cyrilzakka/clinical-trials huggingface dataset:
Single Versus Dual Implant Fixation of Distal Femur Fractures

The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.

Fractures of the distal femur are severe and common injuries sustained by Wounded Warriors in combat. Despite advances in implant technology, these injuries continue to have an unacceptably high rate of nonunion (failure to heal) of approximately 20%. This adverse outcome requires additional surgery to achieve fracture healing, which prolongs recovery and further delays return to duty often beyond one year after injury. The goal of this study is to investigate a potential treatment for distal femur fractures that has the potential to improve the likelihood of fracture healing and accelerate return of patient function during the healing process.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Surgically treated displaced distal femur extra articular or complete articular fractures

Exclusion Criteria:

* Patients with injury features that preclude treatment with 2 implants
* Patients unlikely to follow-up due to homelessness, or planning follow up at another institution
* Body Mass Index (BMI) \> 40
* Injury due to ground level fall
* Patient that speaks neither English or Spanish
* Patients with multisystem injuries that could preclude return to work
* \< 18 years of age
* Prisoner
Effect of Subcision and Suction on Acne Scars

The primary objective of this study is to determine whether the use of standard treatment in conjunction with suction will improve acne scars compared to a standard treatment alone.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Have bilateral rolling acne scars
* Are in good health
* Subject has the willingness and ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or lactation
* Unable to understand the protocol or give informed consent
* Has mental illness
* Recent Accutane use in the past 6 months
* Prone to hypertrophic and keloidal scarring
Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Enucleation of Renal Cell Carcinoma With T1a Stage

To evaluate the feasibility and efﬁciency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.

Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.

Eligibility Criteria:
Inclusion Criteria:

* patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
* patients with normal contralateral renal function (diﬀerential renal function of \>40% as determined by radionuclide scintigraphy)
* patients agreeable to participate in this long-term follow-up study

Exclusion Criteria:

* patients' aged \>80 years
* patients with other renal diseases
* patients not able to tolerate the laparoscopic procedure
* patients with previous renal surgery or history of any inﬂammatory conditions of the operative kidney
* patients with the renal tumor close to the calyces
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes

This trial is conducted in Europe. The aim of this trial is to compare different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.

Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. Each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments.

Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.


Eligibility Criteria:
Inclusion Criteria:

* The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
* ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
* Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:
* Diagnosed with type 2 diabetes mellitus for at least 12 months
* Treated with insulin for the last 3 months prior to screening.
* Body Mass Index (BMI) between 22.0 and 35.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
* A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
A Multi-Center Study of Rehabilitation to Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

This is a multi-center prospective follow-up study.

* to choose the stable COPD patients in community
* to compare different modes of exercise (cycling and walking)
* to compare the effect of different exercises on the quality of life,exercise endurance,dyspnea and depression

This is a multi-center prospective follow-up study.More than 20 hospitals participate the research. More than 300 stable COPD patients will be recruited.It is a two-year study. There are four groups, cycling and walking group(C-WG),cycling and non-walking group(C-nonWG),walking and walking group(W-WG),walking and non-walking group(W-nonWG).

1. All patients from four groups will finish baseline investigation and blood sample, including informed consent,questionaires(SGRQ,CRDQ,MRCQ,Depression Scale,etc.),spirometry,6MWT,MIP,MEP,BMI,CRP,TNF,IL-8, etc.Patients in C-WG and C-nonWG will finish cardiopulmonary test.
2. Patients receive 8 weeks training program, includes upper and lower extremities endurance exercises and respiratory muscle endurance exercises. Patients in both CGs cycling at cycle ergometry. Patients in W-WG and W-nonWG walking instead. All patients receive training program twice per year, for two years. Patients were supervised by physicians or nurses at hospital while they are training.
3. In the non-training period, patients in W-WG and C-WG will continue to walk at community, supervised by nurses who call them every month. The other two groups(C-nonWG and W-nonWG) do not receive special requirement on exercise.
4. Telephone call interview will give to patients every month to find whether they have acute exacerbation. Patients are asked to record their activities during daytime in the diary cards.
5. All patients will finish investigation and blood sample after one year and two year,including questionaires,spirometry,6MWT,MIP,MEP,BMI,CRP,TNF,IL-8, etc.Patients in CG will finish cardiopulmonary test.

Eligibility Criteria:
Inclusion Criteria:

* according to GOLD, patients who are diagnosed as COPD, lung function at II or III grades (II:50%≤FEV1\<60%pre；III:30%≤FEV1\<50%pre）；
* 40≤age≤75 years old；
* don't have acute exacerbation in the past one month；
* SpO2 \> 88% at rest；

Exclusion Criteria:

* diabetes,blood glucose don't control well;
* vascular diseases(vasculitis,deep venous thrombosis,varicose veins, etc);
* joint diseases which may affect activities;
* cerebrovascular diseases which may affect activities;
* unstable angina during the past 1 month of acute myocardial infarction in the past 6 months;
* severe arrhythmia;
* cardia insufficiency;
* hypertension which don't control well(systolic pressure\>160mmHg and/or diastolic pressure\> 100mmHg);
* chronic liver or renal insufficiency;
* cognitive handicap.
ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.

