cyrilzakka/clinical-trials huggingface dataset:
Influence of Weight Loss or Exercise on Cartilage in Obese Knee Osteoarthritis Patients

Obesity and osteoarthritis (OA) co-exist in an increasing part of the population.

The two diseases intertwine in several ways. The evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. The two diseases share pathogenetic features and the development of one disease increases the risk of the other and may be the onset of a vicious circle.

There is a link between treatments of these two diseases as well. There is now solid (gold) evidence that by treating effectively the obesity of patients with co-occurring OA, the functional status is dramatically ameliorated; the short-term results are equal to that of a joint replacement. The long-term efficacy of a weight loss remains to be shown. OA is definitely one of many diseases in which obesity must be taken seriously into account when planning a correct treatment of patients. This trial has two phases, the first (16 weeks) consisting of a dietary intervention with low-energy diet and the second (52 weeks) a randomized, three group (each n\>50 patients) controlled study of maintenance of weight loss by either continuing dietary instruction, exercise, or a control group. The hypothesis is that maintenance of an initially induced weight loss is dependent on attention rather than any specific therapy.

Any patient with osteoarthritis (OA)of the knee and concomitant obesity will be considered for participation. Eligible for this study will be patients with radiographical knee OA. Exclusion criteria are recent or planned knee operations, alloplasties in both knees, ongoing or planned alternative interventions against obesity.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>=30
* Radiographical knee OA
* Age \>=50
* Spoken Danish
* Motivated for weight loss

Exclusion Criteria:

* Bilateral Alloplasty of the knees
* Ongoing or planned surgery
* Ongoing or planned alternative weight loss programme
* Intellectual disability
Trial Comparing Complication Rates Associated With Robot-assisted Thyroidectomy to External Thyroidectomy

The main objective is to compare 12 month complication rates between a new surgical method for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and open thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* The patient is a candidate for total thyroidectomy because of a nodular pathology, a diffuse goiter, thyroiditis, or Basedow's disease
* Patient has calcitoninemia \< 9 ng/pl
* Patient has normal calcemia
* Patient has PTH level between 5 ng/l and 75 ng/l
* The subject has a normal laryngeal mobility

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* The patient is not available for 12 months of follow-up
* Subject has a preoperative diagnosis of cancer on fine needle aspiration biopsy of the thyroid or cervical lymph node
* Lymph node metastasis strongly suspected clinically and/or sonographically
* The subject has an extension of substernal thyroid (diving goiter)
* Family history of medullary thyroid cancer
* The subject has a history of neck surgery
* Contraindication for general anesthesia
Assessment of Functional Capacity and Inflammatory Markers in Women With Heart Failure With Preserved Ejection Fraction

This study assesses the impact of diastolic heart failure on exercise capacity in women who have a previous coronary condition. All the participants will go through the same evaluation.

It is well established that systolic heart failure impacts exercise capacity and quality of life, diastolic heart failure however, is not well documented as a condition that reduces physical performance.

To confirm that patients have a diastolic disfunction an echocardiography will be performed, this will also yield the left ventricle ejection fraction to confirm the preserved ejection fraction heart failure diagnostics.

Exercise capacity will be assessed using the distance walked on the six-minute walking test, performed on a 30m corridor.

Pulmonary function will be assessed with spirometry and values of forced vital capacity and forced expired volume in one second will be recorded and compared to the age-predicted values.

Respiratory strength will be determined by maximal pressure achieved on a respiratory manometer.

Peripheral muscular strength will be assessed with a handheld dynamometer. Knee extension strength of the dominant leg will be recorded.

An echocardiography will be performed to assess systolic and diastolic function and ejection fraction.

Heart autonomic function will be evaluated using a heart rate monitor and a computer software to identify the sympathovagal balance.

