cyrilzakka/clinical-trials huggingface dataset:
Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery

The options for anesthesia in cataract surgery described are: general, regional or local. The local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar), subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar, have made subtenon and topical strategies the most used. Likewise, to improve the effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose of lidocaine.

Subtenon and topical anesthesia are two safe strategies and there were performed multiple studies showing that both are effective in controlling pain, but showing a slight superiority of subtenon. This difference does not appear to be clinically significant. In turn, the addition of gel and intracameral anesthesia, improved pain control. However, lack evidence to compare patient preference when using topical gel and intracameral anesthesia versus sub-Tenon anesthesia.

Multiple advantages has the topical anesthesia. Besides being a safe strategy for the patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia postoperatively, subconjunctival hemorrhage and chemosis.

Because of this the investigators plan to conduct a study comparing the efficacy of gel topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with scleral incision, assessing the patient's preference Hypothesis: Topical administration of lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia in cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* bilateral cataract

Exclusion Criteria:

* refuse to participate, high surgical risk (ASA 4 or 5), allergy to lidocaine or other amide local anesthesics, inability to understand the informed consent, coagulation abnormalities, prior ophthalmologic surgery, small pupil, Fuchs dystrophy, lens luxation, uveitis
Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment

The purpose of this study is to determine the sleep patterns of subjects with or without sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous FDG/PIB PET, structural MRI and brain blood flow scams performed during their participation in the Following studies 'Alzheimer's Disease Core Center (ADCC) Clinical Evaluation' (IRB: 2942), MRI Progression Markers of Cognitive Decline in the Elderly' (IRB:09-0586), or 'Imaging Neuro inflammation in Alzheimer's Disease with \[11C\] Arachidonic Acid (AA) and PET'(IRB: 10-00442).


Eligibility Criteria:
Inclusion Criteria:

* All subjects will have participated in prior CBH studies and have agreed to an FDG, PIB and MRI scans.

Exclusion Criteria:

* Diagnosis of sleep apnea and under treatment with a continuous positive airway pressure (CPAP) machine.
* Active depressive episode during the evaluation with a Geriatric Depression Scale score \>7 and/or a Clinical Global Impression scale for depression score \>4.
* Moderate Cognitive decline (GDS \>3).
* Severe primary or secondary insomnia except insomnia due to SDB.
Evaluation of Individuals with Partial or Finger Amputation After Silicone Prosthesis Use

Objective: This study aimed to evaluate the psychosocial adaptation, functional capacity, and quality of life of individuals who underwent partial hand or foot amputations after using silicone hand and foot prostheses.

Materials and Methods: The study included 32 patients. Demographic and clinical characteristics of the participants were recorded. Participants were divided into two groups as silicone hand or foot prosthesis users. The Visual Analog Scale (VAS) was used to assess pain levels before and after prosthesis use, the Trinity Amputation and Prosthesis Experience Scales (TAPES) were applied to evaluate functional capacity, and the Nottingham Health Profile (NHP) was used to assess quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Hand and foot amputation.
* Aged between 18 and 60 years
* Active employee
* Able to walk, co-operate, move actively with hands
* Who have been using prosthesis for at least 1 year and have good stump-socket compatibility,
* Literate individuals were determined on a voluntary basis.

Exclusion Criteria:

* Multiple amputations
* Severe neurological or traumatic findings
* Individuals with severe deformity or posture disorder that may lead to loss of gait, balance or function.
* With limitation of movement in the upper extremities
Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis

The aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. The target population is subjects with knee osteoarthritis (grade II-III in Kellgren-Lawrence scale).


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers between 35-65 years.
* X-ray evidence of osteoarthritis (grade II-III in Kellgren-Lawrence).
* Chronic joint pain (\>5 visual analogue scale) in knee.
* BMI ≤ 29.
* Voluntary acceptance and signature of informed consent.
* Willing to attend study visits and lab sample recollection.
* Lab values within normal reference values.
* Willing to use effective birth control methods.

