cyrilzakka/clinical-trials huggingface dataset:
A Proposal for a New Classification of Secondary Cleft Lip and Nose Deformities in Repaired Unilateral Cleft Lip

Congenital cleft lip with or without cleft palate is one of the most common congenital malformations with an estimated incidence of about 1 every 500 to 700 live births. Cleft lip and palate are caused by a complex combination of many environmental and genetic factors sharing into the etiology. Patients with cleft lip and palate undergo multiple surgeries to reconstruct the anatomy and function to achieve symmetric, aesthetic, and functional nasolabial region. The most important goals of correction of the cleft are to achieve an acceptable facial appearance and psychological and social well-being for the patient and his or her family. Therefore, assessment of nasolabial appearance following cleft surgery remains an important parameter for evaluating the outcome of the procedure. Unfortunately, some residual deformities in the nasolabial region such as the abnormal shape of the nose, scar of the upper lip, uneven white roll, notched or excess vermilion border will remain noticeable. So, the assessment of secondary cleft nasolabial deformities needs a reliable rating scale. Although many scoring systems have been described in the literature, there is no globally accepted reliable one. A frequently used scoring system is the one proposed by Asher-McDade that uses frontal and lateral view masked prints of the nasolabial area. The use of three-dimensional (3D) imaging seems to be the most reliable in assessing cleft-related facial deformities. However, scoring based on two-dimensional (2D) photographs is easier to perform and more applicable in daily practice because all cleft patients are photographed during their treatment journey at predetermined intervals. Assessment of secondary nasolabial deformities in cleft patients in large numbers of patients helps compare the aesthetic results of the different treatment protocols and techniques.


Eligibility Criteria:
Inclusion Criteria: All Patients with unilateral cleft lip who had undergone primary cleft lip repair surgeries during their first year of life at Sohag University Hospital from January 2006 to December 2020.

Exclusion Criteria:

1. Patients with multiple cleft lip repair surgeries.
2. If the primary cleft lip surgery was performed after the first year of life.
3. Patients with no available photographs
Cohort Study of Pioglitazone and Bladder Cancer in Patients With Type II Diabetes

To assess the potential association between pioglitazone and bladder cancer compared with non-pioglitazone users among patients with type 2 diabetes mellitus.

Following guidance from the United States Food and Drug Administration (FDA) and European Medicines Agency, the University of Pennsylvania and Kaiser Permanente Northern California (KPNC) designed and conducted this study using the KPNC database to assess the potential association between pioglitazone and bladder cancer among patients with type 2 diabetes mellitus.

The study was conducted over the course of 10 years, with a series of interim analyses undertaken during this period and provided to the sponsor (Takeda) and the appropriate regulatory agencies.

In 2011, the planned 5-year interim analysis of this study was published in Diabetes Care. That report included data from 1 January 1997 to 30 April 2008. Following reporting of these data, there was a request from the FDA for an additional fourth interim analysis at 8 years including data from 1 January 1997 to 31 December 2010.

In August 2011 the FDA requested inclusion of a sensitivity analysis to assess change of cohort entry criteria to minimize left censoring of exposure. Included in the FDA request was a duration analysis for other antidiabetic medications.

In August 2014, the final 10-year analyses were completed and submitted to the sponsor and regulatory agencies.

Interim results previously posted on clinicaltrials.gov are available in the public archive

Eligibility Criteria:
Inclusion Criteria:

* The study cohort included both patients with an established diagnosis of diabetes mellitus prior to January 1, 1997 and those who were newly diagnosed prior to December 31, 2002. Patients were eligible for the study cohort if they met any of the following criteria:

  1. As of January 1, 1997 they had been diagnosed with diabetes mellitus, were age 40 or older and were members of KPNC,
  2. They had been diagnosed with diabetes mellitus, reached age 40 between January 1, 1997 and December 31, 2002 and were KPNC members on their 40th birthday, or
  3. Had diabetes mellitus and were age 40 or older when they joined KPNC between January 1, 1997 and December 31, 2002.

