygenation (VV-ECMO) for severe respiratory failure - mainly hypoxaemia - has increased over recent years. Similar to the general population in the Intensive Care Unit (ICU), these patients become deconditioned, severely weak (ICU acquired weakness- ICUAW) and require prolonged rehabilitation after disconnection from VV-ECMO. However, data regarding the magnitude of muscle wasting and recovery in this specific group is lacking.

Both poor muscle quantity and quality have been found to be a predictor or poor outcome. As all patients receiving VV-ECMO at our hospital will get an initial CT scan of their chest, abdomen and pelvis, these CT scans will be used to measure muscle quantity and quality of different muscle groups of the abdomen at admission and then using any follow-up CT scan performed within 10 days. In addition, the relationship between the loss of muscle over the course of VV-ECMO and perceived recovery of renal function at ICU discharge will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients with Severe Respiratory Failure who required VV-ECMO and had one or more CT scans of their abdomen

Exclusion Criteria:

* Critically ill patients with Severe Respiratory Failure who required VV-ECMO and did not have one or more CT scans of their abdomen
* Critically ill patients with Severe Respiratory Failure who required VV-ECMO who have a poor quality CT scan not analysable by the software
Dance Therapy and Obesity

Title:

The effect of dance-therapy on the functional capacity, body image and quality of life of patients with advanced obesity

Project duration:

33 months (August 2010 to June 2013)

Clinical context:

Obesity has reached epidemic proportions. The gait and balance problems in obese people and the associated decreased functional capacity and risk of falling highlight the need to evaluate the benefits of specific treatments on these problems. Attention should be paid not only to metabolic management but also to the physical rehabilitation required in cases of advanced obesity.

Objectives:

The aim of this study is to evaluate the efficacy of dance-therapy on functional capacity (walking ability, postural control and physical activity level), body image and quality of life of patients with advanced obesity.


Eligibility Criteria:
Inclusion Criteria:

* Person with obesity (BMI ≥ 30)
* Aged \> 18 years old
* Being able to walk 10 meters without a walking aid

Exclusion Criteria:

* Foot ulcer at the moment of data acquisition
* Orthopaedic, surgical or neurological (other than diabetic neuropathy ) problems which af-fect patient's gait
* Non diabetic neuropathy (Charcot, chronic alcohol consumption, thyroid dysfunction)
* Mental diseases interfering with group therapies
Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy

To examine whether EBUS with transbronchial needle aspiration (TBNA) can accurately and safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy

There is no single method to investigate mediastinal LN invasion. Hence, a patient may have to undergo several tests and procedures. Noninvasive and invasive approaches are employed. Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA) and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are gaining importance in mediastinal staging. Endobronchial Ultrasound (EBUS) is a procedure that is performed via flexible bronchoscopy under moderate sedation for visualization of lymph nodes in the chest and biopsy under real-time guidance usually for the staging of lung cancer or evaluation of enlarged lymph nodes. In addition, lung lesions or masses can be visualized and biopsied in the same sitting. The use of EBUS has enhanced the safety and diagnostic yield of flexible bronchoscopy. It provides ultrasonographic images and permits needle aspiration under direct vision for cytology specimen analysis. As more evidence is being accumulated on these staging approaches, the number of cervical mediastinoscopies, considered as the gold-standard for mediastinal staging, is diminishing.

Eligibility Criteria:
Inclusion Criteria:

* adults (18 Years and older) with mediastinal lymphadenopathy.

Exclusion Criteria:

* known or suspected malignancy
* no informed consent
* pts with anterior mediastinal lesions
* contraindications to EBUS
A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.

This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants will subsequently receive a single IV dose of RO6836191 for further analysis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, aged 18 to 45 years old.
* No active or chronic disease following a detailed medical and surgical history and complete physical examination.
* A BMI between 18 to 30 kg/m2 inclusive.
* Use of a highly effective form of birth control for the duration of the study and until 90 days after the last dose.

Exclusion Criteria:

* Any clinically relevant current or history of conditions or illnesses.
* Clinically significant symptoms of infection within 5 days of the first dosing day or a history of recurrent infections.
* Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse.
* Smokers unable or unwilling to restrict to 5 cigarettes daily during the study and to not smoke during the stay at the clinic.
* Any cardiac abnormalities.
* Blood donation over 450 mL within three months prior to screening.
* Participation in an investigational drug or device study within 3 months prior to dosing.
* Corticosteroid use within 3 months prior to dosing.
Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on Cardiac Surgery Patients

Open-heart surgeries such as coronary artery bypass grafting and valve replacements have been used to improve patient outcomes related to cardiac symptoms, prolongation of life, and health-related quality of life. Recovery from cardiac surgery is not entirely determined by physical attributes and medical treatment, but social and psychological factors may also influence the process of postoperative short and long-term recovery. The objective of this study is to find out the Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on Physical Health and Quality of Life in Post-Cardiac Surgery Patients. This study will be a Randomized controlled trial and will be conducted in Faisalabad institute of cardiology after ethical approval. The study will be completed within the duration of 10 months after approval of synopsis. Nonprobability convenience sampling technique will be used. The sample size of 46 patients will be taken: 25 post-cardiac surgery patients in each group with a 10% attrition rate. There will be two groups in this study one will be given with the Buteyko breathing technique and other will be provided with corpse-pose technique. Treatment protocol for both techniques will be 4 weeks with 3 sets per day. A pre assessment at week 1 and a final assessment at week 4 will be made by using SF-36 questionnaire. Data will be analyzed on SPSS-25.


Eligibility Criteria:
Inclusion Criteria:

* Stable Post-Op Cardiac Surgery Patients (Post-3 months)
* Both genders.
* Age 40-70.

