cyrilzakka/clinical-trials huggingface dataset:
A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks

Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB. In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure. 50 subjects will be entered into this study. This study is being conducted at Thomas Jefferson University only.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection.

Exclusion Criteria:

* subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.
External Validation of Prediction Algorithm Using Non-invasive Monitoring Device for Intraoperative Hypotension

The goal of this prospective observational study is to externally validate the prediction algorithm using non-invasive monitoring device for intraoperative hypotension. The main question it aims to answer is: Does the prediction algorithm predict intraoperative hypotension effectively?

The hypotension that occurs during surgery is associated with the poor prognosis of patients after surgery. Previous studies have reported that even a short period of time of hypotension increases the risk of postoperative complications such as kidney injury. If anesthesiologists can predict intraoperative hypotension in advance, they can prevent or minimize the damage.

Recently, there are many reports on medical artificial intelligence models that predict the intraoperative hypotension. Among them, the Hypotension Prediction Index (HPI) model has already been commercialized and used in clinical practice. However, HPI has limitations in that it is necessary to perform invasive techniques (arterial cannulation) or to use dedicated equipment at high cost. However, since many of the general anesthesia are performed without invasive monitoring devices, the use of HPI medical devices is subject to considerable restrictions.

The investigators have reported the prediction algorithm for intraoperative hypotension using five non-invasive monitoring devices commonly used in general anesthesia: 1) blood pressure (NBP, number), 2) electrocardiogram (ECG, waveform), 3) end-oxygen saturation waveform (PPG, waveform), 4) end-stage carbon dioxide waveform (ETCO2, waveform), and 5) an anesthesia depth (BIS, number) By conducting a retrospective external validation process using public clinical data from other institutions (tertiary hospital in Korea), the final model was able to have good predictability with an Area Under the Receiver-Operating Characteristic Curve (AUROC) value of 0.917.

However, investigators did not externally validate that algorithm through a prospective designed study. This study intends to externally validate the "hypertension prediction model during surgery using non-invasive monitoring device", which has already reported It is expected that the usefulness and limitations of the prediction model can be evaluated again, and the model can be advanced based on the results.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients aged 19 or more
* Elective surgery under general anesthesia
* American Society of Anesthesiologists physical status I - III

Exclusion Criteria:

* Vasopressor/Inotrope usage before surgery
* Patients who needs invasive arterial cannulation
* Emergency surgery
* Pregnant or lactating women
Post-marketing Clinical Follow-up of the Medical Device DIVA®

Observational, ambispective, longitudinal, comparative, open, multicentric study.

The main objective is to compare the performance of care in patients operated with and without DIVA®.

The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant;
* Patient operated for at least 12 months;
* Patient able to understand the information related to the study;
* Patient having indicated his/her non-opposition to the collection of his/her personal data.

Exclusion Criteria:

* History of pathologies, malformations or surgical interventions on the spine;
* Patient belonging to the first 30 operated by the surgeon with the DIVA® implant;
* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
* Patient not benefiting from a social security scheme.
The Correlation Between Forward Head Posture; Neck Pain, Neck Functional Ability and Deep Neck Core Strength in Jordan

Is forward head posture correlated with neck pain, neck functional ability and deep neck core strength in Jordanian university students having chronic nonspecific pain.

The study is an observational cross sectional study considering the effects of one of the most common spinal deformities such as forward head posture on the quality of life regarding Jordanian university students. University students are among the most common populations having these kinds of deformities because of using smart devices and studying for along periods of time in a faulty posture. 60 students "both male and females" having forward head posture with neck pain will be included in the study and different outcome measure as pain , functional ability and deep neck core strength will be measured to define the impact of this faulty posture on them. Pain measurement will be through using numeric rating scale for pain.

Eligibility Criteria:
Inclusion Criteria:

* The craniovertebral angle is less than 50 degrees .
* Age ranges from 18 to 25 years old
* Forward head is associated with neck pain.
* Studying hours more than 4 hours continuously per day

Exclusion Criteria:

* Previous surgery regarding the spine or shoulders.
* Vertebral fractures regarding the cervical spine or the skull.
* Positive neurological signs or evidence of spinal compression.
* headaches prior to the onset of neck pain and without cervical origin.
* Inner ear or vestibular Problems.
Clinical Hypnosis Before External Cephalic Version (ECV)

Does clinical hypnosis or neuro-linguistic programming improve the success rate of external cephalic version?

Prospective off-center randomisation of clinical hypnosis or neuro-linguistic programming intervention prior to a external cephalic version treatment.

Eligibility Criteria:
Inclusion Criteria:

* singleton
* breech presentation
* gestation age above 36 weeks + 6 days

Exclusion Criteria:

* multiples
* cannot understand German language
A Trial to Assess the Effect of High Nitrogen Intake in Critically Ill Patients

The patients with sepsis are in high risk of malnutrition, which could contribute to infection, difficulty in weaning from ventilators. The investigators speculate whether nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the outcome in these sepsis patients. In this prospective Randomized Controlled Trial, the investigators aim to compare high nitrogen intake with conventional nitrogen supply which were recommended in guidelines.


Eligibility Criteria:
Inclusion Criteria:

* need mechanical ventilation for more than 2 days
* mean blood pressure more than 60mmHg
* predicted ICU stay more than 7 days
* tolerance of parenteral or enteral nutrition

Exclusion Criteria:

* irreversible status of primary disease
* any history of malnutrition before enrollment
* history of steroid cortisol administration
* severe liver dysfunction (Child-Pugh Score C)
* pregnancy
* refuse to enrollment
* re-admission to ICU and has been enrolled during former admission to ICU
ReSure Sealant Pivotal Study

This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens
* Subject must be 22 years of age or older

Exclusion Criteria:

* Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment
* Previous corneal or retinal surgery or planned multiple procedures during cataract surgery.
Vitamin D in Periodontal and Cardiovascular Disease Progression

Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of periodontitis (CP) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and periodontitis in patients with CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

Using a cross-sectional design, a total of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will enrolled in the present study.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least twenty teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With Bowel Involvement

The aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.

To diagnose deep infiltrating endometriosis, a clinical examination may be performed by a gynecologist to look for typical signs of endometriosis, but in 25% of case there can be absent.

According to that, medical imaging is indispensable in diagnosis of pelvic endometriosis. Trans vaginal ultrasonography, and pelvic MRI are major tools in the hands of specialists, but several studies have shown the importance of endoscopic rectal ultrasound, with a sensitivity close to 90% for de diagnosis of digestive impairment.

In recent years the use of elastography and the injection of microbubbles of sulfur hexafluoride in addition to endoscopic ultrasound has made it possible to improve the diagnostic accuracy of the technique in tumoral pathologies, in particular bilio-pancreatic injuries.

However, no study has yet evaluated the endoscopic rectal ultrasound with elastometry and injection of contrast agent to characterize the digestive lesions of deep pelvic endometriosis.

The endoscopic rectal ultrasound has demonstrated its place in the evaluation of deep pelvic endometriosis disease but its latest complementary techniques of interest have not yet been studied prospectively. The aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Woman over 18 years of age
* Diagnosis of deep pelvic endometriosis (clinical and / or MRI and / or transvaginal ultrasound), defined by penetrating endometriosis lesions in the retroperitoneal space and / or pelvic organ wall at a depth of at least 5 millimeters , with digestive impairment.
* Presenting symptoms of deep pelvic endometriosis disabling and / or fertility difficulties and requiring an exhaustive iconographic assessment.
* Belong to a social security scheme.
* Signature of informed consent.

Exclusion Criteria:

* Without medical contraindication to the realization of a low digestive endoscopy.
* Allergy or hypersensitivity to sulfur hexafluoride or one of the components of Sonovue® (contrast agent used in endoscopy ultrasound).
* Severe heart rhythm disorders.
* Angina unstable.
* Recent Acute Coronary Syndrome.
* Heart Shunt Right - Left.
* Severe pulmonary arterial hypertension (PAH) (defined as PAH \> 90 mmHg).
* Acute or severe cardiac insufficiency stage 3 and 4
* Pregnant woman and vulnerable patient population (persons deprived of administrative and / or judicial liberty, and persons under guardianship.
* Mental disability of the subject making participation in the trial impossible.
Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

The purpose of this study is to assess the clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.

Exclusion Criteria:

* Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.
GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)

This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of COPD.

Exclusion criteria:

* Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
* Other inclusion and exclusion criteria will be evaluated at the first study visit.
Walnut and Immunity Study

The main objective of the study is to determine if eating walnuts enhances immune function, in older free-living men and postmenopausal women with overweight.

The main objectives of our proposed study are to determine the effect of walnut consumption on innate, acquired, and gut immunity by assessing whether the ingestion of walnuts enhances immune function, in older free-living men and postmenopausal women with overweight. To accomplish these objectives, a randomized controlled, parallel design study is proposed with two groups consuming their habitual diet, but with one (Walnut group) receiving 15% of their total energy as walnuts and the other (Control group) abstaining from eating any walnuts and limited amounts of other tree nuts and peanuts (up to \<1 serving/wk).

Eligibility Criteria:
Inclusion Criteria:

* Older men and post-menopausal women aged 55-75 years
* Have a BMI of 25-32
* Being able to commute to Loma Linda University.
* Not taking medication or supplements that affect immunity

Exclusion Criteria:

* Intolerance or allergy to walnuts
* Regular intake of walnuts and/or other nuts (\>3 ounces per week).
* Immune system insufficiency or disease.
* Using immune boosting supplements.
* Exposure to antibiotics and corticoids immediately prior to the study.
* Participants with uncontrolled chronic diseases, and relevant psychiatric illness, including major depression will not be included in study
* Flu vaccination or Covid booster within past 6 months
Effects of Exten(d) Supplementation on Training Ability in Recreational Runners

The study will assess running biomechanics and joint inflammation of physically active males between 40 and 60 years of age, mainly runners, suffering from knee joint inflammation and pain after training. Participants were split into two groups, intervention and placebo, to evaluate the safety and efficacy of Exten(d) supplementation during 4 weeks.

