cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participant's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.

The study will be organized as follows:

* Screening Phase
* Single-blind Prospective Treatment Phase
* Single-blind Continuation Phase (Responder)or Double-blind Randomization Phase (non-Responder)
* 30 day Post Treatment Follow-up

Assigned Interventions:

* Escitalopram monotherapy
* Aripiprazole/Escitalopram combination therapy
* Aripiprazole monotherapy

Eligibility Criteria:
Inclusion Criteria:

* Participants with a current diagnosis of a major depressive episode. The current depressive episode must be ≥8 weeks in duration
* Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period
* Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline for the Prospective Treatment Phase

Exclusion Criteria:

* Lack of prior treatment with an antidepressant during the current depressive episode
* Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode.
* Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode
* Participants with epilepsy or significant history of seizure disorders
* Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
* Participants who have received electroconvulsive therapy (ECT) in the last 10 years
Outcome After TIPS

This clinical trial is a retrospective single-centre study. Research data will be acquired via patient histories stored in the hospital data system. Data of patients who received a Transjugular Intrahepatic Portosystemic Shunt (TIPS) at the University Hospital Graz between 1.1.2004 and 31.12.2017 will be included into the study. The aim is to investigate the outcome (transplantation free survival, time to (re)occurrence of ascites, occurrence of hepatic encephalopathy) of patients with portal hypertension after TIPS.

The implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) is a valuable measure to reduce portal hypertension and prevent portal hypertension-related complications. It can be used as a symptomatic treatment in patients with chronic portal hypertension as well as for the treatment of active variceal bleedings or large gastrointestinal varices that go along with threatening bleeding danger.

However, this invasive procedure carries a high risk for complications. 30-days mortality after TIPS implantation amounts between 4% and 45%.

A common complication is the (initial) manifestation or deterioration of hepatic encephalopathy, which occurs in 33-46 % after TIPS implantation.

Other complications that are directly related to the intervention are bleeding, infections and stent migration.

Aim of this retrospective single centre study is to investigate the long-term outcome after TIPS implantation with regard to transplantation free survival and time to (re-) occurrence of portal hypertension-related complications, especially ascites and hepatic encephalopathy.

Intervention-related complications as well as long-term effects should be evaluated to facilitate the decision for or against TIPS.

Eligibility Criteria:
Inclusion Criteria:

* every person at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017

Exclusion Criteria:

* age under 18
Recurrent AA Amyloidosis After Renal Transplantation

End-stage renal disease related to AA amyloidosis is well characterized but there is limited data concerning patient and graft outcomes after renal transplantation. The aim of this study is to evaluate the clinical features of, and risk factors for recurrent AA amyloidosis, as well as the effects of these factors on the ultimate outcome of renal allografts.

AA amyloidosis is a rare but serious complication of several chronic inflammatory diseases including recurrent hereditary periodic fever syndromes. Although end-stage renal disease related to AA amyloidosis is well characterized, there is limited data concerning patient and graft outcomes after renal transplantation, with most of the findings reported from small series. Recurrence of amyloidosis in the renal allograft might be underdiagnosed, assessing graft and patient outcomes in larger study groups will bring better understanding and new strategies in daily practice.

Eligibility Criteria:
Inclusion Criteria:

* Renal transplantation recipients whose primary renal disease is AA amyloidosis; patients with allograft biopsy-confirmed AA amyloidosis (for study group) and patients with no clinical or laboratory signs of recurrence in the renal allograft (for control group 1)
* Renal transplantation recipients whose primary diseases are other than AA amyloidosis (for control group 2)

Exclusion Criteria:

* Patients who are unwilling or unable to consent
Effect of Low Level Laser Irradiation on Muscle Performance and Recovery

Low level laser therapy (LLLT) was shown to affect muscle performance and fatigue. The aim of this study is to investigated the effect of B-cure laser on muscle performance and recovery after intense exercise.


