cyrilzakka/clinical-trials huggingface dataset:
Analgesic Use for Pain Relief in Scorpion Sting

In scorpion stings, patients mostly apply with the complaint of pain. Emergency physicians need to relieve this pain quickly.

Aim: In this study, the analgesic efficacy of intravenous (IV) paracetamol, IV dexketoprofen trometamol and topical lidocaine will be compared in patients presenting with pain after scorpion sting.

Methods: This study is a double-blind, randomized, placebo-controlled study conducted in a tertiary emergency department. Adult patients who applied to the study with no systemic findings after scorpion sting and especially with pain will be randomly assigned to one of 4 groups: IV paracetamol, IV dexketoprofen trometamol, topical lidocaine or placebo. In order to determine the intensity of pain, Visual Analog Pain Score (VAS) will be measured at the time of admission to the emergency department, at the 30th minute and at the 60th minute. Afterwards, the VAS score changes between the groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over
* Scorpion sting with pain
* The diagnostic criteria of Grade 1 for Scorpion sting

Exclusion Criteria:

* Patients who denied to give informed consent
* Taking analgesic treatment (ice application or drugs etc.) in the last 6 hours
* Any symptoms and findings of systemic toxicity of scorpion sting
* Pregnant women
* Hemodynamically unstable patients
* Known allergy to drugs of the study
* Patients with renal disease
* The cases that passed more than 6 hours after the bite
Effects of an Early Rehabilitation Program During Hospitalization in Patients With Cystic Fibrosis

Studies demonstrate that exercise increases the maximal oxygen uptake, peak oxygen consumption, reduce effort-induced lactic acid production, and increase skeletal muscle oxidative capacity, as well as psychological aspects such as increased self-esteem and improvement of the quality of life.

In the literature there is only one study involving rehabilitation in hospitalized pediatric patients with cystic fibrosis. Thus, more information on in-hospital rehabilitation is required in adult cystic fibrosis patients.

The present study aims to evaluate the effects of an early rehabilitation program, based on aerobic training and muscle strength training, in adolescent and adult patients with cystic fibrosis hospitalized at Hospital de Clinicas de Porto Alegre for exacerbation of lung disease.

After completing the study inclusion criteria, the individual will be invited to participate and will receive the consent form for signature.

The patient will be submitted to the following evaluations: quality of life questionnaire for cystic fibrosis, spirometry, Shwachman-Kulczycki score, modified dyspnea questionnaire (Modified Medical Research Council), maximum repetition test, six minute walk test and blood sample for the determination of inflammatory markers. These evaluations should be performed within the first 48 hours of hospitalization, and will be repeated on the last day of hospitalization.

In the period up to 48 hours after hospital admission, patients will be randomized to either the intervention group or the control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 years and older,
* Regularly followed up in the Hospital de Clinicas de Porto Alegre Program for Adolescents and Adults with Cystic Fibrosis with a diagnosis of cystic fibrosis confirmed according to the consensus criteria,
* Admitted to hospital admission due to exacerbation of lung disease.
* Hospital stay will be defined as the stay equal to or greater than 24 hours in any Hospital de Clinicas de Porto Alegre unit.

Exclusion Criteria:

* Patients with cardiac, orthopedic or trauma complications that make it impossible to perform the proposed exercises;
* Pregnant patients;
* Patients with hemodynamic instability, massive hemoptysis, pneumothorax, and continuous use of noninvasive ventilation.
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis

The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue;
* to evaluate the safety and tolerability of teriflunomide.

The study period per participant was approximatively 128 weeks broken down as follows:

* Screening period up to 4 weeks,
* 108-week double-blind treatment period (approximatively 2 years)\*,
* 16-week post-treatment elimination follow-up period.

'\*' Participants successfully completing the week 108 visit were offered the opportunity to enter the optional long-term extension study LTS6050 - NCT00803049.

Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis \[MS\] subject who was ambulatory (EDSS of ≤ 5.5)
* Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
* Meeting McDonald's criteria for MS diagnosis;
* Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
* No relapse onset in the preceding 60 days prior to randomization;
* Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone \[ACTH\] or systemic steroid treatment.

Exclusion Criteria:

* Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
* Significantly impaired bone marrow function;
* Pregnant or nursing woman;
* Alcohol or drug abuse;
* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;
Effects of Local Insulin on Wound Angiogenesis

Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo. Biopsy specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.

Randomized, split plot, double-blind, placebo controlled trial. Non-diabetic patients with full-thickness wounds will be treated in the following manner: in half of the surface insulin will be applied in a daily basis, on the other half, saline solution will be used as placebo. Biopsy specimens of both sides will be obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.

