cyrilzakka/clinical-trials huggingface dataset:
The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible

The use of implants has significantly increased prosthetic options for edentulous patient. However, implant placement in the Posterior mandibular region is often hampered significantly by insufficient atrophic width limitations

Ridge splitting technique causes lateral ridge expansion which creates new implant bed by longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned laterally to create space between buccal and lingual cortical plates, which is filled by an endosseous implant with or without any graft material limitations.

Ridge split technique is a very predictable procedure that can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. This technique allows the clinician to augment the site and do the implant insertion in a single stage surgery, shortening the healing period drastically.

In the conventional ridge splitting technique, a complete flap is raised to allow adequate visibility of the bone defect which can result in disturbance of vascular supply and increase bone resorption rates. In this case report, a new innovative computer guided closed alveolar ridge splitting flapless technique has been advocated to avoid this disruption.

As Guided implant placement showed a statistically superior accuracy when they are compared with freehand placement after guided osteotomy Computer guided ridge splitting may have a superior accuracy than the freehand ridge splitting and may reduce the time of surgery, healing period and post-operative pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems.
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study

The aim of the present study is to compare the effect of the timing (30 vs. 90 minutes) between a fixed exercise and the following test meal on energy intake, appetite feelings and food reward in adolescents with obesity.

The present study will compare the nutritional response to the realisation of an acute exercise 90 minutes or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized 90 minutes before lunch; iii) one session with the same exercise performed 30 minutes before lunch. Their ad libitum energy intake will be assessed during lunch as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks
Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis

\[objective\] to compare the efficacy of Danshu capsule and ursodeoxycholic acid (UDCA) in preventing recurrence of choledocholithiasis after operation. \[methods\] one hundred and fifty ERCP patients with choledocholithiasis were randomly divided into two groups: Danshu group (n = 75) and UDCA group (n = 75). The Danshu group took 2 Danshu capsules three times a day, and the UDCA group took 250 mg of Ursofalk twice a day. The clinical efficacy, changes of liver function indexes before and after treatment and stone recurrence were compared between the two groups.


Eligibility Criteria:
inclusion criteria:

1. Choledocholithiasis was diagnosed by B-ultrasound / CT/MRCP, The patients are generally in good condition, no surgical taboos, and can tolerate general anesthesia and ERCP surgery.
2. Agree to participate in the project research, know the benefits and possible risks of surgery, know the benefits and risks of drugs, and sign an informed consent form.

exclusion criteria：

1. patients with cholecystolithiasis, hepatitis B, biliary ascariasis, liver cirrhosis, hemolytic anemia, congenital jaundice and tumor were excluded.
2. Excluding serious primary diseases such as heart, brain, lung, kidney and blood system.
3. Those who are allergic or allergic to drugs in this test are excluded.
4. Pregnancy vibration or nursing women were excluded.
The Effectiveness of Massage Therapy in Patients With Shoulder Pain

The goal of this clinical trial is to evaluate the effectiveness of massage in pain reduction and its influence on the range of motion of the shoulder complex in SP.

The main questions it aims to answer are:

1. Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
2. Does normalizing tissue tension through massage therapy in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex?

Researchers will compare a dedicated massage protocol to a control group to see if the massage protocol works to treat shoulder pain.

Participants in the massage group will:

Take part in 6 massage sessions (twice a week for 3 weeks) in the

Participants in the control group will:

Take part in 2 massage sessions (after the first and second assessment)

The aim of the study was to evaluate the effectiveness of massage therapy based on tensegrity principle in pain reduction and its influence on the range of motion of the shoulder complex in shoulder pain. .

Eesearch questions:

1. Does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism reduce pain in the shoulder area?
2. Does the normalization of the tension of the tissues involved in the intercostal nerve entrapment mechanism increase the range of motion of the shoulder complex?
3. Does the intercostal nerve entrapment affect the pressure sensitivity of the muscles including the shoulder complex?89
4. What potential mechanisms may be induced by tensegrity massage in diseases of the shoulder complex?

Patients with symptoms of shoulder pain will be recruited for the study by general practitioners.

The following parameters related to the function of shoulder will be assessed:

1. The active range of flexion, abduction and extension-adduction-rotation (hand behind back) of the upper limb were assessed.
2. Pain sensations by the visual analogue scale-VAS
3. The functional status of the shoulder complex by the UCLA scale (The University of California at Los Angeles Shoulder Score).
4. Pain treshold by an algometer, the pressure

The study will rely on the palpation assessment and the massage methodology described in the recommendations of the Polish Society of Physiotherapy, Polish Society of Family Medicine and College of Family Physicians in Poland.

