cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of Platelet-rich Plasma Promoting Tendon-bone Healing in Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament (ACL) injury is a common knee injury, which seriously affects the living ability and sport level of the injured. ACL reconstruction is the main method to treat ACL injury. Due to the reconstructive ligament needs a tendon bone healing and ligament maturation, therefore, in the ACL anatomical study, reconstruction surgery and reconstruction materials under the condition of constant progress, how to improve the ACL reconstruction of tendon bone healing and shorten the time of the ligament mature, improve the clinical effect of ACL reconstruction, has become the focus in the ACL reconstruction.

Autologous platelet-rich plasma (PRP) is full of growth factors and bioactive factors, which has the function of promoting tissue healing, anti-inflammatory and analgesic effects. At the same time of anterior cruciate ligament reconstruction, using autologous PRP in the bone channel might promote tendon bone healing and ligament maturing after ACL reconstruction, promote the recovery of proprioception, prevent bone channel expanding, shorten the postoperative recovery time, speed up the patients recovery exercise ability, improve the clinical effect of ACL reconstruction.

In this study, patients with ACL injuries were randomly divided into two groups: one group underwent ACL anatomical reconstruction, and the other group underwent ACL anatomical reconstruction with PRP. Various clinical scores, KT-2000, Biodex and imaging tests were used to evaluate the differences in the clinical effects of the two surgical methods in terms of postoperative pain, joint swelling, knee function, joint stability, muscle strength recovery, bone channel expanding, ligament vasinization, and ligament maturation.


Eligibility Criteria:
Inclusion Criteria:

* History of knee injury
* History of knee instability
* Anterior drawer test (+), or / and Lachman test (+)
* The tear of anterior cruciate ligament was confirmed by MRI

Exclusion Criteria:

* The injury of other ligaments of knee joint, such as complex posterior cruciate ligament injury, lateral collateral ligament injury and medial collateral ligament injury above III degree
* Patients with meniscus removed
* Patients with moderate to severe articular cartilage injury
* Patients with complex nerves and blood vessels injury
* Patients with compound intra - and periarticular fractures of the knee
* Patients with intra or periarticular fractures of the knee
* Patients with contralateral knee instability
* Patients with severe cardiovascular and cerebrovascular diseases
Efficacy and Safety of Egito Association in the Treatment of Type II Diabetes Mellitus and Hypertension

The purpose of this study is to evaluate the efficacy and safety of Egito association in the treatment of type 2 diabetes mellitus and hypertension


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;
* Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;
* Participants presenting the diagnosis of hypertension, and who did not reach the therapeutic goals with previous therapies.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in a clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Known hypersensitivity to any of the formula compounds;
* Type 1 diabetes mellitus;
* Known or suspected secondary hypertension.
The Treatment Advocacy Program

The purpose of the study is to test the efficacy of TAP, a behavioral intervention, in improving sexual safety and treatment adherence among gay and bisexual men infected with HIV. It is hypothesized that those who are in the intervention group will report reductions in unprotected sex with HIV-negative and unknown-status partners; and will show stricter adherence to their treatment regimens, compared to the individuals in the standard-of-care, control group.


Eligibility Criteria:
Inclusion Criteria:

* HIV+ men who have sex with other men, age 18 or over, in HIV care at one of the collaborating clinics, any sexual contact within the previous six months.

Exclusion Criteria:

* self-reported low likelihood of remaining in treatment or in the study location for 12 months, inability to comprehend the consent quiz administered during the Consent and Enrollment Visit, or unwilling to provide required locator information
ENB Guided RFA for Early-stage Peripheral Lung Cancer

The objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (ENB) guided radiofrequency ablation (RFA) for the treatment of early-stage peripheral lung cancer.

The study is aimed to evaluate the efficacy and safety of ENB guided RFA for the treatment of patients with early-stage non-small cell lung cancer (NSCLC). The study is designed as a single-center prospective trial with one arm. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University, China. Patients diagnosed with early-stage NSCLC will be enrolled into the study. Fifty patients are expected to be enrolled totally.

Eligibility Criteria:
Inclusion Criteria:

1. Patients discovered with peripheral lung nodules that have demonstrated to be non-small cell lung cancer by pathology with the clinical stage of IA.
2. The tumors are solid or part-solid peripheral lung nodules and the length-diameter of the nodules are more than 10 mm and no more than 30 mm.
3. Patients are unsuitable for surgery assessed by multi-modality treatment and agree to the primary treatment of ablation.
4. Patients have good compliance and sign the informed consent.

