cyrilzakka/clinical-trials huggingface dataset:
Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals

This study had the goal of analyse the neurophysiologic effects of both mechanical and manual cervical manipulation, in asymptomatic individuals.

In this study, the investigators compared the effects of manual manipulation and instrument assisted manipulation of C3/C4 on muscle tone, elasticity and stiffness and on pressure pain threshold , and pressure pain perception. The muscles evaluated were upper trapezius and biceps brachialis, bilaterally. The study also had a placebo and a control group. All individuals were asymptomatic.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects.
* Minimum of 18 years old.

Exclusion Criteria:

* Pain in cervical region, shoulders or arms.
* History of trauma or disease in the cervical region or upper limb.
* Use of medication that could affect the outcomes (painkillers, NSAID, or anti depressives) during the last week.
Minimally Invasive Techniques for Treating Large Proximal Ureteral Stones

a prospective comparative study designed to compare the outcomes of transperitoneal Laparoscopic ureterolithotomy (T-LUL), mini-percutaneous antegrade ureteroscopy (A-URS) and retrograde ureteroscopy (R-URS) in treating patients with LPUS (15-20 mm). the following parameters were assessed and compared (demographic data and stones characteristics, Stone free rate and complications)

we aimed in the current study to comprehensively evaluate and to compare the outcome of transperitoneal laparoscopic ureterolithtomy, retrograde ureteroscopy and mini-percutaneous antegrade ureteroscopy for management of large proximal ureteric stone (15 -20 mm) with regards to; operative time, stone free rate, success rate, hospital stay and complications.

A total of 105 participants were enrolled in the trial between April 2021 and June 2023 to accomplish this. Inclusion criteria for this study included patients who had a single proximal Ureteral stone (between the pelvi ureteric junction and the upper border of the sacroiliac joint) measuring 15-20 mm in diameter.

Patients were randomly allocated to receive either TPLU, RURS, or Minin-perc Antegrade URS, with a 1:1:1 allocation ratio. After providing informed permission, the patients were randomly assigned to one of three groups: Group I (35 patients treated with TPLU), Group II (35 patients treated with RURS), and Group III (35 patients not treated with either TPLU or RURS) (Included 35 patients who were treated by Mini-perc Antegrade URS)

Eligibility Criteria:
Inclusion Criteria:

* Adults patients
* large proximal ureteral stones(1.5-2 cm)

Exclusion Criteria:

* larger stones
* multiple stones
* bleeding tendency
* active UTI
* distal stricture
Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery

Despite the development of the control of DM and the great interest for the complications of the disease, even today the diabetic foot represents a challenge for the orthopaedic surgeon. Being frequently correlated to alteration of the plantar pressures, the surgery treatment is recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve this pathologic case.

The purpose of this longitudinal cross-sectional study was to evaluate radiographic and surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic through MIS.

Thirty-two patients with chronic diabetic foot ulcers (CDFUs) were treated by MIS between January 2010 and September 2016. Clinical evaluation was assessed pre-operatively, as well as at 3 months after surgery and at final follow-up, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale. The recurrence of the ulcers and complications were recorded. All the ulcers were evaluated with the University of Texas Diabetic Wound Classification. We used the radiological Maestro's criteria to evaluated the radiographs before and after the operation. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency. The global disability was evaluated with the Short Form Health Survey (SF-36) and the satisfaction's level with the Visual Analogue Scale (VAS). Statistical analysis was carried out using the Wilcoxon signed-rank test. Statistical significance was set at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DM;
* presence of a plantar CDFU, so not healed after 6 months of medical multidisciplinary treatment;
* HbA1c \< 8,5%.

Exclusion Criteria:

* congenital deformities of the foot;
* macroscopic signs of local infection of the soft tissues;
* alteration of CRP\>150 mg/L;
* previous foot and ankle surgery;
* previous foot and ankle surgery;
* rheumatic, neurologic, infective, or psychiatric pathologies.
Lidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy

Lidocaine is widely available and is a very commonly used local anesthetic. When administered intravenously, lidocaine infusions have anti-inflammatory effects and have significantly decreased the reliance on opioid use for adequate pain management in adult abdominal and spine surgeries. A major advantage of lidocaine infusion is that it is not associated with a significant side effect profile.The role of lidocaine in pediatric acute perioperative pain remains limited.

The aim of the study is to determine if using lidocaine continuously during anesthesia care will decrease post-operative pain for children having their tonsils and adenoids removed.

Eligibility Criteria:
Inclusion Criteria:

- scheduled tonsillectomy and adenoidectomy with or without myringotomy/PE tubes at Hasbro Children's Hospital

Exclusion Criteria:

* history of allergies to local anesthetics
* physical or developmental delays
* psychiatric illness
* current use of sedative or anticonvulsive medications
* use of premedication (oral/nasal)
* pre-existing cardiovascular, renal, or hepatic disease
* pre-existing cerebral or neuromuscular disease
* patient with personal or family history of malignant hyperthermia
* recent history of upper respiratory infection within last 7 days
* regular use of analgesic medications
The Association Between Preoperative Sepsis and the Mortality After Hip Fracture Surgery

The worldwide occurrence of hip fracture is high with an annual incidence of approximately 100 per 100.000 people. Mortality for patients undergoing hip fracture surgery is high with a 30-day mortality rate varying between 4.5 and 13.3 %. It is agreed that non-modifiable factors such as age, gender and pre-existing comorbidities contribute to early death of hip fracture patients. However, not many studies have focused on preoperative sepsis as a potential risk factor. Hip fracture patients are commonly identified with sepsis after surgery, but the extent of preoperative sepsis and its consequences are sparsely elucidated. Being able to identify patients at higher risk of postoperative mortality could potentially improve outcome and extensive hospital registries of vital signs and cultures allow identification of preoperative sepsis.

The aim of this study is to assess the association between preoperative sepsis and the 30-day mortality after hip fracture surgery.

This study will be a retrospective analysis of a set of data collected prospectively. Data on relevant cultures, blood samples, co-morbidities, time to surgery and 30-day mortality will be extracted from patient records and clinical databases to examine the pre- and postoperative status of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with one of the following ICD-10 diagnoses for hip fracture: DS720(Fracture of neck of femur), DS721 (Pertrochanteric fracture), DS721A(Intertrochanteric fracture), DS721B (Trochanteric fracture), DS722 (Subtrochanteric fracture)
* Patients who underwent surgery for hip fracture.
* Age \> 18 years

Exclusion Criteria:

* Patients with a pathologic hip fracture related to an underlying metastatic disease (ICD-10: DM907).
* Patients with incomplete preoperative data. All patients must have at least one record of each of the following variables within 72 hours prior to hip fracture surgery: temperature, heartrate, respiratory rate and blood leukocytes.
Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer

The aim of this protocol is to study the deleterious impact of adjuvant chemotherapy or neoadjuvant chemotherapy on ovarian reserve in young women suffering from breast cancer. A new relevant ovarian reserve marker, serum Anti-Mullerian Hormone, will be used in order to evaluate precisely the impact of chemotherapy on ovaries during chemotherapy administrations and after during follow-up (24 months). This strategy offers 2 main advantages : no modification of the traditional care of patients (treatment, organisation, follow up ...) and use of a non invasive marker (serum). The final objective is to give precise information to patients on their future fertility after remission.


Eligibility Criteria:
Inclusion Criteria:

* female 18-39 years
* suffering from breast cancer
* treated with adjuvant or neoadjuvant chemotherapy
Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject

The purpose of this study is to evaluate the safety and efficacy of LMT1-48(Probiotics) compared to a placebo in reducing the body fat in overweight subjects


Eligibility Criteria:
Inclusion Criteria:

* Age between 19 and 70 years
* Overweight (25 kg/m2 ≤ body mass index (BMI) \< 30 kg/m2)

Exclusion Criteria:

* Pregnancy or breast-feeding
* Unstable body weight (body weight change \> 10% within 3 months before screening)
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients

This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

experimental group: HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), once every 3 weeks (Q3W).

Eligibility Criteria:
Inclusion Criteria:

1. Male/female who are at least 18 years of age on the day of signing the informed consent.
2. With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
3. HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) as assessed by a central laboratory on metastatic tumor and was never previously HER2-positive，and was documented HR+ disease in the metastatic setting
4. Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
5. ECOG PS: 0-1.
6. Expected survival ≥ 6 months.
7. Had adequate organ function

Exclusion Criteria:

1. Patients with other malignant tumors within 3 years before the randomization
2. Previous treatment with any HER2-target therapy
3. Uncontrolled or significant cardiovascular disease or infection
4. Lung-specific intercurrent clinically significant illnesses
5. Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
6. Patients with spinal cord compression or clinically active central nervous system metastases
Patient and Physician's Satisfaction After a Long Term Treatment of Glabellar Lines With Dysport®

