cyrilzakka/clinical-trials huggingface dataset:
Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury

The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic spinal cord injury of greater than 18 months
* Osteopenia or osteoporosis of the hip
* Must be able to swallow tablets and sit upright

Exclusion Criteria:

* Bilateral heterotopic ossification
* Bilateral lower extremity metal implants
* Pregnant or lactating females
* Paget's disease
* Osteomalacia
* Steroid induced bone loss
* Untreated parathyroid or thyroid disease
* Symptomatic hypocalcemia or hypophosphatemia
* Treatment in the last year with calcitonin, fluoride or anabolic steroids
* Current treatment with prednisone
Nutritional Approaches in Multiple Sclerosis

The aim of this project is to characterize the influence of a ketogenic diet and intermittent therapeutical fasting on the course of the disease, as measured by T2-hyperintense cerebral lesions with magnetic resonance tomography (MRT) in patients with multiple sclerosis (RRMS). The investigators expect in both intervention groups fewer cerebral T2 lesions occurring after 18 months in comparison to the control group and as detectable by MRT. According to current recommendations of the German Society of Nutrition (DGE), the control group receives a vegetarian-focused, anti-inflammatory diet.


Eligibility Criteria:
Inclusion Criteria:

* Existing health insurance, so that in case of random findings these can also be clarified
* Patients with relapsed-remitting MS according to the MS diagnostic criteria according to McDonald 2010
* Age 18-65
* Consent ability and written consent
* BMI between 19 and 45 kg / m2
* EDSS \<4.5
* Stable immunomodulatory therapy or no immunomodulatory therapy\> 6 months before confinement
* In the last 2 years ≥ 1 relapse or within the last 2 years ≥ 1 new T2 lesions or ≥ 1 contrast-sensitive lesion in MRT
* Consent that possible random findings are reported

Exclusion Criteria:

* Initiation or modification of immunomodulatory therapy during the study
* Cortisone treatment in the last 30 days before enrollment
* Relapse in the last 30 days before enrollment
* Insulin-dependent diabetes mellitus (type I)
* Intake of Omega 3 fatty acids (DHA, EPA) - more than 1 g / day
* Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study
* Malignant disease
* Simultaneous participation in an interventional study or participation in an interventional study in the last two months before study inclusion
* Clinically relevant addiction or substance abuse disorder (defined as alcohol, drug and drug abuse)
* Nicotine consumption of \> 5 cigarettes per day and no willingness to stop consumption during therapeutic fasting.
* Insufficient mental possibility of cooperation
* Eating disorder
* Kidney stones
* Known metabolic disorders (e.g., fatty acid oxidation disorders, ketolysis / ketogenesis or glucogenesis disorder, hyperinsulinism (e.g., nesidioblastoma), pyruvate carboxylase deficiency)
* Therapy with oral anticoagulants (e.g., Marcumar)
* Pregnancy and breast feeding period
* Suspected lack of compliance
* Performing of a diet for weight reduction
* Special diet for medical reasons
* Change of the body weight of more than 5 kg within one month before the start of the Intervention
* Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
* Contraindications to MRT examinations \[persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia\]
Adjuvant Acupuncture for Severe Head Injury

The purpose of this study is to determine the therapeutic effect of acupuncture on severe head injury under conventional treatment. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.

Objective: To investigate the therapeutic effect of acupuncture on severe head injury under conventional treatment.

Methods: 90 subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less) are randomly divided into acupuncture, laser acupuncture and control group. We use restoring consciousness acupuncture (GV26 and 12 Well points) to treat the subjects 3 sessions per week under conventional treatment at Department of Neurosurgery. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' GCS and muscle power is measured.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less)
* with informed consent

Exclusion Criteria:

* dilated pupils without light reflex
* serious complications during therapeutic course
* interruption of therapeutic course
* unfavored condition assessed by physician in charge
* without informed consent
Computer Modeling With Reconstruction of Maxillofacial Skeleton

Investigator initial study to evaluate the use of preoperative computer modeling and the intraoperative navigation to guide reconstruction of the maxillofacial skeleton.

The concept of open reduction and internal fixation of facial fractures is well accepted. However, there are situations in which an accurate reduction and restoration of facial symmetry is challenging. In these more difficult cases, the PI uses computer aided design/modeling software as well as intra-operative computer aided surgical navigation systems to assist with repair of these complex injuries. A retrospective review of these cases has not previously been performed.

Eligibility Criteria:
Inclusion Criteria:

* specific complex maxillofacial trauma

Exclusion Criteria:

* must meet inclusion criteria
A Study of RAY1225 in Participants With Impaired Liver Function

The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.


Eligibility Criteria:
Inclusion Criteria:

1. Participant must be ≥ 18 to ≤ 75 years;
2. BMI ≥ 20 kg/m2 up to ≤ 32 kg/m2;
3. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;
4. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment;
5. eGFR ≥ 60 mL/min/1.73 m2;

   Participants with Normal Hepatic Function Only:
6. Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;

   Participants with hepatic impairment only:
7. Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.

