cyrilzakka/clinical-trials huggingface dataset:
Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Mental Illness

Insomnia is common in patients with co-morbid mental illness and sleeping difficulties is a frequent complaint in most psychological disorders. Mental illness may cause sleep problems, however, sleep problems like insomnia, may also cause or exacerbate mental illness. Insomnia may aggravate symptoms of depression, anxiety and fatigue, and reduce daily functioning in patients with co-morbid insomnia and mental illness. This project aims to evaluate a course offered to patients with insomnia and mental illness at Diakonhjemmet Hospital. The course is based on cognitive behavioral therapy, a documented treatment for insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years with insomnia and co-morbid mental illness.
* Is a patient and receiving treatment for mental illness at Department of Psychiatry, Diakonhjemmet Hospital, at time of referral to the course

Exclusion Criteria:

* Unable to provide informed consent
* Unable to read and/or understand Norwegian
* Unable to complete a survey
* Severe mental disorder, e.g. schizophrenia and bipolar disorder type I
* Mental retardation or dementia
* Known substance abuse
* Other sleep disorder, e.g. narcolepsy and hypersomnia
Treatment Protocol of Child SAA With the Injection of Mesenchymal Stem Cells（Umbilical Cord Derived）

Mesenchymal Stem Cells (MSC) is a non Hematopoietic Stem Cells (HSC) in adult bone marrow and takes part in the bone marrow microenvironment. The response rate of early treatment on Children's SAA application combined with anti-thymocyte globulin (ATG) (40-50 days after ATG treatment) is associated with long-term effect. The injection of Umbilical Cord Derived Mesenchymal Stem Cells combined with ATG improves the efficacy of children with SAA.

1. Mesenchymal Stem Cells were prepared by in vitro separation, screening, and culture from healthy human umbilical cord tissue; The " injection of mesenchymal stem cells (umbilical) manufacturing and verification regulation " was also formulated.
2. The starting dose of Umbilical Cord Derived MSC was 0.5-1.0 \* 106 cells /kg, based on the previous human studies; And the maximum tolerated dose was 1 \* 107 cells /kg
3. The response and complete remission rate, relapse rate of the injection of Umbilical Cord Derived Mesenchymal Stem Cells (or combined with ATG ) for Child with SAA were determined.

Eligibility Criteria:
Inclusion Criteria:

* Non-Severe Aplastic Anemia (NSAA)atients

Exclusion Criteria:

* Severe Aplastic Anemia (SAA) patients
Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery

This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected.

The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique.

Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique.

Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique.

This will be a single-center, single-blinded randomized controlled trial evaluating the impact of peritoneal entry technique on insufflation times, entry failure, post-operative pain and surgical outcomes among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that the blunt fascial entry technique will be associated with shorter insufflation times with no effect on other surgical outcomes. The study will include 2 groups corresponding to the entry techniques: blunt facial entry and Veress needle entry. Participants will be 1:1 allocated to each technique by block randomization.

Blunt fascial entry technique description: a 5 mm incision is made in the umbilicus. Next, a curved Kelly forceps is used to open the fascia, and, if possible, the peritoneum. The Kelly forceps are then used to expand the opening to a 10 mm diameter. A 5 mm trocar is placed into the fascial hole and used to quickly insufflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. 18 years of age or older
4. Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.

Exclusion Criteria:

1. Pregnancy
2. Urgent/non-scheduled surgery
3. Non-eligible for umbilical entry
Follow-up of Myocardial T1 Relaxation Time in Patients With Anderson Fabry Disease

Anderson Fabry disease (AFD) is an X-linked lysosomal storage disorder caused by a deficiency of the enzyme alpha-galactosidase. AFD can involve various organs and lead to a series of clinical abnormalities. Left ventricular hypertrophy in middle-aged men is one of its life threatening complications. It was shown that pending the absence of myocardial replacement fibrosis, substitution therapy could improve myocardial morphology and function as well as exercise capacity. Today, there is no available marker of the efficacy of the treatment on the heart morphology and function.

The T1 time (or longitudinal relaxation time) is one of the major components of the image formation in Magnetic Resonance Imaging (along with T2 time and proton density). Several techniques have been described to assess the myocardial T1-time.

