cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis

To evaluate the safety and efficacy of Intrauterine Biological Barrier developed and produced by Chengdu TopRegMed Medical Technology Co., Ltd on postoperative adhesion after Hysteroscopic Adhesiolysis.

This study is a prospective, multicenter, randomized, parallel positive-control, non-inferior clinical trial, with the purpose to evaluate the efficacy and safety of Intrauterine Biological Barrier for the prevention or reduction of intrauterine adhesions after Hysteroscopic Adhesiolysis.

The trial will be conducted at six clinical centers with 264 subjects who meet all the inclusion/ exclusion criteria. Subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Subjects in the test group were treated with Intrauterine Biological Barrier (IBB) made by Chengdu TopRegMed Medical Technology Co. , Ltd. , while the patients in the positive control group were treated with commercially approved Intrauterine Adhesion Barrier Gel for uterine cavity made by Changzhou Bioregen biopharmaceutical Co. , Ltd. .

Subjects will be followed up for 12 months (360 days ± 30 days) after implantation. 73-days (± 12 days) after operation, the safety and effectiveness of IBB will be evaluated by demonstrating non-inferiority to commercially approved gel. If test group is non-inferiority, further study will be performed to explore whether the safety and effectiveness of the IBB is better than the control group in the aspect of the recurrence rate of intrauterine adhesion, types of intrauterine adhesion, postoperative endometrial repair, menstrual recovery and 1-year pregnancy rate.

Eligibility Criteria:
Inclusion Criteria:

* （1）Age, yr20-40 (including boundary value), Female
* （2）Normal ovarian reserve function (FSH\<10U/ml，AMH\>2ng/ml)
* （3）Who suffered from moderate to severe intrauterine adhesions (AFS ≥ 5 points) diagnosed by hysteroscopy, and prepared to be treated by Hysteroscopic adhesiolysis
* （4）Both husband and wife have fertility intention during treatment
* （5）Accept to treatment and follow-up visits, Sign the ICF

Exclusion Criteria:

* （1）Severe systemic diseases, contraindications of surgical and cycle
* （2）Inflammation of reproductive tract, genital tuberculosis, pelvic infection, tumor of reproductive organs
* （3）Systemic diseases cause uterine bleeding
* （4）Allergic to hyaluronic acid or components
* （5）Allergic to swine sources medical device, or refuse to swine sources medical device for religious, ethnic and other reasons
* （6）Insufficient uterine cavity volume after Hysteroscopic adhesiolysis to place Intrauterine Biological Barrier or inject Intrauterine Adhesion Barrier Gel
* （7）Involved other clinical trial before Hysteroscopic adhesiolysis in 3 months or during the trail
* （8）Unable to tolerate anesthesia
* （9）Estrogen medicine was taken within 30 days of Hysteroscopic adhesiolysis
* （10）Other inadequacy patient assessed by the researchers
Position Of The Tip Of The Inner Catheter And Air Bubbles As Predictors Of Pregnancy During ICSI Cycles

Position of the tip of the inner catheter and air bubbles detection (at time,5min 10min)during embryo transfer influence the pregnancy rate in ICSI cycles .

The aim of this study is to assess the relationship between the position of the tip of the inner catheter, the position of the air bubbles (at time , 5 min ,10 min )after embryo transfer and pregnancy rate outcome in ICSI cycles. Most IVF teams consider not touching the endometrium and the uterine fundus with replacement of the embryos in the lumen of the endometrial cavity the most important factors for successful embryo transfer, it is highly recommended to use agents that can facilitate a smooth embryo transfer and reduce unintended stimulation of the fundus, for example the application of soft-tipped catheters, which can improve pregnancy rate.

The advantage of using the air and liquid content for catheter loading is to prevent the embryo from adhering to the wall of the catheter at the time of injection.The presence of two air bubbles on both sides of the medium that contains the embryo prevents the transfer of the embryo within the catheter and beside, in the transfer under ultrasonographic guidance, the air bubbles are often considered a marker for the embryo's position in the uterus.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 30 kg/ m2.
* Between 20 and 35years old.
* FSH levels on cycle day 3 of \<12 mIU/mL.
* Both ovaries present deprived of morphological abnormalities and adequately visualized in Transvaginal ultrasound.
* Grade one or two embryo quality.