Exclusion Criteria:

* Inflammatory arthritis.
* Generalized infection.
* Active cancer or history of cancer in the past 5 years.
* Receiving oral or intraarticular steroids.
* Positive labs for HIV, Hepatitis B or C.
* Recent trauma in the target joint.
* Debris in joint.
* Subjects that have undergone or need to undergo arthroscopic knee surgery in the target joint.
* History of joint substitution, intraarticular fractures, osteotomy, arthroplasty or menisectomy.
* Clinically significant knee misalignment.
* Other illnesses that the investigator considers clinically significant.
* Participating in another clinical trial three months before enrolling.
* Women that are pregnant, lactating or result positive in the pregnancy test during screening.
* Known allergies to bovine products.
* Subjects taking anticoagulants.
A Safety and Efficacy Study Evaluating CTX001 in Subjects With Severe Sickle Cell Disease

This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in subjects with severe sickle cell disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using CTX001.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of severe sickle cell disease as defined by:
* Documented severe sickle cell disease genotype
* History of at least two severe vaso-occlusive crisis events per year for the previous two years prior to enrollment
* Eligible for autologous stem cell transplant as per investigators judgment

Key Exclusion Criteria:

* An available 10/10 human leukocyte antigen (HLA)-matched related donor
* Prior hematopoietic stem cell transplant (HSCT)
* Clinically significant and active bacterial, viral, fungal, or parasitic infection

Other protocol defined inclusion/exclusion criteria may apply
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™

Effects of norethindrone acetate (NTA) in patients with Nexplanon.

The purpose of this study is to find out what effects norethindrone acetate (NTA) has on the duration and recurrence of frequent and/or prolonged bleeding associated with Nexplanon™.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-48
* Between ages of 14-17 with parental/guardian permission
* Women desiring placement of Nexplanon™
* Willing to keep a daily symptom calendar
* Keep appointments
* Women not desiring to become pregnant in the next 2 years

Exclusion Criteria:

* Known or suspected Pregnancy
* Less than 8weeks postpartum
* Menarche less than two years ago
* Current or past history of thrombosis or thromboembolic disorders
* Hepatic tumors (benign or malignant)
* Active liver disease
* Undiagnosed abnormal genital bleeding
* Undiagnosed headaches
* Known or suspected carcinoma of the breast or personal history of breast cancer
* Hypersensitivity to any of the components in Nexplanon™
* BMI greater than 40
* Depomedroxyprogesterone acetate injection in the previous 12 weeks
Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma

The study is a phase II clinical trial of single arm. The purpose is to evaluate the safety and efficacy of anti-PD-1 antibody Toripalimab combined with chemotherapy(gemcitabine+5-fluorine pyrimidine) in unresectable advanced cholangiocarcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed cholangiocarcinoma
* stage IV disease,no system therapy for advanced disease
* one or more lesions that can be measured by imaging assessment
* 18 to 70 years of age and life expectancy exceeds 3 months
* adequate specimens for detection of PD-1/PD-L1 and MMR
* karnofsky performance status(KPS) score ≥70%
* routine blood routine, liver and kidney function and electrocardiogram were basically normal without contraindication of chemotherapy.

Exclusion Criteria:

* dual cancers other than cholangiocarcinoma
* metastasis of central nervous system
* unreleased biliary obstruction
* acute infections requiring treatment
* non-infectious pneumonia requires glucocorticoid therapy, active autoimmune diseases, or systemic immunosuppressive therapy.
Iris Colors in Neonates: Do They Really Change? Prevalence, Predicting Factors and Associated Characteristics

The goal of our study is to examine eye color at birth and the longitudinal change in eye color of preterm and full-term newborns.


Eligibility Criteria:
Inclusion Criteria:

* Any baby born between the 24-42 week of gestation admitted to the well-baby nursery or the NICU whose parents have signed an informed consent.

Exclusion Criteria:

* Neonatal conjunctivitis
* Neonatal sepsis
* Inborn error of metabolism or genetic syndrome
* Eye abnormalities
* Parental refusal
A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders

This study will explore the relationship between sleep, learning, cognition, mood and behaviour in children with Tic Disorders (Tourette Syndrome and Chronic Tic Disorder) compared to typically developing peers.

This project explores the relationship between sleep and learning in childhood with tic disorders, such as Tourette syndrome (TS) and chronic tic disorders (CTD).

TS/CTD are movement disorders characterized by repetitive involuntary movements and/or vocalizations called tics. Sleep related problems are commonly reported for children with TS/CTD and may include problems getting to sleep, waking up frequently during the night, early wakening and tic-related movements in sleep. For typically developing children, sleep disturbances have been linked to problems with mood, behaviour and learning. To date, the relationship between sleep and learning has not been explored for children with TS/CTD.

