cyrilzakka/clinical-trials huggingface dataset:
Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury

This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.

To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150 years much research has been performed. PEG-Axon fusion on the other hand is relatively new in mammals. Success has already been obtained by two institutions in the rat sciatic nerve transections, demonstrating rapid return of behavioral function4. These however are very controlled injuries and unclear how well these will translate into human studies. For this reason 3 separate clinical studies in increasing order of complexity are proposed.

The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure.

Eligibility Criteria:
* Isolated nerve transections of the digits, forearm, wrist, and palm will be included.
* Class III nerve injury (Sunderland's 4th or 5th degree injury)
* Nerve injuries that can be prepared using minimal or acceptable tension (according to surgeon discretion).
* Pregnant and breastfeeding women cannot participate because of possible unknown and unpredictable risks to the unborn child.
* Injuries beyond 24 hours will be excluded
Community Enabled Readiness for First 1000 Days Learning Ecosystem

The CRADLE (Community-enabled Readiness-for-1000-Days Learning Ecosystem) initiative seeks to improve first-time families' self-efficacy in parenting and to tangibly impact factors in maternal and child care which will result in improved health of mother and child.

Title: CRADLE (Community enabled Readiness for first 1000-Days Learning Ecosystem) Project

Introduction:

The "developmental origins of health and disease" (DOHaD) is a concept that has emerged over the past 50 years, linking the state of health and risk from disease in early childhood and adult life. With increasing evidence in neuroscience of the critical window of the first 1000 days of life which has life- long impact on cognitive, behavioral, physical and mental health of an individual. In present society where new parents learned the skills from social media which are based on personal perception and not evidence.

CRADLE (Community-enabled Readiness-for-1000-Days Learning Ecosystem) initiative seeks to improve first-time families' self-efficacy in parenting and to tangibly impact factors in maternal and child care which will result in improved health of mother and child.

Hypothesis:

Use of an integrated choice architecture in a self-learning eco-community, with calibrated nudges, and group interactions \& interaction with midwives and individualised teleconferencing sessions in the first 1000-days for first-time families will improve parenting self-efficacy.

Method:

This will be an Interventional Cohort Study. Each ARM 250 subjects. ARM 1 : Routine care ARM 2 : Behavioral Intervention with nudges and Facebook interaction ARM 3 : Community Intervention with interaction with midwives and individualised teleconferencing sessions

The follow up period will be from first contact till child reaches 2 years old Measurement.

The investigators will quantify the impact of this initiative through measurements of specific health \& nutrition domains \& patient-reported outcome measures (see below) as well as participant satisfaction.

The two key health morbidities the investigators are addressing are the overall health and mental wellness of first-time families as well as their metabolic health (ie, nutrition).

1. Mother's Height and Weight (BMI)
2. Child's Height and Weight (BMI)
3. PROMIS Global-10 Scale
4. Patient Health Questionaire-2
5. Edinburgh Postnatal Depression Scale
6. Parental Sense Of Competency Scale
7. Tool To Measure Parenting Self-Efficacy (TOPSE)
8. Birth Satisfaction Scale
9. Breastfeeding Self-Efficacy Scale
10. Infant Feeding Questionnaire

Eligibility Criteria:
Inclusion Criteria:

1. First-time mothers
2. Be at least 17 years of age
3. Is residing in Singapore for the next 3 years
4. Understand English, or has a family member who is able to assist.

Exclusion Criteria:

1. Has existing medical conditions such as chronic illnesses
A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants

The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin

The secondary objectives of the study are:

* To evaluate the bleeding risk (ie, major and clinically relevant non-major \[CRNM\] bleeding) of REGN9933 after unilateral TKA through time of venography, compared to enoxaparin
* To assess overall safety and tolerability of REGN9933 in participants undergoing TKA
* To evaluate the efficacy of REGN9933 in prevention of clinically relevant VTE, compared to enoxaparin
* To evaluate the efficacy of REGN9933 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin
* To evaluate the pharmacokinetics (PK) of REGN9933 after single intravenous (IV) administration
* To assess pharmacodynamic (PD) effects of REGN9933 on intrinsic and extrinsic coagulation pathways
* To assess immunogenicity following a single dose of REGN9933 over time
* To compare the efficacy of enoxaparin and apixaban in prevention of VTE after unilateral TKA


Eligibility Criteria:
Key Inclusion Criteria:

1. Undergoing elective unilateral TKA
2. Has a body weight ≤130 kg at screening visit
3. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and Electrocardiograms (ECG) performed at screening and/or prior to administration of initial dose of study drug
4. Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol

Key Exclusion Criteria:

1. History of bleeding in the past 6 months requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis.
2. History of thromboembolic disease or thrombophilia
3. History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months.
4. History of major trauma within approximately the past 6 months.
5. Hospitalized (\>24 hours) for any reason within 30 days of the screening visit
6. Using the Modification of Diet in Renal Disease equation, has an estimated glomerular filtration rate as described in the protocol

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Quality Improvement Initiative for Enhancing Early Mobilization in Intracerebral Hemorrhage Patients

Primary intracerebral hemorrhage (ICH) is a severe and life-threatening condition with a high mortality rate, reaching up to 50% within the first month. Survivors are often at risk of long-term disability due to the extensive brain damage caused by the hemorrhage. Unlike ischemic stroke patients, ICH patients are typically younger, face longer hospital stays, and are more likely to experience acute complications. Modern treatment approaches have shifted from focusing solely on reducing mortality to minimizing disability and enhancing functional outcomes through early rehabilitation. However, the optimal timing and intensity of early mobilization remain unclear, especially for patients with severe ICH, where medical stability is a major concern. Delays in initiating rehabilitation may limit neuroplasticity and hinder recovery, prompting the need for a structured, multidisciplinary approach to early mobilization in ICH patients.

Objective : This quality improvement (QI) initiative aimed to enhance early mobilization in ICH patients by implementing a structured clinical pathway in an academic stroke center. The goal was to integrate evidence-based early mobilization pathways to improve patient mobility outcomes while ensuring safety through standardized assessments of cardiovascular, respiratory, and neurological stability.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary ICH
* ICH score from 0 to 4
* Patients In line with the stroke center's standard criteria for early rehabilitation

Exclusion Criteria:

* Patients with traumatic brain injury, hemorrhagic transformation of ischemic stroke, or hemorrhage related to underlying malignancy
* Patients placed in palliative care or those who died before initial hospital discharge
Comparison of Naloxone Pharmacokinetics

Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 to 55 years of age, inclusive
* Provide written informed consent
* BMI ranging from 18 to 32 kg/m2, inclusive
* Adequate venous access
* No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG
* Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm from the screening visit until 90 days after the last study drug administration
* Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after the last study drug administration. Oral contraceptives are prohibited
* Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study

Exclusion Criteria:

* Contact site directly for more information
Clinical Evaluation of a Progressive Addition Lens (PAL)

The purpose of the trial is to clinically evaluate the performance of a progressive addition lens among presbyopic patients.

This evaluation will be done by performing visual tests and collecting subjective information from subjects wearing the lens which will be manufactured according to personal prescription.


Eligibility Criteria:
Inclusion Criteria:

* An ability to comprehend and give an informed consent for participation in the trial
* Presbyopia

Exclusion Criteria:

* Concurrent participation in another clinical trial
* Age\<18
* For female subjects: pregnancy \\ planning a pregnancy \\ lactating at the time of enrollment
* Imbalanced diabetes \\ high blood pressure \\ thyroid disease
* Infectious disease
* Inability (cognitively) to comprehend the instructions given during the trial and to comply with them
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures

This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia fracture? Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

The study is a multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature,
* Extra-articular fracture of the proximal tibia extending into the metaphyseal with or without intra-articular extension not requiring open reduction with complete anteroposterior (AP) and lateral radiographs,
* Major fracture line not closer than 4cm from the proximal tibial articular surface
* Fracture requiring operative treatment amenable to either IM nail or plate
* Surgeon agreed to randomize patient
* Informed consent obtained
* Patient is English speaking

Exclusion Criteria:

* Tibial shaft fractures not amenable to intramedullary nailing (i.e.fracture is less than 4 cm from joint surface),
* Fracture of the proximal tibia with intraarticular extension requiring open reduction,
* Known metabolic bone disease
* Separate displaced tibial tubercle fragment,
* Soft tissue injuries compromising treatment method with nail,plate or both.
* Fractures with vascular injury (Gustillo Type IIIC injury) requiring repair,
* Compartment syndrome of the leg diagnosed preoperatively,
* Pathological fractures,
* Retained hardware or existing deformity in the affected limb that would complicate IM nailing,plating or both,
* Symptomatic knee arthritis.
* Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures,
* Immunocompromised,
* Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired),
* Current or impending incarceration,
* Unlikely to follow-up in surgeon's estimation.
Importance of Hollow or Solid Centralizer for Polished, Collarless and Tapered Stems in Total Hip Arthroplasty

The study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In a prospective, controlled and randomized study comprising two groups of 30 patients/hips each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In completion general health questionnaires as well as hip specific scoring instruments will be used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the different centralizers will result in different migration patterns of the stems, which might affect the risk for late aseptic loosening.


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of the hip necessitating primary hip replacement
* Charnley classification group A and B
* Age 60 - 85 years old at the inclusion time of the study.

Exclusion Criteria:

* Secondary osteoarthritis
* Rheumatoid arthritis
* Malignant disease
* Severe osteoporosis
* Earlier fracture or operation in the hip to be operated on
* Peroperative fracture
* Ongoing corticosteroid (oral) or immunosuppressive medication
* Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.
Way To Drive Validation Study

Way to Drive is a smart phone-based driving telematics application. Research participants are invited to download the app, which uses phone sensors to track driving behaviors including mileage, hard breaking events, and handheld phone use while driving, measured as the phone screen being unlocked while the phone is in the hand and the vehicle is in motion. Before the study team launches a clinical trial using the app, the researchers will test its capabilities and reliability.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older (only adult drivers will be invited)
* Willing to download Way to Drive and allow it to track the user's location while the user is in motion (i.e. over 5mph)
* Will make at least 4 driving trips per week for the duration of the study.
* Able to provide informed consent

Exclusion Criteria:

* Under 18 Cannot complete online surveys
* Does not have smart phone
* Not willing to download Way to Drive app and allow location tracking while in motion
* Will not be driving at least 4 times per week during the study.
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers

The purpose of this open, multicenter pilot trial is to assess the impact of the use of an amniotic membrane on the healing of a persistent epithelial lesion or of a corneal ulcer.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 80 years old
* Stage 2 (persistent epithelial lesion : LEP) or stage 3 (corneal ulcer) trophic ulcer affecting only one eye. Patient whose contralateral eye is affected by stage 1 neurotrophic keratitis may also be included
* Two or more weeks old LEP or corneal ulcer refractory to one or more conventional nonsurgical therapies
* Absence of objective evidence of improvement of the epithelial ulceration or corneal ulcer within 2 weeks prior to study inclusion
* Failure of amniotic membrane treatment of the trophic ulcer: failure by absence of healing a few day after overlay treatment or 15 days after inlay grafting
* Patient able to understand French language
* Informed and consenting patient
* Patient affiliated to a social security system or beneficiary of such a system

Exclusion Criteria:

* Pregnant or breastfeeding patient or without contraception for non-menopausal women
* Active infectious ulcer
* Preperforating ulcer or ulcer that has reached the posterior 1/3 of the storm
* Allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein
* Current contact lens wear, including scleral lenses
* NSAID eye drops and any drops containing preservatives
* Antibiotic, anti-viral, anti-parasitic eye drops
* Patients with identified causes of the ulcer for which medical treatment without preservatives or other healing treatment is beneficial
* Ocular surgery for other pathology than the trophic ulcer in the 3 months preceding the inclusion in the study
* Ophthalmologic pathology requiring daily eye drops
* Monophtalmic patients
* Persons deprived of liberty by a judicial or administrative decision
* Adults who are subject to a legal protection measure or who are unable to express their consent
Efficacy of Topical Capsaicin on Chronic Neck Pain

The purpose of this study is to determine whether topical capsaicin patch can effectively reduce chronic neck pain.

* Design: This is a double-blind, randomized, controlled study. Participants: Sixty participants with chronic neck pain are recruited and randomly assigned to two groups.
* Intervention: Over an four-week period, the treatment group (n=30) uses capsaicin patch (100 mcg/3cc) at the tender point of neck for 12 hours a day; the control group (n=30) receives Hydrogel patch instead of capsaicin patch.

Eligibility Criteria:
Inclusion Criteria:

* Korean participants with Chronic neck pain are enrolled in our study

Exclusion Criteria:

* Participants with coagulation deficiencies, infections, hypertension, diabetes, heart disease, renal disease, liver disease, cancer, myelopathy, hypersensitivity of drugs, other skeletomuscular disease, allergic response to capsaicin, pregnancy and nursing are excluded
A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst

This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).

Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using open system on cryotopvit. device and thawed with gradual thawing technique using HM according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit. Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.

Eligibility Criteria:
Inclusion Criteria:

* age of the patients 22-37
* All vitrified \& thawed blastocyst.
* unexplained cases or ovarian factors for infertility.

Exclusion Criteria:

* extremes of age
* cases of uterine factor
* endometriosis
A Multi-center Randomized Controlled Trial of Intraportal Chemotherapy Combined With Adjuvant Chemotherapy (mFOLFOX6) for Stage II and III Colon Cancer

To investigate whether intraoperative intraportal chemotherapy combined with adjuvant chemotherapy as treatment could improve disease-free survival (DFS) in patients with curative colorectal cancer resection compared with adjuvant chemotherapy alone.

This is a prospective, blind (doctors who done outcome measures were masked), multi-center, 2-arm randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;
2. Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).
3. Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2007 revision of the International Union Against Cancer TNM staging system)
4. Performance status (ECOG) 0\~1
5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either AST or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
7. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Previous exposure to prior cancer therapy (chemotherapy, radiotherapy or intervention therapy) for colon cancer.
2. Patients with known hypersensitivity reactions to any of the components of the study treatments.
3. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
4. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
5. Known drug abuse/ alcohol abuse
6. Legal incapacity or limited legal capacity
7. Pre-existing peripheral neuropathy.