cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability and Effect of Nexagon™ Applied to the Eye After PRK Laser Eye Surgery for Nearsightedness

Phase 1 randomized, prospective, double-masked, vehicle-controlled, dose-escalation study to evaluate the safety, tolerability and clinical effect of Nexagon™ in subjects following bilateral PRK for the correction of mild to moderate myopia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female pre-presbyopic myopes.
* Aged between 20 and 50 years inclusive.
* Females are eligible to participate only if they are currently non-pregnant and non-lactating. Females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control.
* Subjects willing and able to undergo bilateral PRK for the correction of their myopia.
* Subjects with MRSE \<6.0 D, with less than 2.0 D of astigmatism.
* No more than 1.0 D of refractive difference between eyes.
* Stable prescription in both eyes as defined by \<0.25 D change over the preceding 2 years.
* Subjects who are able to comply with all study procedures, including wearing a soft bandage contact lens in the immediate postoperative period.
* Subjects who are willing and able to give written informed consent to take part in the study.

Exclusion Criteria:

* Subjects who have a past or present disease, which as judged by the investigator may affect the safety of the subject or the outcome of the study.
* Subjects who have previously had corneal surgery.
* Subjects who require Mitomycin C following their PRK.
* Subjects with any ocular disease or corneal abnormality, including but not limited to:

  * Decreased corneal sensation / neurotrophic cornea;
  * Corneal vascularization;
  * Keratoconus;
  * Keratoconjunctivitis sicca requiring chronic treatment;
  * Lagophthalmos;
  * Blepharitis;
  * History of infectious keratitis;
  * History of glaucoma or intraocular pressure of \>21 mmHg or use of glaucoma medications;
  * Significant dry eye disease that requires regular topical treatment;
  * Corneal thickness \<480 µm at the thinnest point, and
  * Posterior elevation \>40 mmHg.
* Subjects with corneal haze \>+1 as assessed using the grading scale in the protocol.
* Subjects who require any topical ophthalmic medication other than the pre- and postoperative regimen defined in the study protocol.
* Subjects with:

  * Diabetes;
  * Collagen disorders associated with autoimmune diseases, e.g., lupus, rheumatoid arthritis;
  * Severe atopic disease;
  * Any systemic disease or condition where the subject is immunocompromized.
* Subjects who require any systemic medication that affects healing, e.g., steroids, hormone replacement therapy.
* Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine, scopolamine, or medications or agents that can cause dry eye.
* Subjects who have participated in a clinical trial within the 30 days prior to the date on which PRK is scheduled.
Comparison of Instrument Assisted Soft Tissue Mobilization and Myofascial Gun in Upper Cross Syndrome

To compare the effects of Instrument Assisted Soft Tissue Mobilization and Myofascial gun in Upper Cross Syndrome

Upper Cross Syndrome is a very common postural abnormality developed due to prolong slouched postures in desk jobs and also in students. Janda explained it that it is simultaneous presence of Forward Head Posture and protracted shoulders.

This includes weakness of lower and middle trapezius, deep neck flexors, rhomboids and serratus anterior. It also includes tightness of upper trapezius, Sternocleidomastoid, Pectoralis major and minor. The simultaneous occurrence of FHP and rounded shoulder is nothing but upper crossed syndrome.

Upper Trapezius is the primary muscle that is involved in Upper Cross Syndrome. Instrument Assisted Soft Tissue Mobilization is applied over the tight muscles to improve muscle length to its normal length. It is applied from origin to insertion with some pressure to apply compression on the muscle.

Myofascial gun is a recent technology that can be applied by the clinician and also by the affected person for self mobilization. They provide varying amount of frequencies through various shaped heads according to the area they are used,

Eligibility Criteria:
Inclusion Criteria:

• Patients with forward head posture and upper crossed syndrome

Exclusion Criteria:

* Congenital anomalies of shoulder
* Malalignment/previous fracture of clavicle
* Malignancy and Tuberculosis of spine
* Pigeon and Barrel chest
Effects of Fish Oil on Post Ablation Arrhythmias

To determine if peri-operative treatment with omega-3 fatty acids is associated with a decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an improvement in probability of long-term maintenance of sinus rhythm after radiofrequency catheter ablation for Atrial Fibrillation.