The aim of this project is to investigate whether there is a relationship between sleep efficiency and learning in boys with and without TS/CTD aged 11-14 years.

Sleep efficiency will be measured using a small actigraphy watch, which will collect information about movements during sleep, night time waking and light exposure. Children will be required to wear the watch for 14 days and nights. Before one night of sleep and again the next morning, children will be asked to complete some tasks on an iPad Air to assess learning. These include 1) 'popping' balloons with faces on them according to specific rules (e.g. boys faces, happy faces), 2) learning novel animal names, 3) navigating a 3D maze. Children will also be administered some standard tests to look at level of intellectual functioning, memory and other thinking skills that may contribute to performance on the computerized tasks. Additionally, children and their parents will be asked to complete questionnaires to assess tics, quality of life, mood and behaviour. The findings of this study will help improve understanding of sleep problems for children with tic disorders to aid the development of specific interventions for this group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Tourette Syndrome or Chronic Tic Disorder (for clinical group)

Exclusion Criteria:

* Diagnosis of Intellectual Disability (i.e. Full Scale IQ (IntellIigence Quotient) below 70), Autism Spectrum Disorder or Depression
* Currently taking medications to support tic, mood and/or behaviour management
Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty

Inguinal hernia is one of the most common types of abdominal hernias. Laparoscopic hernioplasty of inguinal hernia is a good alternative to traditional open repairs even in simple unilateral primary inguinal hernia in terms of decrease post operative pain and complications with comparable recurrence rates.Two techniques are described in laparoscopic hernioplasty and have been extensively studied in randomised trials. The totally extraperitoneal (TEP) approach is more widely used than the transabdominal preperitoneal (TAPP) approach.

In this study we will compare between the results of mesh fixation and non fixation as regard operative and postoperative data.


Eligibility Criteria:
Inclusion Criteria:

* Any male or female above 18 years old that has uncomplicated inguinal hernia

Exclusion Criteria:

* Patients with contraindications to use laparoscopy as cardiac or immunocompromised patients.
* Patients who are difficult to follow up.
Bioavailability of BIBR 953 ZW After BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as Hydroxypropyl Methylcellulose (HPMC) Polymorph II Capsule Relative to HPMC Polymorph I Capsule in Healthy Subjects.

Investigation of the relative bioavailability of BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph II versus BIBR 953 ZW after administration of 150 mg BIBR 1048 polymorph I in HPMC capsules


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP and local legislation
* Age ≥ 18 and ≤ 55 years
* BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of relevant orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after a car accident)
  * commotio cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation of more than 400 ml within 4 weeks prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the reference range of clinical relevance
* History of any familial bleeding disorder
* Platelets \< 150000/μl
The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23

To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in hemodialysis patients.

The investigators enrolled patients on maintenance hemodialysis and randomized them to two groups. One group will receive lanthanum carbonate and another group will receive calcium carbonate. The investigators will compare serum FGF23 levels between two groups after they receive above medication for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Chronic renal failure on maintenance hemodialysis 3 times a week for at least 3 months Serum calcium:8-10.5 mg/dL
* Serum phosphate:3.5-6 mg/dL(before washout period)
* Serum phosphate ≧6 mg/dL after washout period
* Serum i-PTH: 150-600 pg/mL

Exclusion Criteria:

* Diabetes mellitus
* Post parathyroidectomy
* Life expectancy\< 6 months
* Liver disease(hepatitis B,C or liver dysfunction)
* Severe gastrointestinal disorders or other severe comorbidity
* Poor compliance
* Intolerance to lanthanum or calcium carbonate
* Active infection
* Malnutrition(serum albumin\<3 g/dL or clinical assessment)
* Kt/V\< 1.2 (inadequate dialysis)
* Serum phosphate\>7.5 mg/dL after washout period
Adverse Childhood Experiences in Patients with MS: Impact on Quality of Life and on Coping Strategies Towards the Disease and Its Treatment

The goal of this observational study is to evaluate the presence of adverse childhood experiences (ACE) in patients with Multiple Sclerosis. The main questions it aims to answer are:

* Does the presence of ACE impact on quality of life of patients with multiple sclerosis?
* Does it influence how the patients cope with the disease and with disease course-modifying therapies? During follow up visits, planned as part of their regular medical care, participants will answer survey questions on a tablet .

