cyrilzakka/clinical-trials huggingface dataset:
Treatment of Unstable Distal Clavicular Fractures (Neer 2b): Hook Plate vs Locking Plate

The investigators propose to test the hypotheses that compared with Hook Plate (HP), Locking Plate (LP) reduces the postoperative complications and leads to a better functional recovery after unstable distal clavicle fractures (Neer 2b).

Controversy exists regarding the optimal treatment for patients with unstable distal clavicular fractures (Neer 2b). The recognized treatment alternatives are Hook plate.Notably, criticisms on this fixation method also appeared and the potential risks of hook migration, loosening, subacromial impingement or rotator cuff injury, and acromial osteolysis were still unsolved. Recently, Herrmann et al.and Largo et al.stabilized the distal clavicle with Locking plate (LP) and these studies offered encouraging support for LP. Because of small sample size (27 patients) and nonrandomization, the convictive power of these researches is not strong enough.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years
2. Unstable fractures of distal clavicle (Neer 2b fractures), acute or chronic and unilateral fractures.
3. Normal shoulder functions before injury.
4. Internal fixation with either HP or LP.
5. The subjects were in good health and were able to comply with all prescribed follow-up procedures.

Exclusion Criteria:

1. Patients who present multiple traumas.
2. Patients with other serious injuries to either upper limb that would interfere with rehabilitation.
3. Patients with a pathological, recurrent or open clavicle fracture.
4. Patient unwilling to give written informed consent.
5. Patients with cognitive impairment unable to comply with treatment programme.
6. Patients with a serious disorder of bone metabolism other than osteoporosis (e.g., endocrine bone diseases, osteomalacia and Paget's disease)
Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy

Objective of the study is to find out the effects of Proprioceptive training in addition to routine physical therapy on balance and quality of life in patients with Diabetic neuropathy.

Alternate Hypothesis:

There will be significant difference in effects of Proprioceptive training in addition to routine physical therapy on balance and Quality of life in patients with Diabetic neuropathy.

It was a parallel designed single blinded randomized controlled trial conducted in the Green Poly Clinic Bahria town, Lahore, Pakistan using non probability convenient sampling. patients who met eligibility criteria was informed about the aim of study. consent form were signed by all participants.After baseline assessment ,participants were randomly assigned in two groups.(ratio 1:1) The calcualted sample size was 27 in each group. i.e. 54 ( 27 in each group). After adding 20% drop out the final size will become, 64( 32 in each group) using 95% level of significance and 80% power of study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pre-diagnosed DM for seven years.
* Male and female patients with type 2 diabetes.
* Patients with ≥2 DPN symptoms.
* Patients scored\&gt;2/13 on MNSI questionnaire.

Exclusion Criteria:

* Participants with Foot ulcers, Orthopedic or surgical problem in a lower limb, other neurological impairment and Major vascular complication,
* Severe vestibular dysfunction
* Participants with Severe retinopathy and Severe nephropathy,
* Inability to walk independently with or without an assistive device,
* Receiving any structured supervised physiotherapy intervention.
Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients

The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after single subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal blood flow after single SC or IV doses in healthy participants and migraine patients.

This study was a single-dose, double-blind, placebo-controlled, sequential dose escalation study in which participants were to be enrolled into 8 cohorts.

In Part 1 healthy participants were randomized in a 3:1 ratio (erenumab:placebo) into 6 cohorts: 5 cohorts received the investigational product (IP) as an SC administration and 1 cohort received it as an IV administration. In Part 2 a total of 12 migraine patients were randomized in a 1:1 ratio (erenumab:placebo) in cohort 7. An additional 8 migraine patients could have been enrolled and randomized in a 3:1 ratio in the optional cohort 8, however this cohort was not enrolled.

Eligibility Criteria:
Inclusion Criteria:

- Healthy male and female subjects between 18 and 45 years of age, or male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician;

Exclusion Criteria:

- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
Tracking Response to Antidepressants in Advance of Investigational Trials

TRAIT is an open-label observational study to evaluate treatment response to selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) among individuals meeting criteria for Major Depressive Disorder (MDD) and seeking enrollment in investigational trials.


Eligibility Criteria:
Inclusion Criteria:

* Participant has signed an ICF prior to any study-specific procedures being performed.
* Participant is male or female of age ≥ 18 years old.
* Participant has a diagnosis of MDD as confirmed by the MINI semi-structured diagnostic interview and ≥ 14 HAM-D total score.
* Participant is in good physical health and, in the opinion of the investigator, is a suitable candidate for treatment with an ADT.

Exclusion Criteria:

* Participant is pregnant, breast-feeding, or planning to become pregnant.
* A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which in the opinion of the investigator may impact participant safety or study results.
* Participant has a history of any psychiatric condition other than MDD, which in the opinion of the investigator is primary, or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
* Any participant who represents an acute suicidal risk in the opinion of the investigator.
* Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the opinion of the investigator could pose undue risk to the participant, or compromise the study.
* Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma

All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study.