AF is the most prevalent arrhythmia, affecting \>2 million Americans. Antiarrhythmic drug therapy often is ineffective to eliminate recurrent episodes of AF. In recent years radiofrequency catheter ablation has emerged as a highly effective treatment strategy in patients with paroxysmal and chronic AF.6, 7 However, AF may recur within days to weeks after a successful ablation procedure in up to 50% of the patients, probably because of an inflammatory response to thermal injury caused by radiofrequency energy application. These early recurrences of AF after ablation do not necessarily predict long-term clinical outcome and 30-50% of patients who develop early recurrences ultimately remain in sinus rhythm without the need for additional ablation.8 However, early recurrences of AF may be associated with significant morbidity due to troubling symptoms of rapid ventricular rates, multiple hospital visits and cardioversions, need for antiarrhythmic drug therapy and prolongation in duration of anticoagulant therapy. It is also possible that if early recurrences of AF after ablation can be avoided, the probability of remaining in sinus rhythm during long-term follow-up may be higher, as maintenance of sinus rhythm early-on may facilitate reverse left atrial remodeling. A similar phenomenon may occur in post-operative AF, that develops in \~30% of patients who undergo cardiac surgery. Post-operative AF is often transient and usually resolves within 3 months after the surgery. Perioperative treatment with omega-3 fatty acids has been reported to decrease the incidence of postoperative AF after coronary artery by-pass surgery.4 Because the pathogenetic factors that play a role in postoperative AF and early recurrences of AF after radiofrequency catheter ablation may be similar, it is plausible that treatment with omega-3 fatty acids before and after ablation will be associated with a reduction in the incidence of early recurrences of AF.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and \< 70 years old
* Left atrial size \<55 mm

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
* Current therapy with omega-3 fatty acids
* Current therapy with a statin
* Active liver disease
* Significant comorbidity such as end-stage renal disease or cirrhosis
* Valvular prosthesis
Driving Factors of Decision Making for Prophylactic Salpingectomy Versus Tubal Ligation at the Time of Cesarean Section

Prophylactic (Opportunistic) salpingectomy is a cost-effective strategy recommended for reducing the risk of ovarian cancer at the time of gynecologic surgery in women who have completed childbearing. Similar evidence for cesarean section is growing. However, salpingectomy refers to the surgical removal of a female reproductive organ. Some women may have hesitations about salpingectomy with regard to religious concerns, reduced self-image, tubal reanastomosis or lack of knowledge.

The investigators aimed to explore the underlying factors that motivate women for either decisions.

Prophylactic and opportunistic bilateral salpingectomy is an increasing trend among surgeons and also proven as an effective risk-reducing method for ovarian cancer.

The investigators have experienced denials among women who were seeking tubal ligation as a sterilization procedure during cesarean section after a comprehensive counseling for prophylactic salpingectomy. Therefore, the investigators aimed to assess the driving factors of decision making for prophylactic salpingectomy or tubal ligation. It is planned to preoperatively have a non-validated questionnaire for the women after a detailed briefing.

Eligibility Criteria:
Inclusion Criteria:

* Women seeking for surgical sterilization during their cesarean section
* Elective and Category 2 or more planned cesarean sections

Exclusion Criteria:

* Clinical conditions that lead to planned cesarean hysterectomy such as placenta percreata
* History of ovarian cancer, previous chemotherapy or radiation
* Women who previously underwent sterilization
Keratinocyte Growth Factor to Prevent Acute GVHD

This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplantation.