Eligibility Criteria:
Inclusion Criteria:

* age over 40 years,
* written consent to participate in the study,
* pain in the shoulder girdle area lasting at least 3 months,
* no medical contraindication of massage therapy;

Exclusion Criteria:

* Injuries, congenital defects in the chest area, cancer, deep vein thrombosis, heart attack in the last 5 years,
* Presence of inflammatory conditions in the respiratory, digestive, and genitourinary systems
Adaptive Radiotherapy in Locally Advanced Non-Small Cell Lung Cancer (LARTIA Trial)

Anatomical change of tumor during radiotherapy contributes to target missing. However, in the case of tumor shrinkage, adaptation of volume could result in an increased incidence of recurrence in the area of target reduction. This study aims to investigate the incidence of failure of the adaptive approach in Locally Advanced Non-Small Cell Lung Cancer and, in particular, the risk for local recurrence in the area excluded after replanning.

Concurrent chemoradiation is the standard of care for patients affected by locally advanced (LA) NSCLC. Its superiority over radiotherapy alone or sequential chemoradiation has been proved in multiple phase III randomized trials. In a meta-analysis of six randomized studies, concurrent chemoradiotherapy decreased locoregional progression by 6.1% at 5 years when compared with sequential chemoradiation. This resulted in an improvement in overall survival of 4.5% at 5 years that was possibly directly related to locoregional control. Many patients however succumb to locoregional failure or distant metastases. Thanks to modern radiotherapy techniques, some strategies manage the geometrical uncertainties of imaging, treatment planning, and treatment delivery and thereby improve target coverage with a much steeper dose gradient and less irradiated normal tissue. The introduction of image-guided radiotherapy reveals the occurrence of target changes during treatment, and although the percentage of patients who experienced regression is not high (range 25%-40%), the degree of regression is in the range of 29% to 40%, corresponding to a rate of tumor shrinkage per fraction of 0.79% to 1.65%. Anatomical changes during radiotherapy might introduce discrepancies between the planned and delivered dose. Currently, the literature reports only dosimetric experiences and lacks clinical data on outcome when patients are treated with the adaptive approach. This study aims to investigate the failure pattern in patients with LA NSCLC treated with concurrent chemoradiotherapy with an adaptive approach, in particular, to evaluate the risk for local recurrence in the area excluded during replanning.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven NSCLC;
* inoperable stage IIIA/IIIB disease and intrathoracic relapse after surgery;
* positron emission tomography (PET)/computed tomography (CT) and/or total-body CT with contrast excluding metastatic disease (including brain);
* no previous radiotherapy treatment;
* Eastern Cooperative Oncology Group performance status of 0 to 1;
* clinically measurable/evaluable disease;
* minimum life expectancy of 12 weeks;
* adequate respiratory, renal, hepatic and bone marrow function and non-contraindicative cardiovascular disease.

Exclusion Criteria:

* previous radiotherapy treatment
* concurrent systemic disorders incompatible with chemotherapy or radiotherapy
Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration

The purpose of this study is to compare characteristics and safety after oral administration of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets \& Aspirin 100mg 2 capsules coadministration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy male volunteers between the ages of 20 to 50 years old
* weight more than 55kg and within the range of ±20% of IBW
* having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
* doctor determines to be suitable as subjects within 3 weeks ago before administration

Exclusion Criteria:

* Hypersensitivitiy(or history of hypersensitivity) to aspirin and clopidogrel
* Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
* Exceed the normal range of PT, aPTT, BT \& platelet counts under 150,000/㎣ or exceed 350,000/㎣
* Creatinine clearance \< 80 mL/min
* Gastrointestinal diseases or surgeries that affect absorption of drug
* Congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption
* Excessive drinking(exceed 21units/week)
* Smoking over 10 cigarettes per day
Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph

Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.

This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.

Eligibility Criteria:
Inclusion Criteria:

* patients with arm pain not responding to conservative treatment
* lasted longer than 10 weeks
* single level disc degeneration
* mobile spine on dynamic lateral cervical X-rays

Exclusion Criteria:

* severe cardiopulmonary comorbidity
* suspected underlying malignant disease
* radicular syndrome
* spinal-cord compression syndrome
* contraindication for radiography
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects

B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.

Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.

Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older with a minimum body weight of 40 kg
* Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA10%, IGA 3, EASI 16, Pruritus NRS 4)
* Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
* Prior treatment with JAK inhibitors
* Other active nonAD inflammatory skin diseases or conditions affecting skin
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Sleep, Pain and Function in People With Chronic Spinal Pain and Comorbid Insomnia

This study is focused on people with chronic spinal pain. To investigate the impact of sleep problems on pain and function, 45 people with chronic spinal pain and comorbid insomnia will be compared to 45 people with chronic spinal pain without insomnia.


