cyrilzakka/clinical-trials huggingface dataset:
Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection

From November 2004 to June 2020, there were more than 200 patients with acute TAAD patients who underwent aortic surgery at our hospital.Of all the patients in the study period, there were 34 patients (defined as study group) who sought for medical attention with symptoms for several days (median 5 days, range 3-7 days) or deferred aortic surgery several days later (median 3 days, range 2-7 days) even though acute TAAD was diagnosed on the same day when chest pain or back pain occurred. For reducing the selection bias, propensity score matching (PSM) was used to match the study group with the control group from all the patients treated at our hospital during the study period. Comparison between the two groups was performed.

From November 2004 to June 2020, there were more than 200 patients with acute TAAD patients who underwent aortic surgery at our hospital. The research protocol used in this study was approved by the institutional review board of MacKay Memorial Hospital (IRB number: 21MMHIS005e). Of all the patients in the study period, there were 34 patients (defined as study group) who sought for medical attention with symptoms for several days (median 5 days, range 3-7 days) or deferred aortic surgery several days later (median 3 days, range 2-7 days) even though acute TAAD was diagnosed on the same day when chest pain or back pain occurred. The mean age at presentation was 60.2 +/- 13.2 years (range 33.4\~83.5 years). All the patients in the study group were divided into 3 groups: DP group (n=22) with acute TAAD diagnosis delayed by patient but received prompt aortic surgery; DD group (n=4) with acute TAAD diagnosis delayed by patient and received deferred aortic surgery; ID group (n=8) with acute TAAD diagnosis on the same day when the symptoms occurred but received deferred aortic surgery several days later. For reducing the selection bias, propensity score matching (PSM) was used to match the study group with the control group from all the patients treated at our hospital during the study period. Comparison between the two groups was performed.

Eligibility Criteria:
Inclusion Criteria:

* the patients sought for medical attention with symptoms (chest pain, back pain or shortness of breath) for several days or deferred aortic surgery several days later although acute TAAD was diagnosed on the same day when chest pain or back pain occurred

Exclusion Criteria:

-
Proximal Tibial Open Wedge Osteotomy. A Clinical Prospective, Randomized RSA-trial.

In the treatment of osteoarthritis of the medial compartment of the knee, Open wedge high tibial osteotomy is a good choice of treatment for the young and active patient.

However it leaves an open gap which has to be filled with a bone substitute and requires stable fixation.

Hitherto the golden standard has been autograft taken from iliac crest but there are donorsite related problems and limited amount available.

Recently injectable and resorbable calciumphosphate-cements have been introduced and used with promising results in fractures of the distal radius, calcaneus and lateral tibial condyle.

These new cements seem to be a good alternative to other bone substitutes providing high initial strength that might promote early mobilisation; it resorbs and promotes osteoconduction securing safe healing.

The aim of the present study is to evaluate whether there is any difference in clinical outcome, correction, stability and healing in open-wedge osteotomies with three different bone substitutes: Autograft from iliac crest and the injectable calciumphosphate-cement Calcibon and as control a group with an empty gap.

Osteosynthesis is performed with the Dynafix® system (EBI) The investigation is performed as a randomised prospective clinical trial including 45 patients with a planned 2 years follow-up period.

Clinical outcome is evaluated with: Hospital of special surgery score, KOOS, SF 12 and Lysholm score.

Routine standing x-rays is performed. Stability is assessed with Roentgen Stereophotogrammetric Analysis (RSA) that provides the opportunity of exact 3-dimensional measuring of eventual loss of correction.

This combined with urine and serum bone-healing markers gives a very precise picture of the healing in the bone-gap.

