cyrilzakka/clinical-trials huggingface dataset:
Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose

The aim of the study is to compare the FGM glycemic profiles in patients with type 2 diabetes mellitus treated with sitagliptin and acarbose.

In this study, 60 patients with type 2 diabetes were randomly divided into group A or group B after stable glucose control. Flash Glucose Mornitoring(FGM) will be used in patients with two groups. Patients in group A were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks. FGM was used to monitor glycemic variations during the whole four weeks. The opposite therapy was true for patients in group B.

Eligibility Criteria:
Inclusion Criteria:

1. Participate voluntarily and sign the subject informed consent before the test.
2. Patients with type 2 diabetes, aged 18-75 years, meeting the diagnostic criteria of WHO1999, have not been treated with any hypoglycemic drugs.
3. No acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
4. Subjects are able and willing to undergo FGM examination, diet and exercise regularly.

Exclusion Criteria:

1. Patients allergic to insulin.
2. Impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
3. A history of drug abuse and alcohol dependence within the past 5 years.
4. Systemic hormone therapy was used in recent 3 months.
5. Patients with poor compliance and irregular diet and exercise.
6. Patients with infection and stress within four weeks.
7. Patients who cannot tolerate flash glucose mornitoring(FGM).
8. Patients who are pregnant, nursing or preparing to become pregnant.
9. Any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.
Empagliflozin and Sympathetic Nerve Traffic

In this study the effects of the Inhibition of the Sodium-Glucose Linked Transporter 2 in the kidney with empagliflozin compared to hydrochlorothiazide on blood pressure and on central sympathic nervous activity will be examined.

The drug empagliflozin is a selective oral inhibitor of the sodium-glucose co-transporter 2 (SGLT-2) in the kidney.On the market empagliflozin is approved for the treatment of type 2 Diabetes. The mechanism of action can be described as follows: SGLT-2 is responsible for 90% of the reabsorption of Glucose in the kidney. If this Transport System is inhibited the secretion of glucose via the urine is increased. Therefore the blood glucose concentration will be lowered.

It has been noted that the SGLT-2 drugs are lowering the blood pressure as well, but the specific characteristics of the durg leading to this effect have not been examined in adequate clinical trial up to now.

To evaluate the central sympathic nervous activity a microneurography will be performed in this study; this examination will provide Information if empagliflozin dose decrease the sympathic nervous activity. If this is the case new effects of empagliflozin have to be discussed, Otherwise it can be assumed that the blood pressure decrease is a result of an increase of urine volume. In this case the sympathic activity should be increased.

This study will be performed in parallel groups who will receive a double-blind, randomised treatment, either empagliflozin or hydrochlorothiazide. The hypothesis that empagliflozin - in contrast to hydrochlorthiazide - does not increase the sympathic nervous activity in obese, hypertensive subjects with type 2 Diabetes treated with metformin will be tested.

Eligibility Criteria:
Inclusion Criteria:

* women and men \>= 50 and \<= 80 years of age
* type 2 diabetes mellitus for \>=2 years
* only metformin monotherapy is allowed; metformin dose must have been stable for \>=12 weeks

Exclusion Criteria:

* previous empagliflozin treatment within the last 3 months
* heart failure NYHA II - IV
* subjects who have received any investigational medicinal product or have used any investigational medical device within 30 days prior to the screening visit, or who are actively participating in any investigational medicinal product or medical device trial, or who are scheduled for any such trial during the course of the trial.
Efficacy and Acceptability of Thermal Ablation in the Treatment of Cervical Neoplasia

Longitudinal study in two referral centers in Morocco to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

The study population consisted of women with a positive Visual Inspection with Acetic Acid (VIA) screening test referred for ablative treatment. A total of 119 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, the patients were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. The women were followed-up at 6 weeks for any complication and re-assessed by colposcopy and biopsy at 12 months for any persistent or recurrent lesion and for any adverse event.

Eligibility Criteria:
Inclusion Criteria:

* Women having been screened positive at VIA at the primary health center and referred to the diagnosis centre of Fez and Taza for ablative treatment by thermal ablation

Exclusion Criteria:

* Lesion occupying the 4 quadrants of the cervix
* Not visible squamous columnar junction (not Type 1 TZ (transformation zone))
* Vaginal or endocervical lesion
* Lesion subjective of cervical cancer
Effect of Weight & Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle & Adipose

The overall objective of this ancillary study is to obtain skeletal muscle and subcutaneous adipose tissue biopsies from women with polycystic ovary syndrome enrolled in the PULSE Study (NCT01482286).