GVHD remains the major complication of allogeneic BM transplantation and is initiated during the conditioning of the recipient for transplant when the host tissues are damaged. Research has demonstrated that the gastrointestinal (GI) tract is a critical organ in GVHD pathophysiology. Agents that protect the GI tract may provide prophylaxis against the cytokine cascade and can lead to a reduced incidence and severity of GVHD. KGF is a protein that stimulates the growth of epithelial cells including those of the GI tract. KGF can protect the GI tract, prevent GVHD, and preserve donor T-cell function.

Patients will receive standard GVHD prophylaxis in addition to the study drug. Overall GVHD will be graded weekly during the first 2 months after transplant, then every other week to Day 100. Response to therapy will be measured through the use of severity indices, physical exam, and laboratory serum values.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of a hematological malignancy, including myelodysplastic syndromes.
* Eligible for cyclophosphamide and total body irradiation conditioning therapy or busulphan and cyclophosphamide conditioning therapy.
* Must have a 6/6 human leukocyte antigens (HLA)-matched family member donor.
* Women must be post-menopausal, sterile, or using effective contraception for 1 month before, during, and for 2 months after study.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion criteria:

* T-cell depletion for GVHD prophylaxis.
* Active hepatitis.
* Pre-existent inflammatory bowel disease requiring active therapy.
* Active uncontrolled infection.
* Prior bone marrow or peripheral blood stem cell (PBSC) transplantation.
* Documented hypersensitivity to rHuKGF.
* Prior enrollment to a study of rHuKGF.
* HIV-positive.
* Pregnant or nursing.
* Active chronic skin disease requiring therapy.
Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis

To evaluate the clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms (IAs) with coexistence of atherosclerotic intracranial arterial stenosis (AIAS), whose management strategies are inconsistent. Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with IAs with coexistence of AIAS, coincident with inclusion and exclusion criterion and admitted in participating organizations.

Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional multi-stage neurosurgical management or one-stage hybrid operating management correspondingly. The morbidity rate of peri-operative cerebral hemorrhagic/ischemic event is considered to be the primary observing indicator, and morbidity rate of peri-operative cerebral hemorrhagic/ischemic event, while peri-operative mortality rate, and health-economic indicators are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.

Eligibility Criteria:
Inclusion Criteria:

* For aneurysms:
* with diagnosed complex intracranial aneurysm by digital subtraction angiography(DSA);
* got SAH in history;
* neural functional deficits due to aneurysms;
* with \<4 in Hunt-Hess Grades;
* ≥5.0mm in the maximum diameter;
* \<70 years old;
* with irregular morphological features and high rupture risk.

and for stenosis

* Intracranial vessels:
* \>50% in rate of stenosis with ischemic symptoms/perfusing evidence/lacunar infarction in supplying territory, failed in conservative treatment;
* with a deliverable position of intracranial stents devices.
* or Vertebral arterial system:
* ≥70% in the rate of stenosis, with contralateral vertebral arterial occlusion;
* symptomatic vertebral arterial stenosis, accompanied with posterior inferior cerebellum artery derived from the affected artery and related symptoms are caused/clinical benefits can be achieved through angioplasty.
* or Extracranial arterial system:
* ≥70% in the rate of stenosis with symptoms;
* nonsymptomatic patients, ≥70% in the rate of stenosis , with perfusing evidence.

Exclusion Criteria:

* \>70 in age, with low rupture risk;
* stroke history in 6 weeks (contraindication for endovascular intervention);
* coexistence with intracranial tumor or AVM;
* cannot tolerant the operation;
* patient or relative refuses to participate the trail
Study of Bile Acids in Patients With Peroxisomal Disorders

OBJECTIVES: I. Determine the effectiveness of oral bile acid therapy with cholic acid, chenodeoxycholic acid, and ursodeoxycholic acid in patients with peroxisomal disorders involving impaired primary bile acid synthesis.

II. Determine whether suppression of synthesis of atypical bile acids and enrichment of bile acid pool with this regimen is effective in treating this patient population and improving quality of life.