Eligibility Criteria:
Inclusion Criteria:

* Nondiabetic patients with full-thickness acute wounds

Exclusion Criteria:

* Diabetic patients
Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography

The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.


Eligibility Criteria:
Inclusion Criteria:

* Renal allograft performed less than 3 months before enrolment

Exclusion Criteria:

* Contra-indication to magnetic resonance imaging
* Contra-indication to biopsy
Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity.

Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology.

Approximately 80% of patients with liver disease suffer chronic pain and fatigue, which can lead to sensitization of the central and peripheral nervous system. Central sensitization is an increase in the responsiveness of neurons within the central nervous system, which can lead to generalized pain hypersensitivity. It has been shown that some lesions or inflammatory processes can trigger changes in the nervous system, generating persistent pain.

According to the theory of visceral referred pain, there are visceral and musculoskeletal stimuli that converge in higher centers capable of producing referred pain in regions where metameric innervation is shared. This raises the possibility that altered visceral mechanisms may provoke and chronify musculoskeletal pain.

According to this theory, people with structural or functional hepatobiliary pathologies may have referred pain in the right metameric territory of C2-C3-C4-C5, which may generate pain in the shoulder on the same side. This is due to the fact that the phrenic nerve sensitively innervates Glisson's capsule, so any affectation of this structure can generate afferent stimuli to the previously mentioned metameric levels.

The phrenic hypothesis plays a very important role today, having as its main "endorsement" the analgesic techniques of phrenic blockade used for shoulder pain after hepatectomy. In order to eliminate this post-operative shoulder pain, electrical or medical nerve blocks are used.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Subjects presenting right shoulder pain at the time of enrollment in the study.
* Presentation of a hepatobiliary visceral disorder that may justify the visceral etiology of the pain.
* That they agree to participate in the project by signing the informed consent form.

Exclusion Criteria:

* Patients with chronic pain due to other diseases such as malignant disease.
* Patients with rheumatic diseases.
* Cutaneous infection in the area of pain.
* Disease of neurological, traumatic, oncologic, or infectious origin that rules out the visceral origin of the pain.
* Uncooperative subject.
* Severe psychiatric disease.
* Loss of cognitive capacity.
* Contraindication to electrotherapy.
Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck

This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses)
2. Gross total resection, with pathology demonstrating one or more of the following risk factors:

   1. Histologic extracapsular nodal extension
   2. Histologic involvement of ≥ 2 regional lymph nodes
   3. Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual
3. No evidence of distant metastases
4. No synchronous or concurrent head and neck primary tumors
5. Karnofsky score over 60
6. Adequate organ function including the following:

   1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
   2. Platelets count \>= 100 \* 10\^9/l
   3. Hemoglobin \>= 10 g/dl
   4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
   5. Total bilirubin \<= 1.5 times institutional ULN
   6. Creatinine clearance \>= 50 ml/min
   7. Serum creatine \<= 1 times ULN
7. Signed written informed consent

Exclusion Criteria:

1. Evidence of distant metastasis
2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Preservation of Ovarian Function After Hematopoietic Cell Transplant

Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.

This study is to use gonadotropin releasing hormone (GnRH) agonist leuprolide prior myeloablative hematopoietic cell transplantation to prevent ovarian dysfunction in post-menarchal women.

The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure.

The secondary objectives are

* to determine how effective GnRH agonists are at suppressing menses during
* to determine the incidence and timing of resumption of menstrual cycles after HCT
* to determine the incidence and timing of resumption of normal FSH and LH levels after HCT
* to determine the incidence of normal AMH levels after HCT
* to determine the effect of GnRH agonists on immune reconstitution after HCT
* to assess the safety and tolerability of GnRH agonists in the context of HCT

A total of 47 patients will be accrued in this study.

Eligibility Criteria:
Inclusion Criteria:

* Interventional Arm:

  * Eligible for myeloablative allogenic or autologous hematopoietic cell transplant (HCT)
  * Post-menarchal female \< or = 50 years of age
  * Normal antimullerian hormone (AMH) level and/or follicle stimulating hormone (FSH)/leuprolide (LH) levels for age/stage of puberty
  * Those women who have an FSH \> 40 IU/L and whose diagnosis of malignancy and whose chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.
* Observational Arm:

  * Eligible for reduced intensity allogeneic HCT
  * Post-menarchal female ≤ 50 years of age
  * Normal AMH level and/or FSH/LH for age/stage of puberty
  * Those women who an FSH \>40 IU/L and whose diagnosis of malignancy and chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.