Exclusion Criteria:

1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;
2. QTcF\> 450ms;
3. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks;
4. Participates who donated blood or bleeding profusely (\> 400 mL) in the 3 months;
5. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test;
6. Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening;
7. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;

   Participants with Normal Hepatic Function Only:
8. Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.

   Participants with Hepatic Impairment Only:
9. Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.
10. Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices.
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication.

All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old.
* Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).
* Be able to tolerate oral medication.
* Not be pregnant or breast-feeding.
* Sign and date an informed consent form.
Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis

The purpose of this study is to determine whether a single injection of Dysport with a new protocol at forearm is effective in the management of chronic lateral epicondylitis.

Some studies valued the effectiveness of botulinum toxin. There is a great amount of controversy on the amount of botulinum toxin injected and the location of the injection. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo at a new injection site at the forearm in the treatment of chronic tennis elbow unrelieved by corticosteroid injection and physiotherapy. It is a double blind randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Pain: pain will be assessed as the physician touches lateral epicondyle or passively flexing the patient's wrist and while the patient extends his/her wrist or 3rd finger against resistance. Individuals who fulfill two or more of above will be considered to have lateral epicondylitis.
* Symptom duration: should be at least 6 months.
* Previous trial of complete course of physiotherapy and corticosteroid injection.

Exclusion Criteria:

* Rheumatoid arthritis
* Generalized polyarthritis
* Local elbow arthritis
* Simultaneous medial epicondylalgia
* Bilateral lateral epicondylitis
* Neurologic deficits (abnormal light touch sensation, deep tendon reflexes abnormality, radicular pain, radial nerve entrapment, signs of nerve root compression, decreased muscle force, multiple sclerosis, seizures)
* The use of corticosteroid in last 30 days
* Simultaneous use of drugs other than acetaminophen or physical therapy in the course of study
* Pregnancy
* Breast-feeding
* Previous hand surgery
* Having a hobby or job that needs finger extension
Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial

The aim of the study is to compare the effectiveness of injection techniques in the treatment of elbow lateral epicondylitis. The functional and pain levels of the patients will be evaluated with scores such as DASH, VAS, PRTEE. At the same time, USG imaging will be evaluated before injection and in the third month after injection. The study was planned as a randomized controlled prospective study.

Patients diagnosed with epicondylitis in our outpatient clinic will be divided into 3 groups, and patients who will receive saline in 1 group and betamethasone sodium in a group will be selected in accordance with the specified conditions and their treatment will be started, and the treatment will be started, which patient will receive which treatment will be determined by the computerized randomization program. ), 1ml prp (plate-rich plasma to be prepared with the blood taken from the patient on the day of injection), 1 ml saline (0.9 NACI), while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day.Examination and functional scores to be applied to the patients during follow-up: VAS, DASH and PRTEE scores will be checked in the 1st 6th week, 3rd month, 6th month and 12th month VAS: Visual Analog Scale DASH: The Disabilities of the Arm, Shoulder and Hand PRTEE: The Patient-Rated Tennis Elbow Evaluation 2. It will be evaluated by USG in the 3rd month.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18
2. Clinical diagnosis-
3. Symptoms lasting more than 3 months and no injection within this period
4. Radiologically diagnosed -

Exclusion Criteria:

- 1. symptoms for less than 3 months 2. Having been given injection treatment within 3 months

3. Surgical procedure for lateral epicondylitis 4. Having pain caused by the cervical spine 5. Restricted elbow range of motion 6.Having an elbow bony deformity
Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)

LIVEROBOT is a collaboration of high-volume liver surgical centers in Europe (≥60 liver resections per year), supported by the European-African Hepato-Pancreato-Biliary Association Education Committee (E-AHPBA), and the European Registry of Minimally Invasive Liver Surgery (E-MILS) aiming to support the step-up implementation and safety of advanced surgical expertise of robotic liver surgery (RLS) on a European basis. The LIVEROBOT training program aims to promote the safe implementation of RLS throughout Europe. The data from all patients operated on during a surgeons' participation in the training program will be prospectively gathered allowing for learning curve and outcome analyses.


Eligibility Criteria:
Center/Surgeon Eligibility Criteria:

Prior to admission to the LIVEROBOT training program surgeons must demonstrate laparoscopic experience with a laparoscopic cholecystectomy with OSATS score \>3 (reviewed by proctors), participation in the LAELIVE training program or demonstrating more than two-year experience in clinical laparoscopic liver surgery. Additionally, a minimal surgical volume is required for participation. Annual liver surgery volume (open and minimally invasive combined) per two surgeons should be more 60, aiming to reach more than 40 RLS annually. Each participating surgeon should individually perform a minimum of more than 15 hepatectomy procedures annually. Surgeons shall be excluded from the training program if at any point failing to meet the minimal volume criteria (corrected for COVID-19 restrictions).

Inclusion Criteria:

* Age equal or above 18 years
* Eligible for elective minimally invasive and open hepatectomy for malignant, pre-malignant or benign disease located in the liver or biliary tract
* Eligible for both minimally invasive and open surgery according to the operating surgeon
* Fit to undergo the indicated operation according to both the anaesthesiologist and surgeon

Exclusion Criteria:

* Pregnancy
Myofascial Release of Physiological Chains and Muscle Stretching in Patients With Fibromyalgia

Muscle stretching is a therapeutic technique commonly used by physiotherapists, but for the treatment of fibromyalgia it still has weak evidence to support its real effect. On the other hand, myofascial mobilization in the location of tender points, as it is the solution for the population, demonstrating effects on the improvement of the symptoms, but not yet achieving the minimal clinically important change. In this context, myofascial release guided by physiological chains, so far not studied, is presented as an alternative to improve pain and quality of life in patients with fibromyalgia because it acts in a global way and, probably, more effective.

This study evaluates the effect of myofascial release of the trunk physiological chains and muscle stretching on pain, quality of life and functional capacity of patients with fibromyalgia when compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of the diagnosis by rheumatologists according to the diagnostic criteria established by the American College of Rheumatology of 1990 and 2010.
* Moderate to severe pain according to the Fibromyalgia Impact Questionnaire (≥ 4).
* Prescribed treatment (drug and/or psychological) stable in the last month before the selection for those who perform.
* Patients who live in the metropolitan area of Recife - Pernambuco, Brazil.

Exclusion Criteria:

* Nonpharmacologic therapies, except for psychological treatment if prescribed by the doctor at the same time of the study.
* Skin diseases.
* Patients classified as "very active" by the International Physical Activity Questionnaire.
* Women who use intrauterine devices (IUD).
* Pregnant women.
* Patients with other associated rheumatic disease or with modified posture due to congenital anatomic alteration.
* Severe decompensated comorbidities (cancer, thyroid disease and diabetes).
* Infection, fever, hypotension, respiratory alterations limiting treatment.
* Cardiovascular event in the previous year.
* Presence of cardiac, renal or hepatic insufficiency.
* Arterial or peripheral venous insufficiency.
* Presence of a hypertrophic scar on the trunk.
* Obesity grade 3.
* Illiteracy.
* Severe psychiatric illness.
Surgical Treatment of Chronic Neuropathic Pain

Observational registry study assessing the subject's pain history and the impact of surgery for the treatment of chronic neuropathic pain by comparing post-operative outcomes (pain level, pain medication usage, quality of life outcomes, and nerve functional outcome) to pre-operative levels.

This observational registry will evaluate the subject's healthcare journey and pain history through detailed medical history and record review. For patients who undergo surgical treatment for pain, the registry will capture standardized outcomes measures to assess key factors such as post-operative pain, pain medication usage, quality of life outcomes, and functional outcome of associated nerves as compared to pre-operative levels.

Eligibility Criteria:
Inclusion Criteria:

1. Be Age ≥ 18 years
2. Have a documented diagnosis of chronic neuropathic pain
3. In the opinion of the investigator, be considered at the time of screening a likely candidate for surgical treatment of their neuropathic pain according to institutional standard of care.
4. Be willing to participate in data collection and all follow-up assessments throughout and for the entire duration of follow-up

Exclusion Criteria:

1. Subjects who, in the opinion of the investigator, have not or likely will not complete the required follow-up assessments.
2. Subjects who are currently enrolled in another clinical trial;
3. Subjects who have undergone previous surgical treatment of pain from symptomatic neuroma in the target nerve(s);
4. Subjects who are undergoing treatment(s)/intervention(s) for other condition(s) which, in the opinion of the investigator, may confound assessment of pain or interfere with the study measurements.
A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.


Eligibility Criteria:
Inclusion Criteria:

* Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines, in the opinion of the investigator.
* Participant has moderate or severe GL at maximum frown.

Exclusion Criteria:

* History of known immunization to any botulinum toxin serotype.
* History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.
* Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including:
* Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
* Facial nerve palsy.
* Infection or dermatological condition at the site of study drug injection.
A Study to Compare PK, PD and Safety of the AD-213-A and AD-2131

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-A to AD-2131 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults over 19 years of age.
* Weight is more than 50kg and BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2.
* Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
* Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

* A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.
* As a result of laboratory tests, the following figures: ALT or AST or total bilirubin \> 1.5 times upper limit of normal range.
* As a result of laboratory tests, the following figures: Creatinine clearance \< 80mL/min.
* Subjects who judged ineligible by the investigator.
Effects of Yoga on Bone Metabolism in Premenopausal Women

This study examined the effects of 8 months of Yoga training on bone density and bone turnover markers in premenopausal women, ages 35-50 years. The style of Yoga used was power Yoga that involved postures with a jumping component. The investigators hypothesized that the Yoga intervention would result in beneficial improvements in bone turnover markers, by increasing the bone formation marker and decreasing the bone resorption marker.


Eligibility Criteria:
Inclusion Criteria:

* participants had not been engaged in resistance training or in Yoga exercise for at least 12 months prior to the study
* did not have chronic back or joint problems or cardiovascular disease
* not taking antihypertensive drugs or any medication that affects bone density
* not taking hormonal contraception
* they self-reported having regular menstrual cycles.

Exclusion Criteria:

* body weight more than 300 pounds