No additional treatment or intervention will be conducted except for blood sampling that will be limited to one time only.

Blood samples (10 cc in volume) will be collected from all study participants once they provided written informed consent form. DNA will be extracted from peripheral blood samples using DNA isolation kit.


Eligibility Criteria:
Inclusion Criteria:

* All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study
Role of TAP and RS Block in Reduction of Postoperative Pain for Gynecological Surgical Laparoscopic Procedures

The present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of the transversus abdominis plane block (TAP block) and the rectus sheath block (RS block), compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs consumption, patient satisfaction and decrease of LOS (length of stay), in patients undergoing benign gynecological laparoscopic surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing benign laparoscopic gynecological surgery
* age between 18 and 75 years
* BMI \>18 e \<35
* ECOG Performance Status 0-1

Exclusion Criteria:

* age \< 18 or \> 75 years
* BMI \<18 or \> 35
* ECOG Performance Status \>1
* Allergy to local anesthetics
* Allergy to NSAIDs
* Chronic kidney failure \> II class
* Systemic neoplastic disease actual or previous
* Actual pregnancy
* Active or recent pelvic inflammation
* Persistent coagulopathy
* Previous opioids consumption for chronic pain
* Neurological or cognitive disorders
* Conversion from laparoscopic to open surgery
* Onset of intraoperative complications
xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation by Radiologists

xrAI (pronounced "X-ray") serves as a clinical assistance tool for trained clinical professionals who are interpreting chest radiographs. The tool is designed as a quality control and adjunct, limited, clinical decision support tool, and does not replace the role of clinical professionals. It highlights areas on chest radiographs for review by an interpreting clinician.

The objective of this study is to utilize machine learning and artificial intelligence algorithms (xrAI) to improve the quality and efficiency in the interpretation of chest radiographs by radiologists.

The hypothesis is that the addition of xrAI's analysis will reduce inter-observer variability in the interpretation of chest radiographs and increase participants' sensitivity, recall, and accuracy in pulmonary abnormality screening.

To investigate the effect of xrAI for radiologists that interpret chest radiographs as part of their daily responsibilities, the investigators have designed a randomized control trial.

The pulmonary abnormalities detected by xrAI and included in the definition of abnormal are as follows: any linear scar or fibrosis, atelectasis, consolidation, abscess or cavity, nodule, pleural effusion, severe cases of emphysema and COPD (mild cases with hyperinflation but not significant emphysema are not flagged), and pneumothorax.

To assess the causal effect of xrAI the investigators randomly assign 10 to 14 radiologists to either treatment (x-ray images processed by xrAI) or control (no xrAI processing) groups. Participants will only review images once. Each participant will perform 500 radiograph interpretations in total.

Participants in the control group will be asked to interpret the same 500 images without xrAI's analysis.

To increase the precision of the estimate and better investigate potential differences between clinical professionals, investigators block randomize the assignment of treatment or control group.

To analyse the effect of xrAI, the investigators will estimate the average treatment effect (ATE) for each group by comparing the performance of the treatment and control groups using randomization-based inference (Green and Gerber, 2012).

Eligibility Criteria:
Inclusion Criteria:

* Radiologist currently practicing at a Pureform Radiology clinic in Calgary, Canada.

Exclusion Criteria:

* Radiologists not currently practicing at a Pureform Radiology clinic in Calgary, Canada.
* Physicians currently practicing at a Pureform Radiology clinic in Calgary, Canada, but that are not radiologists by training.
Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study

This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.

Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring.

Urinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine.

This study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 80 years
* Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection
* Completed and explicit information about TNM staging
* Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery.
* Patients must have given written informed consent

Exclusion Criteria:

* Unable to comply with the study procedure
* Malignant tumor history within the past 5 years
* Coexisting small cell lung cancer
* Unqualified tissue, blood or urine samples
Progression of Stereopsis Recovery in Strabismic Patients: A One-Month and Three-Month Post-Surgery Evaluation

This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery. The study will be conducted at Mayo Hospital, Lahore, and Sajjad Eye Center, Burewala, with a sample size of 34 using a purposive sampling technique. Eligible participants include patients aged ≥5 years undergoing strabismus surgery for esotropia, exotropia, or vertical deviations, with best-corrected visual acuity (BCVA) of 6/12 in both eyes. Patients with previous strabismus surgery, amblyopia, neurological conditions, or sensory strabismus will be excluded.

Baseline assessments include visual acuity (Snellen Chart), ocular alignment (cover-uncover and prism cover tests), and stereopsis (Titmus Fly Test). The same tests will be repeated one month and three months post-surgery to evaluate changes. The study aims to determine whether strabismus surgery enhances binocular function and stereopsis, helping guide future treatment strategies. Data will be analyzed using paired t-tests to assess differences over time.