Eligibility Criteria:
Inclusion Criteria:

* Healthy physical education students, ages 20-35, light or intermediate skin color

Exclusion Criteria:

musculoskeletal injury to hips or knees in the previous 2 months, use pharmacological agents or nutritional supplements regularly, smokers, physical limitations on completing the exercise tests -
Periodontal Care and Glycemic Control in Diabetes

Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control.

Background:

Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control.

Objectives:

This project will determine the efficacy of a program of periodontal screening and therapy in improving the level of glycemic control in poorly controlled diabetics.

Methods:

Status:

Subject accrual is complete. Data collection is ongoing.

Eligibility Criteria:
Inclusion Criteria:

Patients must have diabetes mellitus, and HbAlc \>9, \>8 teeth, and CPITN scores of 3 or 4 in, at least 2 sextants of the mouth, indicating moderate to high peridontal treatment need.

Exclusion Criteria:
Smallest Significant Value in Osteodensitomery in an Obese Population

The aim of this study is to determined the smallest significant value in osteodensitometry in obese population. The study population will be divided in 3 groups according to their BMI.

Bone mineral density will be measured twice in osteodensitometry, then the smallest significant value will be determined.

Our hypothesis is that the smallest significant value that we use in an non-obese population can be different in an obese population.

The aim of this study is to determined the smallest significant value in osteodensitometry in obese population.

There will be at least 120 patient included. The study population will be divided in 3 groups according to their BMI : the first group has a BMI between 30 and 35 kg/cm² ; the second group has a BMI between 35 et 40 kg/cm² ; and the third group has a BMI over 40 kg/cm².

Patients will be referred by their doctors (rheumatologist and others) to evaluate their bone mineral density in osteodensitometry at CHU of Reims. Patients will be informed of the aim of the study by the prescriptor of the osteodensitometry.

The osteodensitometry will be executed by a nurse. Patients will have to complete a questionnaire about their medical history and their medications.

Bone mineral density will be measured twice in osteodensitometry, at the lumbar spine, the hip and the femur. This exam lasts approximately 40 minutes.

Then the smallest significant value will be determined by comparing each measure for every patients.

Eligibility Criteria:
Inclusion criteria :

* Major patients
* Patients referred to the CHU of Reims to make an osteodensitometric evaluation of their bone mineral density
* BMI \> 30 kg/cm²
* Patient affiliated to a health insurance plan
* Patients who have signed informed consent

Exclusion criteria :

* Minor patients
* Pregnant women
* Patients protected by the law
Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia

The prevalence of insulin resistance is increased in women with recurrent miscarriage compared with matched fertile controls,Insulin resistance (IR) in this syndrome is not only implicated toward early pregnancy loss (EPL) but also pathognomic for various obstetrical complications during pregnancy.An elevated free androgen index appears to be a prognostic factor for a subsequent miscarriage in women with recurrent miscarriage.

There is insufficient evidence to evaluate the effect of metformin supplementation in pregnancy to prevent a miscarriage in women with recurrent miscarriage.

The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive. Pregnancy follow up including the early and second trimester pregnancy loss, Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* women who are diagnosed to have PCOS and/or haven hyper insulinaemia and have a previous history of recurrent miscarriages.

Exclusion Criteria:

* Any patients with PCOS or hyper insulinaemia previously treated by any forms of insulin sensitizers.

Age above forty years old .

* Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice).
* Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
* Fibroids distorting uterine cavity .
* Abnormal parental karyotype .
* Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
19F Hot Spot MRI of Human Adipose-derived Stem Cells for Breast Reconstruction

Six female patients (\>18 years of age, pre-menopausal) who have had loco-regional (lumpectomy and radiation) therapy for breast carcinoma and have been at least one-year disease free will undergo liposuction, the autologous SVF cell fraction will be isolated and labeled with CS-1000 in the operating room without entering cell culture, which will then be returned to the patient at the site of breast grafting. Patients will receive a pre-screening MRI . Patients will have an MRI scans over a period of 1 month at Johns Hopkins. Follow-up MRIs at 6,12, and 18 months will also be performed. Only at Johns Hopkins with fluorine being done as part of this investigational study. By performing fluorine MRI and quantification of 19F signal, we hypothesize that the engraftment of transplanted cells can be tracked in ways not possible before, using the total fluorine signal as surrogate marker for cell persistence and survival. We expect that a clinically successful outcome (maintenance of breast contour and volume) will be positively correlated with cell survival. The outcome of this study may pave the way for using 19F MRI cell tracking as a new tool for stem cell therapy in a variety of clinical applications.


Eligibility Criteria:
Inclusion Criteria:

1. Patient capable and willing to sign the Informed Consent (see attached document)
2. Patient must be willing to complete all visits in this study
3. Female, \>18 years of age
4. Lumpectomy and radiation therapy for breast carcinoma
5. 18 month disease free survival
6. No evidence of metastatic disease
7. Patient is fit for surgery as determined by preoperative medical clearance workup performed by an independent primary care physician.
8. Negative pregnancy test.

Exclusion Criteria:

1. Evidence of metastatic disease
2. Less than 18 months disease-free interval
3. Unable to undergo MRI:

3a) Metallic implant 3b) Claustrophobic 4) High risk for surgical intervention because of comorbidities 5) Received treatment with an investigational drug within 30 days of screening.
Analgesic Effect of Intravenous Patient-Controlled Analgesia (IV PCA) Versus Paravertebral Block After Video Assisted Thoracic Surgery (VATS)

The purpose of this study is to compare the analgesic effect of paravertebral block with that of intravenous patient-controlled analgesia after video assisted thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients receiving video assisted thoracic surgery

Exclusion Criteria:

* patients with cardiovascular disease
* patients with neurologic disease
* patients with contraindications to paravertebral block or epidural block
* patients with history of previous VATS
* patients with pain at the expected incision site
Innovative Nutrition and mHealth Evidence Building Project

The project is the collaboration with the lead agencies National Institute of Public Health, World Vision and Emory University World Vision has a history of successfully implementing "Positive Deviance/Hearth (PDH)" programs across the globe. PDH is a community-based intervention utilizing locally appropriate health and infant feeding practices to rehabilitate underweight children and promote behavioral changes in caregivers. A recent systematic review on the PD/Hearth approach found that although some programs show clear success in particular settings, overall, the results were mixed for program effectiveness.

Furthermore, with the growing use of mobile phones and technology in the world, including Cambodia, there have been various studies and a systematic review that found SMS reminders and voice recordings to have promising impact on behavior change of patients for smoking cessation and improved adherence to drugs for asthma patients. Although there are positive findings around the use of mobile devices to improve behavior change, there has yet to be a study that examines the impact of mobile phones on improving behavior change of caregivers related to nutrition, water, sanitation and hygiene (WASH), health, and caring practices, which as a result, would decrease the prevalence of underweight in children 6-23 months of age.

This study will provide evidence on the effectiveness of the PDH model in Cambodia compared to the current standard of care. Investigators believe the PDH approach will be a powerful tool to reduce child malnutrition. In addition, given the intensity and cost burden associated with PDH, investigators will simultaneously test if the intensity of the PDH model can be reduced by introducing an innovative application of mHealth to replace 50% of face-to-face education sessions (5 days) and all follow up visits with mobile support calls. Collectively this research will provide critical data to inform program operations on the optimal and most effective method to reduce child underweight in Cambodia.

In Year 1, the purpose of this study is to assess the effectiveness of contextualized messages through PDH programs and a mobile technology (mHealth), to improve knowledge, behaviour change, and level of confidence of caregivers with underweight children aged 6-23 months in feeding, hygiene, health-seeking, and caring practices. In Year 2, the study's aim will be to assess the prevention of underweight in the siblings of the children included in the three programs outside of the 360 study subjects from Year 1.


Eligibility Criteria:
Inclusion Criteria for Enrollment:

* Child 6-23 months residing in study area and intending to stay in area for study duration
* Underweight child (Weight for Age Z-score \< -1)

Exclusion Criteria:

* No access to mobile phone
* Severe Acute malnutrition (Weight for Height Z-score \<-3), Edema
An Explorative Study To Develop A Predictive Model Based On Avascular Exposed Root Surface Area For Root Coverage

The aim of this study was to evaluate the reliability of the avascular root surface area as a prognostic identification criterion for gingival recessions and to compare the predictive value of the Miller classification and avascular root surface area (AERSA) calculation on the final root coverage outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Presence of isolated Miller I, II or III recession, (Miller 1985a)
* Presence of identifiable cementoenamel junction (CEJ); presence of a step ≤ 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ,
* Full-mouth plaque score and Full-mouth bleeding score of \< 15% (four sites/tooth),
* No occlusal interferences;
* Non-smokers

Exclusion Criteria:

* Tooth with a prosthetic restoration involving CEJ,
* Patients with a history of periodontitis or abscess formation,
* Presence of systemic disease or taking medications known to interfere with periodontal tissue health
* Pregnant or nursing patients
This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity

The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 in otherwise healthy adults with overweight or obesity.

The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET097 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET097 or placebo. In Part C, participants will receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X to explore the potential for once-monthly dosing.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/Obese but otherwise healthy adult male or female with a BMI within 27.0 kg/m2 to 38.0 kg/m2, inclusively
* At least 18 years of age but not older than 70 years of age
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
* Estimated glomerular filtration rate (eGFR) ≥90 mL/min at the Screening visit

Exclusion Criteria:

* Female who is lactating or who is pregnant according to the pregnancy test at the Screening visit or prior to the first study drug administration
* Seated blood pressure higher than 160/95 mmHg at the Screening visit
* Elevated resting pulse greater than 100 beats per minute at Screening visit
* Presence of clinically significant ECG abnormalities
* Diagnosis of diabetes (type 1 or type 2)
* Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration
* Obesity induced by endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type
A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer

Primary Objective:

To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients with advanced biliary tract cancer

Secondary Objectives:

* To evaluate overall response rate (ORR)
* To evaluate progression-free survival (PFS)
* To evaluate overall survival (OS)
* To assess the safety profile


Eligibility Criteria:
Inclusion Criteria:

* 1.histologically confirmed biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of vater);
* 2.metastatic or unresectable disease;
* 3.no history of chemotherapy or radiotherapy for biliary tract cancer;
* 4.presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be ≥15 mm in the short axis;
* 5.adequate hematopoietic function which is defined as below:

  1. hemoglobin level ≥ 9 g/dL;
  2. absolute neutrophil count (ANC) ≥ 1,500/mm3;
  3. platelet count ≥ 100,000/mm3;
* 6.adequate hepatic function which is defined as below:

  1. total bilirubin ≤ 1.5 times upper limit of normal (ULN) and \< 2 mg/dL, or total bilirubin \< 3 mg/dL if biliary drainage was performed;
  2. Alanine aminotransferase (ALT) ≤ 3 x ULN or ALT ≤ 5 x ULN in the presence of liver metastasis;
* 7.adequate renal function: creatinine clearance rate (CCr) ≥ 60 mL/min ((based upon 24-hour urine collection or calculated by Cockroft-Gault formula);
* 8.age of 20 years or above;
* 9.ECOG performance status 0-1;
* 10.life expectancy of at least 12 weeks;
* 11.ability to take oral medication;
* 12.ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* 1.other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
* 2.history or known presence of brain metastasis;
* 3.presence of grade 2 or above ascites or pleural effusion;
* 4.presence of grade 2 or above diarrhea;
* 5.presence of mental disease or psychotic manifestation;
* 6.active or uncontrolled infection;
* 7.significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
* 8.pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.