Exclusion Criteria:

* Hydrosalpinx.
* Intrauterine lesion.
* Patients undergoing ET after cryopreservation.
* Blood present on the catheter during the transfer procedure.
* A difficult transfer or with a suspicion of touching the fundus.
* Endometrial thickness less than 8mm.
* Known allergic reaction against one of the ingredient of the medications used during the study.
Position Changes During Colonoscope Withdrawal and Polyp Detection

The purpose of this study is to determine whether position changes during colonoscope withdrawal affects polyp detection rate. We hypothesize that positions change during scope withdrawal will increase polyp detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients undergoing colonoscopy
* Age 40 or greater

Exclusion Criteria:

* Inpatient colonoscopy
* Unable to provide informed consent
* Unable to complete colonoscopy to cecum
* Previous bowel resection, inflammatory bowel disease, polyposis syndrome
* Musculoskeletal disorder or other mobility issue limiting effective patient position changes
* Inadequate bowel preparation
The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation

The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on hemodynamic and on parameters of microcirculation in patients with peripheral arterial occlusive disease (PAOD).


Eligibility Criteria:
Inclusion Criteria:

* female or male patients receiving peripheral bypass surgery
* age between 55 and 75 years

Exclusion Criteria:

* metabolic acidosis
The Effect of Oral and Nasal Feeding on Cerebral Small Vessel Disease

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia.

This was a randomized controlled study with 60 CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy. Patients enrolled were randomly divided into the observation group (with IOE, n=30) and the control group (with NGT, n=30). At admission and after treatment, Video Fluoroscopic Swallowing Study (VFSS) and Functional Oral Intake Scale (FOIS), body mass index (BMI), serum albumin (Alb), and hemoglobin (Hb), Modified Barthel Index (MBI) and World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (ADL) and quality of life (QOL). The incidence of pneumonia was recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cerebral Small Vessel Disease;
* Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ;
* Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
* Age between 40 and 70 years;
* Enteral nutrition support was required and feasible.
* No history of prior stroke.

Exclusion Criteria:

* Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
* Complicated with severe liver and kidney failure, tumors, or hematological disorders;
* Simultaneously need to undergo other therapy that might affect the outcomes of this study;
* Pregnant or nursing females.
A Parental Educational Intervention to Facilitate Informed Consent for Pediatric Procedural Sedation in the Emergency Department

This study is planning to develop the computed-assisted information program and determine whether the computed-assisted information program are superior to routine discussion for informing parents in the emergency department (ED) about risks, benefits, and alternatives to receiving procedural sedation for their children.


Eligibility Criteria:
Inclusion Criteria:

* Parents with patients under 18 years of age
* patients receive the procedural sedation and anesthesia in the emergency department

Exclusion Criteria:

* clinically unstable
* refuse to participate
* unable to understand the consent process for this study
Post Isometric Relaxation and Mulligan Bent Leg Raise on Hamstring Tightness in High School Students

This project was a Randomized clinical trial conducted COMPARATIVE STUDY OF POST ISOMETRIC RELAXATION AND MULLIGAN BENT LEG RAISE ON HAMSTRING TIGHTNESS IN HIGH SCHOOL STUDENTS

Non Probability Convenient sampling was done. Patients following eligibility criteria from high schools located in vicinity of Jhang district were considered. Sample size was calculated with Epitool calculator. 28 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A was given post isometric relaxation and Group B was given mulligan bent leg raise Duration of research was almost 6 months. All 28 involved subjects were given 12 treatment sessions over a six-week period, which consisted of 02 treatment sessions per week . Then tightness of hamstrings was assessed by AKET, SLR and FTF test. The baseline outcome measures consisted of pain assessment using Numeric rating scale (NPRS), knee joint goniometry in active knee extension test (AKET) and straight leg raise (SLR), modified finger to floor test (FTF) to assess the flexibility of hamstring muscles. . All participants were provided written informed consent prior to commencement of the procedures. Data was analyzed by using SPSS version 23.

Eligibility Criteria:
Inclusion Criteria:

Asymptomatic Individuals of both gender, aged 13 to 18 years were evaluated for unilateral or bilateral Hamstring tightness. Those who were unable to reach more than 160 degree of knee extension with hip held at 90 degree of flexion, as measured with the thigh held at 90 degrees of hip flexion), unable to complete SLR and meet the criteria of finger to floor test

were included.

Exclusion Criteria:

Individuals were excluded who presented with previous injury of lower limb or pain duration of one year. Also any deformities related to spine, hip and knees or any neurological disorder or with history of lower limb fracture or surgery were also excluded.Subjects with hamstring tightness associated with muscle soreness or with Inflammatory condition that could affect motion were also exluded from the study
Combined Effect of Foam Roller and Gastrocnemius Release on Plantar Fasciitis

this study will be conducted to investigate the efficacy of combining foam roller and gastrocnemius release on pain intensity level, dorsi flexion range of motion of ankle joint ,dorsi flexion range of motion of big toe and foot function in subjects with plantar fasciitis.

Plantar fasciitis refers to degeneration and inflammation of the proximal plantar fascia. The condition presents with plantar medial heel pain, often exacerbated following periods of inactivity, such as upon waking in the morning.The term "plantar fasciitis" has been quoted for years, but this is a misnomer as inflammatory cells are not present in biopsies from involved fascia. Therefore, advocate the terminology "plantar fasciitis" to explain the syndrome characterized by pain along the proximal plantar fascia and its attachment in the area of the calcaneal tuberosity with function impairment, implying a more chronic degenerative process than acute heel pain.Research found that both stretching and foam rolling techniques helped reduce pain and increase the ROM. However, the effectiveness of foam rolling was superior to stretching in terms of increased pressure pain thresholds (PPTs) at gastrocnemius and soleus. there was a gap in the previous literature in combined effect of gastrocnemius release and foam roller in managing plantar fasciitis and assessing dorsi flexion range of motion of both big toe and ankle joint along with pain assessment and foot function. sixty patients with planter fascitis will be assigned randomly to two groups; first one will receive manual and foam roller release of gastrocnemius and conventional treatment and the other one will receive conventional treatment only.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 years and 60 years
* heel pain in the morning with first step, insidious sharp pain under the heel, tenderness on medial calcaneus and symptoms decreasing with slight activity (like walking) and worsening toward the end of the day

Exclusion Criteria:

* Infective conditions of foot, tumor, calcaneal fracture
* Metal implant around ankle
* Dermatitis, acute sepsis and anesthetic areas
* Subject with impaired circulation to lower extremities
* Subject with referred pain due to sciatica
* Corticosteroids
* Injection in heel preceding 3 month
* Patient who cannot co-operate
* history of flat foot
Clinical Trial NuSmile Crowns

A clinical trial comparing two types of NuSmile anterior crowns to composite strip crowns on anterior dental restorations.

Stainless steel crowns have been the most common treatment for large cavities in baby teeth until recently. These crowns are silver in color, and aesthetically are not a good option for restoring front teeth. Several tooth colored options have been developed to meet the growing demand for more aesthetics on front teeth. With the variety of new options for restoring anterior primary teeth, the investigators would like to evaluate the long-term success of three tooth-colored restoration options: NuSmile Signature crowns, NuSmile ZR crowns, and composite crowns. The investigators are interested in looking at the outcomes of these three restoration types, in terms of durability, aesthetics and cost effectiveness for the treatment of front baby teeth. The purpose of this pilot study is to evaluate the clinical performance of two types of NuSmile crowns compared to composite crowns in treating large multi-surfaced cavities on front baby teeth.

Eligibility Criteria:
Inclusion Criteria:

* Patients of record at the University of Washington's Center for Pediatric Dentistry
* Patients in general good health (ASA I)
* Patients aged 5 years old or younger
* Patients in need of at least one preformed crowns, on anterior primary teeth
* Patients undergoing general anesthesia for dental treatment
* Parent or guardian of patient able and willing to provide informed consent

Exclusion Criteria:

* Medically compromising condition
* Teeth with proximal space closures of sufficient magnitude to preclude placement of crown
* Teeth with complete absence of facial or lingual walls following tooth preparation
* Teeth that are expected to be exfoliated/extracted within one year will not participate in the study
* Anterior crowding
* Occlusion class III
Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations

We aimed to evaluate the management and outcome of bladder trauma after gynecological and obstetric operations at Assiut university hospital and to evaluate the methods of treatment of these complications.

We aimed to find out risk factors for vesico uterine fistula after bladder trauma

The female genital and urinary systems are closely related embryologically and anatomically. The surgeon should know the anatomy of this area to avoid urinary tract (UT) injuries during obstetric (Obst) and gynecologic (Gyn) surgeries (Solyman et al., 2022)

UT injuries during Obst/Gyn surgeries are rare but have a significant psychological impact on both patient and surgeon, and their medico legal aspects are very bothering (Safrai et al., 2022)

UT injuries during Obst/Gyn operations range from 0.3 to 1% (Blackwell et al., 2018) Most cases are bladder injury, approximately three times more than ureteral injury (Wong et al., 2018)

The primary goal of the Obst/Gyn surgeon is to avoid UT injuries during his procedure. Still, in some situations, this will be difficult as in patients with abnormal anatomy, difficult operations as in the presence of severe bleeding or pelvic adhesions, and with surgeons with low experience. Immediate intraoperative repair of these injuries is optimal. In some cases, diagnosis and management are delayed postoperatively(Patel and Heisler, 2021)

UT injuries during Obst/Gyn operations are either acute injuries such as bladder and ureteral laceration, and ureteral ligation identified immediately intra operatively or chronic injuries as fistula formation and stricture ureter, which are discovered later on (Lee et al., 2012) Iatrogenic urological complications from gynecological surgery can be prevented and reduced by complying with standard surgical