Multiple sclerosis is a chronic inflammatory, demyelinating, and neurodegenerative disease of the central nervous system, typically affecting young adults. Its etiopathogenesis is multifactorial, with the interaction of genetic susceptibility and environmental risk factors. Among these, childhood trauma and other forms of adverse childhood experiences (ACE) such as divorce or parental loss have been called out as possible risk factors in the development of MS and disease relapse.

Adverse Childhood Experiences are a heterogeneous group of negative experiences occurred during childhood, that may have an unfavorable impact on the later course of life in terms of physical and mental health. These effects may be related to changes in the prefrontal, limbic, and hypothalamic-pituitary-adrenal areas and may cause repercussions on the immune system, as documented on experimental models of autoimmune encephalitis. In addition to that, a history of ACE has been associated with the development of poor coping strategies during adulthood . Since multiple sclerosis represents a chronic and progressive disease, the kind of coping strategies developed from childhood may affect how the patient perceives the disease and may affect his or her adherence to treatment.

To date, data on the prevalence of traumatic events during childhood in patients with Multiple Sclerosis are limited to a few studies, while the impact of such events on how the patient copes with the diagnosis of disease and acceptance of therapy. has not yet been explored.

This study represents a preliminary analysis of the impact of ACE in a cohort of multiple sclerosis patients and aims to evaluate how early negative life experiences may affect patients' coping strategies towards the disease and their compliance to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years;
* Diagnosis of relapsing-remitting multiple sclerosis according to McDonald criteria (2017 revisions) made between 2014 and 2024.
* Signature of informed consent

Exclusion Criteria:

* Presence of language barrier
* Presence of conditions that prevent or limit understanding and proper completion of questionnaires
Correct Endotracheal Tube Placement Using Topographical Landmarks

An optimal endotracheal tube depth is ideally required for preventing the complications associated with mal-positioning of the endotracheal tube. The topographical technique of tube placement considering the individual's morphometric dimensions could help to provide optimal tube placement. hence, to evaluate the efficacy of the topographical technique in providing the optimal tube placement this study will be conducted.

The trachea is a dynamic organ and its length varies by various static and dynamic factors leading to changing the tracheal length and variable endotracheal tube tip to carina (Ti-Ca) distance. Hence, upholding optimal Ti-Ca distance during changing tracheal length is of utmost importance to prevent complications associated with endotracheal tube (ETT) mal-positioning. When the length of ETT, which is to be inserted inside the trachea, is calculated as per an individual's tracheal morphometric dimensions, the appropriate depth of placement could be achieved and tube malpositioning can be prevented. In the topographical landmark technique, an individual tracheal length is estimated by measuring the various distance from mid-thyroid level (corresponds to vocal cords) to manubriosternal joint (corresponds to carina) in the sagittal plane. After estimating the tracheal length, tip to carina distance of 3cm was deducted from the estimated length of the trachea to provide the distance of the endotracheal tube to be kept beyond the vocal cords. Hence, the investigators planned this study to find the "utility and reliability" of the topographical landmark technique compared to the conventional intubation guide mark technique in providing the appropriate depth of endotracheal tube placement.

Eligibility Criteria:
Inclusion Criteria:

* • Age group of 18-75 years

  * ASA physical status I-III patients
  * Oral intubation for general anesthesia

Exclusion Criteria:

* • Patient with upper airway fibrosis

  * Tracheal stenosis or tracheal surgeries
  * Previous head and neck surgeries
  * Contracture neck or irradiated neck
  * Large neck swelling distorting or deviating the trachea
  * Laryngeal or tracheal tumor
  * Intubations requiring flexo-metallic tubes
  * Patient refusal
Expanded Use of Cannabidiol Oral Solution

To allow subjects who have completed Insys 030 extension study to continue to take Cannabidiol oral solution.

To allow subjects who have completed Insys 030 extension study (A multicenter, open-label, flexible dose study to assess the long-term safety of pharmaceutical Cannabidiol Oral Solution as an adjunctive treatment for pediatric subjects with a treatment-resistant seizure disorder who complete INS011-14-029 or Part A of INS011-15-054) to continue to take Cannabidiol oral solution.

Eligibility Criteria:
Inclusion Criteria:

1. Completed the Insys 030 protocol
2. Compliant in drug study procedures
3. Non-pregnant females of child bearing age, willing to utilize a double-barrier method of birth control during treatment and for 30 days after treatment has ended

Exclusion Criteria:

1. Failure to follow study procedures in Insys 030
2. Pregnant females