Eligibility Criteria:
Inclusion criteria cases:

* nonspecific spinal pain (≥3 days per week and ≥3 months of chronic low back pain, failed back surgery syndrome \> 3 years prior, chronic whiplash, or chronic non traumatic neck pain)
* aged between 18 and 65 years
* seeking care because of neck pain or low back pain
* native dutch speaker
* having insomnia: in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as \> 30 minutes of sleep latency and/or minutes awake after sleep onset for \> 3 days / week for \> 6 months
* living or working within a radius of 50 km around the test location
* not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain steady state)
* referring from analgesics, caffeine, alcohol or nicotine in the previous 48 h of the assessments
* nonspecific failed back surgery \> 3 years are permitted
* not undertaking exercise (\>3 metabolic equivalents) 3 days before the experiment

Exclusion criteria cases:

* severe underlying sleep pathology (identified through baseline data of polysomnography)
* neuropathic pain
* chronic widespread pain
* being pregnant or pregnancy (including giving birth) in the preceding year
* history of specific spinal surgery
* thoracic pain in absence of neck or low back pain
* shift workers
* present clinical depression
* BMI ≥ 30

Inclusion criteria controls:

* native dutch speaking
* 18 to 65 years of age
* having chronic nonspecific chronic spinal pain (≥3 days per week and ≥3 months of chronic low back pain, failed back surgery syndrome \> 3 years prior, chronic whiplash, or chronic non traumatic neck pain)
* referring from analgesics, caffeine, alcohol or nicotine in the previous 48 h of the assessments
* not undertaking exercise (\>3 metabolic equivalents) 3 days before the experiment
* No new medication 6 weeks prior to the assessment
* currently not undergoing any treatment (excl. medication) for chronic spinal pain

Exclusion criteria controls:

* specific medical conditions (neuropathic pain, specific neck of back surgery, osteoporotic vertebral fractures, or rheumatologic diseases)
* chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
* having insomnia (in the absence of other intrinsic sleep disorders and shift work, insomnia is defined as \> 30 minutes of sleep latency and/or minutes awake after sleep onset for \> 3 days / week for \> 6 months)
* severe underlying sleep pathology
* being pregnant or pregnancy in the preceding year
* thoracic pain in the absence of neck or low back pain
* diagnosed depression
* BMI over 30
Evaluation of PKU Sphere Liquid

PKU Sphere Liquid is a prospective, open-label, acceptability study to evaluate PKU sphere liquid in up to 15 participants aged 3 and above for the dietary management of PKU over 31 days.

PKU Sphere Liquid is a newly-developed Food for Special Medical Purposes (FSMP) designed for the dietary management of patients with phenylketonuria (PKU).

PKU sphere liquid is a vanilla flavoured, ready-to-drink, low phenylalanine protein substitute containing a blend of casein glycomacropeptide (GMP) isolate, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, and Docosachexaenoic acid (DHA).

This is a feasibility study designed to evaluate the acceptability, tolerance and adherence of children and adults consuming PKU sphere liquid.

Participants will be given a four-week supply of PKU Sphere Liquid and they will be asked to complete a daily diary and short questionnaire for four weeks to record information on: adherence, gastrointestinal tolerance, palatability and how the product is used.

Each participant will be on the trial for 31 days. This includes a 3-day baseline period and 28 days taking the study product. If deemed appropriate in each individual circumstance, the sponsor of the trial, Vitaflo International Ltd, will continue to supply the product free of charge at the end of the trial until available on prescription.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PKU requiring a low protein diet and protein substitute.
* Aged three (3) years and over
* Already taking a minimum of one GMP based protein substitute per day or have previously taken one
* Able to comply with the study protocol and take the study product, according to the opinion of the PI.
* Willingly given, written, informed consent from patient or parent/guardian.
* Willingly given, written assent (if appropriate).

Exclusion Criteria:

* Inability to comply with the study protocol, in the opinion of the investigator.
* Any co-morbidity, which, in the opinion of the investigator, would preclude participation in the study.
* Diagnosis of persistent hyperphenylalaninaemia, or mild PKU not requiring dietary intervention with a low protein diet and protein supplement.
* Unwilling/unable to take a GMP based protein substitute.
* Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.

N.B.: Women who become pregnant unexpectedly during this study will be immediately withdrawn from the study.
Organ Donor Tissue Oxygen Saturation as a Predictor of Number of Organs to Transplant Per Donor

The objective of this study is to quantify the association between tissue oxygen saturation (StO2) during the donor management phase of the Death by Neurological Criteria (DNC) organ donor and the number of organs transplanted per donor.

Specifically the study aims to:

1. Evaluate the association between StO2 level in the DNC organ donor and the number of organs transplanted per donor;
2. Evaluate whether or not tissue perfusion in the DNC organ donor population correlates with currently measured macro-hemodynamic variables during the donor management phase.
3. Assess if StO2 in the DNC organ donor is related to the number of organs with normal end-organ function, and with the number of organs predicted to be transplanted using the organ donor calculator.
4. Assess if StO2 in the DNC organ donor is related with intravenous thyroid hormone treatment.

Investigators will conduct an observational study, including 60 DNC organ donors, in Lifebanc's Donor Service Area (DSA). Investigators will monitor and record blindly the StO2 with near-infrared spectroscopy (NIRS) in the DNC organ donor from the beginning of the OPO (Organ Procurement Organization) organ donor management period until cardiac arrest in the operating room at the time of recovery.

Eligibility Criteria:
Inclusion Criteria:

1. DNC organ donor
2. Age ≥ 15 years old
3. Weight ≥ 45 Kg

Exclusion Criteria:

1. Donor after circulatory determination of death
2. Living donor