One of them called MOLLI (Modified Look Locker Inversion Recovery), was made available in research centres by the Siemens company. In a study published in 2013, Sado et al. showed in a series of various conditions (hypertension, AFD, hypertrophic cardiomyopathy, AL amyloidosis, aortic stenosis and healthy volunteers) that a septal T1 below a threshold of 940ms could discriminate AFD patients. No overlap was shown with other conditions in this study. Our experience with T1 mapping supports that finding (even though our threshold could be slightly different), and we could recently detect by MRI a number of AFD patients, some of them with hypertrophy, some others without hypertrophy. The effect of Replagal® on the T1 relaxation time remains unknown.

The purpose of that study was to follow-up the heart morphology, function and myocardial T1 relaxation time in a population of treated/untreated patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient with proven Anderson Fabry Disease
* Patient with no Agalsidase alpha (Replagal®) treatment or
* Patient with Agalsidase alpha (Replagal®) treatment ongoing

Exclusion Criteria:

* Pace Maker / Implantable Cardiac Defibrillator
* Claustrophobia
* Ocular foreign body
* Allergy to gadolinium chelates
* Pregnancy ongoing
* Age \< 18 years l
Study of Drug Combination on Pharmacokinetics in Healthy Volunteers

The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form

   a) Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.
2. Target Population

   a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results.
3. Age and Reproductive Status

   1. Males and females, ages 25 to 55 years, inclusive.
   2. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
   3. Women must not be breastfeeding.

Exclusion Criteria:

1. Any significant acute or chronic medical illness.
2. Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion).
3. Any major surgery within 4 weeks of study drug administration.
4. Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration).
5. Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.

The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:

1. Is Intralesional acyclovir safe for plantar warts?
2. Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy?


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older, of both genders, with plantar warts

Exclusion Criteria:

* Patients on systemic treatment for warts eg. Acitretin, Acyclovir
* Hypersensitivity to Acyclovir
* Previous treatment to the same wart during the last 3 months
* Immunocompromised patients (as HIV, steroid intake, uncontrolled diabetes, etc.)
* Pregnant and breastfeeding females
* Cognitively impaired patients
Borrelia Species in Cutaneous Lyme Borreliosis

The aim of this study is to identify the species of Borrelia involved in the dermatologic manifestations of Lyme borreliosis in France. Indeed, in Europe, as opposed to North America, many bacterial species are involved in Lyme borreliosis. Yet, very few is known about the prevalence and distribution of different bacteriological species that account for the disease in France. Thus, this a nation-wide study in which all French dermatologists are invited to participate. Every adult patient presenting with one of the cutaneous manifestation of Lyme borreliosis: erythema migrans, lymphocytoma or acrodermatitis chronica atrophicans can be included in the study. If the patient agrees participating, after information and written consent, a cutaneous biopsy will be performed in order to isolate Borrelia by means of culture and PCR. An estimated 400 biopsies should be performed within 2 years.


Eligibility Criteria:
Inclusion criteria:

* Informed adult patient who signed written consent with one the following conditions:
* erythema migrans
* borrelial lymphocytoma
* acrodermatitis chronica atrophicans

Exclusion criteria:

* pregnancy or lactation
* allergy to local anesthesia
* patient who refuses biopsy
Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The investigators are going to investigate the effect of subcostal TAP on early postoperative pain after laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Age 20-65 patients scheduled elective laparoscopic cholecystectomy

Exclusion Criteria:

* Patient refusal
* Allergy to ropivacaine
* Coagulopathy
* Morbid obesity (BMI\>35 kg/m2)
* Previous abdominal surgery.
Endothelial and Metabolic Effects of Glucagon-like Peptide-1 (GLP-1) in Coronary Circulation in Patients With Type 2 Diabetes Mellitus

GLP-1 is an incretin hormone which is discharged from the intestines after food intake. The hormone is known for its powerful insulinotropic and trophic effects on the beta cells in the pancreas and is currently used as an anti-diabetic agent in patients with type 2 diabetes (T2DM).

GLP-1 receptors are widely distributed including on the endothelial cells in both coronary and skeletal muscle circulation and on the myocardium. GLP-1-receptor studies on knock-out mice have shown that they exhibit a reduced myocardial contractility and reduced diastolic heart function. GLP-1 also shows beneficial cardiovascular effects in patients with acute myocardial infarctions and dogs with dilated cardiomyopathy in that the left ventricle function and endothelial dysfunction improves after GLP-1 treatment via insulin-independent mechanisms. Preclinical studies indicate that exogenous administrated GLP-1 in physiological concentrations can improve perfusion but this has never been tested in humans. It is also unknown whether GLP-1 can directly increase the glucose/metabolite uptake across both cardiac and skeletal muscle in an insulin independent manner. Unpublished studies do however indicate that the improvement in the cardiovascular system is largely dependent upon a high blood glucose level and only partially dependent upon the antiglycemic effects of GLP-1.

