cyrilzakka/clinical-trials huggingface dataset:
Oncological Outcome of Contralateral Submental Artery Island Flap Versus Primary Closure in Tongue Squamous Cell Carcinoma

The purpose of this study is to compare the oncological and functional results of the contralateral submental flap with primary closure for reconstruction of tongue squamous cell carcinoma.

Resection of tongue malignancies remains one of most surgical challenges because of its adverse effects on speech articulation, swallowing, and eventual quality of life.

A variety of local flaps such as infrahyoid flap and the Platysma flap, and free flaps like the radial forearm and anterolateral thigh (ALT) flap have been available for reconstruction of tongue. However, all these options have their shortcomings.

When reconstructing particular oral cavity defect the tissue used should be reliable; functional and cosmetically acceptable with minimum donor site morbidity and match the recipient site in terms of color, texture and thickness. The submental island flap (SMI-flap) which has been first introduced by Martin et al in 1990, meets all these requirements and due to its optimal location, ease of harvest, and favorable arc of rotation, the SMI-flap has gained acceptance as a simple, reliable and convenient to repair defects of tongue and oral cavity cancer.

The oncological safety of submental flap in oral cancer patient still debate, this is due to its proximity to the main nodal basins of levels 1A and 1B and the possibility of transfer of occult metastatic lymph node to the recipient site during reconstruction.

in addition some authors has not been recommended submental flap for cases with clinically or radiologically established nodal disease as it might compromise the oncological resection and continuity of neck dissection and so alternative options should be considered. The contralateral submental island flap (CSMI-flap) is believed to offer such alternate option for patient with contralateral negative node.

our a priori-hypothesis is that utilization of the CSMI-flap is not related to an altered prognosis in tongue squamous cell carcinoma patients. In order to test this hypothesis, we will compare the oncological outcome of group of patients receive CSMI-flap with the results of another group of patients not receive CSMI-flap and close tongue defect by primary closure, which is another well-established concept of management tongue cancer defect.

Eligibility Criteria:
Inclusion Criteria:

* Patient with T1\&T2 tongue squamous cell carcinoma.

Exclusion Criteria:

* Patients with contralateral N positive.
* Patients with previous neck surgery that interrupt contralateral facial artery or vein.
* Patients with prior radiotherapy to the neck.
* Patients with lesions crossing the midline, or those reaching the base of tongue requiring total glossectomy.
* Patients second primary tumors at the time of diagnosis.
* Patient with recurrent tongue squamous cell carcinoma.
Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy

Trainees (Residents in internal medicine), naive to real patient endoscopy, will be randomized to receive either 3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator GI-Mentor or no training before starting on-patient endoscopy in the University of Vienna Medical School Endoscopy Unit. Patients satisfaction and pain, technical accuracy and number of found/missed pathologies as well as average time for successful endoscopy will be recorded. After one month or 50 supervised, self performed endoscopies, trainees will be evaluated again with the above mentioned criteria during ten consecutive investigations.


Eligibility Criteria:
Inclusion Criteria:

* Trainees: naive to real patient endoscopy before training phase

Exclusion Criteria:

* Medical doctors with experience in gastrointestinal endoscopy
* Patients sedated for upper GI endoscopy
* Patients unwilling or unable to sign informed consent
3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation

To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES).

Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery lesion who received percutaneous coronary intervention using Ultimaster sirolimus-eluting stent.
* Patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation.
* Patients who have provided written informed consent.

Exclusion Criteria:

* Patients previously experienced stent thrombosis.
* Patients who are unable to clinical follow-up procedure specified in the protocal for the present study.
* Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.
Development of a Newborn Screening Assay for Angelman Syndrome and Prader-Willi Syndrome

The overall purpose of this project is to establish the capability of screening for Angelman syndrome (AS) and Prader-Willi syndrome (PWS) in public health newborn screening (NBS) programs, with an aim of developing and validating a screening test for AS and PWS.

This project will have an assay development phase and an assay validation phase.

In the assay development phase, the investigators will develop a method of assessing SNRPN promoter (located in chromosome 15 q11-q13) methylation status using methylation-specific PCR coupled with a melting curve analysis with de-identified leftover DNA from routine newborn screening dried blood samples for severe combined immunodeficiency and spinal muscular atrophy.

