cyrilzakka/clinical-trials huggingface dataset:
The Dubousset Functional Test in Lumbar Spinal Stenosis

The aim of this study is to investigate the validity and reliability of Dubousset Functional Test in the patients with lumbar spinal stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years, diagnosed with chronic pain (more than three months) due to lumbar spinal stenosis.

Exclusion Criteria:

* Those with fractures, pregnancy, a disease that would prevent physical exertion, those with a body mass index (BMI) of 40 kg/m2 and above, and those with major musculoskeletal or neurological disorders that cause gait disturbance will be excluded from the study.
Scoring Systems covid19

In this study, we planned to investigate the role and determine the predictive performance of both APACHE II and SAPS II scoring systems and compare them in COVID-19 patients admitted to the intensive care unit of Assiut University Hospital.

Since the start of the coronavirus disease 2019 (COVID-19) pandemic, intensive care units (ICUs) worldwide have struggled to treat affected patients who require a completely different approach to treatment than other patients

* \[1\]\* .This study aims to evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anaesthesia alone.Although many severe cases are admitted to ICUs, it is unknown whether the conventional disease-severity scoring systems that were developed for ICU patients can be applied to patients with COVID-19.Several recent studies have used Acute Physiology and Chronic Health Evaluation (APACHE) and Simplified Acute Physiology Score (SAPS) to provide information on the clinical severity of COVID-19
* \[2-4\]\*. However, very few reports have examined their validity of applying them to patients with COVID-19.

Eligibility Criteria:
Inclusion Criteria:•

* • This study will be conducted on laboratory-confirmed COVID-19 patients who will be transferred to the intensive care unit of Assiut University Hospital

Exclusion Criteria:

* Patients would be excluded from this study if they died or were discharged from the intensive care unit prior collection of data required for both the APACHE II and SAPS II scoring systems, if they were discharged before their outcomes were determined and if we could not obtain consent from them or their companions to participate in this study. All patients involved will be subjected to a full history with special stress on age, gender, special habits, and associated diseases. Information such as the patient's need for ventilatory support as well as the length of ICU stay will be entered. Also, the laboratory results and Imaging findings will be registered. Scores of APACHE II and SAPS II were calculated as illustrated in the previously published works \*\[5,6\]\* .Patients will be followed up until their outcome was determined.
Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.


Eligibility Criteria:
Inclusion Criteria:

* Gender: 50% Male and 50% female
* Age: 40-80 years
* Race: Caucasian
* Overweight or obese: respectively BMI25-30 kg/m2 or BMI \> 30 kg m2
* Hypertensive: PA \> 140/90 mmHg
* Normocholesterolemic (LDL\< 160 mg/dl HDL \> 35 mg/dl)
* Liver steatosis

Exclusion Criteria:

* other antihypertensive treatment after wash out period of 2 weeks
* abnormal heart rest function (EF \< 55%).
* valvular heart disease
* congenital heart disease
* heart failure or prior myocardial infarction
* diabetes
* renal disease
* liver disease
* connective tissue disease
* pregnancy or lactation
* serious adverse experience
* sensitivity to the study drugs or its components
* contraindication from an approved label
The Molecular Imaging Research of F-18 Labeled DX600 PET Probe

Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the key target for COVID-19 infection.

DX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression under therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>3 years old; both sex;
* ECoG 0 or 1;
* Patients that would undergo biopsy or surgical operation with high ACE2 expression tumors such as colorectal cancer, renal cancer, pancreatic cancer, gastric cancer, liver cancer, lung cancer, brain cancer or suspected tumor.
* use 18F-FDG PET/CT as baseline evaluation

Exclusion Criteria:

* Significant hepatic or renal dysfunction;
* Is Pregnant or ready to pregnant;
* Cannot lie on their back for half an hour;
* Suffering from claustrophobia or other mental diseases;
* Refusal to join the clinical study;
A Comparison of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease

The purpose of this research study is to assess the efficacy of custom-manufactured compression hosiery (also known as compression stockings) compared to similar off-the-rack (OTR) compression stockings.


Eligibility Criteria:
Inclusion Criteria:

* Ability to comprehend and sign an informed consent and complete study questionnaires
* Patient is participating in usual work and home activities with no changes anticipated for the duration of the study
* The use of compression stocking is prescribed in accordance with the usual practice and management of venous disorders
* The patient will confirm they are willing to pay for the compression stockings.

Exclusion Criteria:

* The patient has a known allergy to any component of the stocking (latex, etc)
* The patient has non-venous source of pain in either leg that could, in the opinion of the investigator, confound the results of the study i.e.Neuropathy, Arterial insufficiency, Diabetes
* The patient is confined to bed
* The patient has uncontrolled Congestive Heart Failure
* The patient has acute dermatitis
* The patient has weeping dermatosis
* Patients with venous ulcers will be excluded.
Treatment of Bacterial Vaginosis (BV) With Tinidazole

We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Although not currently licensed in the U.S., tinidazole is an antimicrobial related to metronidazole which has shown promise for the treatment of BV in European studies and is widely used worldwide for the treatment of trichomoniasis including infections which are resistant to metronidazole. We hypothesize that qualities of tinidazole such as its longer half-life and its seemingly superior side effect profile as compared to oral metronidazole will result in its being a more efficacious drug for the treatment of BV than the currently available options.