This study aims to look at patient and physician satisfaction of long term Glabellar lines (GL) treatment with Dysport in a real life setting. It will also allow better understanding of what patients expect from the treatment, and the injection practices used by doctors.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient with moderate to severe GL naïve of any type of aesthetic treatment/procedure (invasive and non-invasive) for GL who provided written informed consent to take part.
* Patient who has prior to and independent of the study decided to undergo long term treatment of GL only (at least three cycles).
* Patient able to comply with the protocol (completion of web questionnaires).
* Patient whom physician intended to treat with Dysport independent of participation in the study.

Exclusion Criteria:

* Patient already included in this study.
* Participation in an interventional trial within 30 days prior to study entry.
* Patient who is at risk in terms of precautions, warnings, and contraindication (follow local Summary of Product Characteristics (SmPC) of Dysport).
* Female patient who is pregnant, nursing or planning a pregnancy during the study.
* Hypersensitivity to Dysport® or to its excipients.
* Presence of infection at the proposed injection sites.
* Presence of myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis.
HKT288 in Solid Tumors, Including Epithelial Ovarian Cancer and Renal Cell Carcinoma

A first-in-human study using HKT288 in solid tumors, including epithelial ovarian cancer and renal cell carcinoma


Eligibility Criteria:
Main Inclusion Criteria:

* Advanced (metastatic or locally advanced) serous epithelial ovarian, serous fallopian tubal or serous primary peritoneal cancer or advanced clear cell or papillary renal cell carcinoma who have received or are intolerant to all therapy known to confer clinical benefit for their disease, as determined by the investigator.
* Tumor sample is available for retrospective CDH6 expression testing
* Eastern Cooperative Oncology Group (ECOG) Performance status ≤2

Main Exclusion Criteria:

* Patient has central nervous system metastatic involvement. Patients with previously treated CNS metastases are also excluded.
* Patient with any active or chronic corneal disorders
* Patients with monocular vision or have media opacities or any other condition that precludes monitoring of the retina or fundus.
* Patients with a history of serious allergic reactions
* Patients with QTcF \>470 msec at screening ECG or congenital long QT syndrome
* Any prior history of treatment with maytansine (DM1 or DM4)-based ADC
* Patient have received anti-cancer therapies within the following time frames prior to the first dose of study treatment:

  * Conventional cytotoxic chemotherapy: ≤4 weeks (≤ 6 weeks for nitrosoureas and mitomycin-C)
  * Biologic therapy (e.g., antibodies): ≤4 weeks
  * Non-cytotoxic small molecule therapeutics: ≤5 half-lives or ≤2 weeks (whichever is longer)
  * Other investigational agents: ≤4 weeks
  * Radiation therapy (except for localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture): ≤4 weeks
  * Radiation therapy (localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture) ≤2 weeks
  * Major surgery: ≤2 weeks
Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Stroke Survivers

The purpose of this study is evaluate the effects of walking training with partial body weight support on static (floor) and dynamic (treadmill) surfaces in individuals with hemiparesis due to stroke. For this purpose, two training protocols will be employed in three experimental groups: G1 will do the walking training with partial body weight support on static surfaces and G2 will do the walking training with partial body weight support on dynamic surfaces


Eligibility Criteria:
Inclusion Criteria:

* One-sided hemiparesis, No heart disease (or medical clearance to participate in the study), No orthopedic impairments and / or neurological symptoms that may alter the the gait, no history of thrombophlebitis or deep vein thrombosis, Ability to understand and follow verbal commands, Can walk alone or with canes of approximately 10 m; Spasticity degree mild to moderate in the affected lower limb with levels of classification between 0 and 2 in the Ashworth spasticity scale modified

Exclusion Criteria:

* Heart frequency increase more than 75% of the maximum or have any other general instability during training that may lead risk for the health during the training,
Cannabis (THC vs. CBD) in Multiple Sclerosis

The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS).

Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks.

Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system.

Cannabis and cannabis-based medicines (CBM) are often used by persons with MS (PwMS).

Cannabis research to date indicates that its use worsens cognitive function in PwMS. Additionally, cognitive impairment (CI) is already a frequent consequence of MS, with a significant negative impact on quality of life (QOL).

This is pilot randomized, double blinded, double arm clinical trial of Tetrahydrocannabinol (THC) 25 mg or Cannabidiol (CBD) 50 mg orally for 15 weeks in people with MS trial.

The investigators will recruit PwMS with symptoms of neurogenic lower urinary tract dysfunction (NLUTD). These participants can either be on a treatment that has been only partially effective (as per patient report) or has never tried an intervention for their NLUTD symptoms.

The primary aim is to evaluate the differential effect of the tetrahydrocannabinol (THC) and cannabidiol (CBD) on cognitive outcomes in persons with Multiple Sclerosis (PwMS) using cannabis for NLUTD.

The results of our proposed study will better inform both healthcare practitioners and patients with respect to the potential risks of treatment with cannabis-based products and any difference with respect to THC vs. CBD-based products.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 59 years inclusive.
* Confirmed diagnosis of Multiple Sclerosis as per McDonald criteria (any type) \[12\]
* Symptoms of neurogenic lower urinary tract dysfunction (NLUTD) as measured by neurogenic bladder symptom score (NBSS), with a minimum score of 7.
* If already on a medication for NLUTD, must be stable on this medication for at least 4 weeks.
* Sexually active men and women of child-bearing potential must agree to use adequate contraception.
* Written informed consent.

Exclusion Criteria:

* Major psychiatric disorder such as schizophrenia or bipolar disorder
* Major neurological disorder which could affect cognition such as dementia, traumatic brain injury.
* Seizure disorder
* Use of antipsychotic medication
* Use of benzodiazepines other than exclusively at night/bedtime
* Experienced a MS relapse in the last ninety (90) days.
* Current use of cannabis or CBM greater than 3x/week.
* Currently using cannabis/CBM less than 3x/week and being unwilling to abstain for the duration of the study.
* Visual acuity (binocular) worse than 20/70 (in order to complete the cognitive outcomes)
* Significant upper extremity disability that would interfere with the cognitive tests battery.
* Indwelling catheter use/urinary diversion
* Pregnant or Breastfeeding
Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome

This study will investigate the effects of curcumin on the structure/function of the body by investigating whether targeted improvement of intestinal barrier function by supplementation with oral curcumin will result in attenuation of lipopolysaccharide (LPS) translocation and/or intestinal inflammation.

A typical diet in the United States, also known as Western diet, is very high in sugars and saturated fat, and poor in food such as fruits, vegetables, fish and whole grains. This type of diet is associated with higher risk to develop obesity and other health problems such as high blood pressure, high cholesterol, Type 2 diabetes, and heart disease. Western diet can also cause changes in the gut that allow bacteria that are typically only present in the gut to leak out into the bloodstream. It is thought that having gut bacteria in the bloodstream may play a role in the development of diseases like Type 2 diabetes and heart disease.

Curcumin is a dietary supplement that comes from the root of the turmeric plant, and it may have an effect on the function of the gut and the leakage of gut bacteria into the bloodstream. The purpose of this research study is to evaluate the effects of daily curcumin dietary supplements on the function of the gut in subjects who are at risk for cardiovascular and metabolic diseases, for example they have increased blood pressure, increase waist circumference and high triglycerides (fat in the blood).

Eligibility Criteria:
Inclusion Criteria:

1. Based on National Institutes of Health (NIH) definition of Metabolic syndrome, the subject must meet at least 3 of the following criteria:

   A. Waist Circumference: Female ≥ 88 cm, Male ≥ 102 cm B. Blood Pressure: ≥ 130/85 mm/Hg and/or treatment with blood pressure lowering medication C. Impaired fasting glucose or HbA1c (fasting glucose ≥ 100 mg/dl or HgA1c ≥ 5.7 D. HDL-C: Females\< 50 mg/dl, Males \< 40 mg/dl E. Triglycerides ≥ 150 mg/dl
2. Willing and able to comply with the study protocol

Exclusion Criteria:

1. Diabetes
2. Established cardiovascular disease
3. Pre-existing liver disease other than NAFLD
4. Chronic kidney disease (Stage 4 and 5)
5. Rheumatological disease
6. Active malignancy
7. Alcohol consumption greater than 7 drinks per week for females and greater than 14 drinks per week for males
8. Current use of metformin and/or steroids
9. Curcumin supplementation
10. Females of child-bearing potential (NOT of child-bearing potential is defined as s/p hysterectomy or post-menopausal.)
11. Prisoners/wards of the state and individuals with limited English proficiency