cyrilzakka/clinical-trials huggingface dataset:
Neurophysiological Examination in Patients With Brain Death

This study examines muscle movements of elecromyography in adults with brain death. Half of the participants will have brain death, the other half will be healthy volunteers.

In some of the patients who have brain death diagnosis, some movements may be seen. Because of these movements, the doctors sometimes avoid to make brain death diagnosis. So making brain death diagnosis may delay. And in these patients, even if the brain death diagnosis made the family members refuse to donate the organs of the patients because they think their patients may survive when they see muscle movements with touch. These patients with brain death are lost in a short time, so some of the patients can not be used as donors. In this study, the investigators aim to raise awareness the movements in brain death patients can be seen, to study the movements neurophysiologically by EMG, whether EMG can be used as auxiliary method or not in brain death diagnosis and to raise organ donation numbers from cadavers. Investigators will examine the motor response and F response in the facial nerve, median nerve, and tibialis posterior nerve with electromyography neurophysiologically.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with definite diagnosis of brain death,
* Patients with permission from their parents,
* Patients without trauma of medullaspinalis and peripheral nerve injuries,
* Patients without previously known muscle disease (Myasthenia gravis, myopathy, etc.),
* Patients with previously unknown neurological disease (Amyotrophic Lateral Sclerosis, Multiple sclerosis, Guillain Barre syndrome, Poliomyelitis, etc.),
* Patients who have not previous systemic diseases (Connective Tissue Disease, Diabetes mellitus, Chronic renal failure, etc.).

Exclusion Criteria:

* Uncertain brain death,
* Patients without permission of family members,
* Younger than 18 years old and older than 72 years,
* Patients with medulla spinalis and peripheral nerve injuries,
* Patients with known muscle disease (Myasthenia gravis, myopathy, etc.),
* Patients with neurological disease (Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Guillain Barre Syndrome, Poliomyelitis, etc.),
* Patients with previous systemic diseases (Connective Tissue Disease, Diabetes, Chronic Kidney Failure, etc.)
Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia After Abdominal Hysterectomy

The aim of this study is to compare the analgesic efficacy of erector spinae plane block and quadratus lumborum block after abdominal hysterectomy surgery and postoperative opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists (ASA) physical status 1-3.
* scheduled for abdominal hysterectomy surgery.

Exclusion Criteria:

* History of allergy to the medications used in the study.
* Contraindication to regional anesthesia as coagulopathy, local infection.
* Severe hepatic impairment (child C).
* Sever Renal dysfunction (creatinine clearance \< 30).
* Psychiatric or mental disorder affecting patient ability to interpret VAS score.
* Body mass index (BMI) ≥ 40 or ≤ 18 kg/m2.
* ASA IV.
* Patient refusal.
Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars

Objective:

To assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side time of treated patient.

Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and allocation ratio (1:1), equivalence framework.

Preoperative records will be taken (photos, conventional periapical radiographs, and impression to construct acrylic stent to help standardization on follow up apical radiographs). Administration of inferior alveolar nerve block then using rubber dam isolation one of the investigators will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. Then the pulp status will be assessed if bleeding is controlled with direct irrigation with distilled water for 2 minutes then next step will be taken but if not continue excavation of the pulp till bleeding is controlled. if bleeding is not controlled after performing complete pulpotomy, tooth will be excluded from the study Then direct application of capping materials (TheraCal or MTA) according to manufacturer instructions, then Riva self-cure glass-ionomer base and composite resin final restoration. One of the investigators will take immediate standardized postoperative periapical radiographs. Follow-up will be for 12 months. Pre-calibrated blinded dentists will assess out comes separately.

Eligibility Criteria:
Inclusion Criteria:

* Restorable permanent molars with deep caries and pain could be relieved with analgesics

Exclusion Criteria:

* criteria of exclusion of teeth were:

  * pathological mobility, swelling or tenderness to percussion/palpation;
  * pathology is shown in the pre-operative radiographic as resorption periradicular or furcation radiolucency, or a widened periodontal ligament space;
  * at the operative procedure, hemorrhage control is unachievable
Reinsertion Achilles Tendon VS Zadek Osteotomy in Insertional Achilles Tendinopathy

The aim of this study is to Compare functional outcome and the recovery time of reinsertion of achilles tendon VS zadek osteotomy in insertional achilles tendinopathy.

