cyrilzakka/clinical-trials huggingface dataset:
Reducing Symptoms of Depression in Low-Income Mothers

This study will test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in Early Head Start Programs.

Limited resources, poor social support, and complex life problems contribute to the high prevalence and severity of depressive symptoms in low-income mothers. As depressive symptoms persist, they often rob young mothers of the energy they need for school, job training, and positive interaction with their children, which can negatively affect a child's language acquisition, intellectual development, and social conduct. This study will design and implement a home-based treatment to help young mothers manage their depressive symptoms, increase their social support, manage or resolve life issues, and effectively parent their infant or toddler through the use of EHS resources.

Mothers will be randomly assigned to receive either home-based interpersonal depression treatment or an attention control/usual care condition for 26 weeks. Assessments will be made at study start and Weeks 14, 22, and 26. Depression scales, interviews, and analyses of videotaped mother-child interactions will be used to assess participants. Stress, social support, and use of EHS services will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale
* Child who is 6 weeks to 30 months old
* Child who is enrolled in an Early Head Start program

Exclusion Criteria:

* Regular use of psychotropic medication
* Regular use of psychotherapy or drug/alcohol treatment
Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis

Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia \<10mg / dL and proteinuria\> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.


Eligibility Criteria:
Inclusion Criteria:

* Man or Woman whose age ≥ 18 years
* Patient with meningitis Klebsiella sp., hospitalized in one of the hospitals of the Clinical Microbiology Group
* Francophone patient

Exclusion Criteria:

* Patient under tutorship or curatorship
* Patient deprived of liberty
* Patient under safeguard of justice
* Patient opposing his participation
Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents

The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.


Eligibility Criteria:
OBESE SUBJECTS:

Inclusion Criteria:

* Obesity, defined as a BMI \> 95th percentile for age and gender
* Age 10 through 18 years
* Informed consent with assent in accordance with the institutional policies (institutional IRB approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study
* Moderate-severe OSA or Central Sleep Apnea (CSA) as defined by OAHI or CAHI

Exclusion Criteria:

* Patients with other neurological problems, including but not limited to neurocutaneous disorders such as neurofibromatosis or tuberous sclerosis
* Obesity due to other diseases and syndromes (e.g. Prader-Willi syndrome)
* Pregnancy
* Currently unwell, hospitalized or recent viral/bacterial infection in the previous 4 weeks
* Adenoidal and/or tonsillar hypertrophy which may be amenable to surgical intervention to help alleviate OSA
* Patients with severe respiratory distress
* Patients with increased risk of pneumothorax including but not limited to previous pneumothorax, bronchiectasis or severe untreated asthma.

CHILDREN WITH MEDICAL COMPLEXITY SUBJECTS:

Inclusion Criteria:

* CMC recently diagnosed with moderate to severe OSA or CSA requiring CPAP therapy
* 0-18 years of age
* Informed consent with assent in accordance with the institutional policies (institutional IRB approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study

Exclusion Criteria:

* Current upper respiratory tract infection
* Subjects who are receiving oxygen therapy
Clinical and Biological Predictors of COVID-19 Disease in Older Patients

The project is an observational, prospective study. Its aim is to deepen our understanding of COVID-19 in older patients hospitalized and diagnosed with COVID-19.

In particular, socioeconomic, diagnostic, biological, functional, therapy data will be collected at the patients' admission, during hospital stay, at the discharge and 1, 3, 6, 12 months after discharge.

Results and findings will help support changes in clinical practice and decision making, with the aim to reduce the use of healthcare services and the healthcare expenditure.

Current knowledge about clinical and biological characteristics of COVID 19 among older people is very limited. A better comprehension of the clinical picture of older patients affected by COVID-19, (e.g. frailty, multimorbidity and polypharmacy patterns and functional performance) may significantly contribute to deepen our understanding of the clinical epidemiology knowledge of COVID-19 among hospitalized older people.

Therefore, the ReportAge-COVID project aims to collect - using a minimum clinical and biological data set - a series of data and indicators on the conditions of elderly patients that are suspected of having a compatible clinical picture or were confirmed positive for COVID-19. Data will be collected at the patients' admission, during hospital stay, at discharge and 1, 3, 6, 12 months after discharge.

In particular, the following specific pieces of information will be gathered:

* routinely collected demographic, socioeconomic, clinical, biological and diagnostic data
* frailty condition (by using the clinical frailty scale)
* assessment of the functional capacities through ADL and IADL tests
* health conditions; nutritional status; medications; treatments and procedures
* biomarkers of aging including cytokines and anti-inflammatory molecules, previously identified in a focus group of experts

Results and findings will help support changes in clinical practice and decision making, with the aim of reducing adverse outcomes, the worsening of health conditions in the elderly population, the use of healthcare services and, as a consequence, lower healthcare expenditure.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COVID-19

Exclusion Criteria:

* no informed consent
Study of Intraoperative Colonic Irrigation Versus Stent Placement in Obstructive Left-Sided Colonic Cancer

INTRODUCTION: There are several alternatives for one-stage emergency treatment of obstructive left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon lavage (IOCL) with primary anastomosis, and the placement of a stent as a temporary measure prior to scheduled surgery. At present, it is not clear whether emergency perioperative lavage or the placement of a stent is the better technique. The hypothesis is that IOCL and primary anastomosis is equal safe or even safer than placement of a stent as a temporary measure prior to scheduled surgery, less length of stay and less cost.

OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the point of view of morbimortality, economic cost, and long-term survival.

MATERIAL AND METHODS:

Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A simple randomization system was used. The estimated sample size required per group was 21 patients. Demographic variables, risk prediction models, postoperative morbimortality, staging, complications due to the placement of stent, surgical time, clinical follow-up, health costs and follow-up of survival were recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 diagnosed with complete intestinal obstruction due to tumor in the left colon using abdominal CT scan

Exclusion Criteria:

* Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, hemodynamic instability during surgery, immunodepressed state (corticoids, chemotherapy, HIV, major surgery in the last two months) and septic shock.
Inflammatory Response in Laparoscopic and Open Colectomy

This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery


Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer

Exclusion Criteria:

* metastases
* stage 4 colorectal cancer
* recurrent disease
* chronic diseases
* obvious inflammatory condition
Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis

This study conducted a systematic clinical observation of the clinical efficacy of UCB-MNCs in the treatment of hormone-resistant or hormone-dependent ulcerative colitis, in order to observe its clinical safety and efficacy.

This study adopts a randomized and controlled clinical research design. Patients are randomly divided into conventional treatment control group and UCB-MNCs treatment test group. The control group is given conventional treatment: prednisone combined azathioprine or adalimumab; the test group is given conventional treatment combined UCB-MNCs treatment, follow-up observations were carried out, in order to observe the clinical efficacy and safety of UCB-MNCs in the treatment of hormone resistance or hormone-dependent ulcerative colitis.

Eligibility Criteria:
Inclusion Criteria:

* 1. Western medicine diagnosis is consistent with patients with refractory ulcerative colitis.
* 2. 18 Years to 65 Years，male or female.
* 3. Those who voluntarily participate in this clinical study and have signed an informed consent.

Exclusion Criteria:

* 1. Patients with non-refractory UC.
* 2. Those who are pregnant or breastfeeding, or have a childbirth plan in the near future.
* 3. People with severe allergies or allergies to known ingredients in basic treatments.
* 4. Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney, and hematopoietic system.
* 5. There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc..
* 6. Patients with mental disorders and intellectual disabilities.
* 7. Patients who have participated in clinical studies of other drugs in the past 3 months.
* 8. Those who are seriously ill and need emergency treatment.
* 9. Patients who are still undergoing other treatment options for ulcerative colitis.
* 10. Researchers believe that it is not suitable for entry.
Sexual Quality of Patients After Bladder Cancer Cystectomy

Bladder cancer is the second most prevalent urological cancer in France. About 1 in 5 new cases of bladder cancer infiltrate the muscles. The standard treatment is neoadjuvant chemotherapy followed by radical cystectomy associated with reconstruction of the urinary tract. The short-term effects on well-being and quality of life are well known. The long-term effects are, on the other hand, poorly understood, particularly sexual function. This study aim to asses the quality of sexual life in patients with cystectomy for bladder cancer. This will be done via various questionnaires given before and after surgery.

The study is a prospective observational cohort study of the quality of sexual life in patients with cystectomy for bladder cancer. Data is collected via Qlq-C30, EORTC-Shq22, MSHQ if male, Female Sexual Function Index (FSFI) questionnaires that the patients complete by themselves. They are given before surgery and then 8 months after surgery.

The study consists of the compilation of relevant clinical data and questionnaire results.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient who had a cystectomy for bladder cancer
* Affiliated with a social security scheme

Exclusion Criteria:

* No Cystectomy
* Cystectomy for neurological etiology
* Pregnant or breastfeeding women
Vacuum Device for Hemostasis in Obstetrics and Gynecology

Postpartum hemorrhage (PPH), is the leading cause of maternal mortality and is responsible for approximately 25% of maternal mortality deaths.It is defined as blood loss in excess of 500 ml following vaginal childbirth. Primary (immediate) PPH occurs within the first 24 hours after delivery.

In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. After obstetric maneuvers therapeutic, options begin with uterotonic treatments before considering invasive treatments such as embolization, vessel ligation and hysterectomy. However, the morbidity associated with these techniques and the desire to preserve fertility mean that new therapeutic solutions have been conceived, which has recently led to the development of an innovative intrauterine hemostasis medical device : a hemostatic intrauterine suction cup.

Assuming that postpartum hemorrhages are mainly due to uterine atony, we propose in this biomedical research, the study of a new medical device. Our hypothesis is that the uterine walls will append to the walls of the suction cup after the latter is put under vacuum. The actuation of the suction cup will lead to the aspiration of all sides of the uterus.

Considering that postpartum haemorrhage is an emergency situation where vital prognosis of the patient is engaged, we selected to collect the consent of the patient using an emergengy procedure.

In this study, as a first pass in human of this innovative non CE marked medical device, we aim to demonstrate the feasibility of using the hemostatic intrauterine suction cup for patients who present primary PPH (blood loss ≥ 500ml) after a vaginal delivery requiring administration of Nalador®. We will evaluate the placement of hemostatic suction cup in the uterus, the application of vacuum and its removal from the uterus.

Eligibility Criteria:
Inclusion Criteria:

* women between 18 and 45 years old
* patient under loco-regional anesthesia
* patient who presents primary postpartum hemorrhage (blood loss ≥ 500ml) after a vaginal childbirth requiring administration of Nalador®.
* affiliation to the French social security system or equivalent
* patient who has signed a consent to participate

Exclusion Criteria:

* patient with a uterine malformation
* patient allergic to silicon
* patient under general anesthesia
* patient who delivered via caesarean section
* patient with fever or suspected infection during labor
* person deprived of freedom by judicial or administrative decision
* person hospitalized without their consent
* person under legal protection
* person hospitalized for psychiatric care
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.


Eligibility Criteria:
Inclusion Criteria:

* Completed study ALK5461-217
* Be willing to abide by the contraception requirements as outlined in the study protocol
* Be willing and able to follow the study procedures and visits as outlined in the protocol
* Additional criteria may apply

Exclusion Criteria:

* Pregnant, planning to become pregnant, or breastfeeding
* A positive urine drug test for drugs of abuse
* Poses a current suicide risk
* Additional criteria may apply
Stem Cell Transplantation in Cirrhotic Patients

Chronic liver disease end by liver cirrhosis and increases the risk of cancer development. Chronic liver disease in Egypt is recognized as a serious health problem affecting greater than (20 %) of the population, where the main cause is chronic infection.

Liver transplantation is still the standard treatment for advanced decompensated liver cirrhosis. However, this treatment is quite limited in clinical practice. Therefore there is a concerted effort around the world to develop regenerative and alternative therapies, so, stem cell-based therapies are emerging as new alternatives to liver transplantation for end-stage liver pathologies.

This study aimed to transplant autologous bone marrow derived mesenchymal stem cells to the patients with liver cirrhosis to assess liver tissue regeneration, efficacy and safety of stem cell therapy and finally to establish an alternative treatment modality to liver transplantation.

Medical treatment of liver cirrhosis (the last stage of the illness) is very difficult that leads to high morbidity and mortality rate. Liver transplantation is still the most effective treatment for the patients with liver cirrhosis, However, serious problems are accompanied with liver transplantation, donor shortage, long waiting list, high cost, risk of rejection, operative complications and complications related to immunosuppressive drugs.

"stem cells" are cells in the human body that are capable to renew themselves and differentiate to a diverse range of specialized cell types and can be differentiated to specialized cells in appropriate medias in the laboratory. In recent years, advances in stem cell biology, have made the prospect of tissue regeneration a potential clinical reality, and several studies have shown the great promise that stem cells hold for therapy. mesenchymal stem cell based therapy has shown as promising tool in cirrhotic conditions as this type of cells have the ability to differentiate to different cell types including hepatocytes A series of studies have been performed to assess the application of bone marrow derived mesenchymal stem cells to promote liver regeneration and to alleviate cirrhosis. Some animal-based studies showed that stem cell transplantation could ameliorate liver fibrosis and improve liver functions followed by several clinical trials on human, in patients with advanced liver diseases, these studies demonstrated that stem cell transplantation could significantly reverse hepatic failure with only limited side effects. However, the effectiveness of this therapy in recent clinical trials is still conflicting and need further evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Decompensated liver cirrhosis child class b or c

Exclusion Criteria:

* Patients with portal vein thrombosis, or
* Recent recurrent gastrointestinal bleeding, or
* Hepatocellular carcinoma (HCC), or
* Spontaneous bacterial peritonitis
* Pregnant or lactating women
* Vital organs failure
Platelet Inhibition in the Acute Phase of STEMI

Background:

Dual antithrombotic treatment with aspirin and clopidogrel is recommended in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The European Society of Cardiology (ESC) Guidelines recommend a bolus dose of aspirin of 250-500 mg and a 600 mg bolus dose of clopidogrel as soon as STEMI is suspected. Studies have shown that more newly produced platelets are present in the acute phase of STEMI, and it is likely that these immature platelets are haemostatically more active and might be of importance in thrombus formation.

The enhanced platelet reactivity may reduce the effect of aspirin and clopidogrel in the acute phase of STEMI compared to measurements made in the same patients 3 months after primary PCI.

Aim:

This study aims to compare platelet response to aspirin and clopidogrel in the acute phase of STEMI with the platelet response in the same patients 3 months after STEMI .

Design:

This study is an observational follow-up study.

Materials and methods:

46 patients with STEMI referred to primary PCI at Aarhus University Hospital, Skejby will be included in the study. A total of 3 blood samples are obtained in the acute phase of STEMI: Prior to primary PCI (Blood sample 1), at 4 hours (Blood sample 2) and at 12 hours (Blood sample 3) after administration of loading dose aspirin and clopidogrel. When patients are in a stable phase 3 month later, a final blood sample is taken (Blood sample 4). The blood is analyzed 30 minutes after withdrawal of blood by the platelet aggregation test Multiplate® aggregometry (agonists: Collagen, arachidonic acid and adenosinediphosphate) and VerifyNow® arachidonic acid and P2Y12 aggregometry. Platelet count, volume and the immature platelet fraction (IPF) will be measured using Sysmex® flowcytometry.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Patients with ST-segment elevation myocardial infarction (STEMI) referred to primary PCI at University Hospital of Aarhus, Skejby.

Exclusion Criteria:

* Treatment with NSAID, ticlopidine and dipyramidole.
* Treatment with anticoagulants (Vitamin K antagonists)
* Patients diagnosed with platelet disease or haemophilia.
* Patients unable to give written, informed consent to participation in this project.
Efficacy of Different Low Level Laser Therapy Sessions

Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function.

Low-level laser therapy has been a research focus in past few years as it provides effective and conservative treatment modality with minimal patient discomfort. LLLT promotes the release of endogenous opioids, enhance tissue repair and cellular respiration, increase vasodilatation and pain relief Recent systematic review and meta-analysis had reported that the available evidence didn't allow clinicians to draw firm conclusions on effective dosage. This study aimed to investigate the effect of different LLLT sessions' number on pain, maximum mouth opening and quality of life in patients with masseter muscle trigger points.

Eligibility Criteria:
Inclusion Criteria:

1. definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
2. presence of one or more trigger points in the masseter muscle
3. no history of any invasive procedures of the related masseter muscle.

Exclusion Criteria:

1. any painful conditions affecting the orofacial region
2. any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy)
3. pregnancy and lactation.