Muscle and adipose tissues will be appropriately collected and banked for future studies such as to measure expression of candidate genes involved with carbohydrate and fat oxidation and mitochondrial function by RT-PCR, protein content by western blot, enzyme activity by enzymatic assays and to perform functional studies under varying conditions (for example before and after treatment with insulin, testosterone, serum) to quantify insulin signaling and carbohydrate and fat oxidation in primary human cultures.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in PULSE NCT01482286

Exclusion Criteria:

* Withdraw from PULSE NCT01482286
Intra-Abdominal Pressure Effect on Intra-Abdominal Volume and Airway Pressures During Laparoscopy

During pneumoperitoneum insufflation the insufflated gas increase intra-abdominal pressure. The generated pressure can lead to a different increase in volume depending on the abdominal cavity and patients' characteristics.

The primary objective is to determine the relationship between intraabdominal pressure (IAP) and intraabdominal volume (IAV) during pneumoperitoneum insufflation. The secondary objective is to determine the rate of abdominal-thoracic transmission (ATT) assessing the correlation between IAP and respiratory driving pressure (ΔPRS).


Eligibility Criteria:
Inclusion Criteria:

* Enrolled one of the three studies (IPPCollapse I, II or III).
* underwent an initial insufflation procedure with a stepwise change in intraabdominal pressure to record Intraabdominal volume
* data from insufflation at 5 cmH2O of PEEP
Effectiveness or Orthopedic Intervention in Osteoporosis Management After a Fracture of the Hip With Cost-Benefit Analysis

Patients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point of care represents a lost opportunity to prevent future fractures. The medical field treats the fracture as if the fall is the problem, but bone quality is the real problem. Studies have consistently shown that the recommendations of the International Osteoporosis Foundation and World Health Organization are not being followed. Orthopedics treats the patients for their fractures and primary care physicians focus on general health but no one is taking responsibility for bone health. Strategies to convince primary care to assume care have not succeeded. On the other hand, strategies where orthopedics takes some responsibility have shown success. This prospective 2-arm study will evaluate the success of effort by an academic orthopedic department in osteoporosis evaluation and treatment. We hypothesize that with greater effort by the orthopedic department, the better the adherence to standards of care. A cost benefit analysis will be made in parallel.

Patients who present to the orthopedic department in a level I trauma center will be prospectively randomized into one of two groups:

Letter Group: At time of discharge, patients will be sent home with a discharge letter that includes standard recommendations for evaluation and treatment. They will be asked to give the letter to their primary care physician.

Intervention Group: There will be 4 interventions. The patient will be given a short pamphlet with explaining osteoporosis and the importance of treatment. The orthopedic department will perform a bone density testing (DEXA). They will be given a letter with a specific medication recommendation based on a protocol determined by our endocrinology department. They will be asked to give both DEXA and medication recommendation to their primary care doctor to initiate treatment. Finally, a research assistant will contact the patient monthly to encourage them to start treatment.

Eligibility Criteria:
Inclusion Criteria:

* All patients over age 50 with fragility fracture defined as a fall from standing or walking position

Exclusion Criteria:

* Patients with metastatic cancer
* Known metabolic bone disease
* End-of-life care
* Inability to provide consent
* Known MRSA carriers
* Fractures of the trochanter alone, shaft or peri-prosthetic fractures
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.

Median sternotomy patients will be randomized to either wire or rigid fixation groups. A scheduled evaluation period will record clinical parameters. Enrollment has ended with one hundred forty (140) patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing median sternotomy;
* Patients eighteen (18) years of age or older;
* Patients presenting two or more risk factors such as diabetes mellitus, Chronic Obstructive Pulmonary Disease, obesity (BMI \> 30), osteoporosis, Renal failure, Chronic steroid use, Immunosuppression, Redo sternotomy, Neurologic dysfunction severely affecting ambulation,
* Off mid-line sternotomy
* bilateral IMA use
* Long cardio-pulmonary bypass runs
* Transverse fractures of the sternum

Exclusion Criteria:

* Patients with a non-standard sternotomy;
* Patients with an off-midline sternotomy that reduced the bony margin to \<2mm
* Patients under eighteen (18) years of age;
* Patients that are pregnant or currently lactating;
* Patients presenting intra-operative conditions that would require the use of rigid fixation and/or additional post-sternotomy mechanical support beyond wire cerclage due to surgical evaluation,
* Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure,
* Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia;
* Patients undergoing post-operative revision procedures that treat the original sternotomy in such a way as to affect outcome (antibiotic irrigation, debridement or other treatment to the osteotomy);
* Patients unwilling or unable to return for follow-up;
* Lacking the ability to follow instructions;
* Intraoperative death.
Changes of Pelvic Floor Functions in Women at Different Postpartum Time

The main purpose of this study was to observe the pelvic floor muscle strength abnormalities of cesarean section and vaginal delivery at different time points within six months after delivery without any intervention. It was a prospective observational study, and the main study population was healthy postpartum women. Regular follow-up was conducted at 6 weeks, 9 weeks, 3 months, 4 months, 5 months and 6 months postpartum. The follow-ups included gynecological examination, pelvic floor electrophysiological indexes (category I and II muscle fiber strength and fatigue), questionnaire (ICI- Q-SF, OABSS, UDI-6), and pelvic floor ultrasound. The incidence of pelvic floor muscle strength abnormality at different postpartum time points was statistically analyzed, the high-risk factors of postpartum pelvic floor function abnormality caused by pregnancy and delivery were analyzed, and the general rules of the natural development of pelvic floor function were observed.


Eligibility Criteria:
Inclusion Criteria:

* 1)Age: 20 \~35 years old; 2) first parturients registered in the obstetrics department of our hospital; 3) no medical complications before pregnancy, no UI and POP (according to the standard of POP-Q stage); 4) no obstetric complications; 5) the patients agreed to conduct the study and signed the informed consent.

Exclusion Criteria:

* 1) patients with uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity shall be determined by the researcher to affect clinical research compliance; 2) follow up the patients with difficulty.
Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome

The purpose of this study is to determine whether the medication oxytocin is an effective and tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially appropriate behaviors and reducing social anxiety.

Twelve male adolescent (13-24 years) subjects with confirmed genetic diagnosis of FraX (full mutation) will participate in this randomized double-blind placebo-controlled study. They will receive a dose of either 24 IU oxytocin, 48 IU oxytocin or placebo at each of three visits to the lab, with each visit spaced one week apart. The efficacy of each dose will be evaluated using behavioral, cognitive and physiological metrics. If individual subject results suggest that either of the oxytocin dosage levels (24 IU or 48 IU) is superior to placebo in the double-blind phase, a single-blind trial using the optimal dosage of oxytocin will then be administered daily for 14 days by parents at home. Subjects will then come into the lab for a final assessment on Day 30. Determination of beneficial response to oxytocin will be based on a 20% change (improvement) in behavior or test performance (see below). If both oxytocin dosage levels provide similar benefits compared to placebo, the lower dose will be chosen for the 14 day single-blind trial.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed genetic diagnosis of Fragile X (FraX) (full mutation).
2. Male (who have more serious effects due to the X chromosome nature of the disorder)
3. Age 13-29 years.
4. Parent of adolescent must be willing to sign informed consent.
5. Intelligence Quotient (IQ) \> 42.

Exclusion Criteria:

1. Cardiac risk factors.
2. Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or atypical antipsychotics.
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma

RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably. It is not yet known if palliative therapy is more effective with or without chemotherapy in treating patients who have malignant mesothelioma.

PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma.

OBJECTIVES:

* Determine the feasibility of palliative therapy alone versus palliative therapy with mitomycin, vinblastine, and cisplatin versus palliative therapy with vinorelbine in patients with malignant mesothelioma.
* Determine the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms.

* Arm I: Patients receive palliative therapy alone comprising non-chemotherapeutic therapy (e.g., radiotherapy, painkillers, steroids, relaxants, and special pain relief techniques).
* Arm II: Patients receive palliative therapy as in arm I and chemotherapy comprising mitomycin IV (courses 1, 2, and 4 only), vinblastine IV, and cisplatin IV over 4 hours on day 1. Chemotherapy repeats every 21 days for a total of 4 courses.
* Arm III: Patients receive palliative therapy as in arm I and chemotherapy comprising vinorelbine IV over 5 minutes once weekly on weeks 1-6 and 9-14.

Quality of life is assessed at baseline for all patients; at weeks 3, 6, 9, and 12 for arm I; at weeks 4, 7, 10, and 13 for arm II; at weeks 3, 6, 10, and 13 for arm III; at weeks 21 and 29, and then every 8 weeks thereafter for all patients.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Immunohistochemically or cytologically confirmed malignant mesothelioma

  * Epithelial and other histological types
* Symptomatic pleural effusion allowed if treated and controlled by drainage, pleurodesis, or pleurectomy
* Prior surgical resection allowed if stable or progressive disease by 2 CT scan measurements at least 6 weeks apart

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 3,000/mm3
* Neutrophil count greater than 1,500/mm3
* Platelet count greater than 100,000/mm3

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Considered medically fit to receive chemotherapy
* No other disease or prior malignancy that would preclude study
* No clinical evidence of infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for mesothelioma

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
Distress Tolerance Treatment for Substance Users

Despite recent advances in substance abuse interventions, a large percentage of clients entering residential treatment for substance use will drop out of treatment prematurely, and of the remaining, many will relapse soon after treatment completion. Previous research indicates that an individual's ability to withstand psychological distress is a key factor necessary to maintain drug and alcohol abstinence and to remain in substance use treatment without absconding. In previous work, Dr. Bornovalova developed a specific distress tolerance treatment called Skills for Improving Distress Intolerance (SIDI). This intervention features skills training in behavioral and acceptance strategies and intentional clinical exposure to emotional distress. SIDI was developed and piloted with a sample of urban drug users seeking treatment in a residential facility. Individuals receiving SIDI exhibited greater improvement in distress tolerance than those in two comparison groups (receiving treatment-as-usual and supportive counseling).

Current study. The investigators received NIDA funding to conduct a randomized clinical trial with 325 clients entering a residential substance use treatment facility. Study participants will be randomized into two treatment groups: (1) those receiving SIDI and (2) those receiving Supportive Counseling (SC). Participants will receive 10 treatment sessions over a period of 4 months. Then, the investigators will follow clients for one year to examine treatment retention and abstinence.


Eligibility Criteria:
Inclusion criteria:

* 18-65 years of age
* Not evidencing severe cognitive deficits
* Ability to give informed consent

Exclusion criteria:

* \<18 years of age or \> 65 years of age
* Not evidencing severe cognitive deficits (site designation of 'not competent to stand trial')
* Unable to give informed consent
Baby Iron Bioavailability Study

The overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants.

In 30 infants aged 6 to 14 months old, the investigator will administer in random order over 2 phases separated by 14 days, 5 infant cereals containing either ferrous fumarate (4 meals) or ferrous bisglycinate (1 meal) intrinsically labeled with stable isotopes. The investigator will collect one blood sample at baseline and another sample at the end of each phase, thus 3 samples total. In these samples, fractional iron absorption and markers of iron and inflammation status will be measured . In addition, infant and child acceptability of one of the infant cereals will be assessed by using a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Infant age 6 - 14 months
2. Infant exhibits no clinical signs / symptoms of chronic disease or acute illness
3. Capillary haemoglobin concentration \> 70g/L
4. Z-scores for weight-for-age and weight-for-length \> -2
5. Infant's parent(s) / legally acceptable representative is of legal age of consent, has anticipated residence in the area for the duration of the study, and is willing and able to fulfil the requirements of the study protocol
6. Infant is expected to consume the entire 25 g portion during infant cereal feeding based on the Investigator's judgement established via observations of feeding during the adaptation phase
7. Infant received a complete dose of intermittent preventive treatment with dihydroartemisinin piperaquine (IPTi-DP) as well a single dose of antihelminth treatment with Albendazole

Exclusion Criteria:

1. Parents not willing / not able to comply with the requirements of study protocol
2. Infants receiving iron-containing supplements in the 2 months prior to enrollment (other supplements are acceptable)
3. Infants with allergies or intolerance to wheat, oat, gluten or other ingredients in the test cereals (e.g., celiac disease)
4. Infants participating in any other clinical trial prior to enrollment
5. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.
Development of Obesity and Bariatric Surgery

This study focus on the cause of obesity and impacts of bariatric surgery on it.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index ≥18 kg/m2
2. already received bariatric surgery or abdonimal surgery

Exclusion Criteria:

1. acute stroke or acute myocardial infarction in 6 months
2. autoimmune disease
3. long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs
4. pregnancy
5. consists with other endocrine diseases
6. acute infection in2 weeks
7. cancer
8. use of antibiotics in 3 months
9. chronic digestive inflammations 9