     Exclusion Criteria:
* Diagnosis of bladder cancer recorded in the KPNC cancer registry prior to entry to the cohort or within 6 months of entry into KPNC.
Explore the Effects of Cortical Priming on Visuomotor Stepping Learning in Persons With Chronic Stroke

This research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 21 and 90 years
2. Medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment
3. MRI or CT evidence from the imaging report shown that the stroke involves the corticospinal tract
4. Hemiparesis involving the lower extremity (Fulg-Meyer LE motor test)
5. No passive range of motion limitation in bilateral hips and knees
6. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less
7. Visual acuity can be corrected by glasses or contact lens to 20/20
8. Able to walk independently with/without assistant devices for 10 meters
9. Able to maintain standing position without any assistance \> 30 sec (Short Physical Performance Battery)
10. Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24

Exclusion Criteria:

1. Pregnant women
2. MRI or CT evidence of involvement of the basal ganglia or cerebellum, evidence of multiple lesions, or evidence of any other brain damage or malignant neoplasm or tumors
3. Have any metal implants, cardiac pacemakers, or history of seizures
4. Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training
5. Any vestibular dysfunction or unstable angina
6. Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia\*
Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain

This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain. The study is being conducted in 2 parts. Part A enrolled 213 pts dosed with either 3, 20, 60 mg AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 320 pts and dose with either 60, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Irritable Bowel Syndrome
* Moderate or severe IBS pain

Exclusion Criteria:

* Any other uncontrolled disease
* Pregnant or nursing females
Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement

The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.

To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure.

The study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.

Eligibility Criteria:
Inclusion Criteria:

* Subject's age is between 23-75 years.
* Subject is healthy.
* Subject agrees to sign the Informed Consent Form

Exclusion Criteria:

* Contraindication to capsule endoscopy
* Contraindication or allergy to any of the products and materials used for bowel preparation
* Subject is not able to provide written informed consent
Role of Functional Neurosurgery in Management of Spasticity

Spasticity can result from a variety of causes in neural axis from which most common are cerebral palsy, strokes, cerebral haemorrhage, multiple sclerosis , traumatic brain injury and spinal cord injury and underlying mechanism is broadly due to decrease inhibition of the spinal network.

Clinical evaluation for spasticity involve series of clinical assessment , physical examination , and neurophysiological testing. quantitative evaluation of spasticity can be measured using modified Ashworth scale which is the most widely used clinical spasticity scale and can be used for various clinical conditions causing spasticity

Currently, the management of spasticity spans in a continuum between non-invasive and invasive intervention to modulate its effects and improve patients' Quality of life and when spasticity becomes excessive and aggravates disability, functional neurosurgery can be a resource.

Neurosurgical procedures for management of spasticity are classified according to whether their effect is generalized or focal and whether they are reversible or irreversible. Procedures include intrathecal baclofen pump , spinal cord stimulation and lesioning techniques peripheral nerves , dorsal roots , spinal cord or dorsal root entry zone

Eligibility Criteria:
Inclusion Criteria:

* Patients with spasticity refractory to medical treatment (most commonly administered oral medications for managing spasticity are diazepam, dantrolene sodium, and baclofen) and physiotherapy

Exclusion Criteria:

* Patients unfit for neurosurgical intervention
Immediate Effects of Dynamic Cupping on Median Nerve's Mechanosensitivity

The purpose oh this study is to verify the immediate effects of dynamic cupping on median nerve's mechanosensitivity, measured by the upper limb neurodynamic test 1 (ULNT1) in healthy participants.

After completing the socio-demographic and clinical questionnaire, the participants will be randomly assigned into two designated groups, the Intervention Group (IG; n = 30) (dynamic cupping therapy throughout the median nerve course) and the Control Group (CG; n = 30) (remained at rest for 5 minutes), using the software www.graphpad.com/quickcals.

Eligibility Criteria:
Inclusion Criteria:

• Healthy university students of both genders with normal mobility of the joints of the upper quadrant of the body.

Exclusion Criteria:

* Deformities in the upper quadrant region of the body;
* Complaints in this region in the last 6 months;
* Surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies of the upper quadrant that may disturb nerve function;
* Not present any mechanosensitive response to ULNT1;
* Pregnant women;
* Ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients

This was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they received during the double-blind study.

The study consisted of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0 which was typically the same date as Visit 6 of the double-blind lead-in study), visits after 1, 3, 6, 9, and 12 months of treatment (Visits 2-6), and a Follow-up Visit (Visit 7) scheduled within one month after stopping study drug treatment.

Primary:

The primary objective of the study was to evaluate the long-term safety of TNX-102 SL tablets taken daily at bedtime over 12 months in patients with fibromyalgia who have completed Study TNX-CY-F202 (NCT01903265)

Secondary:

The secondary objective was to evaluate the long-term efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of fibromyalgia

Eligibility Criteria:
Inclusion Criteria:

1. The patient met all prior inclusion and exclusion requirements for Study F202 (NCT01903265) originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.
2. The patient completed expected dosing in F202 (NCT01903265) defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on responses from daily IVRS calls recorded during the F202 study (NCT01903265)) and no major protocol violations.
3. The patient has provided written informed consent to participate in this extension protocol.

