cyrilzakka/clinical-trials huggingface dataset:
Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) \<5.3 mmol/l and 1 hour post meal\<7.8mmol/l. Both groups were followed till delivery and outcome studied.

75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar fasting(BSF) \> 5.5 mmol/l \& 2 hours postprandial \>7.8 mmol/l was labelled as GDM. They were randomised to metformin or insulin group. Those assigned to metformin group were started metformin 500mg twice daily \& increased until 2500mg depending on the blood sugar levels. Aim was to achieve blood sugar levels of BSF \<5.3 mmol/l and 1 hour post meal\<7.8mmol/l. If blood sugar levels were not controlled, insulin was added. The insulin group was given 3 injections of regular insulin \& one intermediate acting insulin injection at night subcutaneously. Both groups were followed till delivery and outcome studied

Eligibility Criteria:
Inclusion Criteria:•

* All pregnant Diagnosed GDM in pregnancy by OGTT from 22 week to 34 week with singleton pregnancy

Exclusion Criteria:

* Patients with Known diabetes mellitus
* Patients with multiple pregnancy
* With essential hypertension or pre eclampsia
* Patients having fetal malformation incompatible with life
* Patients with intrauterine death of fetus
Estimation of Glomerular Filtration Flow in Patients of Resuscitation Under Extra-bodily Assistance

The aim of the study will be to evaluate the quality of the GFR estimate of the two estimation equations (CKD-EPI and Cockcroft's formula) against the measured clearance of creatinine, which can be performed routinely in intensive care.

To determine the proportion of patients with ARC under ECMO VV or VA and determine changes in renal vascular resistance index as a function of GFR level in patients with pulsatile cardiac output.

Extracorporeal assistance is recommended for patients with a potentially reversible acute risk of life that does not respond to conventional treatments. Hypoxic refractory syndromes, such as acute respiratory distress syndrome, are referred to as veno-venous ECMO (for Extracorporeal Membrane Oxygenation) (ECMO VV), whereas terminal cardiac dysfunctions require veno-arterial ECMO (VA ECMO). recovery of function (cardiotropic intoxication), or in the most severe cases, pending transplantation or long-term assistance.

This is a qualified pilot study, as it is the first one interested in evaluating the quality of the GFR estimate of the two estimation equations (CKD-EPI and Cockcroft formula) by relative to the measured clearance of creatinine, a method that can be performed routinely in intensive care, for resuscitation patients under veno-arterial or veno-venous ECMO.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18
* ECMO VV or VA after 48 hours of installation
* Hemodynamic stability for at least 12 hours
* Person affiliated or benefiting from a social security scheme
* Having expressed an express consent OR patient for whom a relative has given express consent

Exclusion Criteria:

* Hemodynamic instability
* Chronic renal failure patients receiving dialysis
* Need for continuous or intermittent extra-renal cleansing
* Patients under the protection of justice
* Person participating in another search including an exclusion period still in progress
* Pregnant or lactating woman
Corneal and Tear Film Changes in Chinese Patients With Type 2 Diabetes

Diabetes mellitus has been associated with ocular surface damage and exacerbates dry eye disease (DED) pathology. To investigate clinical and inflammatory changes in the ocular surface of insulin-independent type II diabetic patients. This cross-sectional control study will recruit 200 Type 2 diabetic patients and 200 age- and sex-matched subjects without DM.

Diabetes mellitus (DM) is a developing global health challenge due to the multiple complications associated with long-term hyperglycemia. Although diabetic retinopathy is the most prevalent and well-known ophthalmic consequence, diabetes also causes clinically significant effects on the ocular surface. Among the ocular surface diseases, dry eye disease (DED) is the most common. Multiple mechanisms, such as ocular surface and lacrimal gland inflammation, neurotrophic deficiency, and meibomian gland dysfunction (MGD), play significant roles.

A loss of tear film homeostasis characterizes DED. DM is one of the risk factors for DED; 47% of DM patients suffer from ocular surface damage due to negative alterations to the tear film, corneal thickness, corneal epithelium, corneal nerve, and corneal endothelium. It has been suggested that one or more of the following initial events may lead to alterations described in the tear film and ocular surface of patients with DM: a) chronic hyperglycemia, b) corneal nerve damage, and c) impairment on insulin action.

