cyrilzakka/clinical-trials huggingface dataset:
The Use of 3D Printing in Orbital Fractures

The study is a prospective randomized longitudinal clinical study to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants (the latter being the traditional approach and current standard of care).

Orbital fracture, which accounts for 10-25% of facial fractures, is one of the most difficult facial fractures to treat. The complex bone anatomy and the proximity of adjacent vital structures make reconstruction of these fractures challenging. Inadequate orbital fracture reconstruction leads to cosmetic and functional complications. Cosmetic complications include enophthalmos, which is defined as posterior displacement of the eyeball within the orbit due to changes in the volume of the orbit (bone) relative to its contents (the eyeball and orbital fat). Functional complications include diplopia, defined as a type of vision disorder in which two images are seen of a single object.

This is a prospective randomized clinical study with longitudinal follow-up. The study duration is 2 years, and it will be conducted at Grady Memorial Hospital (GMH). The study targets low-income, urban adults suffering blunt facial trauma who are diagnosed with unilateral orbital fracture.

The purpose of this study is to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants. Main aims of the study are to 1) preoperatively generate a patient-specific model to pre-adapt the titanium mesh for use in unilateral orbital fractures; 2) accurately restore the orbital volume to pre-injury levels; 3) prevent postoperative complications including enophthalmos and diplopia; and 4) decrease the operative time, therefore decreasing overall cost and increasing value.

Eligibility Criteria:
Inclusion Criteria:

* Agreed to be enrolled in the study.
* Indications for surgical repair of orbital floor and/ wall fractures are dependent on several factors:

  * Correction or prevention of cosmetic deformity ( enophthalmos or inferior dystopia; disruption of greater than 50% of the orbital floor is likely to cause cosmetically apparent enophthalmos.
  * Correction of unresolved diplopia (7 to 11 days) in the sitting of soft tissue prolapse with a positive forced duction test.
  * Immediate correction of diplopia in the sitting inferior rectus muscle incarceration and a positive forced duction test.
  * Immediate correction in a symptomatic patient with orbital floor ( trapdoor) fracture that has elicited the oculocardiac reflex.
* At least 18 years of age.
* Unilateral orbital floor fracture.
* No history of orbital trauma.
* Healthy contralateral orbit.
* Underwent orbital reconstruction.
* Admitted to GMH.
* Returned for the 6-week follow-up.

Exclusion Criteria:

* Refuse study enrollment.
* Are younger than 18 years.
* Pregnant women.
* Prisoner
* Unable to obtain consent (cognitively impaired)
* Are admitted to hospitals other than Grady Memorial Hospital.
Restylane Defyne in a Stepwise Treatment Approach

This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.


Eligibility Criteria:
Inclusion Criteria:

* Subjects willed to comply with the requirements of the study and provided a signed written informed consent
* Subjects willed to undergo augmentation and correction therapy in the studied indications
* Adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
* Previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim
* Participation in any interventional clinical study within 30 days of screening
Morphine and/or Nalbuphine as Adjuvants in Ultrasound Guided Interscalene Block: for Shoulder Surgeries

the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder.
* ASA physical status I - Ш.

Exclusion Criteria:

* Infection at the site of injection.
* Coagulopathy or other bleeding diathesis.
* Known allergy to drugs in the study
* Preexisting neurologic deficits in the area to be blocked.
* Inability to communicate with the investigator and the hospital staff.
* History of chronic opioid use.
* Morbid obesity BMI\>40.
Stair Climbing Exercise Versus Traditional Resistance Exercise

Current evidence suggests resistance exercise as the primary therapeutic strategy to prevent age-related functional decline. The National Strength and Conditioning Association recently stated that a properly designed resistance exercise program should include power exercises performed at higher velocities in concentric movements with moderate intensities. We should be aware that not all older adults are easily motivated to train in unfamiliar gym-based settings with high subscription fees. Therefore, implementation of traditional gym-based resistance exercise at a large scale has been found to be difficult. Interestingly, we have previously shown that the use of high external loads, which implies the need for specific facility memberships, is not necessary to induce neuromuscular gains. This provides strong support for home-based training intervention strategies. Stair climbing or stepping-based exercise constitute a promising avenue to ameliorate the cost-effectiveness and implementation potential of resistance exercise in older adults. Such exercises can induce muscular activation levels similar to high-load resistance exercise and result in similar or even better gains in muscle mass, strength and power compared to slow-speed resistance exercise when properly designed. However, the (neuro)-muscular effects of stair climbing exercise have never been compared to the more optimal power-oriented resistance exercise, which is the primary aim of this study. The secondary aim of this study is to examine if stair climbing exercise also has beneficial effects on cognition.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Unstable cardiovascular disease
* Neurological disorders
* Cognitive malfunctioning (MoCA \< 24)
* Low level of physical function (SPPB \< 7)
* Acute infections/fever
* Severe musculoskeletal problems
* Systematic engagement in (resistance) exercise in the 12 months prior to participation
The Impact of COVID-19 on Surgical Practice in Jordan During the Second Outbreak

Background: COVID-19 is an acute respiratory pandemic with no available effective antiviral treatment or widely available effective vaccine. Surgical practice has faced widespread problems due to the pandemic including viral transmission risk and cross-infection, staffing problems, prioritizations of surgical procedures and lack of beds due to occupancy of hospitals and ICU beds with COVID-19 patients; Methods: A survey was conducted between October 31 to November 4, 2020, through google forms. The questionnaire involved 16 questions sent to consultants and specialists of all general and special surgical specialties and subspecialties in Jordan;

A survey was conducted between October 31 and November 4, 2020. The questionnaire was made through google forms, and a consent was taken from the Jordan medical association to send the link to surgeons in Jordan through the social media and the official WhatsApp groups. The survey was introduced with the invitation to participate of surgeons of all general and special surgical specialties and subspecialties. The aim of the survey was mentioned in the introduction which was to evaluate the impact of COVID-19 on surgical practice in Jordan during the second outbreak of COVID-19, and it was explained that the aim of the survey was for research purposes only and that it was totally anonymous with privacy preserved, and no identifying information required. Also, it was noted that we have added spaces for written views and recommendations.

The questionnaire involved 16 questions of the multiple-choice, the dropdown, the multiple check, and the short answer questions. The first 2 questions were about the specialty and the place of work whether it was the ministry of health, the royal medical services, the university hospitals, or the non-governmental organizations. The 3rd and 4th questions were about the hospital where the participant works whether it admits COVID-19 patients and/or ordinary patients. The Questions from the 5th to the 8th were about the volume of work in terms of the number of elective and emergency surgeries during the month of October 2020 in comparison to the average monthly rate during the year 2019. The questions from the 9th to the 15th were about the problems that might have been faced in managing elective and emergency cases during the month of October 2020 in relation to COVID-19. The last question was a multiple checkbox question with an added space for giving the possible recommendations to manage the situation.

Eligibility Criteria:
Inclusion Criteria:

* Consultants and specialists of all general and special surgical specialties and subspecialties in Jordan

Exclusion Criteria:

* None
Impact of Women's Empowerment Program for Abused Pregnant Women

Although domestic violence is recognized as major threat in pregnancy, there is no intervention has been developed or test to support women in India. To evaluate the effect of women's empowerment program administered to abused women in order to reduce domestic abuse, improving health status and safety behavior.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age,
* victims of intimate partner violence, and
* willing to participate

Exclusion Criteria:

* women whose abuser was not their intimate partner or
* who were unable to consent
The Effect of Animation Therapy on Time Perception in Primary School Children

The aim of the study is to determine the effects of animation therapy on time perception and daily activity routine performances of primary school children.

Time is a process that forms the basis of executive functions used to reveal adaptive behavior and motor performance. However, the way we perceive time can be changed by different factors. This may reveal changes in executive functions such as decision making, behavioral inhibition, planning, and accordingly, in the performance levels and daily routines of daily living activities. Animation therapy is the therapeutic use of the process of shooting a stop-motion animation film. It creates a "flow" effect by nature. The concept of flow includes the loss of the sense of time. In this study, it is aimed to examine whether animation therapy has an effect on the perception of time and daily activity routines in primary school children.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 7-10
* Absence of any orthopedic, neurodevelopmental, and psychiatric problems/diagnosis
* Continuing formal education
* Voluntarily agreeing to participate in the research

Exclusion Criteria:

* Receiving orthopedic, neurodevelopmental and psychiatric diagnosis during the study period
* To be absent from the study process or to quit the process
* Not participating in the first and last evaluations
* Voluntary refusal to participate or continue with the research
Hybrid AF -- A Prospective Registry

Atrial Fibrillation (AF) is a form of rapid irregular heart rhythm that starts in the upper chambers of the heart (called atria) and is often associated with many health problems. It can cause stroke, palpitations and heart failure. The management of long standing (chronic) AF may require additional medications and blood thinners, potentially for life. It may also require procedures where the heart is shocked with an electrical current to restore normal rhythm. Some patients require a procedure called radiofrequency ablation to address the arrhythmia.

The purpose of this registry is to collect information on patients undergoing this combination of procedures into a database, and to then use this information for scientific study to improve the treatment of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Documented effectiveness failure of at least one Vaughan-Williams Class III AAD
* Persistent AF as defined by the HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation
* Absence of significant structural heart disease as demonstrated by a transthoracic echocardiogram (TTE) of all four chambers of the heart, computed tomography (CT) scan or magnetic resonance imaging (MRI) scan within 6 months prior to enrollment
* Absence of left atrial thrombus as documented by an imaging study (e.g., TTE, transesophageal echocardiogram (TEE), thoracic CT scan, MRI, or left atrial angiography) within 30 days prior to procedure

Exclusion Criteria:

* History of longstanding persistent AF for more than 3 years
* Documented left atrial size of 60 mm or more
* Documented left ventricular ejection fraction (LVEF) less than 40%
* History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
* Significant underlying structural heart disease requiring surgical or procedural intervention within the last six months of initial procedure
* Known contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
* Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis, etc.)
* Pregnancy, planned pregnancy (females of childbearing potential must have a negative pregnancy test prior to enrollment and agree not to become pregnant during the trial) or breastfeeding;
* Concomitant procedure planned
Remote Ischemic Limb Preconditioning In Healthy Volunteers

The investigators would like to determine if remote ischemic leg preconditioning in healthy volunteers improves cerebral vasomotor reactivity as measured by breath holding and transcranial doppler vasomotor reactivity.

This study is to determine if remote ischemic leg preconditioning improves short and long term cerebral vasomotor reactivity in healthy volunteers as measured by breath holding and transcranial doppler vasomotor reactivity. Previous studies on brachial vasomotor reactivity have shown a beneficial effect of remote ischemic preconditioning. It remains uncertain if a similar beneficial effect can be reproduced with cerebral vasomotor testing. Many biological mechanisms and effector pathways triggered by preconditioning have demonstrated endothelial protection and beneficial vascular effects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Presence of chronic medical conditions such as diabetes, hypertension, cardiac disease etc.
* Any prescribed medication
* Pregnancy \[by history and last menstrual period\]
* Any leg injury that would, in the opinion of the investigator, affect preconditioning
Comparative Effects of Wurn Technique and Mercier Therapy in Women With Endometriosis

This project was a Randomized controlled trial conducted to check the comparative effects of wurn technique and mercier therapy on dyspareunia, dysmenorrhea, and quality of life in women with endometriosis. The duration was 6 months, convenient sampling was done, subjects following eligibility criteria from DHQ Hospital Narowal and THQ Hospital Shakargarh were randomly assigned, a baseline assessment was done, Group A participants were given baseline treatment along with wurn technique 2 sessions per week for 6 weeks, Group B participants were given baseline treatment along with mercier therapy 1 session per week for 6 weeks, the post-intervention assessment was done, via the Marinoff Scale, Mankoski Pain Scale and Endometriosis Health Profile Questionnaire (EHP 30). Data was analyzed by using SPSS version 26.

Detailed Description: Endometriosis

Endometriosis is the condition involving the presence of glands or stroma of the endometrial lining outside the uterus cavity. Its characteristics include unpleasant pain in the pelvic region, impaired fertility, pain during or after sex, and heavy bleeding during periods. Endometriosis occurs as a result of genetic, angiogenic, immunological, and inflammatory factors. In endometriosis, adhesions may be formed due to local inflammation. It can also occur as the blood-filled implants start bleeding in their surroundings. As a result of this bleeding healing occurs which causes scar formation. Pharmacologically, NSAIDS are used for instant pain relief. The most common surgical approach is laparoscopy. Physiotherapy in its various forms can be an excellent complement to the gynecological treatment of endometriosis. as previous studies also reported the effect of pelvic massage, pelvic manipulation, kinesiotherapy, and hydrotherapy. According to researcher knowledge, there is limited evidence on wurn technique and mercier therapy and how these techniques improve dyspareunia, dysmenorrhea, and quality of life in women with endometriosis. This study aims to see the comparative effects of wurn technique and mercier therapy on dyspareunia, dysmenorrhea, and quality of life in women with endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 25-43(17)
* Diagnosed patients with endometriosis
* BMI (18.5-29.9),(normal and overweight)
* Multigravida
* Mode of delivery: vaginal delivery or c section both
* Females having grade 1 or 2 grade on the dyspareunia scale
* Females having moderate scores on EHP -30

Exclusion Criteria:

* Malignancy
* Pregnancy
* Fibroids
* Pelvic congestion syndrome
* Pelvic inflammatory disease
* Females having IUD (inter uterine device)
* Recent abdominal or pelvic surgery
* Ovarian abscess
Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism

Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain control, however, its use inevitably increases the incidence of postoperative nausea and vomiting (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the prevention and treatment of PONV. It is not clear which one has superior antiemetic efficacy for the prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of 5HT3 antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This study evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients using IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic efficacy of the ramosetron and palonosetron. The incidence and intensity of PONV during postoperative 48 h will be assessed. ABCB1 polymorphisms 3435C\>T and 2677G\>T/A will be evaluated in all patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-85 yr
* undergoing spine surgery

Exclusion Criteria:

* Taking steroids or opioids preoperatively
* GI motility disorder
* Uncontrolled diabetes
* Severe renal or hepatic disease
* Transfer to ICU postoperatively
* Obesity (BMI\>35 kg/m2)
* Use of antiemetic agent within 24 h preoperatively
* Pregnancy
* Psychiatric disease
* Drug or alcohol abuser
* Malignancy
Comparison of Two Mechanical Ventilation Modes on Oxygenisation

Comparison the effect of two different mechanical ventilation modes on tissue oxygenization.

Aim of the study is to evaluate and compare the effects of two different mechanical ventilation modes as Volume Controlled Mechanical Ventilation (VCV) and Pressure Controlled Mechanical Ventilation (PCV) on non invasive tissue oxygenization levels of patients who scheduled for bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients with Body Mass Index 35 - 50 kg/m2 Patients classified as American Society of Anesthesiologist (ASA) 1-2-3 classification Patients elected for Bariatric surgery

Exclusion Criteria:

Patients who wants to reject of study participation Patients who has any surgical complication during the surgery period Patients with decompensated cardiac failure Patients with Moderate or Severe obstructive/restrictive lung disease Patients with Reynaud disease Patients with Buerger phenomena Patients whıo has Intraoperative airway pressure more than 45 cmH2O Patients who had previous thoracic surgery Patients with Negative Modified Allen test
Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study

Rationale: The effect of positional distribution of dietary fatty acids on markers of inflammation and blood lipids metabolites on diets containing fatty acids such as oleic acid that are associated with reduced risk of cardiovascular disease is not widely studied.

Hypothesis: There would be difference detected in the concentrations of markers of inflammation and blood lipid metabolites in human volunteers fed controlled diets.

Study design: A randomized, double-blind, crossover clinical trial that involves 41 healthy volunteers. The volunteers will be selected based on inclusion and exclusion criteria. They will consume controlled diets for 5 weeks that provides 15% of energy from protein, 30% of energy from fat, and 55% of energy from carbohydrates. Volunteers will be assigned to each test diets which is cooked with novel olein, palm stearin or partially hydrogenated soybean oil in random order until all three diets has consumed by each person.

Main study parameters: LDL-cholesterol


Eligibility Criteria:
Inclusion Criteria:

* Healthy and free from any disease and absence of family history for arteriosclerosis or hypertension
* Not on any medication or supplements or weight loss program
* Non smokers and alcoholics

Exclusion Criteria:

* Having some health-related problems e.g fever, flu, allergy, chronic diseases
* On some treatment or medication
* Smokers and alcoholics
Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture

The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hip fracture repair aged 18-85.

Exclusion Criteria:

* Patients who have an exclusion to regional anesthesia.
* Patients who are pregnant assessed via self-report or pregnancy test if they have taken one.
* Non-English speakers
* Patients who already had their fracture repaired"