To asses the cartilage of the knee MRI is performed and biochemical markers fore Collagen type II degradation are measured.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of medial compartment of the knee, Ahlbäck gr. 1-2
* Candidate for proximal tibial medial open-wedge osteotomy
* Signed informed consent

Exclusion Criteria:

* Prednisolone treatment.
* NSAID treatment.
* BMI \> or = 35.
* Previous surgery in lateral knee compartment.
* Secondary Arthrosis following fracture(s) of the tibial condyle(s).
* Lack of informed consent.
Insulin Resistance in Type I Diabetes in Pediatric Care

24 children (12 African-American, Hispanic, or American Indian, 12 Caucasian) previously diagnosed with type 1 diabetes mellitus will participate in this pilot study to evaluate the presence of hepatic and peripheral insulin resistance. The investigators will use this pilot information to test the hypothesis that insulin resistance occurs in some children with type 1 DM, is secondary to underlying risk factors, and is responsible for increased insulin needs. Methods will include a "step-up" hyperinsulinemic euglycemic clamp and infusion of the stable isotope 6,6-\[2H2\]-glucose. Patient and parent interviews will be conducted to gather information about nutritional intake, ethnicity, family history, and socioeconomic status. The investigators will also measure inflammatory cytokines and free fatty acids to determine whether they are associated with differences in insulin resistance among type 1 diabetes mellitus patients.


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed with type 1 diabetes
* ages 9 -11 tanner 1 or 16-23 tanner 4-5

Exclusion Criteria:

* None
Tampere Traumatic Head and Brain Injury Study

Tampere Traumatic head and brain injury study is a prospective study aiming to explore neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi. The study is conducted in Tampere University Hospital's emergency department between the 1st of August 2010 and 31st of July 2013.

Aims of the study:

1. To improve clinical assessment of mTBI in the acute phase
2. To assemble better knowledge of diffusion tensor imaging as a diagnostic tool in mTBI
3. To improve neuropsychological evaluation of mTBI Main focus on psychosocial functioning / outcome / correlates E.g. Resilience, PTSD

Eligibility Criteria:
Inclusion Criteria:

* WHO's mtbi criteria
* Inhabitant of Pirkanmaa hospital district
* Age between 18 and 60 years

Exclusion Criteria:

* Detrimental alcohol use
* Drug addiction
* Chronic neurological disease
* Earlier brain injury
* Diagnosed psychiatric disease
* Hearing or sight deficiency
* Native language other than finnish
A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy.

The secondary objectives of the study are:

* To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
* To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
* To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations


Eligibility Criteria:
Key Inclusion Criteria:

* Generally in good health at the screening visit
* Body mass index (BMI) ≤39 kg/m2 at the screening visit
* Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the screening visit
* Moderate-to-severe pain in the index joint
* A history of inadequate pain relief from or intolerance to analgesics used for OA

Key Exclusion Criteria:

* Diagnosis of systemic diseases that may affect joints
* History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or MRI as assessed by the central imaging reader.
* Is scheduled for a joint replacement surgery to be performed during the study period
* Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit
* Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit (topical, intranasal, or inhaled corticosteroids are permitted).
* History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy
* Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in the study
* History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit

Note: Other protocol defined inclusion/exclusion criteria apply.
Preheating in the Improvement of Knee Stability and Quadriceps Strength in Rugby Players

Injuries to the lower limbs are the most common in rugby and within the lower limbs, the most common are those that affect the ligaments of the knee. That is why we will try to improve knee stability and quadriceps strength.

The aim of this study is to evaluate the effectiveness of performing a pre-workout exercise protocol to improve knee stability and quadriceps strength in rugby players.

Randomized controlled study, simple blind and with follow-up. 30 semi-professional rugby players will be randomized to the two study groups: experimental (pre-training exercise protocol that will include continuous running, squats, and squats and monopodal jumps) and control (without intervention). The intervention will last 4 weeks, with 2 weekly sessions of 15 minutes each. The study variables will be: knee stability (Y-Balance) and quadriceps strength (Single leg hop). The sample distribution will be calculated using the Kolmogorov-Smirnov test. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.

It is expected to see improvement in knee stability and quadriceps strength in athletes who performed the exercise protocol, after the study period.