Exclusion Criteria:

1. Patients cannot receive bronchoscopy for the severe cardiopulmonary dysfunction and other indications.
2. Patients have contraindications of general anesthesia.
3. Chest CT suggests that navigation bronchoscopy technology cannot guide treatment equipment to reach the peripheral lung lesion.
4. Chest CT or bronchoscopy shows that the bronchial lumen occlusion or deformation leading to the guided and treatment equipment cannot reach the peripheral lung lesion.
5. There are large blood vessels or important structures adjacent to peripheral lung lesion.
6. Researchers consider the patient do not fit for the study.
Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia

1. Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML.
2. Study correlation between CD56 and CD11b expression with haematological parameters in cases of adult AML.

1. CD11b expression level is a prognostic biomarker for AML patient. CD11b positivity could predict a poor prognosis for AML patients.
2. CD56 antigen expression, an inexpensive, easy to detect and reproduce index, is closely related to the prognosis of AML patients

Eligibility Criteria:
Inclusion Criteria:

Anew diagnosis cases of adult AML

Exclusion Criteria:

1. Pediatric AML .
2. follow up cases of adult AML
Critically-Ill Women Admitted to an Obstetric High Dependency Unit in a Resource-Limited Setting

Sierra Leone faces the highest maternal mortality ratio in the world. Despite this extreme burden, the potential roles of obstetric critical care and high dependency units (HDUs) in this and other resource-limited settings remain scarcely explored. This study investigated epidemiology, clinical outcomes and risk factors for mortality in critically-ill parturients admitted to an obstetric HDU in a high volume, urban resource-limited maternity hospital.

This is a retrospective observational study in women admitted to the HDU of Princess Christian Maternity Hospital (PCMH), Freetown, Sierra Leone, from 2nd October 2017 to 2nd October 2018. The study received ethical approval and waiver of informed consent from the Sierra Leone Ethics and Scientific Review Committee (18/12/18).

A set of predefined variables was assessed at hospital admission, HDU admission and at discharge from HDU. The primary data source was the HDU patient chart, with data crosschecked with the hospital patient charts and the HDU admission book for quality control purpose. Data of hospital deliveries, admissions and mortality were form the hospital register and the maternal mortality hospital database. Data were retrospectively collected by a study physician (CM) and included: patient demographics; admission date and source; main reason for admission in hospital; main reason for admission to the HDU (classified as: haemodynamic instability; sepsis; haemorrhage; acute renal failure; neurological impairment; respiratory distress; severe malaria; coagulopathy; other diagnoses). These are clinical diagnoses included in the hospital checklist to facilitate communication of referral to HDU and are thus based on the clinical assessment of the attending physician rather than on a strict research definitions.

Vital signs and treatments collected at admission included body temperature, heart rate, respiratory rate, neurological status according to the AVPU scale, systolic and diastolic blood pressure, transcutaneous saturation (SpO2). The ratio between SpO2 and fraction of inspired oxygen (SpO2/FiO2) was also measured. The obstetric modified early warning score (OEWS) was also calculated.

Specific treatments received at any point during HDU stay were extracted from the patient file and included: oxygen supplementation, use of vasopressors, blood transfusions, antibiotic therapy, activation of the magnesium protocol for eclamptic seizures prevention and hypotensive treatment protocol with hydralazine. Point of care laboratory parameters such as capillary lactates levels and haemoglobin were collected when available. Time from PCMH admission to HDU admission was calculated. Length of stay and patient outcomes (classified as death in HDU, discharge to ward, or transfer to other facility) were reported at discharge.

Eligibility Criteria:
Inclusion Criteria:

* All women admitted at HDU of the PCMH from the 2nd October 2017 to the 2nd October 2018.

Exclusion Criteria:

* none
Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting

A total intravenous anesthesia (TIVA) is a useful anesthetic technique that reduces the incidence of postoperative nausea and vomiting (PONV).

Investigator hypothesized the incidence of PONV can be further reduced when palonosetron is added to TIVA.


Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status 1 or 2
* Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion Criteria:

* Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
* Vomiting or retching in the 24 h preceding surgery
* Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
* Ongoing vomiting from gastrointestinal disease
RNA-Loaded Dendritic Cell Cancer Vaccine

The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Have a new diagnosis of metastatic renal cell carcinoma;
* Must be at least 18 years or older;
* Have a scheduled unilateral nephrectomy;
* ECOG of 0 or 1;
* Free of brain metastases by CT or MRI;
* Normal renal function in contralateral kidney;
* Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
* Clinically acceptable screening results.
* No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
* No active autoimmune disease
Effect of Clopidogrel on Allergen Challenge in Asthma

In asthma, breathing in an allergen, such as house dust mite induces inflammation in the airways. This process appears to involve an interaction between two different sorts of blood cells, platelets and white blood cells via a receptor called the P2Y12 receptor. The purpose of this study is to determine whether the drug clopidogrel which blocks the P2Y12 receptor on platelets, reduces inflammation following breathing in house dust mite in people with mild asthma.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of asthma
* Step one of treatment by GINA (2006) guidelines
* baseline FEV1 \>80% predicted

Exclusion Criteria:

* current smoker
* ex smoker who quit \<1 year prior to study and pack history \>10 pack years
* current use of aspirin or other anticoagulant medication
* Diagnosis or documented history of bronchopulmonary aspergillosis or uncontrolled infections
* Any clinically significant cardiopulmonary abnormalities not related to pre-existing asthma
* Past or present tuberculosis, systemic lupus erythematosis or multiple sclerosis
* Any clinically significant neurological, renal, endocrine, gastrointestinal, hepatic or haematological abnormalities uncontrolled with standard treatment
* History of psychiatric, medical or surgical disorders that may interfere with study
* Clinical history suggestive of respiratory infection in month preceding study
* Alcohol or recreational drug abuse
* Diagnosis of immunodeficiency requiring treatment
* Treatment with immunomodulators (inhaled corticosteroids in two months or oral corticosteroids in six months prior to study)
* Ongoing allergen desensitisation therapy
* Regular use of sedatives, hypnotics, tranquillisers
* Positive hepatitis viral antigens or antibodies
* Blood donation within 3 months of the study
* Live immunisation \<4 wks prior to study
* Inability to understand directions for study assessment
* Inability to be contacted in case of emergency
* Participation in another study at the same time or within a prior 3-month period
PRevention of End Stage Kidney Disease by Darbepoetin Alfa In Chronic Kidney Disease Patients With nondiabeTic Kidney Disease

The purpose of this study is to ask whether treating non-diabetic chronic kidney disease (CKD) patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and 13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL. The investigators also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to 11g/dL.

Anemia is common among patients with chronic kidney disease (CKD) and is associated with an increased risk of cardiovascular and renal events. Although erythropoiesis stimulating agent (ESA) has been used to correct anemia, use of ESA (hemoglobin level at approximately 13 g/dL) did not reduce cardiovascular or renal events in diabetic CKD patients. Subgroup analysis of a recent randomized study suggested that use of darbepoetin alfa targeting Hb between 11 and 13 g/dL may preserve renal function better than targeting Hb between 9 and 11g/dL in non-diabetic CKD patients.

Eligibility Criteria:
Inclusion Criteria:

1. CKD patients who have not received chronic dialysis
2. eGFR 8 and more and less than 20 mL/min/1.73m2 determined twice in last 12 weeks.
3. CKD patients with renal anemia at Hb less than 10g/dL within last 8 weeks
4. CKD patients with TSAT 20% and higher or serum ferritin 100ng/mL and higher.
5. CKD patients treated with standard care
6. CKD patients provided written informed consent.

Exclusion Criteria:

1. Diabetes (treated, or HbA1c 6.4% IFCC)
2. CKD patients treated with ESA other than epoetins and darbepoetin.
3. CKD patients treated with epoetin 24000 IU/4w or more.
4. CKD patients treated with darbepoetin 90μg/4w or more.
5. Uncontrolled hypertension (180/10mmHg and higher)
6. Heart failure (NYHA III and IV)
7. malignancy, hematological disorder
8. malnutrition
9. Active and continuous gastrointestinal tract bleeding
10. ANCA associated glomerulonephritis, acute infection, active SLE
11. CKD patients who will undergo dialysis or receive transplantation within 6 months
12. Myocardial infarction within last 6 months
13. Stroke or pulmonary embolism within last 12 months
14. Severe allergy
15. Pregnant women, women on lactation, or CKD patients who plant to get pregnant
16. Allergy against erythropoetin
17. Ineligible patients according to the investigator's judgment
The Influence of a Warmed Surgical Bandage System on Subcutaneous Tissue Oxygen Tension After Cardiac Surgery