Eligibility Criteria:
Inclusion Criteria:

* Women;
* Aged between 35 and 70 years;
* Coronary artery disease proven by coronary angiography;
* Diastolic heart failure confirmed by recent echocardiography (6 months);
* Left Ventricle ejection fraction of greater than 50%;
* Absence of acute or chronic pulmonary disease;
* Patient clinically compensated;
* Consent form signed for participation in the research

Exclusion Criteria:

* Inability to perform spirometry;
* Presence of acute or chronic pulmonary disease;
* Chronic inflammatory disease, kidney or liver disease;
* Patients using corticosteroids, aspirin or other nonsteroidal anti-inflammatory;
* Clinical or laboratory evidence of infection;
* Morbid obesity;
* Hemodynamic instability at the time of spirometry;
* Patient's or legal guardian request to leave at any time of the study.
Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

The goal of this clinical trial is to search for biomarkers in tinnitus patients in tinnitus patients and changes in biomarkers before and after treatment. The main questions it aims to answer are:

* What are the biomarkers of tinnitus patients？
* How do these biomarkers change during treatment and is there a good correlation with behavioral outcomes? Participants will be asked to complete audiological examination, tinnitus assessment, and magnetoencephalography examination, and they will receive sound therapy or repetitive transcranial magnetic stimulation therapy.

This study aims to use magnetoencephalography (MEG) to collect the resting state responses before and after treatment in the control group, tinnitus patients in the acoustic stimulation treatment group, and rTMS treatment group. Firstly, compare the differences in power spectrum and brain functional connectivity indicators between tinnitus patients and normal control groups in different frequency bands, providing a theoretical basis for clinical diagnosis, precise positioning of tinnitus damaged areas, and understanding the pathogenesis of tinnitus; Secondly, compare the electrophysiological functional indicators of tinnitus patients before and after treatment to reveal whether the damaged brain network can gradually reshape after treatment, and whether network information can serve as potential biomarkers to indicate the degree of tinnitus recovery; Finally, compare the effectiveness differences between the two treatment methods, analyze their influencing factors, and provide guidance for frequency band precise intervention and rehabilitation of chronic tinnitus patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subjective tinnitus lasting for more than 6 months, with a score of\>36 of the Tinnitus Disability Inventory (THI)；
2. The otoscopy examination showed that the ear canal and eardrum were normal, and the tympanic impedance maps of both ears were Type A, indicating that language ability met the requirements of language testing

Exclusion Criteria:

1. Family or congenital deafness history, ototoxicity drug use history, otitis media patients, etc
2. Suffering from major physical diseases (sensory and motor disorders, neurological disorders, brain injuries, and other organic diseases) or mental disorders
3. The patient has aggressive behavior and an impulse to damage the device
4. Metal in the body (including orthodontics, dental implants), tattoos, and heart stent surgery
5. Having claustrophobia
6. Contraindications to magnetic resonance examination
Electro-acupuncture for Menopausal Transition Symptoms

This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms.

This was a RCT pilot study to assess the efficacy of Electro-acupuncture for menopausal transition participants.90 patients were randomly assigned to electro-acupuncture or sham electro-acupuncture group with a ratio of 1:1.During the whole process,all participants, evaluators and statisticians apart from acupuncturists remained strictly blinded.The changes of average 24 h hot flash scores of week8 from baseline was set as primary outcome. With statistical power of 90%, and a two-sided α at 0.05, as well as a drop-out rate less than 20%, sample size was estimated at 90 participants. Data analysis was based on ITT principles, and 89 participants were included in data analysis(1 participant didn't want to participate).According to methods of LOCF, missing data were imputed to fill any gaps according to the last visit. For comparison between baseline and treatment (average 24h hot flash scores, MRS, hormone levels), data was tested by the t test or nonparametric test; for comparison between two independent samples, data were tested with t test, nonparametric test or X2 test. P\<0.05 was regarded as statistically significance.

Eligibility Criteria:
Inclusion Criteria:

* Participants meeting the following criteria were included in study:

  1. Had a diagnosis of MT (cycle length irregularity: 7 days earlier or later than usual, the last menstruation was no longer than 11 month earliar over the previous year; Specific symptoms of MT: hot flashes, night sweating, insomnia, sexual problems, anxiety, depression etc.);
  2. Aged from 40 to 55 years old;
  3. Pregnancy test was negative;
  4. Participants were informed about the study and signed a consent form voluntarily.