Eligibility Criteria:
Inclusion Criteria:

-

All patients with Urinary bladder injuries related to Obst/Gyn operations

Exclusion Criteria:

* no exclusion criteria in all patients with bladder trauma after gyn \&obs operations
Impact Trial of Helping Educational Leaders Mobilize Evidence

Social, emotional, and behavioral (SEB) problems occur frequently among elementary school students, dramatically impede student outcomes, and have been exacerbated by the COVID-19 pandemic. Evidence based practices exist to address student SEB needs, prevent problems, and ensure academic success. However, the implementation of these programs in schools is frequently incomplete, uneven, and occurs with insufficient fidelity to ensure positive effects for students due to significant implementation barriers across multiple levels. The purpose of this Impact Trial is to test the effectiveness of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in school-wide implementation of a Tier 1 evidence-based practice (EBP) - Positive Behavioral Interventions and Supports (PBIS).


Eligibility Criteria:
Inclusion Criteria:

* School Districts: School districts in Washington State committed to implementing PBIS in its elementary schools
* Educators: Educators working in a public elementary school within an enrolled school district.

Exclusion Criteria:

* Schools with previous HELM exposure will be excluded
Comparison of Egoscue Versus Pilates Exercises in Patient With Mechanical Low Back Pain

Mechanical low back pain arises intrinsically from the spine, intervertebral disc,or surrounding soft tissues.It is causes by muscular spasm, and other soft tissue injuries. The aim of the study will be to compare the effect of Egoscue versus Pilates exercises on pain, range of motion and muscle endurance in patient with mechanical low back pain.

A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore through consecutive sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with Pilates exercises at frequency 2 sets 5 repetitions 5 days a week and Group B will be treated with Egoscue exercises at the frequency of 2 sets with 5 repetitions 5 days a week. Outcome measures will be conducted through pain, disability,lumber range of motion, Muscle flexibility, Extensor muscle endurance, Lateral muscle endurance, Flexors muscle endurance questionnaires after 4 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by ANOVA test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 40 years
* Both gender
* Patient with non-radiating pain
* Pain NPRS \<7
* Positive McGill Extensor Endurance Test ( \<101 seconds)
* Positive McGill lateral flexor endurance test (\<54 sec Right side, \<55sec left side)
* Positive McGill flexor endurance test \< 120 seconds
* Positive Finger to Floor Test : \> 48cm in males, \>50cm for females
* Patient with Oswestry disability index (ODI) \< 40 ODI score
* Decrease lumbar ROM; Lateral flexion, Extension, Flexion

Exclusion Criteria:

* Sacroiliac Joint Dysfunction (SIJD)
* Coccydynia
* Lumber disc pathology
* Malignancy
* Recent fractures
Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy

This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy.

This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy. Adult patients with symptomatic benign, premalignant, or resectable malignant pathologies recommended for resection after multidisciplinary review and have already chosen to have robotic surgery will be evaluated for enrolling into the study.

Relevant operative, postoperative, and pathologic outcomes will be collected prospectively. The well-established enhanced recovery after pancreaticoduodenectomy pathway currently used in our institution will be applied to all patients postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Symptomatic benign, premalignant, or resectable malignant periampullary and pancreatic tumor requiring resection
* Fit to undergo elective pancreaticoduodenectomy after evaluation by the surgical and anesthesiology teams
* Able to consent to participate in the study
* Appropriate for robotic approach as determined by participating surgeons

Exclusion Criteria:

* Arterial (superior mesenteric artery, celiac axis, hepatic artery) or venous involvement (superior mesenteric vein, portal vein) which meets the definition of borderline or unresectable tumor
* Pregnancy
* BMI \>40 kg/m2
* Patient requires an additional surgical resection during the index operation (such as hepatectomy or colectomy)
A Comparison of McGrath MAC®, Pentax-AWS® and Macintosh Direct Laryngoscopes for Nasotracheal Intubation

A comparison of intubation time, difficulty of intubation in nasotracheal intubation using McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes

This trial is prospective randomized trial. The Objects are adult patients who need nasotracheal intubation for surgery. Using computed randomized table, participants are assigned to three groups, McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes.

The intubation will be done by One expert anesthesiologist who have more than 10 years experience.

Investigators compare intubation time, success rate and difficulty between three groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 19 years old
* ASA I or II
* Patients who need nasotracheal intubation for surgery

Exclusion Criteria:

* Anatomical deformity in head and neck
* Modified Mallampati score IV
* Bleeding tendency in preoperative evaluation