Previous studies have explored the association between DM and ocular surface dysfunction. However, ocular surface and tear film parameters in diabetic patients are lacking in the Chinese population. Moreover, corneal nerve damage and ocular surface inflammation have not been systematically evaluated. Our study aimed to investigate clinical and inflammatory changes in the ocular surface of insulin-independent type II diabetic patients in a Chinese population.

Eligibility Criteria:
Inclusion Criteria:

* Participants are diagnosed with dry eye according to the TFOS DEWS II diagnostic criteria: (a) OSDI questionnaire ≥13, (b) Non-invasive tear breakup time (NITBUT) \<10 s, (c) ocular surface staining \>5 corneal spots, greater than nine conjunctival spots (The presence of two or more criteria was used to establish a positive DE diagnosis).
* Age ≥ 18

Exclusion Criteria:

* Active ocular infection, such as infectious, viral, chlamydial, or immunologic conjunctivitis
* A history of ocular surgery that might affect the corneal or tear film, such as corneal refractive surgery, keratoplasty, cataract surgery, or ocular laser surgery
* Long-term contact lens wear
* Other ocular diseases being treated might affect the corneal or tear film: such as glaucoma, dacryocystitis, uveitis, and pterygium.
Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF

This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating hepatitis B virus-related acute-on-chronic liver failure.

Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. But there still lacks of effective therapies in treatment of HBV related ACLF, except liver transplantation. Non-bioartificial liver support system treatments may be effective due to previous clinical data. Plasma exchange (PE) and double plasma molecular adsorption system (DPMAS) are two common ways in clinical practice. This study is to investigate the clinical efficacy and safety of combination treatment of DPMAS and low volume PE in patients with HBV related ACLF. This study will be completed in 6 medical center. Two hundred patients with HBV related ACLF enrolled in this study are divided into trial group (DPMAS, low volume PE, and comprehensive internal medical treatment) and control group (comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
2. Age from 18 to 65 years old;
3. Clinical diagnosis of liver failure (serum total bilirubin level \> 10 times upper limit of normal; prothrombin time activity \< 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and \> 1.5);
4. Platelets \> 50\*10 E9/L.

Exclusion Criteria:

1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events;
6. Other important organ dysfunctions or transplantation;
7. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
8. Patients can not follow-up;
9. Investigator considering inappropriate.
The Evaluation of Glycyrrhizic Acid's Pesticide Effect in Treating Liver Damage (Retrospective Study）

Collect the details about hepatic dysfunctional patients induced by various etiology who have a usage of Glycyrrhizic Acid, then arrange and analyse the data to evaluate the clinical curative effect of glycyrrhizic acid.

This experiment will screen and collect qualified cases from medical records in Shuguang Hospital.to collect the patients with liver injury in clinic, including (1) conforms to ALT\>1.5 times the normal value or \>70 IU/L, age 18 to 70 years of age, sex is not limited; (2) patients with viral hepatitis or cirrhosis of the liver, or autoimmune liver disease, or schistosomiasis, or drug-induced liver damage, or for other reasons clear or unclear leading to abnormal liver function ; (3) except for tumor patients. The index of liver function such as ALT, AST, Alb, et al are detected respectively before and after preventive treatment of the glycyrrhizic acid for liver injury ,and through the synthesizing of the single sample difference t test and clinical practice to analyze the clinical efficacy of glycyrrhizin intervention treatment of hepatic injury

Eligibility Criteria:
Inclusion Criteria:

1. conforms to ALT\>1.5 times the normal value or \>70IU/L, age 18 to 70 years of age, sex is not limited;
2. patients with viral hepatitis or cirrhosis of the liver, or autoimmune liver disease, or schistosomiasis, or drug-induced liver damage, or for other reasons clear or unclear leading to abnormal liver function ;

Exclusion Criteria:

1. patients with tumor;
2. pregnant or lactating women, and pregnancy may not take effective contraceptive measures;
3. complicated with serious heart, lung, gallbladder, kidney, endocrine, hematopoietic system and mental disease;
4. the researchers think that should not be selected for this test.
Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease

The purpose of this clinical trial is to determine the impact of a home-based pulmonary rehabilitation program with health coaching on patient-reported respiratory-related quality of life and physical activity, as compared to usual care in patients with fibrotic interstitial lung disease.