Eligibility Criteria:
Inclusion Criteria:

* Patients (≥5 years and adults) undergoing strabismus surgery for: esotropia, exotropia, vertical deviations (hypertropia or hypotropia)
* Best corrected visual acuity (BCVA) of 6/12 in both eyes
* Willingness to attend follow-up visits at 1 month and 3 months post-surgery.8

Exclusion Criteria:

* History of previous strabismus surgery
* Amblyopia
* Neurological and systemic conditions affecting vision
* Uncontrolled nystagmus and sensory strabismus
* Patients unable to complete stereopsis testing due to cognitive or physical limit
Local Anesthesia Before Arterial Puncture for Blood Gas Analysis

The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a numeric Pain Intensity for all patients included.

In an approach of continuous improvement of the quality of the care, this project joins logically after a reflection on the treatment of pain generated by the care in the department of Pneumology 1 / septic Thoracic and vascular Cardiac Surgery.

The arterial puncture for blood gas analysis is an act with aim diagnosis which allows to study gases of the arterial blood to watch the hematosis of the patient. This act appears at the top of the anticipated care as painful by the nursing teams.

In the literature, we find no study carried out with the eutectic mixture lidocaïne prilocaïne. Other local anesthetics and other local ways of administration were estimated and the results diverge as for the efficiency of a local anesthetic for the arterial blood sample at the level radial nerve. Finally authors showed a correlation between certain factors(mailmen) and the painful character of the arterial blood sample, without defining really of population.

In this context, it is necessary to estimate the interest of a local anesthetic before arterial sampling of blood by a study randomized in insu double and versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years old, having signed an enlightened consent, who have an indication of gazometry by taking radial nerve
* Patients capable of estimating the pain felt with numeric pain intensity scale
* Patients with numeric pain intensity scale = 0 before sample of blood
* Patients with no contraindication or no allergy of an anesthetic such as lidocaine

Exclusion Criteria:

* Patients aged less than 18 years old
* Patients incapable of estimating the pain felt with numeric pain intensity scale
* Patients with numeric pain intensity scale \> 0 before sample of blood
* Patients for whom the arterial taking is impossible for the level radial nerve
* Hypersensibility to local anesthetics of the amide-type or other component of lidocaïne/prilocaïne cream
* Porphyries known
* Pregnant woman
Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.

The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC.

The study is a non-control study.

The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study.

This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of positive ALK.
* Patients must have demonstrated progression during or after crizotinib treatment.
* Age 18 years or older at the time of informed consent.
* Eastern cooperative oncology group performance status (ECOG PS) of 0-2
* At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
* Willingness and ability to comply with the trial and follow-up procedures.

Exclusion Criteria:

* chemotherapy, radiation therapy, immunotherapy within 4 weeks.
* Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
* Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion
Shoe Lifts for Leg Length Inequality in Adults With Knee or Hip Symptoms

Limb length inequality is when a person has one leg that is longer than the other. This research will look at correcting limb length inequality in adults with knee or hip symptoms. This study will examine whether ways of measuring leg length inequality in the clinic are valid and reliable, determine whether foot posture (flat foot, normal, and high arch) is related to leg length inequality, and determine whether shoe lifts are a helpful treatment for leg length inequality and knee/hip symptoms.

The purpose of this study is to examine the optimal clinical assessment method(s) for leg length inequality (LLI), determine if there is an association between foot posture (flat foot, normal, and high arch) and LLI, and gather preliminary data on lift therapy as a treatment for LLI and knee/hip symptoms. The specific aims of the project are as follows:

Specific Aim 1: Determine the validity and reliability of 4 clinical methods for assessing LLI.

Specific Aim 2: Determine differences in static and dynamic foot postures between longer and shorter limbs.

Specific Aim 3: Assess the feasibility of conducting a specific lift therapy intervention among individuals with a LLI and knee or hip pain, refining procedures as needed.

Public Health Impact: Results from the proposed research will be used to: 1) improve diagnosis of LLI by providing evidence on the various assessment methods for the clinicians who most frequently use clinical methods (i.e., physical therapists, chiropractors, podiatrists, and primary care physicians), and 2) develop and test new non-pharmacologic/non-invasive intervention strategies aimed at reducing pain and improving function in individuals with osteoarthritis and LLI.

Eligibility Criteria:
Inclusion Criteria:

* participants from the Johnston County Osteoarthritis Project who have been previously identified to have a LLI and knee or hip symptoms

Exclusion Criteria:

* hospitalized for stroke, myocardial infarction, coronary artery revascularization, or diagnosis of metastatic cancer in the past 3 months
* terminal illness
* rheumatoid arthritis, severe fibromyalgia, or other systemic rheumatic disease
Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects

This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy.
* BMI 18-25 kg/m2.

Exclusion Criteria:

* History of clinically significant illness.
* History of alcohol or drug abuse.