cyrilzakka/clinical-trials huggingface dataset:
Mini Incision Dynamic Hip Screw Technique

Femoral cervical fractures fixation with DHS plate throw 3 cm incision and minimum surgical trauma.

This technique is the same of AO Dynamic Hip Screw (DHS) technique using 4 holes plate or smaller, in this case it is enough to make just a 3 cm skin incision over the guide wire that is inserted parallel to the anteversion wire by using the 135° guide fixed on the T-handle; (step 2-2), and continuing AO technique steps, until step 3-4, for the plate assembling we remove the guide wire, and insert the plate sliding it through the skin cut over the femur shaft under the muscles using the plate for dissection the soft tissue above the bone surface non using any tool as periosteal elevator but the plate itself by holding it from its DHS screw canal and in 180 degree rotation position in axial aspect (transvers aspect) using the plate end for soft tissue gentle dissection over the bone, then turning the plate 180 degree over the bone shaft to the right position and sliding the DHS screw plat canal over the DHS screw using the measuring bar. Two skin stitches are enough.

Technique

Step 1-reduction

In many cases the traction table is used. The reduction is done on this table and before the patient is draped. Important also is to guarantee smooth access of the image intensifier in both planes; AP and lateral.

Step 2-guide wire insertion

1. The anteversion of the femoral neck is determined with a long K-wire inserted with the blunt end first. An alternative is to use a long, non-threaded K-wire.
2. Under X-ray control, the guide wire is inserted parallel to the anteversion wire by using the 135° guide fixed on the T-handle.

Step 3-screw insertion

1. The length of the screw must be measured/determined with the guide wire. Note that the screw must be 10 mm shorter than the length of the guide wire. The surgeon will deduct 10 mm of the measured length to determine the screw length.
2. Set the triple reamer to 10 mm shorter than the measured length. The hole is drilled over the guide wire.
3. Tapping is only required in young patients with dense bone.
4. For the plate assembling we remove the guide wire, and insert the plate sliding it through the skin cut over the femur shaft under the muscles using the plate for dissection the soft tissue above the bone surface non using any tool as periosteal elevator but the plate itself by holding it from its DHS screw canal and in 180 degree rotation position in axial aspect (transvers aspect) using the plate end for soft tissue gentle dissection over the bone, then turning the plate 180 degree over the bone shaft to the right position.

   * The plate is slid over the wrench.
   * The DHS screw is attached to the coupling wrench.
   * The sleeve is assembled over the wrench.

Step 4-plate fixation

Impact the plate in order to have best contact with the femur. The plate is fixed with conventional 4.5 mm screws:

* Drill bit 3.2 mm with sleeve
* Measuring
* Tap (when no self-tapping screws are used)
* Insertion of screw

Eligibility Criteria:
Inclusion Criteria:

* Patients presented with intertrochanteric hip fractures

Exclusion Criteria:

* not operative patients
Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC)

The purpose of this study is to investigate the feasibility of using open masks or no masks in combination with optical surface scanning for radiotherapy in patients with head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Histologically confirmed head and neck cancer.
* Patients treated with radiotherapy (RT) as primary treatment.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0-1 as defined in Appendix 3.
* Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study.
* Patients must be willing to comply with treatment plan and other study procedures

Exclusion Criteria:

* Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study.
* Patients who cannot stay still during fraction because of a disorder (e.g. Parkinson's disease)
A Study of Participants With Cerebral Adrenoleukodystrophy (CALD) Treated With Elivaldogene Autotemcel

The main aim of this study is to assess and describe the safety outcomes, including newly diagnosed malignancies, of patients with CALD treated with eli-cel in the post-marketing setting (tradename Skysona) and to describe major functional disability (MFD)-free survival over time in participants with more advanced early active CALD. All enrolled participants with CALD treated with eli-cel in the post-marketing setting will be followed in this study for 15 years. No investigational drug product will be administered in this study. This study will enroll 120 participants with CALD treated with eli-cel in the post-marketing setting. A subpopulation of 24 participants with more advanced early active CALD will be specifically enrolled as required by the US FDA as a condition of accelerated approval and will be considered as a separate cohort for effectiveness outcomes.