The fibrotic interstitial lung diseases (f-ILD) are a group of progressive and debilitating lung diseases sharing characteristics of lung scarring on imaging and restricted breathing on pulmonary function testing (PFT). Symptoms include shortness of breath, cough, and fatigue, eventually leading to deconditioning and poor quality of life. While medical therapies are available for slowing or stopping the loss of lung function, only pulmonary rehabilitation (PR) has shown a positive impact on patient-reported shortness of breath and physical activity. Unfortunately, PR may not be widely available to all patients, and some patients may become too ill to participate in traditional center-based programs.

A primary hypothesis is that modifying the content, delivery, and setting for PR in patients with f-ILD to improve access or ease of use and supporting behavior change through a health coach will have a measurable and sustained positive impact on patient well-being and quality of life as compared to no participation or non-use.

Eligibility Criteria:
IInclusion Criteria:

* F-ILD diagnosis, any disease subtype, active or prior medical treatment
* \>10% fibrosis on CT imaging
* mMRC dyspnea score \>1
* All racial or ethnic categories, including non-English speakers (professional translators will be engaged to support screening, enrollment, and study participation)

Exclusion Criteria:

* Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
* Cognitive impairment or inability to understand and follow instructions
* Traditional center-based PR completed within 3 months of initial study recruitment
* Transition to hospice or end-of-life care at the time of screening
* Acute exacerbation at the time of screening
A Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy in Participants With Untreated Advanced/Recurrent Gastric Cancer

The purpose of this study is to assess the effectiveness, safety, and actual treatment status of first-line nivolumab plus chemotherapy in participants with untreated advanced / recurrent gastric cancer in a Japanese real-world setting.

The Time Perspective for this observational study is defined as 'Retrospective and Prospective'.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or recurrent gastric cancer
* Have initiated or are confirmed to receive nivolumab plus chemotherapy as the first-line therapy between the date of approval of nivolumab plus chemotherapy and December 31, 2022. For combination chemotherapy, SOX, CapeOX, or FOLFOX is acceptable
* Have signed a written informed consent form of their own free will after they have been given an adequate explanation and a full understanding of this study before enrolling in this study.

Exclusion Criteria:

* Treated with antineoplastic agents as first-line treatment for advanced or recurrent gastric cancer prior to the initiation of nivolumab plus chemotherapy (participants who have received prior perioperative chemotherapy and participants who have received prior bisphosphonates for osseous metastases may be enrolled)
* Confirmed to be positive for HER2
* Diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects
* Initiated with nivolumab plus chemotherapy as the first-line treatment for advanced or recurrent gastric cancer at a site other than the study site and were later hospitalized at the study site.
* Judged by the investigators to be inappropriate for enrollment in this study
Naproxen Versus Tramadol for Post Cesarean Pain Control

Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.


Eligibility Criteria:
Inclusion Criteria:

* all patients after cesarean section

Exclusion Criteria:

* emergent CS
* hypersensitivity to drug
* drug abuse
Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer

25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy.

During this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis)

This is an interventional study for the french law

Eligibility Criteria:
Inclusion Criteria:

* All patient treated by exclusive per-operative brachytherapy in the prior study Mammosite for breast cancer
* Patient with social security

Exclusion Criteria:

* Not applicable
PD2i Analysis of Heart Rate Variability in Competitive Sports

This is a double blind observational analysis of changes in heart rate variability using PD2i analyser in competitive athletes during strenuous exercise and competition.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years, as determined by birth date given on participation form.
* Actively involved in competitive athletics
* Able to give informed consent

Exclusion Criteria:

* Any known prior autonomic dysfunction
* History of seizures or taking anti-seizure medication
* Known learning disability or attention deficit disorder
* Chronic heart conditions such as arrhythmias or valvular disease
* History of diabetes mellitus
* Taking any prescription stimulants such as Ritalin, Focalin, etc.
* Use of any performance-enhancing drugs
* Any deviation from normal found on the pre-participation physical exam such as the presence of a murmur or hypertension.
Impact of Germicidal Light

Visible light at 405nm has been shown to be germicidal. The hypothesis is that use of this light (Indigo-Clean Lights) in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Investigators will evaluate a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without germicidal lights.

