cyrilzakka/clinical-trials huggingface dataset:
Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO)

This study is aimed at women currently going through menopause, either as part of the natural process (physiological menopause), or following hormonal treatment for breast cancer. There are several ways of slowing the weight gain frequently encountered in this situation, reducing the intensity of menopause-related symptoms and improving quality of life in this context.

In this trial, the investigators examine the efficacy and possible adverse effects of intermittent fasting compared with a control intervention. Participation lasts 14 weeks, with an optional 12-month follow-up. Study participants are randomly assigned to either the intervention group or the control group. In the intervention group, study participants fast for 16 hours per day and eat over a period of 8 hours (intermittent fasting often called time-restricted eating \[TRE\] 16h/8h). In the control group, the usual eating pattern is continued for 12 weeks.

The main objective of the study is to evaluate the efficacy of TRE in terms of weight and fat loss, improvement in metabolic profile, menopausal symptoms and bone health. In addition, the study team closely monitors any adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Women with physiological menopause confirmed (group A) or induced menopause in the context of adjuvant therapy for hormone-sensitive non-metastatic breast cancers (group B)
* Age 40-65 years
* Body mass index 25-40 kg/m2
* Stable weight (± 2 kg) over the previous month
* Eating window ≥ 12 hours (self-reported and measured during the run-in phase)
* Able to give informed consent and follow the study procedures for the entire duration
* Confident use of a smartphone and able to take regular pictures of food/drinks

Exclusion Criteria:

* On a hypocaloric restrictive diet, intermittent fasting or in a weight management program over the previous month
* Previous bariatric surgery or planned during the study
* Active eating disorder(s) or major mental illness at inclusion
* Psychoactive treatment with recent or planned changes of drug compound or dosage
* Diabetes with hypoglycemic drug(s) will be excluded, however those with prediabetes (as defined by the American Diabetes Association) or diabetes with no risk of hypoglycemia (i.e. treated with non-hypoglycemic drugs or without medication) will be included
* Active metabolic bone diseases (e.g. Paget disease, osteomalacia)
* Shift work comprising night shifts (working between 11pm and 6am) over the previous 2 weeks or planned during the study
* Travel/trip to a different time zone (≥ 2-hour time difference) over the previous 2 weeks or planned during the study
* Enrolled in another interventional clinical trial (medication, surgery, medical device) over the previous 2 weeks or planned during the study
Effect of Cerebral Oxygen Saturation Monitoring on POCD of Elderly Patients Undergoing Shoulder Arthroscopy

To observe whether adjusting the level of intraoperative controlled hypotension through cerebral oxygen saturation monitoring can improve postoperative cognitive function(POCD) and reduce postoperative neurological complications, a prospective randomized controlled study method will be used in this study. 400 elderly patients undergoing shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block will be selected. They will be randomly divided into control group and experimental group according to whether cerebral oxygen saturation monitoring was used during the operation. The control group maintain the target blood pressure only according to the controlled hypotension guideline, and the experimental group adjust the controlled hypotension level under the guidance of cerebral oxygen saturation monitoring. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded.

Cognitive function will be evaluated within 3 days before operation and 3 days, 14 days and 3 months after operation. Delirium and VAS pain score will be evaluated 24 hours after operation. Venous blood will be taken before operation and 24 hours after operation to detect cognitive related markers and inflammatory factors. In addition, 10 blood samples of patients in each group were selected for RNA omics test. One month, six months and 12 months after operation, cognitive function was evaluated by cognitive function telephone questionnaire (TICS-M), and the ability of daily living was evaluated by IDAL. In addition, 20 non-surgical patients were selected for cognitive function evaluation at the same time point as the exercise effect of POCD detection.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective shoulder arthroscopic surgery under general anesthesia combined with brachial plexus block;
* ASA grade ≤ grade III;
* Patients Can communicate normally, can cooperate and complete cognitive function test;
* Patients volunteered and signed informed consent.

Exclusion Criteria:

* BMI \< 18 or \> 27 kg / m2;
* Previous history of dementia, psychosis or other central nervous system diseases or mental diseases, such as cerebral infarction, stroke, Parkinson's disease, etc;
* Patients taking sedatives or antidepressants;
* Alcoholics or drug addicts;
* Illiteracy, severe hearing or visual impairment;
* Patients with cognitive impairment before operation (MMSE score \< 23);
* Patients with peripheral vascular diseases and contraindication of arterial puncture and catheterization;
* Patients unable to carry out long-term follow-up or poor compliance.
Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes

Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.

