cyrilzakka/clinical-trials huggingface dataset:
Effects of Sterile Kinesio Tape on Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament reconstruction (ACLR) is a surgical tissue graft replacement of the anterior cruciate ligament, located in the knee, to restore its function after an injury. ACLR is used as the gold standard in coping with pain, deformity, and instability for the patients. The most important factors affecting the success of both surgery and postoperative rehabilitation programs are edema, joint movement limitation and pain around the knee in the early postoperative period. If these parameters are managed well in the postoperative period, the quality of life of the patient increases much earlier. In this respect, kinesio taping treatment, which is practical, comfortable, and safe for the patient, is one of the complementary treatment modalities with positive clinical results. No researchers have studied the effects of Sterile Kinesio Tape applied during ACL reconstruction on edema, pain and range of motion in immediate care postoperatively. The purpose of our study İS to assess effects of Sterile Kinesio Tape application on postoperative edema, pain and range of motion after ACLR within 72 hours. Thirty-seven patients who have undergone ACLR will be recruited to our study. Patients will be randomized into 2 groups; Group 1: Sterile Kinesio tape application, Group 2: Control group. All patients will be assessed for pain intensity (with Visual Analog Scale-VAS), edema (with tape measurement) and range of motion (with goniometric measurement-knee flexion/extension). Assessments will be done every day for 3 days (a total of 3 measurements). Group 1 will receive Sterile Kinesio Taping application within 72 hours applied with Sterile Web Cut Kinesio Tape without tension additional to standard during ACLR postoperative care. Group 2 will receive only standard postoperative care.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent anterior cruciate ligament reconstruction

Exclusion Criteria:

* with soft tissue or bone problems affecting the hip or ankle
* who any neurologic problems,
* who had any systematic rheumatic problems,
* had scoliosis,
* who had undergone orthopedic surgery before,
* who were obese (BMI\> 30 kg/m2)
Minipooled-IVIG in Primary Immunodeficiency Disease

1. study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG)
2. Study the safety and efficacy of a newly developed preparation of MP-IVIG in children with primary immunodeficiency (PID) :

   * Adverse reaction of MP-IVIG(anaphylaxis and haemolysis)( no or mild or moderate)
   * Prevention of severe bacterial infection
   * Improvement of general health(weight gain and mentality)
   * Integration in to social live
3. Compare the efficacy of MP-IVIG to standard IVIG in children with primary immunodeficiency (PID).

Primary immunodeficiency diseases (PID) are a heterogeneous group of inherited disorders of the immune system, predisposing individuals to recurrent infections, allergy, autoimmunity, and malignancies. Clinical descriptions have already been made for more than 200 PIDs, for which over 150 forms of PID have been molecularly characterized .

A population prevalence of diagnosed PID in the United States at approximately 1 in 1,200 persons.

A part from local registration in some centres there is no national registry of PID in Egypt, and hence, the prevalence of these disorders in the investigator's population is still unknown .

An increasing number of PID are recognized, and effective treatments are possible. Early use of prophylactic antibiotics and replacement immunoglobulin can prevent significant end organ damage and improve long quality of life in these patients .

Immunoglobulin G (IgG) is an essential plasma derived medicine that is lacking in developing countries .IgG shortages leave immune deficient patients without treatment, exposing them to devastating recurrent infections from local pathogens. A simple and practical method for producing IgG from normal plasma collected in developing countries is needed to provide better, faster access to IgG for patients .

Magdy EL-Ekiaby, et al 2010 introduce the concept of small-scale ("minipool") plasma processing methods implementable with minimum infrastructural requirements. They developed viral inactivation and protein purification technologies in single-use equipment to prepare virally safe solvent/detergent-filtered (S/D-F) plasma Producing a 90%pure immunoglobulin fraction in disposable single-use devices for transfusion as well as minipool S/D-F cryoprecipitate to treat bleeding disorders.

Eligibility Criteria:
Inclusion Criteria:

* Age group: children patients under 18 years.
* The study will include patient diagnosed as primary immunodeficiency disease (PID) in Assiut university hospital on standard IVIG therapy.

Exclusion Criteria:

* Patient has SCID.
* Patient with history of severe IVIG side effect.
* Patient with severe immunodeficiency and has severe disseminated infection.
* Patient with renal impairment
* Patient with hepatic cell failure
* Patient with endocrinal abnormalities
* patient with secondary immunodeficiency diseases
Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC

This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old, regardless of gender;
* SCLC diagnosis based on histopathology according to the Primary Lung Cancer Diagnosis and Treatment Guidelines (2018 edition);
* TNM stage II-IV;
* ECOG PS score ≤2;
* Predicted survival time more than 3 months;
* Provision of signed informed consent.