PROTOCOL OUTLINE: Patients receive oral cholic acid and oral chenodeoxycholic acid on day 1. On day 4, patients receive oral cholic and ursodeoxycholic acids. Patients are assessed at 3 and 6 months for liver function response, neurologic status, and nutritional status.

Patients receive treatment until disease progression or unacceptable toxic effects are observed.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
Biochemically proven peroxisomal disorder, including:

* Zellweger syndrome
* Pseudo-Zellweger syndrome
* Neonatal adrenoleukodystrophy
* Bifunctional enzyme deficiency
* Infantile Refsum's disease
Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)

The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.


Eligibility Criteria:
Inclusion Criteria:

* Patient has evidence of myocardial ischemia or a positive functional study
* Patient has a normal CK-MB
* Target lesion has a visually estimated stenosis of ≥50% and \<100%
* Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.7mm and ≤ 3.3mm
* Target lesion length must be ≤ 14mm

Exclusion Criteria:

* Patient has experienced a myocardial infarction (CK-MB or Troponin \> 5 X ULN) within 72 hours of the procedure
* Patient has a left ventricular ejection fraction \< 25%
* Patient has unprotected lest main coronary disease with ≥50% stenosis
* The target vessel is totally occluded (TIMI Flow 0 or 1)
* Target lesion involves a bifurcation (a lesion with a side branch ≥ 2.0 mm in diameter containing a ≥ 50% stenosis).
* Target lesion is located within a bypass graft
* Target lesion has possible or definite thrombus
Impact of a Parenting Program in Liberia to Improve Parenting, Education, and Health Outcomes for Children in Liberia

The aim of this study is to assess the impact of an intervention to improve parenting practices, pre-academic and developmental skills, and use of mosquito nets for children in kindergarten in Liberia. A rigorous impact evaluation using a randomized, waitlist controlled design will be conducted to measure the impact of the intervention on three primary outcomes: positive parenting skills, children's cognitive and educational skills, and malaria knowledge and prevention behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Parents or primary caregivers (age 18 or above) of children ages 3-7 enrolled in kindergarten
* Resident in one of five study sites

Exclusion Criteria:

* Severe cognitive disability of caregiver affecting ability to provide informed consent
Effect of Weight Loss on Reproductive Function in Overweight Men

Obesity has been found to be a risk factor for female infertility. Studies have indicated that obese men often have poor semen quality and require increased time to make partner pregnant. To date, no studies have investigated the effect of weight reduction on male fertility. The purpose of this study is to investigate the effect of weight reduction in overweight and obese men on their reproductive function.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* BMI \> 27 kg/m2

Exclusion Criteria:

-
Comparison Between Dexmedetomidine and Fentanyl As an Adjuvant to Bupivacaine in the Paravertebral Nerve Block in Laparoscopic Cholecystectomy for Postoperative Analgesia: Randomized Comparative Clinical Trial.

Laparoscopic cholecystectomy is one of the most common surgeries today, cause it has many advantages over open cholecystectomy. Although these advantages pain remains a big problem after laparoscopic cholecystectomy which causes patient admission or readmission. This post-operative laparoscopic cholecystectomy pain causes extreme patient discomfort, extended post-anesthesia care unit stay and restricts early recovery.

To overcome this problem, there were trials of inta abdominal instillation with local anesthetics with no positive results , so they combined this with local infiltration at the laparoscopic access sites with no satisfactory postoperative analgesia.

The aim of this study is to evaluate the effect and the difference between dexmedetomidine and fentanyl in pre-operative unilateral (T5\&6) thoracic paravertebral block for postoperative analgesia in laparoscopic cholecystectomy

The para-vertebral block has been largely used over the past years for post-operative analgesia. Many reports in the literature describe the use of thoracic paravertebral block for providing post-laparoscopic cholecystectomy analgesia. Thanks to the ultrasound, over the past years, paravertebral blocks (PVB) have been increasingly used for providing postoperative analgesia, and in the administration of thoracic paravertebral block which has greatly reduced the incidence of associated complications.

Contrary to the intra-abdominal instillation of local anesthetics and local infiltration, the paravertebral blockade has been reported to provide high-quality afferent blockade with the abolishment of somatosensory evoked potentials. and has also been found capable of attenuating the postoperative stress response associated with traditional cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients within age; (18-60)
* Body mass index (BMI); (18-30)
* ASA I - II

Exclusion Criteria:

* ● Patient refusal to participate in the study

  * Allergy to local anesthetics
  * Coagulopathy
  * Morbid obesity
  * Decreased pulmonary reserve
  * Cardiac disorder
  * Renal dysfunction
  * Pre-existing neurological deficit
  * Psychiatric illness
Determination of Predictive Clinical Signs of Effective Rhizolysis Using the DFL Questionnaire.

Rhizolysis or lumbar thermocoagulation is a therapeutic proposal for certain types of chronic lower back pain that is resistant to medical treatment and outside the field of surgical indications.

A previous study has selected functional and physical signs selected by analysts and a group of experts from the modified "Delphi" prediction method. This study resulted in the creation of a questionnaire (DFL questionnaire) with 16 symptoms: 7 functional and 9 physical.

The aim of this new study is to select the symptoms that have the best positive predictive value among the 16 symptoms, to predict a good result of rhizolysis, on the criterion of their mitigation or disappearance in case of effective rhizolysis.

The frequency of chronic lower back pain is a major economic and social problem. Indeed, there are numerous solutions that can be offered to patients, but sometimes they are unsatisfactory as medical treatments are often insufficiently effective, surgical techniques are often invasive and indications can be limited.

Rhizolysis or lumbar thermocoagulation is a therapeutic proposal for certain types of chronic lower back pain that is resistant to medical treatment and outside the field of surgical indications. This technique, which is minimally invasive, is low-risk for patients and is widely used. However, few studies have shown its effectiveness, so the level of evidence is not enough to make this technique accepted as a standard.

A previous study has selected functional and physical signs for joint involvement in lower back pain. This selection was made by analysts and a group of experts from the modified "Delphi" prediction method. This study resulted in the creation of a questionnaire (DFL questionnaire) with 16 symptoms: 7 functional and 9 physical.

The aim of this new study is to select the symptoms that have the best positive predictive value among the 16 symptoms, to predict a good result of rhizolysis, on the criterion of their mitigation or disappearance in case of effective rhizolysis.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from chronic lower back pain developing for more than 6 months and resistant to the medical treatments.
* Patients with an indication of lumbar rhizolysis for their chronic lower back pain with a facet component, the starting point of which corresponds to the L4L5 and/or L5S1 stages.
* Patient not objecting to their participation in the study.
* Subject registered with a social security scheme

Exclusion Criteria:

* Adults under judicial protection
* Adult under guardianship or trusteeship
* Pregnant women
* Minors
A Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)

The aim of NASTRU was to examine whether ten weeks of nature-based rehabilitation, as add-on to standard management, could influence post-stroke fatigue (primary outcome), depression, work ability or functional outcome (secondary outcomes), compared to controls.

Patients randomized to the intervention undergo a rehabilitation program in groups up to 8 patients in an especially designed garden at the Swedish University of Agricultural Sciences, Alnarp. The intervention is grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilizes the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences.

The enrollment of 101 patients (51 intervention; 50 control) was completed on August 2014. Follow-up is on-going, with assessments by examiner blinded to treatment group, at end of intervention period, 8 months, and 14 months after randomization. A parallel study with qualitative in-depth interviews in a subset of patients, who were randomized to the intervention group, as well as the staff, is also ongoing.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or haemorrhagic stroke
* First ever or recurrence, about 3 months (group 1) or more than one year prior to screening (group 2)
* Age: 55-80 years

Exclusion criteria:

* Dementia
* Severe communication disorder that made it difficult to participate and/or serious illnesses besides stroke (for example, serious cancer disease)