     Exclusion Criteria:
* Participants with any of the following criteria were omitted from the study:

  1. 3 month regular cycle length before enrollment;
  2. Took drugs for treatment in past month like estrogen, soybeans isoflavone, SSRIs, progestin, black sesame or vitamin E;
  3. Ovarian and uterine disease: ovarian cyst, uterine myoma more than 4cm in diameter, history of ovariectomy or hysterectomy;
  4. Willing or plan to become pregnant or to breast-feed;
  5. Regular took sedatives or anxiolytics;
  6. Habitual smoker or heavy alcoholic;
  7. Severe disease: history of radio-chemotherapy, coagulation disorders, severe dysfunction of liver or kidney, application of cardiac pacemaker or artificial joints, insufficiency controlled hypertension, diabetes, thyroid diseases, malignant tumor and psychiatric problems).
Reliability and Responsiveness of the Chinese Version of the Readiness for Return-To-Work Scale in Lost-time Claimants in Outpatient Occupational Rehabilitation in Taiwan

The aim of the study is to measure the reliability and responsiveness of the Chinese version of the readiness for return-to-work (RRTW) scale. We would conduct a multiple-centered, prospective cohort study to require RRTW data in lost-time claimants in outpatient occupational rehabilitation in Taiwan.


Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of occupational injuries
* Participating the work hardening program
* Age from 20-65
* Still not return to work
* Willing to participating the study

Exclusion criteria:

* Cannot read the sentences or express their own idea, which causing the cannot finish the questionnaires
* Brain injuries (e.g. traumatic brain injury, cerebrovascular acciden
Relationship of Deep Cervical Flexor Muscle Endurance With Neck Position Sense and Body Balance

The aims of this research are to investigate relationship of deep cervical flexor muscle endurance with neck position sense and body balance in non-specific chronic neck pain, and to compare the results with healthy individuals.

The investigation will be included 2 groups which include 30 individuals with non-specific chronic neck pain and 30 healthy individuals. In evaluation of participants, endurance of deep cervical flexor muscles will be measured using Stabilizer Pressure Biofeedback Unit with cranio-cervical flexion test. Pressure rise which increases from 20 mmHg to 30 mmHg with 2 mmHg increments will be performed in 5 stages. There are 10 seconds contractions at every stage and these contractions will be made 10 times. Endurance will be calculated by the cumulative performance index with the information obtained from this test. Neck position sense of 6-direction (flexion, extension, right-left lateral flexion and right-left rotation) will be measured by CROM device (cervical range of motion device). Joint position error will be calculated by taking the average of the absolute angular difference by 3 trial for each direction. Body balace will be measured by Balance Master System. Modified clinical test of sensory interaction balance (mCTSIB), limits of stability (LOS), rhythmic weight shift (RWS), unilateral stance (US), walk across (WA) and step/quick turn (SQT) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific chronic neck pain for at least 3 months
* Neck pain is at most 7/10 according to VAS

Exclusion Criteria:

* Musculoskeletal treatment for neck complaints or balance within the last 3 months
* Musculoskeletal disease that may affect balance
* Spine, upper or lower limb fractures or surgical history
* Diagnosis of vestibular disorder
* Diagnosis of neurological or systemic musculoskeletal disease
* Pregnancy
Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer

To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Survivors of cancer
* Age 18 or older
* Speak and understand English
* Have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) ≤10 years prior to enrollment.
* Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
* Be willing to commit to the fucoidan supplement dosing and delivery method, to complete evaluation instruments, and to attend all study visits.
* Completed Informed Consent

Exclusion Criteria:

* Current warfarin or other anti-coagulation medication use.
* Current use of supplements that contain fucoidan
* Any allergy to fucoidan
* Be diagnosed with a major psychiatric illness requiring hospitalization within the last year.
* Be diagnosed with dementia.
* Be pregnant or nursing
Body Weight Gain, Parkinson, Subthalamic Stimulation

Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.

Patients will be studied before (between 3 and 1 months) and after (1 month) STN-DBS surgery. Each time the same measurements will be taken. The principal ones will be :

* Clinical examination
* Autoevaluation dietary questionnaire
* Biological tests
* Study in calorimetry chamber (only in Clermont-Ferrand centre)
* Heart rate recorded during 7 days in usual conditions of life
* Energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)
* Acute Ldopa challenge (in both conditions of dopa and stim)
* Apathy evaluation
* Body weight, and body compositions measurements

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70 years old
* Diagnosis of Parkinson' disease established for 5 years at least
* Ldopa effect \> 50 %
* Hoehn and Yarh score \> 2.5 in On phase

Exclusion Criteria:

* Metabolism disorder
* Biological analysis abnormal
YpsoPump Occlusion Detection Algorithm: Collection of Real-world Data for In-silico Evaluation of a New Software Algorithm to Refine Occlusion Detection in Subjects With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

A common difficulty related to the insulin pumps are occlusions of the insulin infusion set (IIS). This study aims to evaluate the performance of a new software algorithm to detect catheter-occlusion in silico in order to refine the current automated occlusion detection algorithm of the mylife™ YpsoPump®.