This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.

452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of histo or cytopathology confirmed, advanced NSCLC (with known histology) with the presence of EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21).
* It is acceptable for subjects with the presence of the exon 20 T790M mutation together with either EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21) to be included in this study
* No prior treatment with systemic therapy for locally advanced or metastatic NSCLC. Minimum of 12 months disease free interval between completion of neoadjuvant/adjuvant systemic therapy and recurrence of NSCLC
* Adequate tissue sample must be available for central analyses.
* Adequate renal, hematologic, liver function.
* ECOG PS of 0-1.
* Radiologically measurable disease.

Exclusion Criteria:

* Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
* Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation.
* Any history of brain metastases or leptomeningeal metastases.
* Any previous anti-cancer systemic treatment of early, locally advanced, or metastatic NSCLC.
* Any surgery(not including minor procedures such as lymph node biopsy), palliative radiotherapy or pleurodesis within 2 weeks of baseline assessments
* Any clinically significant gastrointestinal abnormalities that may impair intake, transit or absorption of the study drug.
* Current enrollment in another therapeutic clinical study.
* History of, or currently suspected, diffuse non-infectious pneumonitis or interstitial lung disease
* Uncontrolled medical disorders.
* Prior malignancy and concurrent malignancy except for non melanoma skin cancer or in-situ cervical cancer with no evidence of active disease.
* Use of narrow therapeutic index drugs that are CYP2D6 substrates from screening to randomization.
Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults

The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and eliminated by the body under defined maximum dosing conditions and to evaluate the safety under these conditions.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent form
* Men, women, 18 to 55 years
* Females must not be pregnant or plan to become pregnant
* BMI 18 to 30 kg/m2
* Past or non-smoker
* High probability of compliance with completion of study
* Healthy as determined by investigator based on medical history, physical exam, clinical laboratory tests, vital sign measurements, ECGs

Exclusion Criteria:

* Presence or history of disorder that could interfere with completion of study
* Unstable medical condition
* Surgical or medical condition that may interfere with absorption, distribution, metabolism or excretion of test drug
* Positive Hep B, Hep C and/or HIV test
* Positive urine drug screen
* Any history of skin disorders, including psoriasis, eczema, tattoos, significant scarring, healing wounds, skin lesions on knees or elbows
* Significant disease
* Any clinically important deviation from normal limits in physical exam, vital sign measurements, 12 lead ECG, clinical laboratory test
* History of drug abuse with 1 year
* History of alcoholism with 1 year
* Use of prescription medications or ibuprofen within 30 days of Day 1, use of OTC drugs, herbal supplements and vitamins within 14 days of Day 1.
* Use of investigational drug within 30 day of Day 1
* Acute disease state within 7 days of Day 1
* Consumption of grapefruit or grapefruit containing products within 72 hours of Day 1
* Tobacco use/caffeine use within 48 hours of Day 1
Screening for Convergence Insufficiency in School-age Children

The purpose of this study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting.

The purpose of the Screening for Convergence Insufficiency in School-age Children study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting (where it may not be feasible to do more than one test).

Eligibility Criteria:
Inclusion Criteria:

* Age 9 to 17 years
* Enrolled in participating school
* Parental permission, assent
* Ability to complete testing

Exclusion criteria: referral on vision screening for reduced distance visual acuity or significant uncorrected refractive error
Emergency Department (ED) Triage of Alcohol Abuse

Retrospective study of adult patients (\> 16 y) admitted to Geneva University Hospitals with alcohol abuse. Triage criteria will be reviewed. Patients characteristics and patient flow in the ED will be described.

A retrospective analysis of triage notes and electronic medical records will be performed in order to identify how triage evaluation is performed accordingly to the Swiss Emergency Triage Scale criteria. The proportion of patients leaving without being seen will be computed. Caracteristics of these patients will be compared to patients with medical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Triage code = alcohol abuse
* \> 16 y

Exclusion Criteria:

* No alcohol abuse identified at triage
* \< 16 y
IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, regardless of gender;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
* Life expectancy ≥ 12 weeks;
* Patients with CMML diagnosed according to WHO 2016 criteria, including CMML-1 and CMML-2;
* White blood cell count ≤ 13×10⁹/L before the first treatment with the study drug (hydroxyurea and leukapheresis are allowed, but not within 3 days prior to the first treatment with the study drug).
* Patients must be treatment-naïve to any hypomethylating agents (e.g., azacitidine, decitabine), chemotherapy or allogeneic stem cell transplant for CMML. Immunomodulators ( lenalidomide), immunosuppressants (antithymocyte globulin, cyclosporine), targeted agents (ruxolitinib), etc. are also excluded, as these agents are considered disease-modifying therapies. Note: During screening and study participation, subjects may continue oral corticosteroids for diseases other than CMML (e.g. asthma) at a stable daily dose equivalent to ≤ 10 mg prednisone. In addition, supportive care in the form of blood transfusions or growth factors is not considered prior therapy in this case and is permitted prior to and as needed during the study.

Exclusion Criteria:

* Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein;
* History of allogeneic stem cell transplant and other organ transplants; Patients who have undergone autologous haematopoietic stem cell transplant;
* Prior diagnosis of: therapy-related myelodysplastic syndrome(t-MDS); MDS evolved from a pre-existing myeloproliferative neoplasm (MPN) ;MDS/MPN including atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN. Patients positive for BCR-ABL fusion genes, PDGFRA, PDGFRB, and FGFR1 rearrangements need to be excluded;
* Current or history of central nervous system (CNS) leukemia, extramedullary leukemia, or myeloid sarcoma;
* Diagnosis of other malignant neoplasms within 3 years prior to the first dose. Exceptions: a. Radically treated cervical carcinoma in situ or non-melanoma skin cancer; b. a second primary cancer that has been curatively treated and has no recurrence within three years;
Talonavicular Arthrodesis and Surgical Treatment of Ankle and Varus Foot

This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.


Eligibility Criteria:
Inclusion Criteria:

* Hemiparesis secondary to a lesion of the central nervous system, regardless of the etiology dated within 6 months
* Orthopedic equine-varus deformity of the foot and ankle requiring surgery
* Patient able to move by walking preoperatively at least 2 meters with or without technical assistance or may earn postoperative walking ability

Exclusion Criteria:

* History of foot surgery the side to be operated
* Significant deformation set foot and ankle (requiring treatment with triple arthrodesis)
* Bilateral surgery
* Progressive neurological disease
* Dystonic movements or movement disorders
* Realization of a botulinum toxin injection in the 6 months preceding gesture
* Important cognitive impairment
Eeva™ Pregnancy Pilot Study (PPS)

The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs
* ≤ 40 years
* ≥ 4 diploid embryos (i.e. having 2 PNs)
* ≤ 3 Prior ART cycles (IVF, ICSI and related procedures)
* All 2PN embryos (for all 3 arms) must be imaged by Eeva
* Subject willing to comply with study protocol and procedures
* Subject willing to provide written informed consent

Exclusion Criteria:

* Preimplantation genetic diagnosis or preimplantation genetic screening
* Planned "freeze all" cycle (eggs or embryos)
* Asherman's Syndrome
* Donor egg
* Gestational carrier
* Presence of Hydrosalpinx on ultrasound
* Concurrent participation in an interventional clinical study
The Impact of Material on Microbiota in Association With Tongue and Lip Piercing

Biofilms on oral piercings may serve as a bacterial reservoir and lead to systemic bacteraemia or local transmission of periopathogenic microbiota.

The investigators hypothesize that there are microbiological differences in bacterial samples collected from tongue /or lip piercings made of different materials. The investigators also hypothesize that the piercings carry the same characteristic bacteria as found in the piercing channels and that independently the biofilm on the tongue/adjacent teeth is similar to the other study locations.

85 subjects with tongue and 85 subjects with lip piercing will participate. Periodontal clinical parameters, traumata of hard tissues, and characteristics of the stud are evaluated. Sterile piercings of four different materials will be randomly allocated to the study subjects. After two weeks, microbiologic samples are collected and are processed by checkerboard DNA-DNA hybridization methods.


Eligibility Criteria:
Inclusion Criteria:

* lip/tongue piercing for at least six month in situ

Exclusion Criteria:

* pregnancy and lactating women
* medication with known effects on gingival tissues
* antibiotic medication in the last six months or need for antibiotic prophylaxis
* chlorhexidine use in the last six months
* non-plaque induced gingival disease
* prior diagnosis of periodontitis
Contraceptive Hormones and Women With Cystic Fibrosis

Primary Objective Our primary objective in this study is to evaluate satisfaction of hormonal contraception in this sample of women and to evaluate the impact that this hormonal contraceptive has on cystic fibrosis (CF) disease in women with regular menstrual cycles accompanied by cyclic exacerbations.

We hypothesize:

1a) women with CF who perceive an overall benefit of hormonal contraception will be more satisfied than women with CF who do not perceive a benefit,

1b) women with CF who have cyclic exacerbations will have decreased Pseudomonas aeruginosa mucoidy conversion while using hormonal contraception,

1c) women with CF who have cyclic exacerbations will have improved patient-reported quality of life indices while on hormonal contraception, and

1d) women with CF who have cyclic exacerbations will have improvement in pulmonary function tests while on hormonal contraception.

Secondary Objective We plan to secondarily evaluate the cervical mucus of women with CF at the time of ovulation and compare it to that of healthy controls.

We hypothesize that women with CF have ovulatory cervical mucus similar to healthy peers.


Eligibility Criteria:
Inclusion Criteria:

* female, reproductive age (18-40), cyclic CF exacerbations, regular menstrual cycles

Exclusion Criteria:

* pregnant, desires pregnancy, contra-indication to hormonal contraception, currently using hormonal contraception