Operating room S. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. Visible light at 405nm has been shown to be germicidal. Investigators plan to install ambient, germicidal lighting (Indigo-Clean Lights) that uses this wavelength in 4 operating rooms. Patients will undergo surgery according to usual practice. Investigators will conduct a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without the germicidal lights. Patients will be matched by procedure then case duration then American Society of Anesthesiologists (ASA) physical status health classification. These patients will undergo infection surveillance. Infection surveillance will involve use of National Healthcare Safety Network (NHSN) checklists applied to patients who are positive for one or more of the initial screening criteria (elevated white blood cell count, fever (\>38.4 degrees Celsius), office note documentation of infection, positive culture (sputum, blood, urine, wound, other body fluid), or anti-infective order within the 90 postoperative day period.

Eligibility Criteria:
Inclusion Criteria:

* Adult, at least 18 years old
* Adult patients undergoing orthopedic, cardiothoracic, gyn/onc, and neuro surgery and general anesthesia according to usual care with peripheral and/or central venous access.

Exclusion Criteria:

* Pediatric (\<18 years old),
* Incarcerated, and/or
* Pregnant patients
* Undergoing surgery and/or without peripheral or central venous access.
* Undergoing surgery outside of the classifications above
The Mobile Lifestyle Intervention for Food and Exercise Study

The goal of the study is to examine long term sustained weight loss digital intervention in a diverse cohort of adults with overweight/obesity. The intervention includes social gaming (using game-like elements in nongame contexts to promote supportive social interactions and openness to positive behavioral influences) to reward behaviors, such as self-monitoring and social support.

Investigators will accomplish objectives and test hypotheses by following two specific primary aims:

1. Determine if the intervention plus gaming produces significantly more weight loss at 12 months than the same intervention without gaming among 240 adults with overweight or obesity and ≥3 T2DM risk factors.
2. Examine the differences in social support provision and receipt between groups at 12 months.

This is a 1-year behavioral intervention with standardized behavioral content that reinforces self-monitoring behavior delivered via twice-weekly podcasts, tips of the day, weight, physical activity and diet daily tracking. The mLife App will also encourage and facilitate social support among participants (to both groups).

Participants will be randomized to one of two groups: 1) a gamified mLIFE app (n=120) or 2) regular mLIFE app (n=120). Participants will attend a study orientation, complete all baseline measures, be randomized, and then attend a training session for their group. In addition, participants will complete assessment at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18-65 years old
* ≥3 T2DM risk factors (as defined by the American Diabetes Association)
* Own and use a smartphone with a data plan
* BMI must be between 25-49.9 kg/m2
* Must be willing to reduce caloric intake and increase physical activity
* Not currently participating in a weight loss study in a weight loss program
* Be free of major health or psychiatric diseases, drug or alcohol dependency.
* No current use of medications that may impact blood glucose

Exclusion Criteria:

* Over the age of 65 years old
* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months
* Diagnosed with type 2 diabetes
Autologous Bone Marrow Concentration for Avascular Necrosis of Femoral Head

This study aims to evaluate the effect of bone marrow concentration on avascular necrosis of femur head by comparing clinical and imaging outcomes between patients receiving core decompression surgery with intraoperative bone marrow concentration and those receiving core decompression surgery only.

Avascular necrosis (AVN) of femoral head is a progressive disease that predominantly affects younger patients. Although the exact pathophysiology of AVN has not yet to be elucidated, the disease is characterized by a vascular insult to the blood supply of the femoral head, which can lead to collapse of the femoral head and subsequent degenerative changes. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, several studies have applied the autologous bone marrow concentration in halting the progression of AVN of femoral head. However, a higher level of evidence for its use on patients suffering from femoral head avascular necrosis has not been reported. This clinical trial will evaluate and compare the eligible patients who undertake core decompression surgery plus intraoperative bone marrow concentration with those who received core decompression surgery only. All patients will be followed for one year and clinical and imaging outcomes will be compared and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 30 and 60 years
* With diagnosis of avascular necrosis of femoral head, Stage I - Stage III

Exclusion Criteria:

* With diagnosis of avascular necrosis of femoral head, Stage VI - Stage VI
* With prior history of hip surgery
* With current or prior history of trauma or infection at hip
* Platelet count \< 50,000/µL
* With current diagnosis of coagulopathy
* With current or prior history of cancer
* With current or prior history of hematological disease
* Pregnancy
* Patients who will not cooperate with one-year followup