Exclusion Criteria:

* All Arms:

  * History of ovarian cancer
  * Surgical resection of one or both ovaries. Prior hysterectomy is allowed as long as the ovaries are intact.
  * Use of GnRH agonist in last 12 months will exclude patients if lab results are not available to demonstrate adequate ovarian function prior to initiation of GnRH therapy.
A Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia

This study will evaluate the efficacy and safety of combination therapy with remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalized patients with COVID-19 pneumonia.


Eligibility Criteria:
Inclusion Criteria

* Hospitalized with COVID-19 pneumonia confirmed per a positive polymerase chain reaction (PCR) of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
* Requiring more than 6 L/min supplemental oxygen to maintain SpO2 \> 93%
* Agrees to not participate in another clinical trial for the treatment of COVID-19 while participating in this study

Exclusion Criteria

* Known severe allergic reactions to tocilizumab or other monoclonal antibodies
* Known hypersensitivity to remdesivir, the metabolites, or formulation excipients
* Active tuberculosis (TB) infection
* Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months
* Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 within 24 hours prior to study drug dosing. In addition, participants with prior or current treatment with \> 2 doses of remdesivir for COVID-19 are excluded
* Participating in other drug clinical trials
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min (including patients receiving hemodialysis or hemofiltration)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 x upper limit of normal (ULN) detected within 24 hours of screening (according to local laboratory reference ranges)
* Absolute neutrophil count (ANC) \< 1000/uL at screening
* Platelet count \< 50,000/uL at screening
* Body weight \< 40 kg
* Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor

This is a trial comparing the efficacy of oral ritodrine in the form of sustained release capsules for the maintenance of uterine quiescence after successfully treated episode of threatened preterm labor.

We randomized 120 women with singleton pregnancy who were successfully treated for threatened preterm labor before 34 completed weeks to receive either maintenance tocolysis with two 40 mg ritodrine sustained release capsules three times a day (study group, n=62) or no treatment (control group, n=58) for three days. The primary outcome measure was the recurrent episode of threatened preterm labor within 72 hours, which was defined as regular palpable uterine contractions and change in cervical effacement and/or cervical dilatation on clinical examination. Secondary outcome measures included the incidence of preterm birth, neonatal adverse outcomes, and maternal side effects.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy between completed 24 to 24 weeks
* Successfully treated episode of threatened preterm labour by intravenous preparations
* No uterine contractions

Exclusion Criteria:

* Uterine contractions (painful, clinically palpable, or present on cardiotocography)
* Cervical dilatation of ≥5 cm
* Clinical and laboratory signs of infection defined as offensive vaginal discharge on clinical examination, vaginal pH ≥5, white blood cell (WBC) count \>16×109/L, and C-reactive protein (CRP) \>10 mg/L
* Positive findings of microorganisms rather than normal vaginal flora on high vaginal swab
* Any signs of fetal distress according to cardiotocography, Doppler assessment of blood flow in umbilical artery, and biophysical profile of \<8.
Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery

Patients undergoing major spinal surgery usually experience moderate-to-severe postoperative pain. Inadequate pain control may lead to severe complications. Dexamethasone as an adjunctive infiltration to local anesthesia (LA) presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis showed that the additional analgesic effect of dexamethasone in incision/wound infiltration was only statistically significant, but not clinically significant, and the overall benefits were marginal. Compared with dexamethasone, dexamethasone palmitate emulsion (DXP) is a targeted lipo-steroid with stronger anti-inflammatory effect, longer-acting duration and fewer adverse effects. To date, no studies have evaluated the additive analgesia effects of DXP on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of DXP emulsion and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-64 years;
* Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia
* American Society of Anesthesiologists (ASA) physical status of I-III;
* Anticipated full recovery and cooperation within 2 hours postoperatively.

Exclusion Criteria:

* History of spinal surgery;
* Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS);
* Body mass index (BMI)\<15kg/m2 or \>35kg/m2;
* Peri-incisional infection;
* History of diabetes mellitus and other metabolic diseases;
* History of severe cardiopulmonary, hepatic or renal dysfunction;
* Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value);
* History of allergies to any of the study drugs;
* History of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery;
* Use of systemic steroids within 1 week before surgery;
* History of psychiatric disorders, chronic neck or back pain;
* History of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively;
* Pregnant or breastfeeding;
* Refusal to sign informed consent.
A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet Form

In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). The amount of CP-690,550 available in the blood following administration by vein will be measured and is expected to reflect the maximum amount possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the blood following oral tablet administration will also be measured and compared to that achieved following administration by vein in order to estimate how much of the maximum amount possible is actually absorbed into the blood following administration by mouth as a tablet.

To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550) compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non childbearing potential)
* Subjects between the ages of 21 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria:

* Evidence or history of any clinically significant illness, medical condition, or disease.

  2. Evidence or history of any clinically significant infections within the past 3 months.

  3. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.