cyrilzakka/clinical-trials huggingface dataset:
Effects of Low-Level Laser Therapy on Mouth Opening and Surface Electromyography in Temporomandibular Disorders

This is a one year followup study that aims to assess the efficacy of low level laser therapy (LLLT) on pain, mouth opening and masticatory muscle activity in cases of temporomandibular dysfunction (TMD) as compared to soft occlusive splints.

A prospective, parallel randomized, controlled study will be conducted at the outpatient university clinic. Participant recruitment started following approval from the Ethics Committee .The patients will participate in the study after signing an informed consent form prior to data collection. Per inclusion criteria, subjects included are females less than 30 years of age, diagnosed with unilateral arthrogenous TMD, having complete permanent dentition and showing normal occlusion. Prior to participating in any study-related procedures, participants read and signed the informed consent form approved by the Institutional Review Board. Participants will be divided into three groups; three groups: LLLT (Group A); soft occlusive splint therapy OST (Group B); waitlist as controls (Group C).

Outcome measures: TMJ opening index (TOI), VAS, sEMG. Participants were not given information on which treatment they were receiving; they were only told that they could receive one of two different treatment techniques. Sessions were scheduled 3 days a week (every other day) for a total of 10 sessions

Eligibility Criteria:
Inclusion Criteria:

Females less than 30 years of age, Diagnosed with unilateral myogenous TMD, Having complete permanent dentition Showing normal occlusion

Exclusion Criteria:

Prior experience of Laser therapy, Systemic diseases (rheumatoid arthritis, ankylosing spondylitis, diabetes... etc. History of trauma in the TMJ or cervical regions; Neurological disorders, Muscular diseases; Cervical pain; Bruxism, Pregnancy; Currently on medication (analgesic, anti-inflammatory, muscle relaxants or anti- depressants) Current use of dental prosthetics; Previous orthodontal treatments; or Fixed restorations affecting occlusal surfaces.
A Dose-Finding Study of MM-120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM-120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

The study will enroll approximately 200 male and female subjects 18 years to \< 75 years of age who meet DSM-5 criteria for GAD and have a minimum HAM-A Total Score of 20. Subjects on contraindicated concomitant medications, supplements or other therapeutics at Screening (Visit 1) will undergo a medication taper prior to advancing to Baseline (Visit 2).

Eligibility Criteria:
Inclusion Criteria:

* Bodyweight of ≥ 50 kg
* Body mass index \[BMI\] ≥ 18 to ≤ 38 mg/kg2
* Diagnosis of DSM-5 generalized anxiety disorder
* Acceptable overall medical condition to be safely enrolled into and to complete the study
* Ability to swallow capsules
* Ability to provide informed consent

Exclusion Criteria:

* Women of childbearing potential (WOCBP) (i.e., physiologically capable of becoming pregnant) who are unwilling or unable to use a highly effective method of contraception for the duration of the study, OR Men physiologically capable of fathering a child who are sexually active with WOCBP but are unwilling or unable to use barrier contraception (e.g., condom with or without spermicidal cream or jelly) for the duration of the study
* Women who are currently pregnant or breastfeeding or plan to become pregnant or breastfeed during the study
* Men who plan to donate sperm during the study
* Prior history (lifetime diagnosis) with a lifetime diagnosis of schizophrenia spectrum, or other psychotic disorders or bipolar disorder
* Has a significant risk of suicide attempt based upon medical history or has active suicidal ideation
* Unwillingness or inability to discontinue prohibited concomitant medications, supplements or other therapeutics (prescription or over-the-counter)
Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.

During gynecological exams, vaginal discharge samples will be are taken for testing the pH level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections).

One additional sample will be taken intended for the Gyni™ system diagnosis. This additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the Gyni table-top scanner. The result diagnosis will be anonymously kept in the cloud.

The diagnosis suggested by the Gyni system will not be visible to the physician in order to prevent any bias. Results from the physician, from the device and from the lab will be summarized and compared by the chief investigator

Eligibility Criteria:
Inclusion Criteria:

* Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain
* Age \>= 18y

Exclusion Criteria:

* Age \< 18y
* Not eligible to sign an informed consent
* Vaginal discharge samples found microscopically not interpret-able by the investigator due to patient using vaginal creams, ointments, lubricants or sperm presence.
* During menstruation
Effect of Reformer Exercises on Pain Perception in Chronic Musculoskeletal Pain.