Warmed Surgical Bandage may improve tissue oxygenation and thus on the long run reduce wound infections

Wound infections are common and serious complications of anesthesia and surgery. The morbidity associated with surgical infections is considerable and includes substantial prolongation of hospitalization.

The wound infection risk in patients undergoing cardiac surgery ranges from 0.8 to 17.7% including both superficial and deep sternal infections.

Major factors influencing the incidence of surgical wound infection other than site and complexity of surgery, underlying illness, timely administration of prophylactic antibiotics, intraoperative patient temperature, hypovolemia and tissue oxygen tension. The primary determinant of tissue oxygen availability is local perfusion. Thermoregulatory status is one of the major factors influencing tissue perfusion. Local warming induces pre- capillary vasodilation and improves tissue oxygenation. Local warming of surgical wounds may provide a simple and inexpensive way to reduce perioperative wound complications. Specifically, we will test the hypothesis that Warm- Up therapy increases postoperative tissue oxygen tension in patients undergoing cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age scheduled for elective cardiac surgery on normothermic cardio-pulmonary bypass will be invited to participate

Exclusion Criteria:

* Emergency surgery
* Pre - or postoperative on intraaortic balloon pump
* Preoperative mechanical ventilation
* Postoperative respiratory failure
* Postoperative extracorporal membrane oxygenation
* Left ventricular function \< 40%
* Fever (core temperature \> 38 °C) or current infection
* No anticipated or no definitive primary closure of surgical wound.
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.

The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients


Eligibility Criteria:
Inclusion Criteria:

* Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
* Patient is a primary liver transplant recipient
* Patient must receive first dose of XL or Prograf (or IV tacrolimus for subjects unable to tolerate oral study drug) within 48 hours of transplantation
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant

Exclusion Criteria:

* Patient has previously received or is receiving an organ transplant other than a liver
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Patient has received a liver transplant from a non-heart beating donor
* Patient has received an ABO incompatible donor liver
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria 21 and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully
* Patient has fulminant hepatic failure, unless hemodynamically stable
* Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
* Patient has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
* Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
* Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids
* Patient is pregnant or lactating
* Patient is unlikely to comply with the visits scheduled in the protocol, including the protocol biopsies
* Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator
Trial of Mannitol Cream for Pain Relief After a Long Run

Mannitol cream has been shown clinically to be effective for pain control. To determine if this effect is worth testing on a larger scale, 170 runners will receive a sample of 25% mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg following a 10 km or longer run, and for the following five days. Mannitol and control legs will be chosen at random for each runner. Pain scores before and after cream application will be acquired each day for each leg. Means and standard deviations found will be used to determine the size of a larger study.

The hypothesis for this study is that Mannitol cream will reduce post long run pain more than vehicle cream alone. In this parallel design, 170 runners who usually experience a pain level greater than 5/10 on a numerical rating scale from 0 to 10 where zero is no pain and 10 is the worst pain ever, will be given a cream containing 25% mannitol to apply on one leg and the vehicle cream to apply on the other leg. The cream assignment will be randomized, and the runner, the person supplying the cream and the person inputting the data will be blinded as to which leg received which cream. Pain levels in each leg following the long run will be recorded, via an e-mail questionnaire, or, failing this, by telephone, the day of the run, and each day, for five days following the run. Mean and standard deviations for pain levels will be calculated for each treatment leg, and a repeated measures ANOVA (Analysis Of VAriance) will be done comparing the pain levels in each leg over the six days. Using this information, if the NRS (Numeric rating scale) pain levels differ by more than 1/10 between the two groups, a larger study will be conducted using the information gathered in this study to determine sample size.

Eligibility Criteria:
Inclusion Criteria:

either:

* never ran 10 km or more, or;
* NRS pain level greater than 5/10 in both legs following a 10 km or more run

Exclusion Criteria:

* no major skin allergies
* no allergy to mannitol