cyrilzakka/clinical-trials huggingface dataset:
Upper-Extremity Bone or Joint Surgery: Long Term Outcome

The specific aim of the study is to obtain long-term follow-up information on patients who have completed their standard clinical care in the Orthopaedic Hand and Upper Extremity Service. The study will help to qualify and quantify long-term recovery and outcomes from uncommon upper extremity fractures, as well as non-fracture bone and joint conditions. The hypotheses vary, but generally focus on the patterns of injury, the results of treatment and the complications encountered.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of complex arm or leg trauma who have completed their normal care in the Orthopaedic Hand and Upper Extremity Service

Exclusion Criteria:

* Vulnerable populations
Long-term Outcome of Patients Treated With Extracorporeal Membrane Oxygenation

Outcomes and Long-term Quality-of-life of Patients Treated With Extracorporeal Membrane Oxygenation are not known in china.A cross-section survey will be performed to assess the long-term outcome of these patients.

Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2011 to March 1,2017 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO.

Eligibility Criteria:
Inclusion Criteria:

* patients treated with ECMO

Exclusion Criteria:

* non-survivors of patients treated with ECMO，declined or lost to follow up
Reduction of Smoking in Cardiac Disease Patients

This study evaluates the effect of smoking reduction vs usual care (quitting advice only) for individuals with peripheral arterial disease who smoke.

This study randomly assigns smokers who do not have a quit date set to either a smoking reduction grop or usual care group. The smoking reduction group receives behavioral counseling on smoking reduction and nicotine patch and/or gum to reduce the number of cigarettes smoked per day by at least 50%. The usual care group is given brief advice to quit smoking and referral to local cessation services. To be included in the study, participants must have peripheral arterial disease (defined as ankle Brachial Index equal to or less than 0.85 or history of prior revascularization) and they must be daily smokers (defined as at least 1 cigarette, cigar, or tobacco pipe daily). Participants complete questionnaires that measure mood, functional ability, smoking history, and motivation to quit smoking. Participants will be followed in this study for up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* To be included in the study, participants must have peripheral arterial disease (defined as ankle Brachial Index equal to or less than 0.85 or history of prior revascularization) and they must be daily smokers (defined as at least 1 cigarette, cigar, or tobacco pipe daily).
Dornase Alfa Administered to Patients With COVID-19 (DACOVID)

Mechanically ventilated patients with coronavirus disease 2019 (COVID-19) have a mortality of 24-53%, in part due to distal mucopurulent secretions interfering with ventilation. Dornase alfa is recombinant human DNase 1 and digests DNA in mucoid sputum. Nebulized dornase alfa is FDA-approved for cystic fibrosis treatment. DNA from neutrophil extracellular traps (NETs) contributes to the viscosity of mucopurulent secretions. NETs are found in the serum of patients with severe COVID-19, and targeting NETs reduces mortality in animal models of acute respiratory distress syndrome (ARDS). Thus, dornase alfa may be beneficial to patients with severe COVID-19-acting as a mucolytic and targeting NETs.

Demographic, clinical data, and outcomes were collected from the electronic medical records of five mechanically ventilated patients with COVID-19-including three requiring veno-venous extracorporeal membrane oxygenation (VV-ECMO)-treated with nebulized in-line endotracheal dornase alfa co-administered with albuterol (used to increase delivery to the alveoli), between March 31 and April 24, 2020. Data on tolerability and responses, including longitudinal values capturing respiratory function and inflammatory status, were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated patients with COVID-19

Exclusion Criteria:

* healthy, non-ventilated
A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented advanced cancer, Eastern Cooperative Oncology Group (ECOG) 0-1;
* Platelets \> 100,000, ANC \> 1500;
* Ccr \> 60 or serum creat. \<1.5
* Non-small cell cancer cohort:
* Eastern Cooperative Oncology Group (ECOG) 0-2, prior platin, \< 4 prior chemotherapy regimen
* HgA1C \<5.7%

Exclusion Criteria:

* Active Central Nervous System (CNS) metastases;
* prior IGF1-R targeted therapy
* Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.
Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease Patients

The study will evaluate the safety and tolerability of ACR325 in Parkinson disease patients and evaluate the effect on levodopa induced dyskinesias.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson"s disease according to the United Kingdom Parkinson's Disease Society brain bank diagnostic criteria
* Levodopa induced dyskinesia

Exclusion Criteria:

* Previous surgery for Parkinson's disease
* Any current or history of heart condition or increased pro-arrhythmic risk
* Severe or ongoing unstable medical condition
Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite appropriate management, 90% of the patients will develop relapse or progression. After progression, the median survival is 5.2 months (Stupp, 2009).