Insertional Achilles tendinopathy is characterized by chronic posterior heel pain associated with posterosuperior calcaneal exostosis or intratendinous ossification. The etiologies include retrocalcaneal exostosis, the diseased tendon, enthesopathy, and Haglund's deformity. The nonsurgical therapies, such as physical therapy, stretching and strengthening of the gastrocnemius-soleus muscle complexes, nonsteroid anti-inflammatory drugs, and footwear modifications, are chosen as the initial treatment. Local injection of the steroid is not recommended because it might lead to increase risk of tendon rupture.

Surgical intervention is a suitable option when conservative treatment for more than 6 months has failed. Open detachment with reattachment of the Achilles tendon is a common surgery combined with calcaneoplasty and debridement of the retrocalcaneal bursitis and pathologic Achilles tendon. Suture techniques using bone anchors have been described to reattach the Achilles tendon with excellent results. percutaneous Osteotomy is another option, first described by Zadek in 1939 which was later modified in 1965. zadek osteotomy is a dorsal closing wedge calcaneal osteotomy that allows the tuberosity of Haglund deformity to be brought forward. This operation can change the calcaneus' anatomical length and elevate the distal insertion point of the AT. The rationale of a ZO was to reduce the impingement between the anterior aspect of the Achilles tendon and the superior angle of the posterior calcaneal tuberosity. By shortening the calcaneus and altering the orientation of the Achilles tendon fibers it is believed to decrease stress across the tendon at its insertion.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18 - 65
* Insertional Achilles tendinopathy without steroid injection, infection, tendon rupture and ankle fracture

Exclusion Criteria:

* Age \< 18 years, \> 65
* General medical contraindications to surgical interventions
* Calcaneal Fracture, subtalar fusion
* infection.
* Pathological tendon rupture
* History of steroid injection
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL

To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 187004 CL within a predefined dose range


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects
2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Histology Post-Endoscopic Eradication Therapy (EET)

This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradication of intestinal metaplasia (CE-IM) in patients undergoing routine surveillance biopsies and compare these data to a direct measure of reflux using 24hr pH impedance, to determine the correlation between histology and persistent reflux. These data will allow us to more accurately risk stratify patients for recurrence of BE following EET.


Eligibility Criteria:
Inclusion Criteria:

* - Patients who have undergone endoscopic eradication therapy and 24hr pH impedance testing as part of standard of care between 2009 and 2014.
* - Individuals who have signed a consent to be part of the Prospective Evaluation of Barrett's Esophagus Study population.

Exclusion Criteria:

* - Individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners will be excluded from the study.
* - Patient who were previously unable or unwilling to give consent to the Prospective Evaluation of Barrett's Esophagus Study will be excluded.
Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens

Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffer from HIV type 1 infection
* Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors
* Patient has shown a depression of viral load before limit of detection (\< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1
* Patient is male or female with age greater than or equal to 18 years
* Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation

Exclusion Criteria:

* Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> five times upper limit of normal (ULN))
* Patients is hypersensitive to Viramune® or to any of its excipients
* Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism
* Patients is breast-feeding
* Patient is pregnant
* Patient is a woman and does not use effective contraception
Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's Disease

This is multicentre, proof of concept, randomized, double-blind, parallel-group, placebo-control study in 40 Parkinson's Disease (PD) patients. Patients will be randomized in 2 groups receiving Bumetanide or placebo for 4 months:

* Group 1 (20 PD patients): bumetanide
* Group 2 (20 PD patients): placebo intake identically to group 1.


Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic Parkinson's disease fulfilling the UK Parkinson's Disease Brain Bank (UKPDSBB) criteria (cf. Appendix VII)
2. 40 \< Age \< 80 years old
3. Hoehn \& Yahr 1.5-4 (OFF stage)
4. Walking and balance or freezing ≥ 1in the MDS-UPDRS II
5. Motor fluctuation defined by a score ≥ 1 on the item "time spent in the OFF state" of the MDS-UPDRS IV
6. Dose of L-DOPA ≥ 150 mg/d (concomitant treatment)
7. PD medications regimen stable for at least 3 months
8. Patients expected to remain on stable doses of PD medications during all the study
9. Covered by Health Insurance System
10. Able to understand and to sign the informed consent prior to selection
11. Negative pregnancy test at screening
12. Blood Pressure (BP) and Heart Rate (HR) considered Non Clinicaly Significant (NCS) by investigators
13. Electrocardiogram (ECG) recording on a 12-lead ECG considered NCS by investigators
14. Laboratory parameters within the normal range of the laboratory. Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator

Exclusion Criteria:

1. Atypical parkinsonism or drug-induced parkinsonism
2. Cognitive impairment (MMSE ≤ 24)
3. Active psychiatric disorder (mood disorders, hallucinations or delirium with strong functional impact and not controlled by medication or which happened during the last 3 months before inclusion)
4. Treatment by Deep Brain Stimulation or continuous infusion of apomorphin/dopa gel
5. Renal or hepatic insufficiency
6. Electrolyte disturbances
7. A corrected QT (QTcF) interval \>450ms for male or \>470ms for female on the electrocardiogram
8. Any medical condition that might interfere with the protocol except those defined in Section 5.3
9. Contraindications to bumetanide : persistent anuria, hepatic encephalopathy included coma
10. Women pregnant, nursing or of childbearing age without effective contraception. Patients should not be enrolled if they plan to become pregnant during the time of study participation
11. Patient unable to attend scheduled visits or to comply to the protocol
12. Patient under legal guardianship or judicial protection
13. Patient in the exclusion period of another protocol
14. No possibility of contact in case of emergency
15. Known allergic reactions induced by Burinex (Bumetanide)
A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome

This was an adaptive design phase 2 study to establish safety and efficacy; and to characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome. LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor.

This study was planned as an adaptive Phase 2 randomized, double-blind, placebo-controlled, multi-center, integrated dose-ranging study to evaluate the safety and efficacy of multiple remibrutinib doses in patients with moderate to severe Sjögren's Syndrome.

Of the initially planned two parts, only Part 1 of the study was conducted. In Part 1, the highest expected biologically active single dose of remibrutinib (100 mg) was tested in two different dosing regimens, a once daily dose (qd) or twice daily dose (bid), and compared to the placebo group. Each patient in Part 1 of the study underwent a screening period of up to 6 weeks, a treatment period of 24 weeks, and a follow-up period of 30 days post-treatment before the End of Study (EOS) visit. The total duration for each patient in the study, including Screening, was up to 35 weeks. For the treatment period, patients were randomized in a 1:1:1 ratio to one of the 3 treatment groups: remibrutinib 100 mg bid, remibrutinib 100 mg qd and placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SjS according to the 2016 ACR/EULAR criteria
* Screening ESSDAI (based on weighted score) ≥ 5 derived from 8 domains
* Screening ESSPRI ≥ 5
* Seropositive for anti-Ro/SSA antibodies at or within 3 months prior to screening
* Unstimulated salivary flow \> 0 mL/min.

Exclusion Criteria:

* Sjögren's Syndrome overlap syndromes with another autoimmune disease as primary illness
* DMARDs or kinase inhibitors within 3 months prior to baseline above certain doses OR maintained during study
* Rituximab or other B cell depleting drug within 12 months of Screening .
* Current use of prednisone or equivalent \> 15mg/d or dose change within 2 weeks prior to Screening
* Use of medication known to cause, as a major side effect, dry mouth / eyes
* HIV, Hepatitis C, Hepatitis B, known or suspected history of an ongoing, chronic or recurrent infectious disease such as tuberculosis
Argireline in Treatment of Periorbital Wrinkles

The purpose of this study is to determine whether La Jolie gel is effective in the treatment of periorbital wrinkles.

Argireline has mechanism of action that significantly inhibited neurotransmitter release with a potency similar to that of BoNTA. Inhibition of neurotransmitter release was due to the interference of the hexapeptide with the formation and/or stability of SNARE complex. Notably, this peptide did not exhibit in vivo oral toxicity nor primary irritation at high doses. These findings demonstrate that Argireline is a anti-wrinkle peptide that emulates the action of currently used BoNTs.

In vivo study, Topical Argireline 10% is applied on lateral preorbital area twice daily for 30 days. The result demonstrates a significant anti-wrinkle activity by decreased skin wrinkle 30%. These findings demonstrate a significant anti-wrinkle activity for Argireline, in agreement with its in vitro and cellular activities. Topical Argireline represents a bio-safe alternative to BoNTs in anti-wrinkle therapy.

Eligibility Criteria:
Inclusion Criteria:

* healthy woman at 35-45 years old
* Presence of periorbital wrinkles

Exclusion Criteria:

* Pregnancy
* Nursing
* Keloids /scar at periorbital area
* pre-treatment with topical periorbital products within 1 month
* Botulinum toxin A injection,facial plastic surgery within 1 year
* Allergic to active ingredients including acetyl hexapeptide-3 Argireline®, sodium hyaluronate,adenosine,arbutin,fucus vesiculosus)
Outcome of Transanal Specimen Extraction Surgery for Elderly Colorectal Cancer Patients

Retrospective analysis of a cohort of elderly CRC patients (aged ≥ 65 years) underwent transanal-NOSES between August 2008 and February 2022 was constructed. Data were obtained from China NOSES Database (CNDB). The primary outcomes included time to first flatus, postoperative hospital stays, 30-day postoperative complication and hospital mortality. The secondary outcomes were overall survival (OS) and disease-free survival (DFS).


Eligibility Criteria:
Inclusion Criteria:

patients diagnosed as T1-4N0-2M0 colorectal cancer pathologically

patients underwent transanal-NOSES

patients aged 65 years or older

Exclusion Criteria:

patients with multiple primary colorectal cancer

patients with total colectomy

patients without complete data
A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer

This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older.
* Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
* May have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies.
* Measurable disease, according to RECIST criteria.
* Negative pregnancy test (women of childbearing potential only).
* Pretreatment laboratory levels that meet specific criteria.

Exclusion Criteria:

* Prior treatment with Volociximab (M200) or inhibitors of α5β1 integrin (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens.
* Known hypersensitivity to murine proteins or chimeric antibodies or other components of the product.
* Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
* Monoclonal antibody therapy within 4 weeks of the first dose of Volociximab.
* Central Nervous System (CNS) tumor or metastasis.
* History of bleeding disorders within the past year.
* Medical conditions that may be exacerbated by bleeding.
Ahmed Valve Glaucoma Implant With Adjunctive Subconjunctival Bevacizumab in Refractory Glaucoma

The investigators aim to demonstrate the efficacy and safety of subconjunctival injection of Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory glaucoma.

Several studies have revealed evidences on the substantial role of Vascular endothelial growth factor-A (VEGF-A) in enhancing neovascularization processes. Some studies have shown the efficacy of intravitreal Avastin in reducing level of VEGF-A to improve NVG. On the other hand, recent pathological studies demonstrated that neutralization of VEGF reduced vascularity and decreased scar formation during wound healing, showing that VEGF strongly influence scar tissue formation. This may reduce the formation of encapsulated cyst after glaucoma surgeries and thus might improve the surgical success rate. The effect of subconjunctival bevacizumab as an adjunctive therapy in filtering glaucoma surgeries has been recently illustrated.

We aim to demonstrate the efficacy and safety of subconjunctival injection of Avastin as an adjunctive therapy for Ahmed valve glaucoma implant in patients with refractory glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of refractory glaucoma defined as uncontrolled IOP (\> 21 mm Hg) despite maximal antiglaucoma medication, previously failed surgical treatment, or a combination thereof

Exclusion Criteria:

* No light perception
* elevated IOP associated with silicone oil
* previous glaucoma drainage device implantation in the same eye
* previous cyclodestructive treatment
* increased risk of endophthalmitis (e.g., active adnexal and ocular surface infection, immunosuppression, or immunodeficiency, including the use of systemic steroids)
* posterior segment disorders, or pre-existing ocular comorbidities (e.g., pterygium, phacodonesis, corneal opacity, or corneal endothelial dystrophies).

Only 1 eye per patient was included in this trial.