Eligibility Criteria:
Inclusion Criteria:

1. Written Informed Consent
2. Subject is diagnosed with T1D
3. Subject on CSII (except patch pumps) for at least 6 months
4. Subject using any type of insulin approved for mylife™ YpsoPump®: Fiasp®, NovoRapid®, Humalog®, Apidra®, Lispro Sanofi
5. Subject using a CGM system for at least 6 months
6. Age ≥ 18
7. Subject willing to continue CSII with mylife™ YpsoPump® during the study
8. Subject willing to use CGM system during the study
9. If the subject wants to use the CGM smartphone app instead of a receiver: Subject ensures to use a compatible smartphone and is willing to share CGM for the duration of the study
10. HbA1c \< 9.5% (based on last measurement by treating physician)

Exclusion Criteria:

1. Known allergy/hypersensitivity to medical grade adhesives and/or to physical activity tracker material
2. Known severe nickel allergies
3. History of frequent catheter abscesses associated with pump therapy
4. Treatment with \> 1000 mg of acetaminophen every 6 hours
5. Treatment with hydroxyurea
6. Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
7. Severe late complications of diabetes mellitus, e.g. severe macro- and/or micro-angiopathy (as determined by the investigator)
8. Known hypoglycaemia unawareness
9. Occurrence of self-reported severe hypoglycaemia event requiring third-party assistance within the last 6 months prior to study start
10. Occurrence of self-reported diabetic ketoacidosis requiring healthcare assistance within the last 6 months prior to study start
11. Participation in another investigation with an investigational drug or a pre-market medical device within the 30 days preceding and during the present investigation
12. Female subjects: pregnancy, lactation period, lack of a negative urine pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use a contraception during the study (for sexually active subjects of childbearing potential)
13. Dependency from the sponsor or the clinical investigator
14. Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
Comparison of Limb Size of Transverse Coloplasty Pouch

The aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision.

No detailed description necessary, see brief summary.

Eligibility Criteria:
Inclusion Criteria:

* all patients in need of rectal resection due to benign or malign disease
* \>=18 years

Exclusion Criteria:

* anamnestic rectal resection
* life expectancy of less than 2 years
* pregnancy
* \<18 years
* missing informed consent
OFDI Capsule Imaging in Patients With Atrial Fibrillation Undergone Radio Frequency (RF) Ablation

12 patients with Atrial Fibrillation, a kind of irregular heart beat who have undergone Radio frequency (RF) ablation will be asked to swallow the capsule.

As they swallow the capsule, images of the esophagus will be taken to see if the RF ablation caused any form of damage to the esophagus considering it being so close to the heart.

After the capsule has been removed from the mouth, they will be asked about the tolerability of the capsule.

A total of 12 patients with a known diagnosis of Atrial Fibrillation who have previously undergone Atrial RF ablation will be enrolled in the study. Patients will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be over 18 years of age
* Subjects must be able to give informed consent.
* Subjects must be referred to Massachusetts General Hospital (MGH) endoscopy for RF Ablation treatment of their Atrial Fibrillation.

Exclusion Criteria:

* Subjects with current esophageal strictures and dysphagia
* OR subjects with a prior history of intestinal strictures, prior GI surgery or intestinal Crohn's disease.
* OR subjects with a known history of chronic aspiration.
* OR women who are currently pregnant.
A Comparison of the Drug Therapy Versus Re-Ablation

The hypothesis of this study was that early re-ablation (test) was superior to AAD therapy (control) in patients with previous failed PVI ablation for paroxysmal AF.


Eligibility Criteria:
Inclusion Criteria:

* history of symptomatic PAF

Exclusion Criteria:

* congestive heart failure
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm
FNB in Meniscal Tear Under GA

The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear under general anesthesia

This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with meniscal tear from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo general anesthesia for arthroscopic meniscal surgery. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.

Eligibility Criteria:
Inclusion Criteria:

- individuals who are scheduled to undergo meniscal surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.

Exclusion Criteria:

* who require simultaneous surgery for concomitant cartilage injury, collateral ligament tear.
* who have previously undergone surgical treatment within the knee joint.
* who have declined to participate in the research.
* where medical, surgical, or anesthetic complications occurred during surgery.
* other cases deemed necessary by the researchers.