In the proposed studies the investigators wish to examine the physiological role of GLP-1 receptor stimulation both with regard to perfusion, metabolic improvement as well as cardiac inotropic. These studies will be conducted in both healthy and in T2DM patients.


Eligibility Criteria:
Inclusion Criteria:

* Caucasians over 18
* Emitted for non-acute coronary arteriography (CAG) in Gentofte hospital
* BMI 23-35 kg/m2
* Normal hemoglobin
* Who gives informed consent
* Those with type 2 diabetes: HbA1c 6-10%
* Those without type 2 diabetes: Normal oral glucose tolerance test (OGTT) according to WHO criteria

Exclusion Criteria:

* Liver disease (ALAT \> 2x normal)
* Diabetic nefropati (Creatinine \> 130 µM or albuminuria)
* Treatment with medicine that cannot be paused 12 hours before intervention
* Pregnancy or breastfeeding
* Insulin- or glitazone treatment
* Healthy controls: close family history with diabetes
* Unstable angina pectoris
* Non-STEMI
* Atrial fibrillation
* Valvular disease
* LVEF \< 50%
* Severe systemic disease
* Type 1 diabetes
The Relationship Between Moderate-to-severe Psoriasis and Sleep Disturbance

Psoriasis is a common chronic and systemic immune-mediated disease, induced by a combination of genetic and environmental effects. The increasingly worrying question is the negative impact on patients' sleep, which has become an important comorbidity of psoriasis. To investigate the causal relationship between psoriasis and sleep status, a prospective cohort study will be conducted by separating moderate-to-severe psoriasis patients and healthy individuals into distinct cohorts in order to observe their sleep status.

Target follow-up duration for the study is 24 weeks, during which participants will undergo a sleep monitoring session every 8 weeks. The sleep monitoring data collected includes time to fall asleep, time to bed, sleep perception, and the Pittsburgh Sleep Quality Index (PSQI). The Dermatology Quality of Life Index (DLQI), the Psoriasis Area and Severity Index (PASI), and the Visual Analog Scale (VAS) will simultaneously be used to assess the severity of the disease in the cohort of patients with psoriasis.

Eligibility Criteria:
Inclusion Criteria:

1. In line with the diagnostic criteria of psoriasis
2. PASI\>10 or BSA\>10%
3. Understand and agree to participate in this study and sign the informed consent.

Exclusion Criteria:

1. Those with serious mental diseases, such as depression, anxiety, etc;
2. PSQI\>5 points;
3. Long term use of sedative and hypnotic drugs;
4. Patients with diabetes mellitus or severe heart, liver and kidney disease;
5. Those diagnosed with sleep disorders, such as apnea syndrome, periodic limb movement disorder, restless legs syndrome, narcolepsy, etc;
6. There are serious cardiovascular and cerebrovascular diseases, respiratory system diseases, and immune system diseases;
7. Pregnant women during pregnancy, lactation, or planned trials;
8. Those who have participated in other clinical studies or are participating in other clinical trials within 3 months;
9. Unable to cooperate with the study for any reason, such as the following situation: language understanding, unable to complete the scale tester.

If any one of the above items is met, it shall be excluded.
Prospective Study to Quantify the Change in Weight at a Pneumonia

This study is based on the change in weight of hospitalized patients knowing that the diagnosis of malnutrition based on the presence of at least one clinical or laboratory test which anthropometric measures (Evaluation of diagnostic protein energy malnutrition in hospitalized adults ANAES , Guidelines Department, September 2003; HAS Strategy supported in cases of wasting energy and protein in the elderly April 2007).

The goal of this study is to find the correlation between hospitalization and weight loss, significant risk factors for malnutrition in a situation of community-acquired pneumonia infection.