Exclusion Criteria:

None
Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Quality of Recovery Score

The goal of this prospective observational study is to learn about the correlation between obstetric comorbidity index and obstetric quality of recovery score in pregnant patients who undergo cesarean section. The main question aims to answer are:

* Are there a correlation between the obstetric comorbidity index and the obstetric quality of recovery score? Can we predict the postoperative quality of recovery by calculating the obstetric comorbidity index before delivery?
* What is the relationship between these scores with the type of anaesthesia given? Participants will answer an 11-question assessment scale to evaluate their recovery of quality in the postpartum period.

After the approval of the ethics committee and the written informed consent of the patients, the patients who are meeting the criteria of inclusion will be included in the study. The demographic data, type of anaesthesia, intraoperative haemorrhage, length of hospital stay and intensive care unit stay(if applicable), the urgency category of the cesarean section, and complications will be recorded. patients will be evaluated with obstetric quality of recovery assessment score on postpartum 1st and 2nd days

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are admitted for Cesarean section \> 18 years old
* Speaking Turkish or English
* Agreeing to participate in the study

Exclusion Criteria:

* Pregnant women \< 18 years old
* Can not speak Turkish or English
* Not agreeing to participate in the study
Characterisation of Gut Microbiota in Patients Undergoing Gastrointestinal Surgery With Postoperative Delirium (GIM-POD)

The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups depending on whether postoperative delirium or not. This study aims to characterise the gut microbiota in patients undergoing gastrointestinal surgery with postoperative delirium. The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.

The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups depending on whether postoperative delirium or not. This study aims to characterise the gut microbiota in patients undergoing gastrointestinal surgery with postoperative delirium. The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.

General anesthesia was induced as follows: 0.3 mg kg-1 intravenous (IV) etomidate, 2 mg IV midazolam, 0.4 μg kg-1 IV sufentanil, and 0.2 mg kg-1 IV cisatracurium. Anesthesia was maintained with an end-tidal concentration of 2-3 vol% sevoflurane and 0.2-0.3 μg kg-1h-1 sufentanil to maintain the bispectral index between 40 and 60.

Eligibility Criteria:
Inclusion Criteria:

* 1. ethnic Chinese;
* 2. age, 18 to 80 years old;
* 3. American Society of Anaesthesiologists (ASA) physical status I or II;
* 4. required Gastrointestinal Surgery

Exclusion Criteria:

* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Previous treated by radiotherapy or surgery
* Inability to conform to the study's requirements
* Deprivation of a right to decide by an administrative or juridical entity
* Ongoing participation or participation in another study \<1 month ago
Prospective Evaluation of Needle Exsufflation for Pneumothorax

Monocentric observational study of needle exsufflation for pneumothorax in the ICU.

The main objective of this prospective observational non interventional study is to investigate a possible relationship between prior duration of pneumothorax (defined as the duration from first occurence of chest pain reported by patient to exsufflation) and the success of exsufflation procedure (defined by the absence of a chest tube insertion in the following 24h).

Eligibility Criteria:
Inclusion Criteria:

* adult ICU patients requiring needle exsufflation for spontaneous pneumothorax

Exclusion Criteria:

* refuse to participate
* contraindications to needle exsufflation (acute respiratory failure requiring immediate chest tube insertion)
Application of a New X-ray Protective Device in Coronary Interventional Therapy

This is a multi-center, prospective and controlled clinical trial which will enroll 200 coronary arteriography or percutaneous coronary intervention with 2-4 interventional cardiologist. The interventional cardiologist performed 100 interventional procedures using either a new protective device (NPD) or a traditional lead clothing (TLC). The cumulative dose outside the NPD or TLC and the first operator at each height (110cm, 90cm, 50cm, 10cm) was measured. The main indicators of the study are the average X-ray shielding efficiency of the NPD and the TLC at four different heights. The investigators will record all operation information in this study.

In this study, the investigators developed a new protection device (NPD) and compared its effects on the reduction of radiation exposure compared with the traditional lead clothing (TLC).

The NPD (WLXP-006, Yingnuoweite Medical Science and Technology, Co., Ltd., Nanjing, China) is a floor-standing medical radiation protection device mainly composed of a barrel-like frame and protective lead rubber (0.5 mm lead equivalent).

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients were admitted to the group for coronary arteriography (CAG) or percutaneous coronary intervention (PCI).