Physiological iodine requirements are increased in pregnant women, from 150 μg / day to 250 μg / day. The iodine intake is assessed by the iodine concentration in the urine, the target of which in pregnant women is ioduria between 150 and 250 μg / l. The general French population is not deficient in iodine according to the national nutrition health study in 2006-2007, with a median ioduria of 136 μg / l (therefore greater than 100 μg / l) for all elderly adults aged 18-74. However, according to French studies, the median ioduria of pregnant women is between 50 and 100 μg / l, which suggests a moderate iodine deficiency. To maintain euthyroidism, the mother must increase her T4 production by 40- 50% (10-150%), which requires an additional iodine intake of 150-250 μg / d The thyroid contains a reserve of iodine, but this is depleted during pregnancy in the absence of supplementation. Our study therefore aims to assess the amount of iodine supplementation prescribed in pregnant women diagnosed with gestational diabetes because this group of patients benefit from early specialized care for their pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* pregnant woman with gestational diabetes
* age ≥ 18 years
* subject informed of the study and not having opposed it.

Exclusion Criteria:

* already known pathology of the thyroid
Effect of Modified Lumbar Sustained Natural Apophyseal Glide on Postnatal Low Back Pain

This study will be carried out to evaluate the effect of modified lumbar Sustained Natural Apophyseal Glide on low back pain in postnatal women.

In fact, up to 75% of women who suffer from pregnancy-related back pain may continue to have pain after giving birth. Women who experience LBP or pelvic girdle pain (PGP) at 3 months postpartum were found to be at higher risk for persistent or chronic LBP. Of these women, only 6% recover within 6-18 months after giving birth.

A modified lumbar Sustained Natural Apophyseal Glide (SNAG) is an existing Mulligan mobilization technique performed with a combination of joint glide and physiological spinal movement. The glide can be applied to the spinous processes, facets, or unilaterally over the transverse processes while the patient performs the active exercise.

Few studies have been concerned with the effects of modified "SNAGS" on the lumbar spine . So, this study will be done to investigate its effect on low back pain in postnatal women aiming to improve their function to accomplish their daily living activities and reduce the side effects of medical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. All participants will be diagnosed as chronic postnatal low back pain.
2. Their ages will be ranged from 20 to 35 years old.
3. Their body mass index (BMI) will not exceed 30 kg/m2.
4. All participants have the same social level.
5. All participants have the same lifestyle.
6. Their number of parity will be ranged from 2-4 children.

Exclusion Criteria:

1. Spinal fracture or any other neurological disorders.
2. Lumbar spinal stenosis from lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
3. Women with BMI \> 30 kg/m2.
4. Participants who had pelvic pathology.
5. Skin disease interferes with mobilization application.
6. Gynecological diseases (chronic pelvic pain, uterine prolapse and retroversion flexion of the uterus).
The Effect of 6 Week Adductor Exercise Programs on Adductor Muscle Function and Performance

This research project will investigate the effects of two 6-week adductor (hip muscle) exercise programmes on adductor muscle function and performance.

Measures of adductor muscle strength and performance (jump height, hopping and sprint) and self reported hip and groin function using a questionnaire will be recorded pre and post a 6-week period. A group of footballers will be recruited and randomly allocated to an intervention or control group. Two different intervention groups will complete two different, six-week adductor exercise programmes in addition to their regular training programme. The exercise programmes will last 15 minutes (approximately) per session, with 3 sessions per week. The control group will continue their regular training programme.

Participants will be recruited from the local university sports clubs. Club chairpersons will be asked to send an email to club players. Players interested in participating in the study will be asked to attend a meeting where the study will be explained to them. Those who were interested will then be assessed for inclusion and exclusion criteria.

Group allocation:

A four block randomization method will be used to allocate participants to the Copenhagen adductor exercise protocol or the adduction and abduction partner exercise protocol.

Interventions:

Copenhagen adductor exercise protocol or the adduction and abduction partner exercise.

Testing procedure:

The isometric strength of the participants' hip adductors and abductors will be recorded before and after the exercise intervention.

A 10 point visual analogue scale will be used to record the level of muscle soreness experienced after each training session.