Exclusion Criteria:

* Patients on other medications. (Corticosteroids)
* Patients with underlying severe medical conditions
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation

The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.

Patients will received Imatinib at a dose of 400mg daily. The tolerability of Imatinib given at a daily dose of 400mg will be assessed. The hematologic, cytogenetic and molecular responses will be evaluated at various check points.

Donor/recipient chimerism during Imatinib therapy will be assessed. Survival will be estimated.

Eligibility Criteria:
Inclusion Criteria:

* CML Ph+ (assessed by cytogenetic or FISH)
* Age ≥ 18 year at inclusion
* PS grade 0 to 2 (ECOG)
* previous allogeneic stem cell transplantation
* molecular, cytogenetic or haematological relapse in chronic phase after transplantation
* Immune therapy for graft versus host disease stopped within 2 months from inclusion
* Adequate and organ function, defined as the following: total bilirubin \<3x uln, sgpt \<3x uln, creatinine \<2x uln.
* informed consent sign up

Exclusion Criteria:

* Age less than 18 y
* accelerated or blastic phase
* previous therapy with imatinib
* active malignancy other than CML or non-melanoma cancer of the skin
* current treatment with another investigational agent
Effects of Mulligan Mobilization With and Without Dry Needling in Runner's Knee

The aim of this study is to determine the effects of Mulligan mobilization with and without dry needling on pain, range of motion, flexibility, functional disability and muscle strength in patients with Runner's Knee.

Runner's knee or patellofemoral pain syndrome (PFPS) is a common cause of anterior knee pain in young active individuals. Patellofemoral pain (PFP), or anterior knee pain (AKP), is a common musculoskeletal disorder. It involves dysfunction in mechanical forces between the patella and the femur. The worldwide PFP prevalence has been reported as 15-45% of population. Females are at two times higher risk of PFP than males, especially young active females. The aim of this study is to determine the effects of Mulligan mobilization with and without dry needling in Runner's Knee in a randomized clinical trial.

The study will be randomized clinical trial. The study will be conducted at Johar Pain Relief Center, Lahore. The study will be completed within eight months after synopsis approval from ethical committee of Riphah College of Rehabilitation and Allied Health sciences. Sample size will be 40 (20 in each group). Non-probability convenience sampling technique will be used to recruit the Runner's Knee patients in the study and then they will be divided into two groups by simple randomization through sealed opaque envelope. Mulligan mobilization with dry needling will be given to group A. Mulligan mobilization without dry needling will be given to group B. Outcome measures will be pain, knee range of motion, flexibility, functional disability and muscle strength measured through Numeric pain rating scale (NPRS), goniometer, Kujala Patellofemoral Scale and Modified Sphygmomanometer Test (MST) respectively. Data will be analyzed by SPSS version 25.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders.
* Individuals aged 20-45 years with a clinical diagnosis of Runner's Knee.
* Participants experiencing retropatellar or anterior knee pain during at least two activities such as ascending and descending stairs, squatting, kneeling, or prolonged sitting, jumping or running.
* Pain scoring rate on numeric pain rating scale (NPRS) ≥ 3 during at least two activities.
* Duration lasting longer than two months.

Exclusion Criteria:

* Patients with a history of meniscus tears, bursitis, patellar tendon injury, ligamentous injury, joint degeneration, patellofemoral dislocation and / or recurrent subluxation.
* Participants with a history of arthritis.
* Individuals with a history of lower extremity surgery.
* Patients having knee pain referred from hip, lumbar spine and ankle joints.
* Any systemic disease and/or connective tissue disorders, or lumbosacral nerve root compression.
* Patients taking any pain medications.
* Individuals who previously received acupuncture therapy, injection, or dry needling technique for knee extensor muscle in last six months.
Survey of COVID-19 Infection

Using online questionnaires, we will obtain data regarding COVID-19 infection and treatment, including incidence rate, hospitalization rate, severity of the infection, medications, mortality rate, etc, in both hospital and communities after the change of disease control policy in China.


Eligibility Criteria:
Inclusion Criteria:

* N/A

Exclusion Criteria:

* N/A
A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds

This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups.


Eligibility Criteria:
Inclusion Criteria:

* 18\~59 years old at the time of screening.
* Should not have received any meningococcal vaccine in the last 3 years.
* Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
* Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
* Willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial.

Exclusion Criteria:

* Fever before vaccination, axillary temperature \>37.0°C.
* History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders.
* Volunteers with current meningitis or a history of meningitis.
* Blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner.
* Hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group A meningococcal podophyllotoxin, group C meningococcal podophyllotoxin, group Y meningococcal podophyllotoxin, group W135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
* Severe hypertension uncontrolled by medication (at on-site measurement: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
* Previous vaccination-related hospitalizations or emergencies.
* Bleeding constitution or condition associated with prolonged bleeding that investigators consider contraindicated for intramuscular injection.
* Other vaccinations within 14 days.
* Participation in other studies involving interventional studies within 28 days prior to study entry (\<28 days) and/or during study participation.
* Other circumstances that, in the judgment of the investigator, make participation in this clinical trial inappropriate.
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira

The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.

The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.

Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 18 years of age at time of screening
* Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
* Moderate to severe psoriasis as defined at baseline by:

  * PASI score of 12 or greater
  * Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,
  * Body Surface Area affected by plaque-type psoriasis of 10% or greater
* Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type
* Drug-induced psoriasis
* Ongoing use of prohibited psoriasis treatments
* Previous exposure to adalimumab
* Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab

Other In-/Exclusion criteria may apply