In the assay validation phase, the investigators plan to assess the assay sensitivity and specificity using a set of DNA samples extracted from dried blood spots in each following group:

1. Healthy individuals
2. AS patients with genetic testing confirmation that the maternal copy of chromosome 15 q11-q13 is deleted, or that there are two paternal copies of chromosome 15 q11-q13 or imprinting center defect.
3. PWS patients with genetic testing confirmation that the paternal copy of chromosome 15 q11-q13 is deleted, or that there are two maternal copies of chromosome 15 q11-q13 or imprinting center defect.

For participants with AS or PWS, blood samples will be obtained via a self-administered finger prick performed in the participant's home. The participant will mail the sample to the researchers using a provided envelope. If the team is not able to reach the participant after two phone call attempts, the study team may approach them at their next clinic visit to assess interest in study participation. If participants opt to join the study at this clinic visit, the blood sample may be obtained in clinic.

For healthy controls, blood samples will be obtained via a self-administered finger prick, and participants will verbally respond to a brief demographic questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Angelman Syndrome, confirmed by molecular testing (deletion of maternal allele of chromosome 15q11-q13, paternal uniparental disomy, and imprinting center defects)
* Diagnosed with Prader-Willi Syndrome, confirmed by molecular testing (deletion of paternal allele of chromosome 15q11-q13, maternal uniparental disomy, and imprinting center defects)
* Angelman Syndrome or Prader Willi Syndrome: Current patient at UW Health in the Madison, Wisconsin metropolitan area
* Healthy controls 18 years old or older and have not received a diagnosis of Angelman syndrome or Prader Willi syndrome

Exclusion Criteria:

* Angelman Syndrome/Prader Willi Syndrome: family requires a translator for medical visits
* Healthy Controls: Participants are unable to consent and complete study procedures in English.
Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma

The purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma.

For MGMT unmethylated glioblastoma patients undergoing STUPP regimen adjuvant therapy, during adjuvant chemotherapy, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14).

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70 years,
2. Histologically proven diagnosis of glioblastoma (WHO grade IV),
3. Have received standard STUPP treatment plan,
4. Gross resection or partial resection of the tumor (confirmed by MRI)\> 50%,
5. The pathological tissue specimens are detected as MGMT unmethylated,6.Karnofsky performance status ≥ 60,
6. No previous radiotherapy, chemotherapy, immunotherapy or biotherapy 7.Adequate bone marrow function: Hemoglobin ≥ 100g/L，Platelets ≥ 80×109/L，Absolute neutrophil count (ANC) ≥ 1.5×109/L

8.Adequate renal function: Serum creatinine ≤ 1.25 x UNL (upper normal limit) or creatinine clearance ≥ 60 ml/min 9.Adequate hepatic function: serum bilirubin ≤ 1.5 x UNL, AST and ALT ≤ 2.5 x UNL，ALP≤5x UNL 10.For females of child-bearing potential, negative serum pregnancy test within 14 days prior to registration. Women of childbearing potential and male participants must practice adequate contraception during participation in the study and within 8 weeks after the last administration of the drug 11.Able to provide written informed consent

Exclusion Criteria:

1. Recurrent or multiple malignant gliomas
2. Subtentorial glioblastoma or metastatic lesions outside the skull
3. Have received radiotherapy, chemotherapy or other anti-tumor drugs for the disease before surgery
4. Previously received radiation therapy for the head and neck cancer
5. Have received any antibody treatment before
6. Contraindication of radiotherapy and chemotherapy defined as follows: Acute bacterial or fungal infection，Unstable angina and/or congestive heart failure within the last 6 months，co-morbidity with immunosuppressive therapy
7. Evidence of bleeding diathesis or coagulopathy
8. Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in situ of cervix)
PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study

This pilot study will investigate the use of PSMA-PET/MRI (Positron Emission Tomography/ Magnetic Resonance Imaging)to guide radiation treatment planning in patients with known or suspected locally metastatic prostate cancer at the time of diagnosis. Patients will undergo a single PSMA-PET/MRI (or PET/CT (Computed Tomography) in some circumstances) prior to initiation of treatment. Following development of a PSMA-PET guided radiation treatment plan, therapeutic radiation will be delivered per standard-of-care parameters and assessments of feasibility and tolerability will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven treatment-naïve prostate adenocarcinoma with pelvic metastases known to suspected on standard-of-care staging imaging
* Eligibility and plan to undergo definitive radiation therapy for prostate cancer per established standard-of-care radiation oncology clinical guidelines
* Be at least 18 years of age

Exclusion Criteria:

* Inability to tolerate or undergo PET/MRI or PET/CT
* Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
* Recurrent prostate adenocarcinoma
* Known distant metastatic disease
* Current or prior treatment for prostate cancer
* Known allergy to glucagon
* Previous diagnosis of insulinoma or pheochromocytoma
Hypnosis as a Treatment of Chronic Widespread Pain in General Practice. A Pilot Study.