The specific aims of this project are:

1. To compare the efficacy of two different doses of tinidazole with oral metronidazole for the initial treatment of symptomatic BV as well as short-term recurrence rates
2. To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV
3. To compare drug levels of tinidazole and metronidazole in the vaginal secretions and correlate with microbiologic cure of BV as well as rates of recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Women be at least 18 years of age
* Have symptoms of vaginal odor and or/discharge
* Meet the clinical (Amsel) criteria for BV
* Willing to participate in research

Exclusion Criteria:

* Presence of another vaginal infection or STD
* Allergy to metronidazole
* Pregnant or nursing
* Use of oral or intravaginal antibiotics within the past 2 weeks
* HIV or other chronic disease
* Inability to keep return appointments
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP \> 1,5N) and aminotransferase (AST or ALT \> 1N) activities; c.Histological hepatic injuries consistent with PBC.
3. Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response.

Exclusion Criteria:

1. Pregnancy or desire of pregnancy.
2. Breast-feeding.
3. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis.
4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
5. History of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn).
6. Hepatotoxic drugs use before recruiting.
7. Fenofibrate anaphylaxis.
Expanded Access to ANG1005 for Individual Patients

This is an expanded access study with ANG1005 treatment for two individual patients from Protocol ANG1005-CLN-03 with WHO Grade III Anaplastic Astrocytoma and WHO Grade III Anaplastic Oligodendroglioma and one individual patient from Protocol ANG1005-CLN-04 with Recurrent Brain Metastases and Leptomeningeal Carcinomatosis.


Eligibility Criteria:
Inclusion Criteria:

1. Neurologically stable
2. Karnofsky performance status (KPS) ≥ 80
3. Adequate laboratory results

Exclusion Criteria:

1. Radiotherapy within 3 months.
2. Evidence of significant intracranial hemorrhage
3. NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy
4. Inadequate bone marrow reserve
5. Any evidence of severe or uncontrolled disease
Comparison of Cosmetic and Functional Outcome of Silicone Sheeting and Micro-needling on Hypertrophic Scars

Hypertrophic scars and keloids are frequently encountered in plastic surgery OPD. due to any reason, the normal wound healing is impaired, hypertrophic scars or keloids occur. These are thickened, wide and raised scars. Many treatment options are presented over time, but most of the treatments remain insufficient. Treatment options include massage therapy, silicone sheet, occlusive dressings, pressure garments, adhesive tape, intra-lesional steroid injections, laser therapy, cryotherapy, radiotherapy, 5-fluorouracil, interferons, bleomycin, imiquimod 5%cream, tranilast, botulin toxin and surgical excision. In this Study outcomes of treatment with silicone sheeting and microneedling will be compaired.

Hypertrophic scars and keloids are one of difficult conditions to treat. Prevention of abnormal scaring is more effective than treatment, so avoiding unnecessary wounds in patients is a solution but flawed one. Many treatment options are presented over time, but most of the treatments remain insufficient. Treatment options include massage therapy, silicone sheet, occlusive dressings, pressure garments, adhesive tape, intra-lesional steroid injections, laser therapy, cryotherapy, radiotherapy, 5-fluorouracil, interferons, bleomycin, imiquimod 5%cream, tranilast, botulin toxin and surgical excision. Silicone sheeting is considered first line therapy of hypertrophic scar. It works by maintaining hydration and occlusion at scar site. But silicone sheeting is expensive and need 12 to 24 hours of constant application daily for at least 2 months for desired results. Level 1, 2 and 3 evidences show newer technique 'percutaneous collagen induction(micro-needling)', shows significant improvement in hypertrophic scars. Micro-needling causes controlled dermal injury to initiate inflammatory and healing reaction, which in turn leads to remodelling of collagen and stimulate regeneration of scared skin. Silicone sheets is an expensive treatment requiring multiple applications and are often difficult to use in hot and humid environment. These reasons often lead to poor patient compliance. Keeping these issues in mind we planned to study an alternative option i.e. micro-needling, which is relatively of low cost and better patient acceptability. When doing the literature review the investigator found scanty evidence so the investigator decided to perform this RCT.

Eligibility Criteria:
1. All the patients presenting with hypertrophic scars ≥1cm in size
2. Any age
3. Both genders

Exclusion criteria:

1. Pregnant or lactating mothers
2. Patients who already taking systemic steroid as confirmed through clinical record
3. Patients with renal failure or liver failure as confirmed through clinical history
4. Patient with uncontrolled diabetes.
5. Patients who received treatment for keloids or hypertrophic scar in past.
6. Patients with active inflammation in area of hypertrophic scar or in its vicinity.
The Reliability of a Wearable Inertial System in Healthy Adults.