Eligibility Criteria:
Inclusion Criteria:

* cough
* Fever \> 38.5 ° C
* Tachycardia \> 100 / Min
* Chest pain lateralized
* Absence of infection high respiratory tract
* Global Impression of Severity
* Fireplace auscultatory signs (rattle crackling)

Exclusion Criteria:

* Pregnant women
* Dialysis patients
* Any patient with home oxygen or under a home care for BPCO stage 3 or 4
* Patients transferred from intensive care
* Patients with severe sepsis and requiring a "filler"
* Enteral or parenteral nutrition
Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin

The purpose of this study is:

* To observe the feasibility of biweekly oxaliplatin and infusional 5-fluorouracil (FU)/Leucovorin (LV) in patients with advanced gastric adenocarcinoma who have prior exposure to taxane, fluoropyrimidine, and cisplatin
* To determine the activity of this combination regimen.
* To evaluate the treatment-related toxicities.

There is presently no chemotherapy regimen considered to be the standard of care for patients with advanced gastric cancer. However, more and more patients will receive fluoropyrimidine, platinum, and taxane combination or sequential chemotherapy. Unfortunately, about half of the patients receiving chemotherapy are unresponsive and treatment results of salvage chemotherapy are unsatisfactory. For these patients, there are currently no established palliative chemotherapy options, and there is urgent need for novel, active, and less toxic regimens for patients with advanced gastric cancer failing front-line chemotherapy.

On these bases, we will investigate the activity of biweekly oxaliplatin and 5-FU/LV in patients with advanced gastric cancer who failed prior taxane, fluoropyrimidine and cisplatin chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven non-resectable adenocarcinoma of stomach
* Measurable disease based on Response Criteria in Solid Tumors (RECIST)
* Prior chemotherapy with taxane, fluoropyrimidine, and cisplatinum in combination or sequentially, there is no time limit for the last chemotherapy
* Age 18 to 70 years old
* Estimated life expectancy of more than 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
* Adequate bone marrow function (white blood cell counts \>4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL, hemoglobin \>9.0 g/dL, and platelets\>100,000/µL),
* Adequate kidney function (creatinine\<1.5 mg/dL)
* Adequate liver function (bilirubin\<1.5 mg/dL , transaminases levels\<3 times the upper normal limit \[5 times for patients with liver metastasis\], and serum albumin of \>2.5 mg/dL)

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* Presence or history of central nervous system metastasis
* Obvious or impending bowel obstruction (including obvious peritoneal carcinomatosis)
* Evidence of active gastrointestinal bleeding
* Other serious illness or medical conditions
Mulligan and Proprioceptive Neuromuscular Fasciliation Techiniques in Rotator Cuff Pathology

The aim of this study is to investigate the effects of Mulligan Mobilization techniques, Mobilization with Movement (MWMs) and Proprioceptive Neuromuscular Facilitation (PNF) techniques, Hold-Relax Active Movement Technique, on pain, normal joint range of motion, proprioception, scapular dyskinesia and functional status in individuals with rotator cuff syndrome.

A total of 60 people were included in the study: 20 participants in the censervative rehabilitation group (Conservative Treatment), 20 participants in the Treatment A (Mulligan Mobilization Application) Group, and 20 participants in the Treatment B (PNF Application) Group. Individuals were treated for 5 days for 4 weeks. Pain before and after treatment with Visual Analog Scale; joint range of motion with goniometer; With proprioception Angle Repetition Test; Scapular dyskinesia with Lateral Scapular Slide Test; quality of life with SF-36; shoulder functionality was assessed with the Western Ontario Rotator Cuff Scale (WORC).


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 25-75,
* diagnosed with rotator cuff syndrome,
* patients who did not have any obstacle to the evaluation parameters

Exclusion Criteria:

* having had shoulder surgery,
* presence of scoliosis,
* presence of cardiac pacemaker,
* history of recent myocardial infarction,
* presence of malignancy,
* corticosteroid treatment within the last 3 months
AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study

The purpose of this study is to verify performance claims for method comparison for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer in whole blood (WB) and plasma (PL).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
* Subjects must be 18 years of age or older.
* Subjects with expected NT-proBNP concentrations within the measuring range of NTproBNP2 assay.

Exclusion Criteria:

* Subjects known to be pregnant or breast-feeding.
* Subjects previously enrolled in the study.
* Subject, who has withdrawn consent.
A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants

The purpose of this study is to compare the taste, and the levels in blood plasma of different tablet formulations of BMS-986165 when taken by healthy adults.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
* Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of/or active liver disease
* Inability to tolerate oral medication
* History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply