cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity

The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity.

The main question it aims to answer is:

•How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo?

Participants will be:

* Be given injections every month for 5 months over the right and left flanks.
* Be asked to be seen in the clinic for 13 visits and 3 phone call visits during a duration of 1 year.

Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or non-pregnant female 18 to 55 years old.
* Subject has provided written informed consent.
* Subject has qualifying fat evaluation and skin laxity scores on each right and left flanks.
* Subject has had a stable body weight for the past 6 months prior to starting study.
* Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.

Exclusion Criteria:

* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject has loose skin in the right and left flank areas, unrepaired abdominal injury or defect, scars, tattoos, or other features that may interfere with evaluation of localized fat, in the opinion of the investigator.
* Subject has any medical condition or taking medications that affects clotting and/or platelet function
* Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.
Effect of Different Frequencies Weekly Training in Overweight/Obese Women

The aim of this study was to evaluate the effects of a resistance training programme of one or three times a week on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women

This study aimed to determine the effects of supervised structured 6 months resistance training and a restricted caloric diet on body composition, cardiometabolic risk factors and handgrip strength in overweight and obese women. 45 women were randomly assigned to one of two groups: a group with a high-weekly frequency of three times a week (HIGH) and a group that performed only one weekly session (LOW).HbA1c, percentage of fat mass and handgrip strength were taken before and after the intervention period.

Eligibility Criteria:
Inclusion Criteria:

overweight or obese

Exclusion Criteria:

-
Effects of Bilateral GPI DBS on Freezing of Gait in PD

This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) on freezing of gait in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years of age,male or female patients
* Idiopathic Parkinson's disease with freezing of gait
* Had GPI deep brain stimulation implant

Exclusion Criteria:

* Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
* Epilepsy
* Pregnant female
* History of severe neuropsychiatric disease
* Patients are taking part in other clinical trials in recent several months
Efficacy of Intravenous Dexamethasone on Postoperative Caudal Analgesia in Pediatric Orchiopexy

The purpose of this study is to evaluate postoperative pain control for pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients scheduled for elective day-case orchiopexy.

Exclusion Criteria:

* Infants or children with history of steroid allergy, renal, hepatic disease, or contraindication for caudal analgesia.
"Cataract Surgery in Eyes With Epiretinal Membrane"

The purpose of the study is to evaluate retinal thickness change and the occurrence of central structural retinal changes after uneventful small-incision cataract surgery in eyes with asymptomatic early stages of epiretinal membrane.

Optical coherence tomography (OCT) is nowadays used in daily clinical practice and has become a helpful tool for detection of macular changes also in presence of opacification of the lens before cataract surgery. Using recent high-resolution OCT technology, early stages of epiretinal membranes can easily be detected and analysed. Since cataract surgery is one of the most frequently performed operations worldwide, this study was aimed to investigate the influence of uncomplicated cataract surgery on central retinal thickness and the incidence of structural and morphological macular changes after surgery in eyes with asymptomatic epiretinal membrane.

Eligibility Criteria:
Inclusion Criteria:

* visually compromising cataract and asymptomatic early stages of epiretinal membrane with no structural changes such as cysts or photoreceptor distribution in optical coherence tomography.

Exclusion Criteria:

* visual impairment or metamorphopsia due to epiretinal membrane
* history of branch retinal vein occlusion
* central retinal vein occlusion
* wet or dry macular degeneration
* diabetic retinopathy
* uveitis or other inflammatory eye disease.
Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but it may provide insufficient anesthesia which requires the intraoperative use of additional topical local anesthetics and raises the need for sedation.

The present study is constructed to evaluate the effect of pregabalin on sedation using dexmedetomidine for cataract surgery under topical anesthesia . In the dexmedetomidine-pregabalin group, the patients will be premedicated by pregabalin. In the placebo group (control group) the patients will be premedicated by placebo capsules. All patients will be sedated by dexmedetomidine. Sedation will be assessed as a primary outcome measurement where pain, vital signs, intraoperative and postoperative pain, total analgesic needs and side effects will be assessed as secondary outcome measurements.

Eligibility Criteria:
Inclusion Criteria:

* American Society Of Anesthesiologists (ASA) I and II physical status.
* Scheduled for cataract extraction under topical anesthesia.

Exclusion Criteria:

* Hepatic or renal impairment.
* Taking chronic psychotropic medications.
* Mental instability.
* Morbid obesity.
* Alcohol abuse.
* Substance abuse.
* Pregnant and lactating females.
* History of allergy to the study drugs used
Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens

This is a pilot randomized controlled trial to assess the effects of advanced supply of emergency contraception versus routine care in a teen postpartum population. The goals are to assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. English speaking
3. Aged 14-19 at enrollment
4. Immediately postpartum of a live infant
5. Planning to parent the baby
6. Desiring to delay another pregnancy for at least one year
7. General good health
8. Willing and able to follow the study protocol

Exclusion Criteria

1. Allergy to levonorgestrel
2. Current substance abuse
3. Plans for relocation outside of Philadelphia
First in Man Aer-O-Scope

A single center study intended to evaluate the Aer-O-Scope Colonoscope System.

A clinical study in Zagreb Croatia, intended to evaluate the Aer-O-Scope Colonoscope System. The study includes 120 subjects and has the following endpoints:

Evaluation of the Aer-O-Scope advancement, imaging and retraction throughout the Colon.

Safety: No occurrence of any device related major adverse event (for details see section 9.5)

Efficacy:

1. Advancement of device towards the ceacum and retraction
2. Visualization of the colon mucosa by the traveling imaging device
3. Procedure duration
4. Handling and operation (assessment by operator)

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 and 65 years of age.
* Sign informed consent.

Exclusion Criteria:

* Subjects with any known GI related symptoms complaints or GI diseases.
* Subjects with cancer or other life threatening diseases or conditions.
* Pregnant women.
* Subjects who underwent any abdominal surgery.
* Morbid Obesity (BMI \> 40).
* Drug abuse or alcoholism.
* Bed-ridden subject.
* Inadequate communication with the subject.
* Subjects under custodial care.
* Participation in any clinical study within the last 30 days.
* Subjects with known cardiovascular and pulmonary diseases.
Genetic Epidemiology of Primary Biliary Cirrhosis (PBC)

Primary Biliary Cirrhosis (PBC) is a progressive liver disorder of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of PBC.

This study is being done to investigate whether genes make people more likely to develop PBC. Discovery of these proposed genes will help us better understand how PBC developes, and subsequently, to apply new approaches for its prevention, diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18-90 who have a history of PBC.
* PBC patients who have undergone a liver transplant are eligible.
* Family members (1st degree relatives) of enrolled PBC patients are eligible.

Exclusion Criteria:

* Individuals with no history of PBC or those unable to provide consent.
Is There a Role for Hip Arthroscopy in Patients With Femoral Head Fractures?

Femoral head fractures, often caused by high-energy trauma, pose significant challenges due to complications like avascular necrosis, post-traumatic osteoarthritis, and sciatic nerve damage. While traditionally treated with open reduction and internal fixation (ORIF) or total hip replacement (THR), hip arthroscopy has emerged as a minimally invasive alternative that reduces surgical trauma, offers direct fracture visualization and manipulation, and may result in shorter recovery times and fewer complications.

Femoral head fractures are uncommon but serious injuries often happen because of high-energy trauma, such as traffic accidents or falls from heights. These fractures can result in complications such as avascular necrosis (if associated with hip dislocations), post-traumatic osteoarthritis, heterotopic ossification, and sciatic nerve damage. The management of femoral head fractures is challenging and depends on several variables, such as the fracture pattern, the degree of displacement, the existence of associated injuries, and the patient's age and physical activity.

Traditionally, open reduction and internal fixation (ORIF) or total hip replacement (THR) have been the treatment of femoral head fractures, depending on the extent of the damage and the patient's expectations. However, these procedures have some drawbacks, such as increased blood loss, infection risk, surgical trauma, and implant-related complications. Furthermore, THR might not be appropriate for young, active patients who wish to maintain their natural hip joint, whereas ORIF might not be able to adequately reduce and fixate the fracture fragments, particularly in situations of comminution or impaction.

Nevertheless, hip arthroscopy has surfaced as a minimally invasive alternative for the treatment of selected femoral head fractures. Arthroscopy could be useful in femoral head fractures as it minimizes surgical aggression, in contrast to surgical hip dislocation applied in ORIF, allowing for direct control of fracture reduction, minimizing surgical morbidity, and optimizing early recovery. Hip arthroscopy allows for direct visualization and manipulation of the fracture fragments, as well as the removal of loose bodies and debris from the joint. Hip arthroscopy can also be combined with percutaneous fixation techniques to stabilize the fracture and restore joint congruence. When compared to open surgery, hip arthroscopy may offer several benefits, including shorter recovery times, less discomfort, less blood loss, and better cosmetic results. Arthroscopic-assisted percutaneous fixation has been reported as an effective treatment in selected cases of femoral head fractures.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pipkin 1 fractures

Exclusion Criteria:

* any associated pelvic fractures
* severe medical conditions that prevent the patient from undergoing surgery
* delayed presentation after 2 weeks from initial fracture date
Voice Rest and Injection Laryngoplasty

The purpose of this study is to evaluate the subjective, objective, and aerodynamic impact of voice rest following injection augmentation and compare the outcomes to patients with no post-procedure voice restrictions.

Glottic insufficiency resulting from vocal fold immobility can have a significant negative impact on health and quality of life and is a major cause of dysphonia, dysphagia, and dyspnea. Vocal fold immobility can be unilateral or bilateral and complete or partial. Most commonly, it is caused by iatrogenic injury to the recurrent laryngeal nerve from thyroidectomy or anterior cervical disc fusion surgeries. Other causes include traumatic, idiopathic, malignant, and neurogenic. Variability exists in approach to surgical management. Degree of spontaneous recovery and thus timing of intervention varies based on severity and permanency of neurological injury. Initially described by Wilhelm Brünings in 1911, injection laryngoplasty, also known as injection augmentation, is a technique to improve glottic closure by injection of material to move the immobile vocal fold closer to midline. This improves voice quality and strain in patients with either unilateral or bilateral vocal fold hypomobility, immobility, atrophy, presbylarynx, vocal fold scar, and soft tissue loss. Improvement in glottic closure also results in better swallowing outcomes. Injection augmentation can be performed under general anesthesia in patients unable to tolerate the procedure while awake. Injection can be performed peroral, through a working channeled flexible laryngoscope, or a percutaneous approach. Percutaneous approaches can be further divided into transthyroid cartilage, transcricothyroid membrane, or transthyrohyoid membrane. All cases are performed under endoscopic guidance to ensure correct needle placement and adequate medialization of affected vocal fold. Congruent with the heterogeneity of injection laryngoplasty materials, approaches, and techniques, there also appears to be no data or expert consensus regarding voice rest following this procedure. This study aims to quantify the benefit of voice rest following vocal fold injection augmentation.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old
2. Undergoing injection augmentation by Dr. McGarey, Dr. Torrecillas, or Dr. Daniero for the following conditions:

   1. Glottic insufficiency from atrophy, scar, or presbylarynx
   2. Unilateral or bilateral vocal fold immobility
   3. Unilateral or bilateral vocal fold hypomobility

Exclusion Criteria:

1. Prior history of head and neck radiation.
2. Active or recent (within 3 months) chemotherapy.
3. Age \<18 years old
4. Incarcerated individuals will be excluded due to inability to enroll in post-intervention clinic visit
5. Presence of posterior glottic stenosis
6. Presence of acute laryngeal injury
7. Bedside inpatient injection augmentation
8. Vocal fold Injection with steroids or cidofovir
Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma

The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).

Transarterial chemoembolization (TACE) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion or extrahepatic spread. There has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent.

Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE.

Regimen 1: lipiodol combined chemotherapy with embolization

Regimen 2: lipiodol combined chemotherapy without embolization

Regimen 3: lipiodol single agent chemotherapy with embolization

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with minimal height of 150cm and minimal weight of 50 KG
* Histological confirmed HCC
* with no previous treatment
* With unresectable tumor
* With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
* No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
* No significant renal impairment (creatinine clearance \< 30 mL/minute)
* The following laboratory parameters:

  * Platelet count ≥ 60,000/µL
  * Hemoglobin ≥ 8.5 g/dL
  * Total bilirubin ≤ 1.5 mg/dL
  * ASL and AST ≤ 5 x upper limit of normal
  * Serum albumin ≥ 35 g/L
  * Serum creatinine ≤ 1.5 x upper limit of normal
  * INR ≤ 1.5 or a Pt/PTT within normal limits
  * Absolute neutrophil count (ANC) \> 1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Avascular tumor
* Main portal vein obstruction without cavernous transformation
* Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
* Obstructive jaundice
* Severe underlying cardiac or renal diseases
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or breast-feeding patients.
* History of organ allograft
* Active clinically serious infections
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Prospective Cohort Study in Evaluation of Risk Factors for Infection During and After Coronary Graft Operations.

We aim to prospectively evaluate the risk factors that can play a role before, during or after the surgical period.

Surgical site infections (SSIs) are either superficial or deep and may involve the organs, or spaces accessed during an operation. The reported incidence of SSIs in coronary artery bypass grafting (CABG) surgery ranges between 0.3% and 8%.

There is a strong suggestion that an impairment of vascular supply of the sternum may be one of the most important factors influencing the incidence of deep sternal wound infection (DSWI). Several studies have studied the risk factors for SSIs including DSWI in cardiac surgery. These risk factors included obesity, diabetes mellitus, chronic obstructive pulmonary disease (COPD), connective tissue disease, steroid use, smoking, peripheral vascular disease and renal insufficiency. In addition, intraoperative factors (e.g., use of bilateral internal mammary arteries \[BIMA\] grafting, prolonged cardiopulmonary bypass \[CPB\] duration) and postoperative variables (e.g., prolonged mechanical ventilation, reoperation for bleeding, postoperative transfusions and gastrointestinal, nephrological and respiratory complications) have been shown to be associated with DSWI.

The risk for sternal wound infection (SWI) is increased if cardiac surgery involves internal thoracic arteries grafting and a valve procedure, or use of a ventricular assist device.

Leg wound infections at donor sites account for \>70% of cases with severe infection following cardiac surgery.

Cardiac SSIs increase the length of hospital stay (LOS) and increase treatment costs in proportion to the severity of the infection. These costs increase by 3.8%, 14.7% and 29.4% in mild, moderate and severe infections respectively.

Treatment is often confounded by the emergence of antibiotic-resistant pathogens and in addition, substantial proportions of these infected patients are elderly and have co-existing medical problems. In the past, such elderly patients with significant comorbidities would not have been considered for surgery.\[8\] As the population ages, it is reasonable to assume that older and sicker patients will be admitted for surgery, and this will inevitably increase the risk and incidence of SSIs.

Eligibility Criteria:
IInclusion Criteria:

1. patient aged more than 18 yards old
2. sternotomy for: coronary artery bypass,

Exclusion Criteria:

1. patient under age or 18years old.
2. patient who has endocarditis.
3. patient who underwent surgery with prothetic material, within the 12 months preceeding cardiac procedure.
Conditioned Pain Modulation in Patients With Hemophilia

Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli.

Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic.

Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A or B.
* Patients over 18 years of age.
* Persons with a medical diagnosis of bilateral hemophilic ankle arthropathy.
* Patients with clinical assessment by Hemophilia Joint Health Score (\>4 points).
* Persons with hemophilia on prophylactic treatment with FVIII / FIX coagulation concentrates or monoclonal antibodies.
* Have signed the informed consent document.

Exclusion Criteria:

* Patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests.
* Patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study.
* Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study.
* Patients who are undergoing an intervention (physiotherapeutic or orthopedic) at the time of the study.
Length of Post Operative Dressing After Carpal Tunnel Release

The purpose of the study is to prospectively compare the functional, satisfaction, and wound outcomes of patients treated with one of two accepted methods of postoperative dressing following carpal tunnel release. Hypothesis: There will be no difference between the short term (approximately 2 - 3 days)and longer term (9 to 14 days)bulky dressing groups in terms of outcomes.


Eligibility Criteria:
Inclusion Criteria:

* adults
* carpal tunnel syndrome

Exclusion Criteria:

* previous surgery for Carpal Tunnel Syndrome
* ipsilateral hand, arm, shoulder surgery with continued symptoms