Gait analysis is an effective tool used for a variety of purposes, including assessing neurological diseases, risk of falling, orthopedic disability and progress during rehabilitation.The analysis of gait and jump performance must be applicable in a clinical setting. Thus; it needs to be easy to apply in a variety of life situations.The measurements should be reproducible, stable, accurate, capable of distinguishing between normal and abnormal conditions, and cost-effective. Jump measures can predict injury risks, serve as talent identification, and replicate explosive competitive activities of athletes. Furthermore, the performance in vertical jumping can be associated with neuromuscular fatigue.The purpose of this study was to confirm the test-retest reliability of the G-walk wearable sensor system for gait and jump parameters in healthy adults.

The G-Walk determines spatiotemporal parameters as well as pelvic rotations during gait and allows objective and precise analysis of movements with its wearable inertial sensor. It also enables 3D kinematic analysis of the pelvis, providing a functional analysis of disorders in gait caused by neuromuscular diseases The device is placed on an elastic belt and worn on the waist of the person being evaluated, with the center of the device at the fifth lumbar vertebrae. To ensure correct placement of the device, the L4-L5 intervertebral space was palpated via the posterior superior iliac spines.

After the accelerometer was placed, the participants were asked to walk calmly at normal speed, on a 10 m track, and to return to the starting position.

The values and gait characteristics of acceleration in the anteroposterior and mediolateral axes were transferred to the computer software program.

The tilt of the pelvis in the sagittal plane in the flexion-extension direction, the oblique displacement in the coronal plane, the angles of the rotation of movement in the transverse plane and the symmetry values of the right and left sides are obtained. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrical Following gait assessment, Countermovement jump, static squat jump and Countermovement jump with arms thrust was measured using the device.

Eligibility Criteria:
Inclusion Criteria:

* Accepting to participate in the study,
* Healthy adults,
* Being 18-35 years old,

Exclusion Criteria:

* having any musculoskeletal, neurological or other pathology potentially affecting their gait and jump performance,
* Refusing to participate in the study,
* Having limited cooperation which prevents participation in the study,
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.

This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 at the time of enrollment
* Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
* Eastern Cooperative Oncology Group performance status 0 or 1
* Adequate hematologic, renal, liver, cardiac and pulmonary organ function

Exclusion Criteria:

* Prior therapy with an anti-CD19 targeting agent
* Active or chronic graft versus host disease requiring therapy
* Prior allogeneic stem cell transplantation
* Central nervous system (CNS) lymphoma, prior CNS malignancy
* Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
* Primary immunodeficiency
* Current or expected need for systemic corticosteroid therapy
* Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted
* Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence
* Unwillingness to follow extended safety monitoring
Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.

All patients enrolled will be submitted to laparoscopic cholecystectomy. The primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, and placebo to reduce the rate of surgical site infection.

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic cholecystectomy;
* patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps.

Exclusion Criteria:

* acute cholecystitis;
* acute cholangitis;
* acute pancreatitis;
* pregnant or lactating women;
* antibiotic allergy;
* antibiotic therapy within 48 hours to 7 days prior to surgery;
* clinically active infection at the moment of surgery;
* evidence of common bile duct stones;
* contraindications for laparoscopic cholecystectomy;
* no other additional procedure;
* indication of obligatory antibiotic prophylaxis because the medical condition was different from biliary disease (immunosuppression, corticoid use, etc).
* patients unable to give informed consent.
A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents

To evaluate the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children under less restrictive conditions than randomized controlled trials. Participants included children(aged 7 to 18 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.

This multicenter real world study will be conducted in at least 100 hospitals: Beijing Tongren Hospital will be the initiator of the study, other hospitals such as the Capital Institute of Pediatrics will serve as sub-centers. The whole study will last for three years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, and two-year follow-up. Participants who used 650 nm low-level red-light would be recruited. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 7 to 18 years
2. The cycloplegic spherical equivalent error (SER) is +0.5D or less in both eyes
3. Astigmatism of 2.5 D or less (≤2.5D)
4. Willing to participate in the study and sign the informed consent form

Exclusion Criteria:

1. Including but not limited to the following eye diseases: strabismus, amblyopia, ocular tumors, glaucoma/macular disease and other fundus diseases (including heredity), keratitis, eye trauma, uveitis
2. Including but not limited to the following systemic diseases: epilepsy, tumor, heart disease, asthma, systemic immune diseases, infectious diseases
3. Mental diseases
4. Similar interventions have been used in the past year
5. Allergic to cycloplegic agents or to red light
6. The 650nm red light intervention was not suitable for the condition evaluated by the researchers
7. are currently using atropine or similar drugs, or have stopped using them for less than 1 month