Eligibility Criteria:
Inclusion Criteria:

Participants who fulfill the following criteria will be eligible for inclusion in this Registry Study.

* Participant must be treated with eli-cel in the post marketing setting at a center in the United States (US) that participates in the Registry Study.
* Participant must have provided an informed consent and/or assent to participate in Center for International Blood and Marrow Transplant Research (CIBMTR) registry.
* Participant must have provided an informed consent and/or assent to participate in the Registry Study.
* Participant must receive follow up care by a US-based physician with the ability to submit REG-502 data.

Registry Study Subpopulation inclusion:

Twenty-four of the 120 patients in the Registry Study must meet the following inclusion criteria which will be used to create the more advanced early active CALD subpopulation:

• Participant must meet the above inclusion criteria and have a Loes score of 4.5 through 9.0 with GdE+ (gadolinium enhancement positivity) from an MRI performed before treatment with eli-cel and with NFS of 0 or 1 at baseline.

Exclusion Criteria:

There are no exclusion criteria for this Registry Study.
Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health Coaching

Treatment options for lumbar spinal stenosis include surgical and non-surgical approaches. For most people, the decision depends on how bothered they are by their symptoms and how they feel about having surgery. Since individuals with the same clinical presentation may feel differently about their symptoms and how they view the benefits and harms of their options, there is no agreed upon "best"treatment. It has been shown that, for "preference-sensitive" decisions like this one, decision aids (tools that pair balanced, evidence-based information regarding treatment options with values clarification) improve patients'knowledge and realistic expectations, lower decisional conflict, increase patient involvement in decision making, decrease the number of undecided, and increase agreement between values and choice.1 The Spine Center, in collaboration with the Center for Shared Decision Making (CSDM) at Dartmouth Hitchcock Medical Center (DHMC), has been providing patients with decision aids (DAs) for several years.

Hypothesis:

Patients identified as having low literacy and/or high decisional conflict after viewing a video decision aid will show greater resolution of their decisional conflict, higher decision self-efficacy and less decision regret if a coaching intervention is paired with a video decision aid.

Decision support in the form of coaching develops patients'skills in preparing for a consultation and deliberating about their options.2 A study of women with abnormal uterine bleeding showed that pairing coaching with a DA helped patients clarify their values and preferences, reduced costs, and increased long term satisfaction.3 The investigators plan to assess the impact of coaching in patients with lumbar spinal stenosis who are referred to the CSDM for a video decision aid about their treatment options. The investigators are also interested to learn whether screening for low literacy and high decisional conflict can identify a subgroup of patients who are more likely to benefit from coaching.


Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* Adults over 18

Exclusion Criteria:

* Non-English Speaking
* Anyone under the age of 18
* Prisoners
Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II

The purpose of this study is to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.

This is a prospective, single-arm, single center, non-randomized feasibility study of the CorPath 200 System to examine its performance during complete interventions (DCB, Stenting) of the femoropopliteal arteries and patient outcomes at 30 days.

Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria

* At least 18 years of age;
* Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in the femoropopliteal arteries; and
* The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.

Angiographic Inclusion Criteria Femoropopliteal artery lesion(s) with stenosis (\>50%) or occlusion of up to 120 mm in length as determined by imaging (MRA or Angio) prior to index interventional procedure.

Exclusion Criteria:

General Exclusion Criteria

If any of the following criteria are met, the subject cannot be enrolled in this study:

* Failure/inability/unwillingness to provide informed consent;
* Target vessel has been previously treated with bypass; or
* Enrolled in concurrent clinical study.

Angiographic Exclusion Criteria

• Target vessel:

* Shows evidence of previous dissection or perforation, or
* Has adjacent acute thrombus; or
* Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.
Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung Cancer

This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the efficacy and safety of the PD-1 antibody tirelizumab combined with chemotherapy monotherapy in patients with relapsed/metastatic non-small cell lung cancer.