Eligibility Criteria:
Inclusion Criteria:

* Female rugby players
* With an age range of 18 to 30 years
* That participate in the Valencian territorial category 1
* Without diagnosis of lower limb injury at the time of starting the study

Exclusion Criteria:

* Players who suffer an injury or illness that prevents them from performing the protocol
* Are performing another specific physiotherapy program of knee stability and quadriceps strength
* Who had undergone the anterior cruciate ligament less than a year ago
* Have not signed the informed consent.
Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

The ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase (CML-CP). In ENESTnd and DASISION trials, both nilotinib and dasatinib achieved DMR more effectively than imatinib. In the guidelines for diagnosis and treatment of chronic myeloid leukemia in China (2020 edition), flumatinib has been recommended as an appropriate first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia (CML-CP) patients. There is no doubt that the second-generation TKIs show great advantages in deep molecular response, which further increases the possibility of achieving treatment-free remission. However, there is no direct comparative study to determine which TKI is better for de novo CML-CP. Thus, we conducted a multi-center, open-lable and real world study to compare the efficacy and safety between flumatinib and nilotinib.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥18 years of age;
2. CML-CP patients diagnosed with CML within half a year；Patients who have been using second-generation TKI nilotinib or flumatinib for first-line treatment in clinical practice, but the history of continuous treatment does not exceed 3 months；3.patients are allowed to receive hydroxyurea treatment before first-line treatment with nilotinib or flumartinib; patients treated with interferon for no more than 3 months and other TKIs for no more than 2 weeks;

4.Patients who must sign informed consent before screening

Exclusion Criteria:

1. T315I mutation ; Y253F/H, E255K/V, F359C/V/I mutations in the nilotinib group;
2. Entry into another therapeutic clinical trial;
3. Concomitant diseases that, according to the investigator's judgment, pose a serious risk to the patient's safety or completion of the study;
4. History of neurological or psychiatric disorders, including epilepsy or dementia;
5. Major surgery within 4 weeks prior to Day 1 of study;
6. Patients with another primary malignancy,unless the other primary malignancy is currently stable or does not need active intervention;
7. Women of reproductive age or men who are unable to use adequate methods of contraception, including women who are pregnant or breastfeeding;
8. ECOG≥3;
9. Patients who are unable to compliance with study or follow-up procedures;
Efficacy of Automated Text Messaging Services

The goal of this clinical trial is to test automated text messaging as an effective behavior change intervention in physical therapy patients. The main purpose of this study was to trial sleep hygiene education for improving physical therapy patients' sleep through the use of daily automated text messaging. Researchers will compare two groups to see if the intervention group which consisted of participants getting daily automated text messages for sleep hygiene tips would be effective in improving sleep, health, pain, and function compared to a group that is receiving traditional physical therapy alone.

Participants will be recruited from the outpatient physical therapy clinic verbally by their therapist and by an informational handout they receive from the therapist. The student researcher (who also works at this clinic) will then contact the participant to set up a time to complete the initial survey questions at the clinic in a private treatment room. During the initial visit, participants will read through and sign informed consent explaining the procedures and expectations of them during the study. The participants will then complete the following questionnaires: Pittsburgh Sleep Quality Index, Sleep Hygiene Index, Medical Outcome Survey-sleep 9, Perceived Stress Scale, Numeric Pain Rating Scale, and Patient Specific Functional Scale. The participants will randomly be assigned to one of two groups. The intervention group will receive daily automated text messages scheduled for 8:00 pm every evening. The text messages will include a variety of sleep hygiene behavioral tips for the participant to try. This will last for a total of four weeks. The control group will not receive any intervention during this time frame. Following the four weeks, student researchers will return to each participant's clinic to collect the same data that was collected at the initial visit. Each participant will have a total of 2 sessions to complete with each session taking approximately 15-30 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

Adults 18 years and older seeking outpatient Physical Therapy

Exclusion Criteria:

Inability to access a smart-phone or computer
Multi-Center, Randomized Trial of the Pulsed Dye Laser for JORRP

The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the time interval between surgeries and improve voice outcomes in children with severe RRP.


Eligibility Criteria:
Inclusion Criteria:

1. Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention
2. Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP

Exclusion Criteria:

1. Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment.
2. Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E7.
3. Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.
4. Children whose families do not sign an informed consent to enter into the study.
5. Children whose families anticipate discontinuing care at a participating institution during the study period
A Study of BGB-24714 as Monotherapy and With Combination Therapies in Participants With Solid Tumors

This study aims to understand how safe and well-tolerated a drug called BGB-24714 is when used alone, or in combination with chemotherapy or radiation therapy, for people with advanced or spreading solid tumors. The main objective is to identify the highest tolerable dose or the highest administered dose of BGB-24714. Additionally, the study aims to identify the most suitable doses for further investigation in larger groups of participants.