This study was planned to investigate whether reformer pilates exercises, which are recommended for the development and maintenance of well-being in musculoskeletal problems associated with low back, neck and back pain, change the pain perceptions of patients with chronic musculoskeletal diseases by improving the mind-body relationship.

Although many symptoms are observed in musculoskeletal system disorders, pain which progresses gradually and even progresses to the point of causing incapacity for work is the most common. Although musculoskeletal system disorders indicate a very broad concept, it is also observed that low back, neck and back pain are in the first rank in studies conducted worldwide and in our country .Pilates training plays an important role in regaining and maintaining muscle strength, flexibility, endurance and functioning of proprioceptive mechanisms. Although there are many physical activity programmes, Pilates has become an increasingly widespread and recommended physical exercise method worldwide in recent years. The Pilates method is an exercise concept established by Joseph H Pilates in the early 1900s and currently applied to both sick and healthy individuals. Exercises can be performed on a mat and special equipment such as Cadillac, Reformer and Wundachair are also used. Pilates training plays an important role in regaining and maintaining muscle strength, flexibility, endurance and functioning of proprioceptive mechanisms. Therefore, although Pilates exercises are not designed to reduce body weight, they are a good option for sedentary, overweight and obese people who have difficulty in performing traditional exercises .

This study was planned to investigate whether reformer pilates exercises, which are recommended for the development and maintenance of well-being in musculoskeletal problems associated with low back, neck and back pain, change the pain perceptions of patients with chronic musculoskeletal diseases by improving the mind-body relationship.

Eligibility Criteria:
Inclusion Criteria:

Sedantry male and female aged 30-50 years chronic musculoskeletal pain diagnosed for at least 6 months

Exclusion Criteria:

neurological disorders communication and psychiatric disorders
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients. The screening period for this study will take up to 2-weeks. Afterwards, patients will be randomized to placebo, 2.5 mg obicetrapib, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* LDL-C \> 70 mg/dL and TG \< 400 mg/dL,
* Treated with a stable statin therapy; Atorvastatin 20/40 or Simvastatin 10/20

Exclusion Criteria:

* BMI \> or =35 kg/m2
* Significant cardiovascular disease
* HbA1c \> 10%
* Uncontrolled hypertension
* Active muscle disease
* GFR \< 60 ml/min
* Hepatic dysfunction
* Anemia
* Existing CETP deficiency
* History of Homozygous Familial Hypercholerstrolemia
* History of malignancy
* Alcohol abuse
* Treatment with investigational product
* Treatment with PCSK9
* Clinically significant condition
* Known CETP inhibitor allergy
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)

To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.


Eligibility Criteria:
Inclusion criteria

1. Participants who are diagnosed as Lennox-Gastaut syndrome with tonic/atonic seizures and atypical absence seizures (A history of atypical absence seizures will also be incorporated).
2. Participants who had a slow spike-and-wave pattern in an electroencephalogram within 6 months prior to the enrollment for the Observation Period.
3. Participants who had at least a total of 90 seizures in the 28 days prior to the enrollment for the Observation Period.
4. Participants who have been on 1 - 3 anti-epileptic drugs from 28 days prior to the enrollment for the Observation Period and have not changed the type of the anti-epileptic drugs.
5. Participants who have not changed the type nor the dose or administration of the anti-epileptic drugs they are taking in the Observation Period.

Exclusion criteria;

1. Participants who had a history of generalized tonic-clonic status epilepticus within baseline.
2. Participants who received drug therapy at least 4 times to be rescued from status epilepticus within baseline.
3. Participants who had a history of hypoxia which needed emergency resuscitation within 12 months prior to the Treatment Period.
4. Participants who were on a ketogenic diet or have received adrenocorticotropic hormone (ACTH) therapy or Vitamin B6 therapy within 6 months prior to the Treatment Period.
5. Participants who had a history of suicide attempt within the 1 year prior to the Treatment Period.
6. Participants who had a history of or has an allergy to triazole compound.
7. Participants who have clinically significant electrocardiogram abnormalities at baseline.
8. Participants who are pregnant, who may be pregnant, who are lactating or who wish to be pregnant.
Predictive Factors of Visual Recovery After Paraoptic Tumors Removal