This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the efficacy and safety of the PD-1 antibody tirellizumab combined with chemotherapy monotherapy in patients with relapsed/metastatic non-small cell lung cancer. This study prospectively collected disease history, treatment history, demographic data, baseline data during treatment, each treatment visit data, efficacy data, and safety data of NSCLC patients with EGFR and ALK driver negative ECOG PS 2 scores treated with tirellizumab combined with monotherapy. The subjects did not voluntarily withdraw from the test or the researchers believed that the subjects were not suitable for further test. Each subject will be treated until the disease progresses or the toxic and side effects caused by the drugs are intolerable, and the follow-up treatment plan, treatment status and survival data of the patients still need to be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed recurrent/metastatic non-small cell lung cancer with local recurrence or distant metastasis after prior radiotherapy and/or surgery, or with distant metastasis at the time of admission.
2. The age range is between 18 and 85.
3. Predicted survival ≥12 weeks.

Exclusion Criteria:

1. Patients with other malignant tumors.
2. Positive tests for EGFR mutation and ALK fusion gene have been confirmed.
3. Partial comorbidity.
4. other.
Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women

Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world.

There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican population.

Metformin has been used during pregnancy in women with gestational diabetes and women with polycystic ovary syndrome, with acceptable security for mother and fetus.

Metformin decrease the insulin resistance and weight gain, we believe that metformin may be decrease the risk of gestational diabetes mellitus in high risk women.


Eligibility Criteria:
Inclusion Criteria:

* Mexican women with pregnancy \< 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria:

  1. Body mass index \> 27 kg/m2
  2. Maternal age \>25
  3. History of infertility with polycystic ovary syndrome
  4. History of macrosomic newborn (Weight \>4000g)
  5. History of diabetes mellitus in first or second degree.
  6. History of gestational diabetes in previous pregnancy

Exclusion Criteria:

* Any form of pregestational diabetes
* Fasting glucose \> 126 mg/dL at first prenatal visit.
* seric creatinine \> 1.5 mg/dL
* Hyperthyroidism
* Heart disease
* Hepatic disease
* Renal diseases
* Epilepsy
* Lupus
* Chronic hypertension.
Droperidol and QTc Interval Changes in ED Patients

Objectives To assess the association of low-dose Droperidol administration in the emergency department with changes in the QTc interval.

Hypothesis Our study is designed to test the null hypothesis that there will be no clinically significant change in QTc interval after administration of 2.5mg of IV Droperidol during an emergency department visit.

The investigators plan to conduct ECG evaluation for QT interval both before and after patients are given 2.5 mg of droperidol. Specifically, a convenience sample of consenting adult patients, ages 18 years and older, who present to the ED, and are in a cardiac-monitored bed in the ED who, at the discretion of their treating physician, have an ECG recorded and then receive a dose of 2.5 mg of droperidol IV will be enrolled in our study. The investigators will then have a second ECG printed at least 5 minutes and no more than 30 minutes after the droperidol is given. Change in QT interval between the two ECGs will be documented. It may be necessary to review the EMR in order to document the time of droperidol administration.

These post-droperidol ECGs will not be stored in the electronic medical record nor read by a physician in real time. Treatment decisions regarding the patient's medical care in the ED will not be affected by these second ECGs; decisions about whether other ECGs may be needed will be made by the treating physician. The primary study outcome will be the percentage of the study population who experience a clinically significant increase in QTc after low-dose droperidol administration, defined as an increase in QTc of 20 ms or greater. Secondary outcome measures will be the mean change in QTc across the study population, and the percentage of the study population for whom the administration of low-dose droperidol is associated with an increase in QTc that re-classifies them as having a prolonged QTc (\>450 ms in men and \>470 ms in women).

Eligibility Criteria:
Inclusion Criteria:

* ED patients ages 18 years or older in a cardiovascular-monitored bed who have both an ECG and a 2.5 mg dose of IV droperidol ordered by their treating physician will be eligible for inclusion.

Exclusion Criteria:

* Refusal to provide consent.
* Administration of droperidol before the first ECG is performed.
* Inability to complete the consent form and questionnaire due to clinical instability, severe pain, or disorientation as determined by a study physician.
Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress

The purpose of this research study is to learn more about variants in the TP53 gene both associated with Li-Fraumeni Syndrome (LFS), a hereditary cancer risk condition, and TP53 variants found in the blood for other reasons (e.g. ACE/CHIP and mosaicism).