Eligibility Criteria:
Inclusion Criteria:

* free from hip and groin injury in the 6 months prior to the study • currently competing in team sports at least three occasions per week

Exclusion Criteria:

* history of a hip or groin injury in the 3 months prior to the study
* a history of involvement in an adductor strengthening, injury prevention programme in the 3 months prior to the study.
MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus

An exploratory study to evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared with Sitagliptin in Patients with Type 2 Diabetes Mellitus

This clinical trial is an exploratory study, and does not calculate the subject number based on statistical assumptions, and enrolls 50 subjects per group and a total of 100 subjects are registered to evaluate the effect of improving blood glucose variability in type 2 patients with anagliptin 100 mg twice a day(BID) and sitagliptin 100 mg once a day(QD).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM
* Metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks.
* 6.5% ≤HbA1c\< 8.5%
* Agreed Therapeutic Lifestyle change during the study period
* Obtained Informed Consent Form

Exclusion Criteria:

* Type 1 diabetes mellitus,
* History of intestinal obstruction
* NYHA class III to IV congestive heart failure,
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 X upper limit of normal (ULN) or Total bilirubin \> 3 X ULN
* Creatinine clearance (CrCl)\* \< 50 mL/min
* Thyroid-stimulating hormone (TSH) ≥ 1.5 X ULN
* Allergic history for Anagliptin 또는 sitagliptin
* Being pregnant or nursing or suspected of being pregnant, or
* History of participation in other clinical studies in the preceding 3 months.
The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

This study used a multi-center, randomized, blinded, double-dummy placebo controlled, three-period crossover design to assess the effect of once daily QVA149 q.d vs. placebo and tiotropium 18 μg q.d. in terms of patient reported dyspnea as assessed by Baseline Dyspnea Index (BDI)/Transient Dyspnea Index (TDI)(SAC version) in patients with moderate to severe COPD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe stable chronic obstructive pulmonary disease
* Smoking history of 10 pack years
* Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between 30 - 80%
* Patients must be able to use computer mouse and display
* mMRC grade\>2

Exclusion Criteria:

* Patients with a history of long QT syndrome
* Patients with Type I or uncontrolled Type II diabetes
* Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
* Patients with any history of asthma
* Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
* Patients with concomitant pulmonary disease
* Patients requiring long term oxygen therapy (\>15 h a day)

Other protocol-defined inclusion/exclusion criteria may apply.
Identifying Ultrasonic Diagnostic Characteristics of Cervical Lymphadenopathy: A Retrospective, Multicenter Study

The observed indexes of the four cervical lymph node diseases were identified by informatics methods, and the differences in the diagnosis of the four diseases were evaluated, so as to improve the clinical diagnosis rate and provide a research basis for the ultrasonic evaluation of the surgical indications of cervical lymph node diseases in the future.


Eligibility Criteria:
Inclusion Criteria:

* Patients with one of these four diseases

Exclusion Criteria:

* 1. Patients with severe heart and brain diseases and poor coagulation function. 2. Undiagnosed patients are not included in the statistical analysis. 3. Image distortion of CEUS acquisition cannot be analyzed.
Platelet Indices in Decompensated Post Hepatitic Liver Cirrhosis

The aim of the present work is to study platelet indices ( platelet count - mean platelet volume - platelet distribution width ) as noninvasive predictors in decompensated post hepatitic liver cirrhosis .

Cirrhosis is an advanced liver disease characterized by fibrosis and alteration in hepatic architecture with the development of structurally anomalous nodules . Ascites is a condition in which pathological collection of fluid occurs within the peritoneal cavity mainly because of portal hypertension. It is a major complication of liver cirrhosis, The appearance of ascites in cirrhotic patients indicates a poor prognosis , Spontaneous bacterial peritonitis is a severe infection, commonly occurring in cirrhotic ascitic patients.

Platelets are attributed to preserve hemostasis. Yet, recently, there has been growing recognition that they also play an essential role in inflammatory and immune response. Platelets release prothrombotic and proinflammatory agents and participate in the induction and advancement of vascular and inflammatory disorders . Larger-sized platelets contain many granules, and are therefore more efficient in their hemostatic and proinflammatory actions . This is why the mean platelet volume (MPV) and platelet distribution width (PDW) are worth considering as potential tests for platelet function and activation .

The MPV and PWD can be calculated using almost all automated hematology analyzers. The MPV indicates the average platelet size in femtoliters. The PDW, reflecting homogeneity of platelet size, is calculated from the MPV by the equation (SD of platelet volume divided by MPV×100) or the distribution width at 20% frequency .

