cyrilzakka/clinical-trials huggingface dataset:
LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.

Remission Induction:

* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
* Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
* Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13

Results:

1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks

2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C

Intrathecal chemotherapy:

Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22

CONSOLIDATION TREATMENT 1

Start in two weeks after last dose of induction chemotherapy:

* Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
* Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
* VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
* ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
* Intrathecal treatment, days 28 and 56.

6.4. CONSOLIDATION TREATMENT 2

Start in a week after last dose of mercaptopurine of previous cycle

* Dexamethasone (DXM):
* 10 mg/m2 day, p.o. or i.v. days 1-14
* 5 mg/m2 day, p.o. or i.v., days 15-21
* Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
* Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
* CFM 600 mg/m2 day, i.v., days 1 and 15
* L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
* Intrathecal treatment days 1 and 15.

TRANSPLANTATION

Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.

Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1

Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching

Eligibility Criteria:
Inclusion Criteria:

ALL BCR/ABL+ patients Age \< 65 years No previous treatment

Exclusion Criteria:

1. Other LLA variability
2. Previous history of coronary valvular, hypertensive cardiopathy illness
3. Chronic hepatic illness
4. Chronic respiratory insufficiency
5. Renal insufficiency not caused by LLA
6. Severe neurological problems not caused by LLA
7. Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
Adherence to Weight Loss for Hypertension in African American Women

To develop a culturally tailored intervention intended to promote adherence to nutrition and physical activity regimens designed to result in weight loss for African American women.

BACKGROUND:

Besides smoking cessation, weight loss and improved nutrition are the most important behavioral changes, which can lead to improved health. Weight loss is also a critically important behavioral recommendation for treating certain illnesses such as hypertension and diabetes; for recovery from stroke or myocardial infarction; and for primary prevention of these conditions as well as certain cancers. Unfortunately, adherence is very poor even with motivated patients. This is a serious issue for all but especially African American women. These diseases affect them disproportionately. They are more likely to be overweight and there is a serious scarcity of culturally appropriate programs available. Also, many of these women receive their care in high demand/low resource clinics so that any program must also be practical and affordable within these constraints.

The study is in response to a Request for Applications issued in January, 2001 on "Overcoming Barriers to Treatment Adherence in Minorities and Persons Living in Poverty."

DESIGN NARRATIVE:

The current research involves studying adherence to recommend changes in behaviors related to nutritional intake and physical activity designed to reduce weight. The investigators will develop and test two versions of a 16-session weight loss program with the content delivered by videotape. They are nearing the end of another study, SisterTalk, for which a culturally appropriate weight control program was designed in partnership with and then delivered to African American women by cable television. Based upon that previous study, they plan to address a number of specific barriers to adherence by designing one version for clinic delivery and another for home delivery. Both approaches, each addressing different adherence issues, will be compared to a Wait List Control Group at 4 and 12 months after beginning the program. The primary outcome measures are adherence to recommended nutritional behaviors and physical activity levels. The program is based upon Social Action Theory and provides the opportunity to study many of that theory's mediating variables and their relationships to specific adherence behaviors. This will include extensive process evaluation procedures.They will also gather a great deal of data concerning the specific barriers and facilitators to adherence to nutrition and physical activity recommendations encountered by low-income African American women who are hypertensive or at high risk for hypertension.

Eligibility Criteria:
No eligibility criteria
Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis

Part 1 is a randomized, double-blind, placebo-controlled phase 1b study to evaluate AT193 in approximately 34 patients with nail psoriasis for 16 weeks. Part 2 is an open-label extension phase where all patients will receive active drug for an additional 16 weeks followed by a 2 week nontreatment period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nail psoriasis for at least 3 months preceding study entry
* Diagnosis or history of plaque psoriasis or psoriatic arthritis
* A female participant of childbearing potential must use appropriate contraceptive measures during the study period
* A female participant of childbearing potential must have a negative urine pregnancy test result at screening
* Written informed consent must be obtained before any study procedure is performed

Exclusion Criteria:

* Pregnant or breastfeeding
* Diagnosis of other active skin or nail diseases or skin or nail infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis
* History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.


Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis
* Subject is ≥18 years of age
* Subject is able to comply with study protocol and follow-up requirements
* Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form

Exclusion Criteria:

* Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region)
* Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent
* The subject has malignant biliary disease
* Subject has known pregnancy
* Participated in protocol involving investigational drug or device within 90 days prior to entry into this study
AZD3355 Dose-escalation Study in Healthy Males

The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo ("inactive substance"). Safety and tolerability variables will be closely monitored throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects without concurrent diseases who do not require any medical treatments
* Provision of signed informed consent.

Exclusion Criteria:

* History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
* Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
* History of clinically significant orthostatic reaction or syncope
* Clinically important abnormalities related to the heart function
Efficacy of a Deep Cleansing Gel Containing 2% Salicylic Acid, 0.2% Zinc Gluconate and 0.05% Lipohydroxy Acid in the Management of Mild to Moderate Facial Acne

A clinical study with 56 healthy subjects (both sexes) aged between 13 to 25 years old. Subjects enrolled had a minimum of 5 inflammatory lesions (papules, nodules and pustules) and 10 non-inflammatory lesions (open and closed comedones), determined by dermatologist. The clinical evaluation considered in oiliness, shininess and global aspect of the skin too. Instrumental assessment of oiliness and shininess was performed, respectively, by Sebumeter and Sebutape.

IThe tested cleanser was used twice daily (morning and evening) during 28 days.


Eligibility Criteria:
Inclusion Criteria:

* subjects aged 13-25 years
* mild to moderate acne on the face
* signed informed consent

Exclusion Criteria:

* subjects below 13 years and above 26 years
* severe acne on the face
Changes in Functional Movement Scores Associated With Multimodal Chiropractic Care: a Pilot Feasibility Study

Emergency medical services (EMS) personnel are at high risk of injuries, often related to overexertion while lifting or carrying patients or equipment. They require a high level of functional fitness to operate safely and avoid injuries. The purpose of this pilot study was to explore feasibility and assess effects of multimodal chiropractic care on Functional Movement Screen (FMS) scores among EMS students.

EMS students at a local community college voluntarily completed baseline FMS testing. Those who obtained 14 or less, a sign of movement dysfunction, were recruited to participate in a study to evaluate effects of multimodal chiropractic care on FMS scores. Participants received multimodal chiropractic care with an emphasis on spinal manipulation and corrective exercise for up to 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* current healthy paramedic students;

Exclusion Criteria:

-
Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

This phase II trial studies low-dose radiation therapy as a treatment for patients with severe COVID-19 pneumonia to improve clinical status.

PRIMARY OBJECTIVE:

I. To compare treatment of severe COVID-19 pneumonia between supportive care and standard of care drug therapies versus supportive care and standard of care drug therapies plus low-dose, whole-lung radiation therapy

OUTLINE:

Patients undergo 1.5Gy of single low-dose radiation therapy. After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Have had a positive test confirming the diagnosis of COVID-19;
2. Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment);
3. Have visible consolidations/ground glass opacities on chest x-ray or computed tomography;
4. Have been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy;
5. They voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form.

Exclusion Criteria:

1. Have received chest radiotherapy before
2. Bacteria, fungi and other infections other than novel coronavirus infection;
3. Combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic and endocrine system or immune system diseases (the upper limit of liver function ALT and AST\> normal reference value, the upper limit of Scr\> normal reference value, poor blood glucose control);
4. Mental retardation, mental disorders;
5. Planned pregnancy, pregnancy, lactation women and during the trial;
6. Allergy constitution or allergy to the drug ingredients and excipients of this test;
7. Participated in other clinical trials in the recent 1 month;
8. The Investigator does not considered appropriate to participate in this clinical trial.
Fraction of Inspired Oxygen and Atelectasis in Children