This research study looks to enroll as many people with LFS or TP53 gene variants as possible in order to:

* Better estimate cancer risks in individuals with TP53 variants or LFS, which is a rare condition.
* Learn the range of cancer risks linked to TP53 variants to help individuals and families to improve our ability to counsel patients and families about cancer risks more accurately.
* Improve opportunities for cancer prevention, early detection, and treatment.
* Learn more about the meaning of TP53 variants in the blood that are not inherited (e.g. ACE/CHIP and mosaicism).

Study procedures will include:

* Collecting information from the participant's medical record and short questionnaires.
* Collecting blood, saliva, eyebrow hair and tumor tissue samples (optional).
* Sharing study information with family members (optional).

It is expected that about 1500 people will take part in this research study. Participants will be in this study until it closes or the participant withdraws consent.

The National Cancer Institute is providing funding for part of this study and is considered a study sponsor. They will require that some of the genetic information be made available to the research community without personal identifying information.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a TP53 pathogenic or likely pathogenic variant identified in blood or saliva,
* Individuals with variants of uncertain significance in TP53 may be eligible at the PI's discretion,
* Blood relatives of individuals with a TP53 variant, who may be presumed obligate carriers or healthy controls,
* Individuals who meet Classic or Chompret LFS criteria whether or not they have a TP53 gene variant,
* Individuals may enroll their deceased relatives in the study.
* Individuals with a known TP53 variant that is not LFS, but rather ACE, CHIP, or mosaicism.
* Individuals participating in other LFS studies can still enroll in LiFT UP. Investigators may be collaborators.

Exclusion Criteria:

* Individuals who decline to sign consent
* Individuals who are unable to give consent or assent and are without a designated healthcare proxy
Asthma Implementation Research Trial

Asthma is the most common chronic disease among children worldwide, with 80% of asthma related deaths occurring in low- and middle-income countries (LMICs), such as Peru. While evidence-based guidelines exist for asthma treatment and management, adherence to guideline-based practices is low in high-income country (HIC) and LMIC settings alike. There a clear need for effective, locally-tailored solutions to address the asthma treatment gap in low-income communities in LMICs, such as Peru. This study aims to develop and test a locally-adapted intervention package to improve adoption of self-management practices and utilization of preventive health services for asthma among children in Lima. There is a paucity of research regarding the development and testing of interventions to improve asthma self-management in LMIC settings, which experience unique or exacerbated barriers to receiving evidence-based care. To the investigators' knowledge, no studies have systematically developed and evaluated an asthma management program in Peru. Therefore, the long-term goal of this study is to disseminate locally appropriate asthma management strategies to reduce asthma-related emergency department visits and improve service utilization in LMIC settings. For the current study, the investigators will carry out a randomized controlled trial to test the effectiveness of the intervention package in a group of 110 children with asthma who will be randomized to the intervention (55 children) or no intervention (55 children) arm. Participants in the intervention group will receive case management from a designated nurse manager, who will provide ongoing educational, social, and self-management support during monthly follow-up home visits and text-message based communication. Participants will be followed up every month for data collection over a six-month period. Throughout the follow-up period, the investigators will collect data on asthma control, healthcare utilization, medication adherence, quality of life of children with asthma and the children's caregivers, caregiver mental health, fidelity to the intervention, and acceptability and feasibility. Ultimately, this study will inform the scientific community about effective strategies and treatment programs for asthma in low-income settings.


Eligibility Criteria:
Inclusion Criteria:

* Currently living in Lima, Peru
* 5-17 years of age
* Has a physician diagnosis of asthma
* Has attended the emergency room or urgent care for asthma, or has been hospitalized for asthma at least once in the previous 12 months

Exclusion Criteria:

* Family plans to move out of the study community within the next 12 months
* Co-occurring chronic respiratory or cardiovascular disorders other than asthma
* Active tuberculosis or are currently taking tuberculosis medications
* Diagnosis of HIV/AIDS
Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)

This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).


Eligibility Criteria:
Key Inclusion Criteria:

* Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)
* Had a relapse with onset ≤42 days prior to the Baseline Visit
* Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom
* Had failed to obtain improvement of at least 1 point in one or more functions on the Function Systems Score (FSS) 14 days following their first dose of high dose corticosteroids
* Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit