cyrilzakka/clinical-trials huggingface dataset:
Clinical and Electrophysiological Evaluation of the Effectiveness for Manual Lymphatic Drainage

When the other usage areas of the manual lymphatic drainage technique in the literature, except for the treatment of lymphedema, were examined recently, it was seen that it was also applied in orthopedic and neurological cases in a limited number of studies. The aim of our study is to investigate the effectiveness of manual lymphatic drainage on clinical and electrophysiological findings in carpal tunnel syndrome


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate carpal tunnel syndrome on electrodiagnostic examination
* Being between 20-55 years old
* Volunteering to participate in the treatment to be given

Exclusion Criteria:

* Have a systemic inflammatory disease
* Having any disease that may cause polyneuropathy, such as diabetes mellitus
* Cognitive impairment
* Receiving psychotherapy
* Having a pacemaker
* illiterate
* Having a disease affecting the central nervous system
* Having a hearing problem
* Any skin disease that would contraindicate manual lymphatic drainage
* Arterial or venous circulation disorder that would contraindicate manual lymphatic drainage
Levetiracetam in the Management of Bipolar Depression

A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of bipolar disorder
* Presence of a current major depressive episode on the SCID
* Score of 17 or great on the HDRS
* Capable of giving voluntary written consent

Exclusion Criteria:

* Significant current substance dependence/abuse within 3 months preceding the trial
* Active suicidal ideation
* Pregnant/lactating mothers
* Significant medical history
Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use

This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare personnel involved in decision-making associated with performing episiotomies who work in the hospital selected to pilot the proposed intervention.

Exclusion Criteria:

* Healthcare personnel who are not involved in the decision-making process over performing episiotomy during delivery.
PEEP and Spontaneous Breathing During ARDS

Prospective, physiological study to systematically assess the effects of high positive end-expiratory pressure (PEEP) with and without inspiratory synchronization in patients with moderate to severe acute respiratory distress syndrome (ARDS) exhibiting intense inspiratory effort while on assisted ventilation.

This prospective, physiological, randomized, cross-over study will be conducted in the 20-bed general ICU of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. Patients with ARDS will be screened for eligibility. ARDS will be defined according to the Berlin Definition.

Intubated patients fulfilling ARDS criteria, undergoing assisted ventilation as per clinical decision and exhibiting intense inspiratory effort (occlusion pressure equal or greater than 13 cmH2O) will be enrolled.

Patients will be placed in a 30°-45° head up position during all study phases. According to our institution protocol, pressure support setting will be selected by the attending physician to target a predefined tidal volume range of 6-8 mL/kg of predicted body weight (PBW) (female PBW \[kg\] = 45.5 + 0.91 \[cm of height - 152.4\]; male PBW \[kg\] = 50 + 0.91 \[cm of height - 152.4\]).The lowest pressure support level allowed will be 7 cmH2O, even if Vt \<8 ml/Kg PBW is not achieved.

In each patient, four different ventilator settings will be applied in a random order. Each step will last 45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* (a) ARDS according to the Berlin definition (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg);
* (b) assisted ventilation, as prescribed by the attending physician
* (c) intense inspiratory effort, defined as a negative deflection in the airway pressure equal or greater than 13 cmH2O in the first breath recorded during an end-expiratory occlusion

Exclusion Criteria:

Pregnancy, clinically documented barotrauma, contraindication to electrical impedance tomography (EIT) use (e.g., presence of pacemaker or automatic implantable cardioverter defibrillator), impossibility to place the EIT belt in the right position (e.g., presence of surgical wounds dressing), and any contraindication to the insertion of a nasogastric tube (eg, recent upper-gastrointestinal surgery, esophageal varices), chest tubes with active air leaks, fever.
Efficacy and Safety of Lima Association in the Control of Type II Diabetes Mellitus.

The purpose of this study is to evaluate the efficacy and safety of Lima association in the control of type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes, aged 18 years or more;
* Participants presenting the diagnosis of type II diabetes mellitus, which have already received previous dietary and physical exercise guidance, who are not receiving any antidiabetic treatment, defined as never taking any antidiabetic medication, or in antidiabetic therapy after being subjected to a washout period;
* Treatment-naive participants with HbA1c between 7.5% and 10.5% and pretreated patients with HbA1c between 7,5% and 9,5% at the screening visit;
* Patients with HbA1c between 7.5% and 10.5% at the randomization visit;
* Participants with BMI (body mass index) \> 19 Kg/m2 and ≤ 45 Kg/m2.
* Signed consent.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* History of alcohol abuse or illicit drug use;
* Participation in clinical trial in the year prior to this study.
* Fasting glycemia above 300 mg/dL;
* Risk factors for severe volume depletion;
* Diuretic use less than 60 days, except for spironolactone;
* History of diabetic ketoacidosis;
* Medical history of acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to informed consent;
* Impaired hepatic function;
* Impaired renal function and end stage renal disease;
* Bariatric surgery in the last two years and/ or other gastrointestinal surgeries;
* Current medical history of cancer and/ or cancer treatment in the last 5 years;
* Medical history of blood dyscrasia or any other hemolytic disorders;
* Medical history of pancreatitis and chronic pancreatitis;
* Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months;
* Current and prolonged treatment for more than 15 days with systemic steroids at the moment of informed consent;
* Any other uncontrolled endocrine disorder, except type 2 diabetes mellitus;
* History hypersensitivity to the active ingredients used in the study;
* Pregnancy or risk of pregnancy and lactating patients;
* Systemic disease that is not controlled and can put the participant at risk;
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

The purpose of this multi-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.


Eligibility Criteria:
Main inclusion Criteria:

* Clinical and laboratory diagnosis of HAE
* Plasma level of functional C1INH of less than 50% of normal
* Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE.

Main exclusion Criteria:

* Acquired angioedema
* Pregnancy or breastfeeding
* Participation in another clinical study within prior 3 months
Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content

This study evaluates the addition of video presentation on conventional informed consent. Participants divided two randomly, one group read only conventional informed consent, the other video presentation was watched after reading conventional consent.


Eligibility Criteria:
Inclusion Criteria:

* being a being bariatric metabolic surgery candidate according to international guidelines

Exclusion Criteria:

* illiterate
* previous bariatric surgery
* age \<18
Total Intravenous Anesthesia and Recurrence Free Survival

The investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total intravenous anesthesia or sevoflurane-based balanced general anesthesia.

The investigators will test the primary hypothesis that recurrence-free survival after esophageal cancer surgery is longer in patients randomized to propofol-based total intravenous anesthesia than to volatile sevoflurane anesthesia.

The investigators will test the secondary hypotheses that propofol-based total intravenous anesthesia: 1) speeds discharge from the ICU; 2) speeds discharge from the hospital; and, 3) improves the quality of recovery, as assessed by QoR-15 on postoperative day 2.

Eligibility Criteria:
Inclusion Criteria:

* Primary esophageal cancer without known extension beyond the esophagus. (i.e. believed to be Tumor Stage 1-3).
* Scheduled for potentially curative esophageal cancer surgery.
* Written informed consent, including willingness to be randomized to intravenous versus volatile anesthesia.

Exclusion Criteria:

* Previous surgery for esophageal cancer (except diagnostic biopsies) Age \<18 or \>85 years old.
* ASA Physical Status ≥4.
* Any contraindication to propofol or sevoflurane.
* Other cancer not believed by the attending surgeon to be in long-term remission.
* Systemic disease believed by the attending surgeon to present ≥25% two- year mortality.
HepciFer Study: Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?

Hepcifer Trial is designed to assess the value of iv iron administration immediately after liver surgery and consequences of inflammation on iron balance. Fifty patients will be randomized in two treatment groups. Patients will be assigned to receive either iv iron or placebo immediately after liver resection surgery. Biological inflammation parameters, hemoglobin, serum iron and hepcidin levels will be assessed prior to surgery and at day 1, 3, 7, 15 and 30 after surgery.

The iron homeostasis is now well known. Indeed, the discovery of hepcidin, a protein synthesized by the liver, has provided a better understanding of iron metabolism and the resulting anemia disruption of this homeostasis.

Although morbidity decreased hepatic surgery remains a major surgery as by surgical difficulty by support intra- and postoperatively.

A preliminary study, the investigators found that patients had preoperative anemia (oncological context) increased postoperatively, increasing the morbidity.

Few clinical studies on hepcidin and anemia were carried out, because of the difficulty of metering (mass spectrometry) as well as its cost.

In this clinical trial, the investigators plan to assess the value of iv iron administration versus iv placebo treatment immediately after liver surgery and consequences of inflammation on iron balance. In addition, an evaluation of the well being of patients will be performed postoperatively to measure the functional and psychological impact of anemia.

This is a monocentric, randomized, double blinded and placebo controlled trial. Iron iv injection will be administered postoperatively. Hematology assessments, biological iron deficiency, inflammation and coagulation will be realized pre and postoperatively. Hepcidin is assayed by an ELISA method.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled liver surgery,
* Liver resection \> 2 segments.

Exclusion Criteria:

* Age below 18yrs,
* Pregnancy,
* Emergent surgery,
* Sepsis,
* Immunosuppressive therapy,
* Renal insufficiency (GFR\<30ml/min/m2),
* Hypersensitivity to iron,
* Iron overload.
Epidemiologic Register on Diabetes and COVID-19 in Tunisia

CoviDTUN is a multicenter observatory set up by a steering committee to determine the presentation and evolution of diabetes in COVID-19 and study its pathogenesis.

The observatory comprises a dataset consisting of routinely collected clinical information anonymously to be entered by the investigator as a participating clinician/researcher.

The study will be an opportunity to understand the relationship between COVID-19 and diabetes, to enrich Tunisian data on diabetic and de novo diabetic patients who have contracted COVID-19 and to evaluate the prognostic severity factors for better management of these patients.

It is a multicentric Tunisian observatory for COVID-19 patients. Confirmed COVID-19 patients, treated on an outpatient basis, in containment centers or hospitalized in COVID-19 units were included retrospectively from March 2020 and had continued prospectively til June 2022. The study had selected eligible patient recorded for inclusion by free practice physicians and hospital physicians. General data, medical history, epidemiological characteristics, clinical examination, biological assessment (blood glucose, NFS, CRP, D-dimer, etc.), clinical course and complications were therefore recorded in a structured and anonymized database. Data collection was carried out by DACIMA Clinical Suite® solution, in accordance with the normative and regulatory provisions in force in the management of health data.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19 infection confirmed by an evocative clinical picture according to INEAS score or a positive polymerase chain reaction \[PCR\] test and/or chest CT specific radiological signs and/or a rapid diagnostic antigen test.
* Diabetes known before COVID-19 (known diabetes patient before COVID-19: Diabetic patient before COVID-19: History in medical record and/or presence of antidiabetic therapy and/or HbA1c ≥ 6.5%).

or

- De novo diabetes (the de novo diabetic patient is defined as: Fasting blood glucose ≥ 1.26 g/L (7mmol/L) or postprandial blood glucose ≥ 2g/L (11.1 mmol/L) within 2 weeks of COVID-19 infection, no history of diabetes before the COVID-19 episode)).

Exclusion criteria:

* children
* pregnant women
Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis

Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Metformin, an anti-diabetic drug, has recently been suggested to have a suppressive effect on tumorigenesis via inhibition of mTOR pathway, and have an inhibitory effect on polyp recurrence after removal of sporadic colorectal polyps. In addition, metformin has a number of potential mechnisms of carciovascular bebefit. We devised a randomized, open-label, comparative study to evaluate the effect of combination of celecoxib and metformin on polyps of colorectum and duodenum in FAP patients.

This clinical trial is a randomized, open-label, comparative study to evaluate the effect of combination of celecoxib and metformin on polyps of colorectum and duodenum in FAP patients. FAP patients, satisfied an enrollment criteria, will be randomly assigned in a 1:1 ratio to receive celecoxib monotherapy or combination of celecoxib and metformin orally for 6 months. The base-line and six-month endoscopic examination (colonoscopy/sigmoidoscopy and upper gastrointestinal endoscopy) will be recorded, and photographs will be taken at the tattoo-marked area. The number and size of polyps, and a qualitative assessment of the total extent of polyposis will be measured.

Eligibility Criteria:
Inclusion Criteria:

- 1. Patients with familial adenomatous polyposis(FAP) who are 20 to 55 years of age.

2. FAP patients who have colonic or duodenal polyp. 3. FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination.

Exclusion Criteria:

* 1. FAP patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization.

  2. FAP patients with malignant disease, including colorectal cancer. 3. FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 3 months of randomization.