Exclusion Criteria:

* There were no exclusion criteria, and the patients were continuously enrolled for interventional diagnosis and treatment.
Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults

HIV lipoatrophy is a condition marked by fat loss; it occurs in many patients taking antiretroviral (ARV) therapy that includes nucleoside reverse transcriptase inhibitors (NRTIs). Lipoatrophy may be related to mitochondrial toxicity, a condition that can damage the heart, nerves, muscles, kidneys, and liver, and can affect the body's ability to produce energy. NucleomaxX is a food supplement consisting of a sugar cane extract high in nucleosides, which are building blocks that may counteract the negative effects of NRTIs. Tenofovir disoproxil fumarate (TDF) is an NRTI that may cause less lipoatrophy than other drugs in its class, such as zidovudine (ZDV) or stavudine (d4T). The purpose of this study is to determine whether nucleoside supplementation with NucleomaxX and substitution of TDF for ZDV or d4T in an ARV regimen can reverse fat loss caused by mitochondrial toxicity in HIV infected adults.

Study hypotheses: 1) The substitution of TDF for d4T or ZDV in patients with HIV lipoatrophy will result in an increase in mitochondrial DNA content in fat, skeletal muscle, and peripheral blood mononuclear cells (PBMCs), which in turn will lead to an improvement in mitochondrial function as assessed by electron transport chain (ETC) and oxidative phosphorylation pathway (OXPHOS) activity. The latter should lead to a decrease in fat apoptosis and in mitochondrial and lipid oxidative damage biomarkers. 2) Supplementation with uridine (via NucleomaxX) will increase mtDNA content in adipose tissue and increase body fat content.

NRTIs are an important part of many ARV regimens used to treat HIV infected patients; however, the relationship between NRTI-induced mitochondrial dysfunction and lipoatrophy is still unclear and requires additional research. Additionally, the relationship between the gain in dual-energy x-ray absorptiometry (DEXA)-measured limb fat and mitochondrial DNA (mtDNA) content, mitochondrial function, fat apoptosis, and oxidative damage will also be examined in this study.

Patients will participate in this study for 48 weeks. Participants will be randomly assigned to one of two groups. Group 1 patients will receive NucleomaxX every other day. Group 2 patients will substitute TDF for ZDV or d4T every day in their current stable NRTI-containing ARV regimen. NucleomaxX will be provided to Group 1 patients, but TDF or any other ARV will not be provided by this study.

There will be 10 study visits, which will occur at study entry and Weeks 2, 4, 8, 12, 18, 24, 30, 36, and 48. Blood collection will occur at all visits. Additionally, urine collection, DEXA scans, and fat biopsies will be done at study entry and Weeks 24 and 48.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HIV lipoatrophy
* Receiving a stable stavudine- or zidovudine-containing ARV regimen
* HIV-1 RNA viral load less than 50 copies/ml

Exclusion Criteria:

* Coagulopathies or other bleeding disorders
* Diabetes requiring medication
* Creatinine clearance less than 50 ml/min
* Pregnancy or breastfeeding
Effects of RLIC on Motor Learning in Middle-aged and Older Adults

The purpose of this research is to determine if the beneficial effects of remote limb ischemic conditioning on learning seen in young adults are found in middle-aged and older adults.

Ischemic conditioning is an endogenous phenomenon in which exposing a target organ or tissue to one or more brief episodes of ischemia results in protection of that organ against subsequent ischemia. The effects of ischemic conditioning are not confined within an organ but can be can be transferred from one organ to another, a technique called remote ischemic conditioning. A clinically feasible method for this is remote limb ischemic conditioning (RLIC), where episodes of ischemia and perfusion are induced with a blood pressure cuff placed on the arm.

The overall goal of this line of work is to use ischemic conditioning to enhance learning and outcomes in persons with neurologic injuries. Two previous studies have shown that remote limb ischemic conditioning (RLIC) can enhance learning a motor task in healthy young adults. The next step is to determine which individuals would receive maximum benefit from RLIC before applying these findings to clinical rehabilitation populations such as stroke. Numerous factors, such as age, body mass index (BMI), sex, and cardiovascular comorbidities may influence the response. The current study determines if RLIC can enhance learning in middle-aged and older adults with their burden of co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

1. 40-80 years old
2. Had sufficient cognitive skills to provide informed consent and actively participate.

Exclusion Criteria (determined by self-report):

1. History of a neurological condition, balance impairment, or vestibular disorder.
2. History of attentional disorders (ADD/ADHD) that could affect learning.
3. History of sleep apnea which could confound the effects of RLIC.
4. Presence of lower extremity condition, injury, or surgery that would compromise performance on the balance task.
5. Learning disability, sensory, or communication problem that would prevent completion of the study.
6. History of epilepsy, peripheral vascular disease, or blood diathesis which could contraindicate RLIC.
7. Current intensive weight lifting or interval training exercise which could confound the effects of RLIC.
8. Current substance abuse or dependence.