Investigators hypothesized that maintaining low fraction of inspired oxygen would be beneficial to prevent anesthesia-induced atelectasis in mechanically ventilated children undergoing general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Expected operation time between 1 to 3 hours under general anesthesia
* Mechanically ventilated after endotracheal intubation

Exclusion Criteria:

* Cardiac, thoracic, abdominal surgery
* History of surgery on the lungs
* Laparoscopic surgery
* Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia
* Considered inappropriate by the investigator
Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients

This is a study on the utility of the modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment with Sustiva.

Currently, efavirenz is dosed systematically, without taking into account the individual characteristics of each individual patient. However, plasma concentration of efavirenz may widely vary between different subjects that receive the same dose of the drug (interindividual variability).

Therapeutic drug monitoring (TDM) signifies individualised pharmacological dosing, based on the plasma levels that each patient presents. This strategy has been broadly used in the field of the treatment of other medical conditions and is acquiring growing interest in the field of antiretroviral treatment. Thus, the use of TDM for the treatment of naïve patients with nelfinavir or with indinavir has translated into an increase in the proportion of individuals with suppressed viral load and also into a reduction in HAART-induced adverse events . However, data on the utility of the therapeutic monitoring of the levels of efavirenz in HIV-infected patients are very scant.

On the basis of the above, it might be thought that the modification of the doses of efavirenz, guided by its plasma concentration, in patients receiving this drug and whose plasma levels of efavirenz are outside the therapeutic range, might improve the tolerability of the treatment without compromising virological efficacy.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 patients.
* According to the criteria of the treating physician, the need to initiate a regimen of antiretroviral treatment that includes efavirenz (both antiretroviral-naive patients and others on treatment with protease inhibitors switching to efavirenz for salvage reasons or for simplification of the anti-retroviral therapy are included).
* Absence of opportunistic infections and/or tumours in the three months prior to inclusion.

Exclusion Criteria:

* History of allergic hypersensitivity to the investigational drug.
* History of previous failure with antiretroviral treatment with non-nucleoside reverse transcriptase inhibitors or previously documented resistance to efavirenz
* History of psychiatric comorbidity which, in the investigator's opinion, renders the use of efavirenz inadvisable.
* Active consumption of alcohol (\>50 g/day) or other illegal drugs (except cannabis)
* Suspicion of unsuitable compliance with the antiretroviral treatment.
* Pregnant women or breast-feeding mothers.
The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy

The purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation after abdominal hysterectomy.Sodium Chloride is the placebo. The following parameters are registered:

1. Pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery.
2. The postoperative use of additional analgesics.
3. Inflammatory parameters before and after surgery.
4. Time until mobilization.
5. Time until discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients having an abdominal hysterectomy on a benign indication.
* Patients who speak and understand Danish.
* Patients who can give informed consent.

Exclusion Criteria:

* Diabetics
* Regular use of glucocorticoids, opioids or tranquilizers
* Regular treatment with immunosuppressives
* Alcohol or drug abuse
* Morphine intolerance
* Age under 18
* Chronic pain disease eg fibromyalgia, rheumatoid arthritis
* Malign indication for hysterectomy
* BMI over 35
* Decreased kidney function
* ASA III or IV
A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy

Patellar tendinopathy is one of the most frequent causes of non-traumatic knee pain and reduced function in patients. Standard treatment options for patellar tendinopathies include non-steroidal anti-inflammatory drugs, corticosteroids, cryotherapy, manual therapy, eccentric exercises, and ultrasound. Unfortunately many patients fail to respond to these therapies and return to normal activity levels, and recurrence rates for those who do respond are unacceptably high. Many patients who fail to respond display persistent degenerative changes on imaging studies suggesting a failure to regenerate the pathological tissue. Developing new therapies that can directly promote the synthesis of new, healthy extracellular matrix tissue could therefore address an important therapeutic need and make a substantial improvement in our ability to effectively treat patellar tendinopathy and reduce recurrence rates. Somatropin (human growth hormone of recombinant DNA origin) has been shown to increase protein synthesis and matrix production when delivered directly into the tendon. This study will evaluate the ability of somatropin to improve clinical outcomes and tissue quality in patients with chronic tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 18 - 50
* Patients with a greater than 3 month history of anterior knee pain
* Patients with a confirmed diagnosis of patellar tendinopathy (confirmation by ultrasonography demonstrating local anterior-posterior thickening of the tendon of at least 1mm compared with the mid-tendon level, and a hypo-echoic area)

Exclusion Criteria:

* Patients who have received corticosteroid injections within 12 months
* Patients who have full-width disruptions of the patellar tendon
* Patients who have undergone previous knee surgery or intraarticular injury
* Patients who have have arthritis (Kellgren and Lawrence grade 2 or higher), open growth plates, diabetes, cardiovascular disease, history of cancer or any major medical illnesses or endocrine disorders
* Patients with a body mass index greater than 35
* Women who are pregnant or planning to become pregnant
* Patients who are current collegiate, professional or elite athletes, or are participating in sports organizations that currently ban the use of somatropin
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules

Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study

In many cases, non-small-cell lung cancer(NSCLC) manifested as synchronous ground-glass nodules(GGNs) and makes complete surgical resection impossible. At the same time, there is no good solution for the remaining GGNs after resection of the main lesion. Theoretically, pre-operative anti-PD-1 therapy is optimal for promoting anti-tumor immune response on the basis of maximum tumor mutational burden (TMB). In addition, neoadjuvant immunotherapy should have long-term anti-tumor effect even after surgery, because tumor recurrence may cause memory cells activation and differentiation. This is a pilot study to analysis the pathological remission rate of neoadjuvant immunotherapy and adverse events related to the treatment

Eligibility Criteria:
Inclusion Criteria:

* not less than two GGNs on chest CT
* at least one lesion is diagnosed as NSCLC from biopsy pathology
* no contraindication for surgery
* ECOG score of 0 or 1
* no detectable evidence of distant metastasis

Exclusion Criteria:

* medical history of malignancy
* pregnant or breeding period
* severe organ failure (heart, liver, kidney, and lung)
* high risk of cerebral-cardiovascular evens
* infection out of control
* received or receiving chemo- and radiotherapy
* history of severe reaction due to allergy or hypersensitivity
* severe mental disorder
* currently been enrolled in other trials
* autoimmune or chronic inflammatory disease
A Study of Artificial Intelligence Assisted Small Incision Lenticule Extraction (SMILE) for Surgical Design and Influencing Factors

The goal of this observational study is to learn about the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and the influenced factors of refractive outcomes in patients who underwent Small Incision Lenticule Extraction(SMILE) at the Refractive Surgery Center of Tianjin Eye Hospital. The main questions it aims to answer are:

* Compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design
* Analysis the influenced factors of refractive outcomes

In this ambispective observation study, to compare the difference of refractive outcomes between Artificial Intelligence and experienced surgeon predicting Nomogram assist SMILE surgical design and Analysis the influenced factors of refractive outcomes, patients have been continuously recruited and the data can then be used for further case-control and cohort studies.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years and older
* Stable refraction over the past 2 years
* Corrected distance visual acuity (CDVA) of 20/25 or better
* Soft contact lens discontinued 2 weeks or longer
* Rigid contact lens discontinued 4 weeks or longer

Exclusion Criteria:

* Abnormal corneal topographic features
* Severe dry eye
* Active keratitis
* Corneal scars
* Keratoconus or suspected keratoconus,
* Glaucoma
* Retina diseases
* History of intraocular or corneal surgery
* Pregnant or lactating women, required chronic systemic corticosteroids or immunocompromised subjects were also excluded from this study