Paraoptic tumors - including mostly sellar meningiomas, pituitary gland adenomas and craniopharyngiomas - classically affect the visual function. Some preoperative factors, determined on retrospective studies, are known to constitute bad prognostic factors, such as duration of symptoms and retinal nerve fiber layer thinning on OCT. We propose to perform a single center prospective study in which detailed preoperative ophthalmological and radiological criteria will be collected before surgery. Intraoperative information will be noted as well. All these data will be statistically examined regarding the postoperative visual recovery at 3, 6 and 12 months


Eligibility Criteria:
Inclusion Criteria:

* tuberculum sellae meningioma surgical indication

Exclusion Criteria:

* surgical contra indication MRI contra indication optical disease
Efficacy and Safety of Addition of IL-2 to Pegylated Interferon Alpha 2a and Ribavirin in HIV/HCV Coinfected Patients

The purpose of this pilot study is to evaluate efficacy and safety of addition of IL-2 to pegylated interferon alpha 2a and ribavirin in HIV-HCV coinfected patients non-responders after three months of standard therapy with pegylated interferon alpha 2a and ribavirin. IL-2 may enhance numbers and function of CD4 T lymphocytes and specific anti-HCV immune responses and could participate to the control of HCV replication

This pilot study evaluate efficacy and safety of addition of IL-2 to pegylated interferon alpha 2a and ribavirin in HIV-HCV coinfected patients non-responders after three months of standard therapy with pegylated interferon alpha 2a and ribavirin Eligible patients should have CD4 cells count higher than 300/mm³ if pretreated by antiretroviral therapy or higher than 400/mm³ if naive of antiretroviral therapy, Metavir score with histological fibrosis score F1, F2 or F3.

Recombinant IL-2 will be given subcutaneously at a dose of 3 MUI twice daily for 5 days every 8 weeks for 5 cycles from week 14 to week 46. This national multicenter study will enroll around 75 patients in order to give IL-2 to 20 non-responders.

The primary endpoint is sustained virologic response, defined by undetectable serum HCV-RNA at week 72, six months after the end of therapy

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection and HCV infection
* Naive of ribavirin
* CD4 higher than 300 if pretreated by antiretroviral therapy or higher than 400 if naive of antiretroviral therapy
* Signed informed consent

Exclusion Criteria:

* Cirrhosis (histological fibrosis score F4 in Metavir score)
* Other liver disease
* Pregnancy
Correlation Between Melatonin Levels in Different Biological Fluids

The goal of this observational study is to evaluate and to correlate melatonin levels in plasma, saliva and cerebrospinal fluid (CSF) samples of patients undergoing lumbar puncture diagnostic for specific neurological diseases.


Eligibility Criteria:
Inclusion Criteria:

* Neurodegenerative disease

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Coagulations disorders
* Anticoagulant therapy
Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function

The investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism. The values will be compared to those obtained in healthy volunteers. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in children with obesity with or without type 2 diabetes.

One-center prospective study performed in collaboration between the Pediatric Endocrine and Diabetology unit of the University Hospitals of Geneva (HUG) and Prof. Pierre Maechler, Diabetes Center of the Faculty of Medicine, University of Geneva Switzerland.

1,5-anhydroglucitol (1,5-AG), a deoxyhexose present in almost all foods and forming a stable pool in human subjects, has recently been found to be correlated with functional beta-cell mass in two different mouse models of beta-cell dysfunction leading to diabetes. The decline of this biomarker precedes the development of hyperglycemia in lean b-Phb2 -/- and obese db/db diabetic mice, where beta-cell loss occurs through two different mechanisms.

Additional studies have shown a correlation of 1,5-AG levels with risk of progression of type 1 diabetes (T1DM) in auto-antibody positive children, as well as with glycaemic control in patients with type 2 diabetes (T2DM).