  4. Pregnant or breast-feeding patients. 5. Patients with cardiovascular diseases, peptic ulcer diseases and diabetes. 6. Patients with abnormal results of serum laboratory tests (renal function and liver function test).
Effect of Different Types of Anesthesia on Perioperative Brain Natriuretic Peptide Levels in Parturient Cardiac Patient Undergoing Elective Cesarean Section

comparing the effect of general anesthesia versus spinal anesthesia on brain natruretic peptide hormone levels preoperatively and postoperatively in parturient cardiac patient undergoing cesarean section

In our study, investigators will detect changes in brain natruretic peptide (BNP) levels in parturient patients at risk undergoing cesarean section, in relation to type of anesthesia used, general anesthesia versus spinal anesthesia, in order to evaluate the safety of type of anesthesia used for this kind of patient.

It is very important to assess and predict risk in the cardiovascular system in such cases. A number of cardiac indexes for predicting risk have been developed like Goldman Multifactorial risk index, Eagle's risk index and Detsky's cardiac index. It is recommended to evaluate patients using these indexes and to institute preoperative medical treatment based on the results. These clinical scoring systems, although simple to use, are somewhat inconvenient and have limitations in their predictive value, whereas other cardiac investigations such as exercise or pharmacologic stress imaging are sensitive, but limited in practice by time and resources. Recently brain natriuretic peptide (BNP) was spotlighted as a predictor for diagnosing and predicting the prognosis of various heart diseases. BNP is a cardiac hormone that is synthesized by ventricular myocytes in response to ventricular dysfunction. Recent studies have demonstrated that elevated serum BNP levels predict first cardiovascular event and death in the general population. In addition, it has been reported that BNP measured before major surgery can be used as a predictor of postoperative cardiac complications.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate valvular heart lesions.
* Cardiomyopathic lesions with ejection fraction \> 40%
* Ischemic heart disease
* Hypertension
* Non-fatal arrhythmias eg. Controlled AF

Exclusion Criteria:

Cardiomyopathic lesions with EF less than 40% Tight stenotic lesions Severe regurgitant lesions Pregnancy induced hypertension Fatal arrhythmia eg. Ventricular tachycardia renal impairment Cr \> 1.2 surgery related problems: operation longer than 3 hours patient resuscitation with \> 3 litres blood loss more than 1 liter
Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls

Endometriosis is a chronic inflammatory disease that affects 10-17% of women in childbearing age, 35-60% of women with chronic pelvic pain and can cause infertility, costing as much as 2.8 billion dollars per year. For this reason, every step taken in diagnosis and treatment is of great importance both materially and spiritually. Patients can be diagnosed about 8-9 years after the onset of their complaints due to inadequacy of diagnostic methods In the study, it is decided to look at the basis of the disease, endometrial cells. And aimed to find the difference between the two women who are thought to be no different from each other among our current knowledge but one has endometriosis while other have not.

Endometriosis is the appearance of a tissue similar to the endometrium in the ovaries, large intestine, and many other organ walls, except the uterus. The reason is unknown yet. Severe periodic pain, infertility, and pain during intercourse, affects approximately 2 million women in Turkey on average, 10% of women around the world. Endometriosis is a chronic inflammatory disease that affects 10-17% of women in childbearing age, 35-60% of women with chronic pelvic pain and can cause infertility, costing as much as 2.8 billion dollars per year. For this reason, every step taken in diagnosis and treatment is of great importance both materially and spiritually. Patients can be diagnosed about 8-9 years after the onset of their complaints due to the inadequacy of diagnostic methods In the study, it is decided to look at the basis of the disease, endometrial cells. And aimed to find the difference between the two women who are thought to be no different from each other among our current knowledge but one has endometriosis while others have not. For this reason, mapping of all genomes with the nanoclonal technique, the most advanced genetic screening method currently available from endometrial samples of patients and healthy women, is to identify the possible copy numbers, translocation, insertion and inversion anomalies, and to name them functionally by proteomic analysis. We believe that the results obtained from our study will guide the diagnostic tests and possible gene therapy in the future.

Eligibility Criteria:
Inclusion Criteria:

surgically diagnosed with endometriosis disease

* no diagnosıs for malignancy
* gave informed consent for application to the study enrolle as patient group females
* between 18-45 years old
* without any health conditions
* applied to the clinic for routine checkups for control group

Exclusion Criteria:

* being diagnosed with any kind of malignancy having trouble with endometrial cavity sampling
Mathematical Modeling Analysis of Serum Prostate Specific Antigen After Radiotherapy

Clinical data are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

Clinical data (prostate-specific antigen \[PSA\] response after radiotherapy) are being used to build a mathematical model to describe the clinical results of radiotherapy for prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer treated with radiotherapy +/- hormones

Exclusion Criteria:

* Prostatectomy