Eligibility Criteria:
Key Eligibility Criteria :

1. Participants must sign a written informed consent form (ICF); and agree to comply with study requirement
2. Phase 1a (Dose Escalation):

   Part A, A-CN, and B: Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor previously treated with standard systemic therapy or for whom treatment is not available or not tolerated Note: Only Chinese participants will be eligible for Part A-CN.

   Part C: Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III Non-small cell lung cancer (NSCLC) suitable for definitive chemoradiotherapy (CRT)

   Part D: Participant with locally advanced, histologically confirmed inoperable esophageal squamous cell carcinoma (ESCC) suitable for definitive CRT

   Phase 1b (Dose Expansion): Participants with histologically or cytologically confirmed solid tumors of selected types previously treated with standard therapy.
3. Participants must be able to provide formalin-fixed paraffin embedded (FFPE) tumor tissue sample.
4. Phase 1a Part A, A-CN, B and Phase 1b: ≥ 1 measurable lesion per Response evaluation criteria in solid tumors (RECIST) v1.1
5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

Key Exclusion Criteria:

1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
2. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
3. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s).
4. Clinically significant infection requiring systemic therapy ≤ 14 days before the first dose of study drug(s).
5. Prior exposure to agents with second mitochondria-derived activator of caspases (SMAC) mimetics, or other Inhibitors of apoptosis proteins (IAPs) antagonists.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.
A Clinical Trial on Effectiveness and Safety of Hydrogen Generator to Treat Dyspnea for the Patients With Tracheal Stenosis: A Randomized, Double-blind and Single-center Clinical Study

Investigators aim to study the effectiveness and safety of inhaling hydrogen-oxygen which produced by a hydrogen generator with nebulizer to decreases inspiratory effort for the patients with tracheal stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 65;
2. Diagnosed moderate/severe tracheal stenosis by chest CT and/or bronchoscopy;
3. Difficulty breathing symptoms
4. Agree to participate in this trial and sign the informed consent form.

Exclusion Criteria:

1. Those who were suffered from respiratory failure or more severe caused by dyspnea;
2. Combined other serious systemic diseases (severe arrhythmia, acute myocardial ischemia, uncontrollable hypertension crisis, active gastric ulcer, uncontrolled diabetes, renal failure, blood system diseases or coagulation dysfunction);
3. Those who were suffered from severe mental illness or could not take care of themselves;
4. Pregnant or lactating women;
5. Those who could not understand the trial procedures and correctly the trial equipment;
6. Those who participated in other clinical trials in the first 3 months before the screening date.

Quit criteria

1. The subjects requiring emergency intubation or other intervention or surgical treatment due to worsened tracheal stenosis;
2. Subjects who had severe adverse events during treatment;
3. Subjects who did not want to continue to participate in the trial;
4. The subjects who were necessarily terminated for the trial by the investigators.
A Comparison of Clinical Parameters in With and Without Abnormal Glucose Tolerance.

Cystic fibrosis (CF) is autosomal recessive, genetic disorder cause of cystic fibrosis transmembrane regulatory (CFTR) gene mutation. CF often is observed in caucasian population. CFTR protein in cell apical membrane is canal responsible of transport sodium and clorid ions. Impaired sodium ion transport causes production viscous mucus. Disease include problems such as mucus, breathlessness and coughing. Blood glucose levels fluctuation are observed. This study aims comparison between lung function, functional capacity, muscle strength, physical activity, physical fitness and activities of daily living activities in cystic fibrosis with and without abnormal glucose tolerance

The study aimed that comparison of clinical parameters in children with and without abnormal glucose tolerance in Cystic fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. Cystic fibrosis with impaired glucose tolerance or cystic fibrosis-related diabetes for Abnormal glucose tolerance group
2. Cooperation for tests
3. Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests,
4. To volunteer for the study.

For the control group

1. Cystic fibrosis with normal glucose tolerance
2. Cooperation for tests
3. Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests,
4. To volunteer for the study.

Exclusion Criteria:

Patients having following disease

1. Acute pulmonary exacerbation
2. Acute or chronic respiratory failure
3. FEV₁ lower than %40
4. Cooperation problems,
5. Bronchopulmonary aspergillus and using steroid.