The present project will analyse the correlation between functional beta-cell mass and the circulating levels of 1,5-AG in children with obesity with or without T2DM. This should contribute to the evaluation of a novel biomarker of beta-cell mass and function in T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 12 to 16 years
* Obesity. Defined as a body-mass index above the 97th percentile.
* Ability to give informed consent as documented by signature

Exclusion Criteria:

* Patients with diabetes mellitus and positive autoantibodies against islets, insulin, islet antigen 2, glutamic acid decarboxylase or Zinc transporter 8.
* Patients with known liver disease (other than NAFLD)
* Patients treated with an oral antidiabetic drug, glucagon-like peptide-1 analogues or insulin at the time of or less than 2 weeks prior to inclusion.
* Patients treated with a drug known to affect liver function
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent Chronic Kidney Disease (DD-CKD).


Eligibility Criteria:
Inclusion Criteria:

* Male and female Japanese participants ≥20 years of age
* Receiving chronic maintenance hemodialysis for end-stage kidney disease
* Hemoglobin (Hb) \<10.0 grams per deciliter (g/dL)

Exclusion Criteria:

* Anemia due to a cause other than chronic kidney disease (CKD) or presence of active bleeding or recent blood loss
* Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red blood cell transfusion within 4 weeks prior to or during screening
* Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation
Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

Hip fractures are one of the most frequent operated fractures procedures in orthopedics, with a world wide annual incidence of approximately 1.7 million. These fractures are associated with substantial morbidity and mortality. As populations age and life expectancy increases worldwide, the incidence of these fractures is likely to raise, expected to triple in the next 50 years. The use of fluoroscopy and resultant exposure to radiation, is an integral part of surgical procedures aiming to reduce and fixate the fractured femur. The risk of contracting cancer is significantly higher for an orthopedic surgeon as Hip surgery is a major slice of the total radiation dose. Optimal positioning and control of the imaging intensifier device may result in significant reduction of radiation dose and time and in substantial shortening of the procedure.

The investigators hypothesis is that this technique would substantially shorten procedure time and reduce unnecessary radiation exposure for both the patient and the medical staff. Furthermore, by using this technique the investigators can eliminate the need for fluoroscopy technician during the surgery, as there is no need to alternate fluoroscopy views.


Eligibility Criteria:
Inclusion Criteria:

* patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.
International Weight Control Registry

The IWCR is a global scientific study aimed at better understanding the opportunities and barriers for reducing the prevalence of obesity by collecting information from people who have experience with weight management in their everyday lives. The investigators seek to gather information on a wide range of weight management experiences, ranging from weight loss and weight loss maintenance to weight gain and inability to lose weight.


Eligibility Criteria:
Inclusion Criteria:

* The IWCR is open to anyone 18 years or older who is considering weight loss, is actively engaged in weight loss, or has previously attempted weight loss (including successful and unsuccessful attempts)

Exclusion Criteria:

1. Minors, below the age of 18
2. Adults who are not able to give informed consent online and complete online surveys
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).


Eligibility Criteria:
Inclusion Criteria:

* Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
* Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period.
* If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
* Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
* If treated for clinical depression with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
* Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.

Exclusion Criteria:

* Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
* Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
* Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
* Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
* Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
* Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
Effects of Bariatric Surgery on Pelvic Floor Fonctions in Obese Women

Urinary incontinence is well documented as a comorbidity of obesity. Studies demonstrate improvement of incontinency after weight loss. However, the mechanisms are still not clear. Aim of our study to analyze the effects of bariatric surgery on pelvic floor function in women.

Obesity is considered an important public health problem, both in developed and developing countries. Obese people are at a higher risk for developing various comorbidities: type II diabetes, dyslipidemia, cardiovascular and cerebrovascular diseases, coagulation disorders, degenerative joint disease, some types of cancer, sleep apnea and urinary incontinence Women suffering from obesity are more likely to develop urinary incontinence, especially when related to stress. Excess weight is a modifiable risk factor. It is believed that weight reduction may be an effective treatment for urinary incontinence. The aim of this study is to analyze the effects of weight loss induced by bariatric surgery on pelvic floor function. Taking into account that modest weight loss (5% to 10%) already brings benefits to women with obesity and incontinence, one may assume even more marked improvement owing to the massive loss of weight by surgical means.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 40 kg/m2
* \>18 years old
* participants who provided written informed consent

Exclusion Criteria:

* History of gynecologic operation time under one year
* History of pelvic physiotherapy
* Chronic obstructif lung disease
* Norologic disease
* Women in menopause