Triple-blind, randomized, placebo-controlled, parallel group, pilot safety, and efficacy study.

30 healthy physically active males (40 to 60 years old) suffering from knee joint inflammation and pain after training were randomly assigned to the Exten(d) or Placebo group. During the first visit and after 4 weeks supplementation (either 2 g daily of Exten(d) capsules or placebo capsules) the participants were subjected to a three-stage exercise session: (i) running biomechanical assessment, (ii) exercise physiology maximal effort test and (iii) running biomechanical assessment after the incremental exercise to exhaustion. The volunteers have been assessed to determine: (1) inflammation by I-R thermography and pain perception, (2) running technics though biomechanic analysis and (3) performance.

Eligibility Criteria:
Inclusion Criteria:

* Male recreational runners who run for at least 150 minutes per week divided into two or more sessions.
* The participants were expected to describe some degree of knee inflammation and/or discomfort after training in order to be accepted. Knee discomfort was considered significant whenever a subject referred to a punctuation of ≥ 2 in a Visual Analogue Scale (VAS).
* Agree not to initiate any new exercise or diet programs during the entire study period
* Agree not to change their current diet or exercise program during the entire study period
* Agree not to stretch, utilize ice massage, take anti-inflammatory medications (eg, aspirin, ibuprofen), or use any other treatment during the trial.

Exclusion Criteria:

* Use of anti-inflammatory medications or pain medications 1 week before the screening visit and during the study
* Daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
* Antibiotic use in the past 3 months
* Chronic disease
To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes

The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.

This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be of non-childbearing potential.
* Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2
* Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP
* Participation in another clinical study during the last 30 days prior to enrollment
* Significant cardiovascular event within the last 6 months prior to enrollment
Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma

Melasma is a common, acquired, esthetically disfiguring hypermelanosis of the face. Melasma is considered a disappointing challenge when treatment options are addressed. Diverse treatment modalities such as retinoic acid, hypo-pigmenting agents like hydroquinone, azelaic acid, and kojic acid, chemical peels, microdermabrasion, and lasers have been tried for the treatment of melasma. There is no universally proven therapy that induces and maintains remission of the condition. Q-switched: Nd YAG laser toning and platelet rich plasma (PRP) are promising treatments for melasma.The aim of this work is evaluate the efficacy and safety of combined PRP and Q-switched: NdYAG laser in the treatment of melasma using clinical assessment, in addition to assessment of Melanin Index and Erythema Index.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral nearly symmetric melasma on the face.

Exclusion Criteria:

* Patients receiving systemic or topical or laser treatment relevant to melasma within three months before enrollment into the study.
* Use of oral or injectable contraceptives or hormone replacement therapy during treatment or 12 months before
* Patients active skin infections and active HSV
* History of hypertrophic scars or keloids.
* Patients with hypercoagulable state or bleeding diatheses
* Pregnant and lactating females.
* History of liver diseases
* Intake of systemic chemotherapy, corticosteroids, antiplatelets or anticoagulants
Hybrid-everted Versus Hand-sewn or Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

The investigators improved the hybrid everted esophagogastrostomy and expected to prevent the incidence of anastomotic stricture. The purpose of this study is to determine the clinical value of this kind of operation type, and analyzes the clinicopathological factors causing the postoperative complications.

This randomized clinical trial compared a hybrid everted esophagogastric anastomosis with conventional hand-sewn or stapled esophagogastrostomy for prevention of anastomotic stricture. The patients were completely randomized to receive either a hybrid everted esophagogastric anastomosis (HE group), or the conventional hand-sewn (HS group), or a stapled (SA group) anastomosis, after the removal of esophageal tumor. The primary outcome measured the incidence of anastomotic stricture at 3 months after the operation (defined as the diameter of the anastomotic orifice \<= 0.8 cm on esophagogram), analyzed by intention-to-treat.

Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed esophageal neoplasms
* undergoing the Esophagogastrostomy

Exclusion Criteria:

* the patients with previous the upper gastrointestinal tract surgery
* the esophageal carcinoma patients with previous neoadjuvant chemotherapy
* the esophageal carcinoma complicated other esophagogastric diseases
The Mannitol-Asthma-Ciclesonide-Study

Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway hyperresponsiveness assessed with mannitol.

Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of hyper-responsive patients compared to 20% only in the placebo group and the group without airway hyper-responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness.
* Asthma symptoms partly controlled according to GINA (Global Initiative for Asthma, October 2006) 1 week prior to randomization
* FEV1 ≥ 70% predicted

Exclusion Criteria:

* Smoker and ex-smoker with \>10 pack years
* COPD (chronic obstructive pulmonary disease)
* Upper respiratory tract infection within the past 4 weeks.
* ICS or oral steroids during the previous month before inclusion
* beta-blockers within the past 4 weeks
* Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers)
* Pregnancy
* Known malignancy