Objective: The study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP).

Design: A randomized control group-controlled study. Setting and subjects: 16 patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions.

Intervention: The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy.

Main outcome measures: A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering.


Eligibility Criteria:
Inclusion Criteria:

* Chronic widespread pain for at least three months and at most five years.

Exclusion Criteria:

* Patients having primarily other organic diseases or serious psychiatric disorders were excluded.
Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy

This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.

It is estimated that more then 5 million people in the United States suffer from Diabetes Mellitus, and of these up to 80% suffer from painful diabetic peripheral neuropathy. Multiple medications have been tried for the treatment of painful diabetic neuropathy. These medications are directed at symptomatic relief and do not address the underlying cause of painful peripheral neuropathy. Thiamine is a water-soluble vitamin that participates in carbohydrate metabolism. Deficiency of thiamine causes beriberi, characterized by painful peripheral neuropathy and cardiomyopathy. Basic research has suggested that thiamine deficiency may also be involved in the etiology of diabetic neuropathy by preventing the glycation of nerve fibers as well as apoptosis of endothelial cells. A study in the developing world found that oral thiamine and pyridoxine were helpful in improving the pain experienced in diabetic peripheral neuropathy as well as improving signs of neuropathy seen on neurological examination. A screening study of patients with type II diabetes found that 76% of patients tested had a low serum thiamine level.

Our study will examine the effect of oral thiamine supplementation on the symptom of pain in painful diabetic peripheral neuropathy. In addition we will follow serum thiamine levels to see if clinical change correlates with changes in serum thiamine levels

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of Diabetes Mellitus Painful diabetic neuropathy for \> six months with a score of \>40mm on a visual pain analog scale Age \>18 years Hemoglobin A1c obtained within the last 3 months. Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

Known history of alcohol abuse, recreational drug abuse, thyroid dysfunction, syphilis, multiple myeloma, known nutrient deficiency, history of gastric bypass surgery or HIV. Hgb A1c\>11
Activity at 25% Above the Ventilation Threshold on Appetite and Food Intake in Boys

The investigators hypothesize exercise increases short term appetite and food intake, and interferes with satiety and satiations to a preload in normal weight, boys.

The effect of exercise (EXR) on short-term food intake (FI) and subjective appetite was investigated in normal weight (NW), boys were randomized into 4 treatments. Each boy consumed either a non-caloric sweetened control (CON) or GLU drink after either exercise (EXR) or sedentary activity. Subjects exercised at 25% above their ventilation threshold (VeT).

Eligibility Criteria:
Inclusion Criteria:

* Healthy boys with no emotional, behavioral or learning problems

Exclusion Criteria:

* Girls
Effects of Forest Therapy on Physical and Psychological Parameters in the General Population

In recent years, nature and forest therapy has increasingly become the focus of medical research. Recent scientific findings indicate overall positive effects of nature and forest therapy on physical and mental health. In Asia and Australia, it has already been implemented as a public health concept of prevention and health promotion. The aim of the project is to replicate the experience gained in Asia over the last three decades on the physical and psychological effects of nature/forest therapy in the context of the German forest and to investigate it further scientifically.


Eligibility Criteria:
Inclusion criteria:

* Women and men aged 18 to 90 years.
* Capacity to consent

Exclusion criteria:

* Serious acute or chronic medical conditions
* Immobility or limitation of mobility due to orthopedic, neurological or other medical causes
* Participation in another study
* Serious mental illness
* Pregnancy and lactation
Examination of the Relationship Between Foot - Body Posture and Balance and Gait in Duchenne Muscular Dystrophy

Foot and body postures of patients with DMD will be evaluated. Foot structure characteristics such as foot length, metatarsal width, calcaneal valgus angle will be calculated for the foot posture. Also, the Foot Posture Index (FPI-6) scale will be used. The body posture will be evaluated with the New York Posture Scale. Many gait characteristics such as step length, cadence, support surface of the patients will be determined with GaitRite instrumented walkway. Patients' balance assessment will be evaluated with Bertec Balance Advantage. The statistical analysis method will determine the relationship between foot and body posture and gait and balance.