Exclusion Criteria:

* Previous interventional therapies such as iodine seed implantation (within the past six months), ablation, BACE, or immunotherapy;
* Concurrent presence of other incurable malignant tumors;
* White blood cell count less than 3×10\^9/L, neutrophil absolute count less than 1.5×10\^9/L, neutrophil/lymphocyte ratio equal to or greater than 3, platelet count less than 50×10\^9/L, hemoglobin concentration less than 90 g/L;
* Hepatic and renal insufficiency (creatinine level exceeding 176.8μmol/L); Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels more than twice the upper limit of normal;
* Uncorrectable coagulopathy or concurrent active hemoptysis;
* Complicated with active infection requiring antibiotic treatment;
* Uncontrolled hypertension, diabetes, or cardiovascular disease;
* Allergy to contrast agents;
* Women who are pregnant or lactating.
Physiotherapist Led Triage in Primary Care for Patients With Hip or Knee OA

The overall aim with the study is to evaluate physiotherapist led triage in primary care compared to usual care (assessment by an orthopaedic surgeon in an orthopaedic department) for patients with hip or knee osteoarthritis referred for orthopaedic consultation.

The primary aim of the study is to evaluate if there is any difference in perceived quality of care using the item "I received the best possible examination and treatment (as far as I can tell)" between physiotherapist led (PT led) triage in primary care compared to usual care (assessment by an orthopaedic surgeon (OS) in an orthopaedic department) for patients with hip or knee osteoarthritis (OA) referred for orthopaedic consultation. Furthermore, to evaluate whether there is any difference in 2) perceived quality of care as a whole, 3) management outcome and hip/knee replacement surgery conversion rate, 4) patient reported outcome measures such as health related quality, pain and function in short and long term and 5) costs between the two care models.

Eligibility Criteria:
Patients with hip or knee OA assessed by a GP at any of the included health care centers in the study, and referred on for orthopaedic consultation to any of the included hospitals in the Västra Götaland.

Inclusion Criteria:

* primary OA in hip or knee
* understands and speak Swedish

Exclusion Criteria (if stated in the referral)

* Previously been assessed for the same condition by an orthopaedic surgeon
* Referred by an orthopaedic surgeon
* Secondary OA due to fractures or osteonecrosis of the femoral head
* Referral to a specific orthopaedic surgeon
Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition

Primary Objective:

1- Proportion of patients with mean daily glycemia \<140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale.

Secondary Objective:

1. Incidence of moderate hyperglycemia (\>140mg/dL) during the treatment period.
2. Incidence of hypoglycemia (\<60mg/dL and \< 40mg/dL) during the treatment period.
3. Incidence of severe hyperglycemia (\>400mg/dL) during the treatment period.
4. Total dose of insulin and correction dose in each group.


Eligibility Criteria:
Inclusion criteria:

* Men and women with type 2 diabetes that will need enteral nutrition with carbohydrate content.
* Glycemia \>140mg/dL and \< 400mg/dL at admission on the ward.
* Informed consent (patient or legally authorized representative)

Exclusion criteria:

* Hypersensibility to insulin glargine or glulisine, or any other component of the insulin formulation.
* Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months.
* History of diabetic ketoacidosis or hyperosmolar hyperglycaemic state or ketonuria.
* Subjects with conditions that are expected to need surgery or intensive care unit (ICU)admission based on discussions with the treatment team and attending physician.
* Pregnancy.
* Severe hepatic disease or active hepatitis.
* Cardiac failure class III or IV (Classification de la New York Heart Association:NYHA).
* Diagnosed advanced autonomic neuropathy.
* Diagnosed cancer.
* Active infection.
* Current therapy with steroids.
* Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Use of Real-time Continuous Glucose Monitoring System in Patients With Type 1 Diabetes Mellitus

The purpose of this study is to determine whether a real-time continuous glucose monitoring system is able to improve HbA1c in patients suffering from type 1 diabetes compared to conventional finger prick glucose measurements. In addition it will investigate whether number of episodes with serious hypoglycemia is changed in those same patients, and whether quality of life (health status and treatment satisfaction) increases.


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes Mellitus, Type 1 \> 3 years.
2. For practical reasons patients should live in Trondheim, Malvik, Melhus or Klæbu.
3. Level of HbA1c (measured by DCA 2000) between 7 and 10 % and/or experience blood glucose \< 3 mmol/L (verified by finger-prick measurement) at least once a week and/or at least one episode with serious hypoglycemia the previous half a year.(Defined as need of help from others)
4. Only patients who use insulin pumps or multi-injection regime (=3 daily injections with short term acting insulin or insulin analogue + at lest one daily injection with NPH-insulin or long term acting insulin analogue.

Exclusion Criteria:

1. Patients with other diseases such as untreated hypothyroidism, adrenal gland failure, celiac disease, renal failure, unstable coronary heart disease, serious psychiatric disorder, or mental retardation.
2. Patients who are not able to learn how to use the continuous glucose monitoring system given a reasonable amount of effort.
3. Patients who are not able to do the glucose measurements, insulin dose change and diary notes which the study demands.
4. Unsuited for participating from any other cause.
Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity Potential

To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina Delicata.


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin II and III;
* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestation;
* Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
* Diseases which can cause immunity decrease, such as HIV, diabetes;
* Use of drug photosensitizer;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease which can change the study results;
* History or photodermatosis active;
* Family or personal antecedent of cutaneous photoinduced neoplasias;
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
* Intense solar exposure in the study area;
* Use of new drugs or cosmetics during the study;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression

The purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app with esketamine therapy in participants with Treatment-resistant Depression.