Eligibility Criteria:
Inclusion Criteria:

* post hepatitic liver cirrhotic patients

Exclusion Criteria:

* renal failure patients
* pregnents
* diabetic patients
* patients with bone marrow disorders specially platelet disorders
* patient with other cause of liver cirrhosis
Effects of Niacin on Intramyocellular Fatty Acid Trafficking in Upper Body Obesity and Type 2 Diabetes Mellitus

Muscle insulin resistance is a hallmark of upper body obesity (UBO) and Type 2 diabetes (T2DM). It is unknown whether muscle free fatty acid (FFA) availability or intramyocellular fatty acid trafficking is responsible for the abnormal response to insulin. Likewise, the investigators do not understand to what extent the incorporation of FFA into ceramides or diacylglycerols (DG) affect insulin signaling and muscle glucose uptake. The investigators will measure muscle FFA storage into intramyocellular triglyceride, intramyocellular fatty acid trafficking, activation of the insulin signaling pathway and glucose disposal rates under both saline control (high overnight FFA) and after an overnight infusion of intravenous niacin (lower/normal FFA) to provide the first integrated examination of the interaction between FFA and muscle insulin action from the whole body to the cellular/molecular level. By identifying which steps in the insulin signaling pathway are most affected, the investigators will determine the site-specific effect of ceramides and/or DG on different degrees of insulin resistance.

Hypothesis 1: Greater trafficking of plasma FFA into intramyocellular DG will impair proximal insulin signaling and reduce muscle glucose uptake.

Hypothesis 2: Lowering FFA in UBO and T2DM by using an intravenous infusion of niacin will alter trafficking of plasma FFA into intramyocellular ceramides in a way that will improve insulin signaling and increase muscle glucose uptake.

Hypothesis 3: Lowering FFA in UBO and T2DM by using an intravenous infusion of niacin will alter trafficking of plasma FFA into intramyocellular DG in a way that will improve insulin signaling and increase muscle glucose uptake.


Eligibility Criteria:
Inclusion criteria:

* Women and Men (Women premenopausal)
* BMI 29-37
* Weight stable
* Not pregnant/nursing

Exclusion criteria:

* Ischemic heart disease
* Atherosclerotic valvular disease
* Smokers (\>20 cigarettes per week)
* Bilateral oophorectomy
* Concomitant use of medications that can alter serum lipid profile:

  * High dose fish oil (\>3g per day),
  * STATINS (if yes hold for 6 weeks and receive PCP's approval),
  * Niacin
  * Fibrates
  * thiazolidinediones
  * Beta-blockers
  * Atypical antipsychotics
* Lidocaine or Niacin/Niaspan allergy
* Subjects with 1.5 times upper limit of normal of serum creatinine, Alkaline phosphatase, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) unless participant has fatty liver disease, Total bilirubin (unless the patient has documented Gilbert's syndrome)
MARGINAL BONE LEVELS AROUND IMPLANTS PLACED BY PARTIAL OR FULL-THICKNESS FLAP: A 3-YEAR RANDOMIZED CONTROLLED CLINICAL TRIAL

Each enrolled patient received one implant placed with the partial-thickness flap disconnect mode (PT Test Group) or the full-thickness flap disconnect mode (FT Control Group) from the same implant system (Anyridge, MegaGen Implant Co., Gyeongbuk, South Korea). Each implant was placed at 0.5 mm sub-crest as per protocol guidelines. This choice was made according to the current scientific literature. This implant system has specific macrostructural and microstructural techniques that allow high levels of standards. The fixture-abutment connection is internally conical at 2.8 mm with 5° indexing: this feature makes it possible to reduce the prosthetic microgap, move the platform away from the bone margin while maintaining an optimal crestal margin and prevent rotation or unscrewing of the prosthetic component. Each implant was placed at 1 mm sub-crest as per protocol guidelines. This choice was made according to the current scientific literature.


Eligibility Criteria:
Inclusion Criteria:

* 1. ≥18 years of age; 2. Need for implant placement therapy in the posterior area (from the second premolar to the second molar) due to a failing tooth; 3. Presence of adjacent and opposing natural teeth; 4. Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration; 5. Sufficient apical bone to achieve a minimum primary stability of 30Ncm.

Exclusion Criteria:

* 1. Diagnosis of periodontal disease; 2. Medical or general contraindications for the surgical procedure, such as systemic diseases, history of head and neck radiation therapy, current steroid treatment, neurological or psychiatric conditions affecting oral hygiene, immune-compromised status, severe clenching, or bruxism; 3. Heavy smoking (\>10 cigarettes/day); 4. Active infection at the implant site.