Eligibility Criteria:
Inclusion Criteria:

1. To be between 5-13 years old
2. Being at level I or II according to Brooke Lower Extremity Functional Classification Scale
3. In the balance assessment, there should be at least 90 degrees of joint range of motion in the ankle to provide base contact on the force platform.
4. Agree to participate in the research voluntarily

Exclusion Criteria:

1. Having serious mental and psychological problems,
2. Failure to cooperate adequately with the physiotherapist making the evaluations,
3. Severe contracture in lower extremities,
4. Any injury and / or surgery of the lower extremities in the past 6 months.
Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy

We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.

The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status 1 and 2
* Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* BMI \> 30
* Known gastro-oesophageal reflux disease
* predicted or documented difficult airway
* contraindications to drugs in the standardized anaesthesia protocol
Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients

The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients\&#39; sleep habits and maladaptive sleep behaviors.

The purpose of sleep restriction is to reduce the patient\&#39;s time in bed, bringing it closer to their actual sleep time, thereby improving sleep efficiency and quality. Stimulus control, on the other hand, aims to associate the bed with a rapid sense of falling asleep, reducing the negative association between the bed and insomnia.

Eligibility Criteria:
Inclusion Criteria:

Meet the diagnostic criteria for insomnia disorder as per DSM-5. Pittsburgh Sleep Quality Index (PSQI) total score \> 5. Age ≥ 18 years, at least a junior high school education level. Assessment of sleep-wake behavior by sleep diary. Assessment of "maladaptive sleep behavior" by self-designed 8-item questionnaire.

Voluntary participation in the study and signing an informed consent form.

Exclusion Criteria:

Presence of severe physical or severe mental illness, and suicide risk. Clinical diagnosis or suspicion of sleep-breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as individuals working in rotating shifts or with shift work.

Pregnant or lactating women. Currently undergoing any form of psychological therapy.
Assessment of Chiropractic Treatment Using Reaction and Response Times in Members of the Special Operation Forces (ACT2)

This study is a randomized controlled trial designed to evaluate changes in reaction times (RTs) and response times (RespTs) following chiropractic treatment compared to controls in the Special Forces Qualified (SFQ) population, including Special Operation Forces who are part of the 160th SOAR regiment on flight status.

The Assessment of Chiropractic Treatment 2 (ACT2) assesses changes in reaction/response times following Chiropractic Manipulative Therapy (CMT) using a randomized controlled trial in members of SFQ or SOAR. This population is faced with simultaneous physiological and cognitive demands. The ability to give an accurate and appropriate motor response in a short time is required for successful completion of the types of missions they are expected to undertake.

It is possible that chiropractic care can improve performance in reaction and response times in populations that have low back pain and in populations that are asymptomatic. One possible theory for improvement, even in asymptomatic persons, is that they may have experienced an insult or stress to the body which is subclinical but alters their ability to function in an optimal manner. Thus a person may be asymptomatic and able to accomplish many activities in a normal manner, but when stressed to the limits of maximum capability, the effects of subclinical abnormalities may cause that person to function at a less than optimal level. If CMT is able to restore normal, more efficient mechanisms of functioning, it is therefore possible that the performance of challenging tasks could be improved.

Eligibility Criteria:
Inclusion Criteria:

* Age range at least 20 years of age
* Written informed consent
* Active duty SFQ personnel or Special Operation Forces who are part of the 160th SOAR regiment on flight status stationed at the Ft. Campbell, KY military site

Exclusion Criteria:

* Pain Intensity (NIH's PROMIS- question #29) \> 4 at the Initial Visit
* Additional diagnostic procedure needed (e.g. x-ray)
* Bone and joint pathology contraindications for CMT. Potential participants with recent spinal fracture, concurrent spinal or paraspinal tumor(s), spinal or paraspinal infection(s), inflammatory arthropathies and significant osteoporosis will be referred for appropriate care.
* Other contraindications for CMT (i.e., unstable spinal segments, cauda equina syndrome)
* Currently being treated for traumatic brain injury (TBI)
* Reasonable chance that within 2-4 weeks of initial participation they may be unable to complete the study, i.e., deployment, receive orders for a distant duty assignment or training site or otherwise be absent from the current military site over the study participation period.
* Received care from a Doctor of Chiropractic within the past 30 days.
* Pregnant or planning to become pregnant within 4 weeks.