Eligibility Criteria:
Inclusion Criteria:

* Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features, based upon clinical assessment confirmed by the Mini International Neuropsychiatric Interview (MINI)
* Participant must have had nonresponse to greater than or equal to (\>=) 2 different oral antidepressant treatments of adequate dose and duration in the current episode of depression
* Participant must be currently taking an oral antidepressant.
* Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided

Exclusion Criteria:

* Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT
* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the MINI), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
* Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary
* Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of nasal spray study drug
* Participant has known allergies, hypersensitivity, intolerance, or contraindications to esketamine/ketamine and/or its excipients
Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension

The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP ≥ 90 mmHg for drug-treated patient, sit DBP ≥ 95 mmHg for drug-naïve patient)
* Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)

Exclusion Criteria:

* mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
* mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg treatment
* has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
* Secondary hypertensive patient or suspected to be
* Uncontrolled diabetes mellitus patients
* Severe heart disease or severe neurovascular disease
* Known as severe or malignant retinopathy
* Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
* History of malignancy tumor
* History of autoimmune disease
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, has an intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with othe reason
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects

The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight must be ≥50 kg and \<130 kg with a BMI of ≥18 (kg/m2) and ≤36.0 (kg/m2).
* Must use acceptable forms of birth control during the course of the study and for 3 months following the single dose of study drug.
* Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in.
* Must have adequate vital sign reads at screening and check-in.
* Must be able to comply with dietary and fluid restrictions required for the study
Male Fertility Program

Following spinal cord injury, most men are infertile and require medical assistance to father children. The conditions that contribute to their infertility are erectile dysfunction, ejaculatory dysfunction, and semen abnormalities. The Miami Project Male Fertility Program is a research study designed to understand and improve impairments to male fertility resulting from spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Any man with spinal cord injury over the age of 18. Control Subjects will be any healthy man over the age of 18 with no recent history of infertility

Exclusion Criteria:

* Women will be excluded.
Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained.

Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years, or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas.

An additional adaptive trial for COVID-19 is also being conducted on these randomized double blinded type 1 diabetic subjects receiving BCG or placebo injections.

An expanded study arm has been approved for repeat dosing of BCG in adult Type I diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes treated continuously with insulin from time of diagnosis
* Age 18-65
* HIV antibody negative
* Normal CBC
* HCG negative (females)
* Anti-GAD Positive (except for subjects with c-peptide \<10pmol/L)
* Fasting or stimulated c-peptide between 5-200 pmol/L
* Participation in protocol #2001P001379, "Autoimmunity: In Vitro Pathogenesis and Early Detection"

Exclusion Criteria:

* History of chronic infectious disease such as HIV or hepatitis
* History of tuberculosis, TB risk factors, positive interferon-gamma release assay (IGRA, also known as the T-SPOT.TB test), or BCG vaccination
* Current treatment with glucocorticoids (other than intermittent nasal or eye steroids), or disease or condition likely to require steroid therapy
* Other conditions or treatments associated with increased risk of infections such as patients with a previous history of severe burns, or treatment with immunosuppressive medications of any type (e.g. imuran, methotrexate, cyclosporine, etanercept, infliximab) for any reason
* Current treatment with aspirin \> 160 mg/day or chronic, daily NSAIDs
* Current treatment with antibiotics
* History of keloid formation
* Average HbA1c over the past 5 years (or since diagnosis if duration is less than 5 years) \<6.5 or \> 8.5%
* History or evidence of chronic kidney disease (serum creatinine \> 1.5mg/dL)
* History of proliferative diabetic retinopathy that has not been treated with laser therapy
* History of neuropathy, foot ulcers, amputations, or kidney disease
* Pregnant or not using acceptable birth control
* Living with someone who is immunosuppressed and/or at high risk for infectious diseases (for example HIV+ or taking immunosuppressive medications for any reason)
An Observational Study on the Identification of Prescription Patterns of STAFEN Cap

An observational study on the identification of prescription patterns of STAFEN Cap., changes in blood lipid concentration, and statin-related muscle symptoms in Korean patients with mixed dyslipidemia

This study aims to observe the effectiveness of STAFEN capsule such as changes in blood lipid concentration and safety including statin-related muscle symptoms, and prescription patterns under daily clinical treatment in patients who have been prescribed STAFEN capsules for the treatment of complex dyslipidemia.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 19 years of age
2. A patient diagnosed with mixed dyslipidemia
3. A patient who was first prescribed a STAFEN cap. for the purpose of treating mixed dyslipidemia according to the clinician's judgment
4. A patient who voluntarily agreed in writing to this study

Exclusion Criteria:

1. Pregnant women, lactating women, or those planning to conceive
2. A person who is prohibited from administering the STAFEN cap. under the permit
3. If the person in charge of other clinical studies and the person in charge deems it inappropriate to be the subject of this clinical study