The treatment of GBM relapse remains investigational. Reirradiation is an option in selected cases.

The objective of this study is to compare 2 schemes of stereotactic hypofractionated radiotherapy in the management of recurrent GBM.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* KPS equal or greater than 60
* Anatomopathological confirmation of GBM
* Previous RT with therapeutic doses
* At least 5 months from the end of RT course
* Not a candidate to surgical resection
* Patients with partial resection after resection of recurrent GBM will be allowed
* Patients with local progression after resection of recurrent GBM will be allowed
* Lesion with a maximal 150cc volume, as defined by enhancing portion in contrast enhanced MRI
* Hemoglobin levels (Hb) equal or greater than 10ng/dl. Blood transfusions to correct the Hb will be allowed.

Exclusion Criteria:

* Important comorbidities
* Concomitant chemotherapy
* Contraindication to MRI
* Brainstem glioma
Platelet Rich Fibrin in the Treatment of Palatal Wounds

In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the epithelialized connective tissue graft palatal donor site healing acceleration and in the patient's morbidity reduction. Forty patients, with at least one gingival recession will be treated by a coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from the de-epithelialization of a free gingival graft. In the test group (20 patients) a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the control group patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.


Eligibility Criteria:
Inclusion Criteria: are as follows:

* to have a single gingival recession to be treated by a mucogingival surgery intervention
* to be in good systemic health
* to have a good oral hygiene

Exclusion Criteria:

* no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation;
* no smoking habits;
* no periodontal surgery on the experimental sites;
* no inadequate endodontic treatment
* no tooth mobility at the site of surgery
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. These procedures are considered to be experimental.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-49 years
* 1) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis
* Insulin pump or automated insulin delivery systems
* Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2
* Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics)
* BMI 20-45 kg/m2
* Adequate contraceptive method for females

Exclusion Criteria:

* HbA1c \>9%, recent diabetic ketoacidosis (DKA) or hospitalization
* Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy
* History/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis
* Current/planned pregnancy or nursing
* Uncontrolled thyroid disease or hypertension (HTN) (≥ 160/100 mm Hg despite optimal therapy)
* Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months
* Use of atypical antipsychotics
* Significant systemic illness such as cancer
* Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure)
* MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy
Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths

To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine

All subjects were previously primed with one of the two formulations of the combined DTPw-HBV/Hib vaccine. At the age of 10 months, 50% of each group received a plain PRP challenge to assess the immune memory to PRP. In this booster study in the second year of life, all subjects who received DTPw-HBV/Hib and plain PRP will receive DTPw-HBV as a booster vaccination. All other subjects will receive as booster the same vaccine they received in the primary vaccination study.

Eligibility Criteria:
Inclusion criteria

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* A male or female of at least 15 months of age at the time of the booster vaccination, who had previously received 3-dose primary vaccination and, if applicable, plain-PRP vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering the study.

Exclusion criteria for enrolment

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV).
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
* Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B or Hib with the exception of plain PRP challenge.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Trial of Cognitive Behavioral Therapy for Schizophrenia

The following study addresses the hypothesis that cognitive-behavioral interventions will be effective in reducing positive and negative symptoms of schizophrenia under the conditions of the German health care system. It is also hypothesized that interventions designed to reduce delusions will reduce cognitive biases and dysfunctional self-concepts.

Background: In spite of the proven effectiveness in a series of randomized controlled studies, cognitive-behavioural interventions for the treatment of symptoms of schizophrenia have been not yet been evaluated under the conditions of the German health care system. Additionally, it remains unclear which processes are responsible for reducing positive symptoms using CBT-interventions.

Hypothesis: The following study addresses the hypothesis that CBT will be effective in reducing positive and negative symptoms of schizophrenia. It is also hypothesized that CBT will reduce cognitive biases and dysfunctional self-concepts.

Method: 70 patients with a primary diagnosis of schizophrenia will be randomized to a CBT-treatment- and a waiting-list-control-group. CBT involves a formulation-based treatment of approximately 25 sessions by trained and supervised therapists plus standard care (psychiatric medical treatment) in an outpatient setting. Participants will be referred from cooperating psychiatrists. Patients randomized to the waiting-list condition take part in the assessment phase, then receive standard care alone for 12 weeks and are then offered CBT. The primary outcome measure will be the Positive and Negative Syndrome Scale. Additionally, depression, dysfunctional self-concepts and cognitive biases will be assessed before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* persons with a primary diagnosis of schizophrenia, schizoaffective disorder, delusional disorder acute or in incomplete remission a value of at least 3 on delusions, P1, P3 or G9 in Positive and Negative Syndrome Scale

fluent in German language

Exclusion Criteria:

* severe organic brain disease
Effect of Procrit (Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation

Delayed graft function (DGF) is a major complication following deceased donor renal transplantation. The surgical procedure of harvesting a kidney from a cadaveric donor and implanting the kidney into the recipient inevitably causes some amount of injury. While not always clinically significant, anywhere from 10-50% of transplant patients may develop DGF. Ongoing research in animal models has demonstrated benefit with administration of erythropoietin. The investigators propose to study the effect of Procrit(Epoetin Alfa) on delayed graft function in subjects undergoing kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting for kidney transplantation
* Age \> 18
* Deceased donor kidney transplant

Exclusion Criteria:

* History of thrombosis or hypercoagulable state
* Receiving Coumadin or Heparin
* Hemoglobin \>=14 g/dl
* Uncontrolled hypertension
The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment

The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment

We compare the effect of risedronate with placebo in bone mineral density changes in patients receiving high dose corticosteroids for their underlying diseases

Eligibility Criteria:
Inclusion Criteria:

1. Patients with various medical conditions who require high dose glucocorticoid treatment: (1) pulse methylprednisolone; (2) oral prednisolone (\>=0.8mg/kg/day) or equivalent for at least 6 weeks.
2. Age\>=18 years and \<75 years.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Uncorrected hypocalcemia.
3. History of esophageal stricture.
4. Previous intolerance or hypersenstivity to biphosphonates.
Dynamic Humeral Centering Exercises in Subacromial Pain Syndrome

Subacromial pain syndrome is one of the most common musculoskeletal health conditions, causing decreased of range of motion, loss of muscle strength and disability in the shoulder region. It has been proposed that dynamic humeral centering exercises could contribute to overcome these disorders, through the modification of the dimensions of the subacromial space, however, there is no consensus on its effectiveness nor direct variables that account for its efficacy. Therefore, the aim of this research is to determine the effects of a dynamic humeral centering exercise program on the functionality and disability of patients with subacromial pain syndrome.The effects of the dynamic humeral head exercises program, as well as the objective description of factors and variables associated with subacromial pain syndrome, will also allow rehabilitation science professionals to aim their interventions according to the knowledge of direct variables, which will allow objective follow-up of interventions on subacromial pain syndrome diagnosed patients.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old and less than 60 years old.
* Pain in the lateral and upper arm region for more than two weeks of evolution.
* At least three positive tests in the following: Neer's impingement sign, Hawkins-Kennedy impingement sign, Pattes' maneuver, Jobe's test or painful arch.

Exclusion Criteria:

* Having any of the following diagnoses: frozen shoulder, shoulder girdle joint instability, cancer, glenohumeral arthrosis, symptomatic acromioclavicular arthritis, glenohumeral arthritis, rheumatoid arthritis, or fibromyalgia.
* Cervical or thoracic pain.
* Fracture or surgery in the shoulder region or in the last 6 months.
High Dose Inhaled Mannitol Study

This study is to investigate the safety and tolerability of high doses of inhaled mannitol in subjects with bronchiectasis to further direct development of an improved drug delivery system.


Eligibility Criteria:
Inclusion Criteria:

* adult subjects with non-CF bronchiectasis
* FEV1 \> 50 % predicted and \> 1.0L

Exclusion Criteria:

* bronchiectasis due to CF or endobronchial lesion
* respiratory infection requiring IV antibiotics in last 4 weeks
* pregnancy
* significant haemoptysis in last 6 months
* active TB
* end stage ILD
* contraindications as determined by investigator
Efficacy, Safety, and Tolerability of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study compared the efficacy and safety of NVA237 with tiotropium in patients with moderate to severe COPD. Tiotropium belongs to the same drug class as NVA237.

This was a randomized, blinded, double-dummy, parallel-group 12-week study to assess the efficacy, safety, and tolerability of NVA237 (50 μg o.d.) compared to tiotropium (18 μg o.d.) in patients with chronic obstructive pulmonary disease (COPD).

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe stable COPD (Stage II or Stage III) according to the current GOLD Guidelines (GOLD 2010).
* Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥ 30% and \< 80% of the predicted normal, and a post-bronchodilator FEV1/ Forced Vital Capacity (FVC) \< 0.70 at screening
* Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack/day x 10 yrs, or ½ pack/day x 20 yrs).
* Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Patients who, in the judgment of the investigator, or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition before Visit 1.
* Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (BPH patients who are stable on treatment can be considered).
* Patients receiving medications in the classes listed in the protocol as prohibited.

Other protocol-defined inclusion/exclusion criteria apply and can be found in the study protocol