cyrilzakka/clinical-trials huggingface dataset:
Effectiveness Study of Psychotherapy in Systemic Lupus Erythematosus

Psychosomatic is a new approach to understanding the phenomena of somatization using the knowledge of medicine and psychology to treat human being. A Brief Group Psychanalytic Psychotherapy (BGPP) for psychosomatic patients has been used to supplement the treatment of some diseases including Systemic Lupus Erythematosus (SLE). The hypothesis of the study is that BGPP beside clinical treatment can improve the quality of life and coping in SLE patients. The aim of the study is to evaluate the effectiveness of BGPP in Brazilian SLE patients.

Primary objective: To evaluate the effectiveness of BGPP to improve quality of life. Secondary objectives: To evaluate the effectiveness of BGPP to improve coping, anxiety and depression symptoms. SLE patients will be randomized to receive Psychotherapy or only clinical treatment. The effectiveness will be assessed through specific questionnaires.

This is a prospective randomized clinical trial. Patients with SLE (ACR criteria, 1997) treated at Rheumatology Division out-patient clinic of a university hospital were enrolled. A sample of 80 patients was assessed at the beginning of the study (baseline) and will be re-evaluated after 20 weeks (final) by clinical and psychological scales. Patients were randomized by computer program and divided into experimental group (EG) and control group (CG). Patients of both groups continued their medical treatment at the clinic. EG will be treated with BGPP for 20 sessions once a week for 20 consecutive weeks in small groups. The control group will be on a waiting list until the end of the study and will be treated subsequently.

Inclusion criteria:

* Female gender
* Four or more ACR criteria for classification of SLE
* Age above 18 years
* Follow-up at the clinic for at least 6 months

Exclusion criteria :

* Illiterate patients
* Mental or physical comorbidities that compromise their participation

Evaluation:

The following scales (adapted and validated for Portuguese Language) were being applied for a blinded evaluator to assess patients at baseline and after 20 weeks:

* Systemic Lupus International Disease Activity - SLEDAI Bombardier,1992);
* Systemic Symptom Checklist (SSC)(Freire, 2008);
* Systemic Lupus Erythematosus Quality of Life - SLEQOL (Freire, 2008);
* Coping strategies inventory of Folkman and Lazarus (Savoia,1996).
* Hospital Anxiety and Depression (Botega, 1995);
* Vital events scale of Holmes and Rahe (1967) (Savoia, 1995) and

Comparisons inter and intra groups were being analyzed using the Q square test for categorical variables and Student's t test, Mann-Whitney, Wilcoxon or ANOVA for quantitative variables. P values \<0.05 will be considered as significant.

Eligibility Criteria:
Inclusion Criteria:

* Female patients,
* SLE (ACR criteria)
* over 18 years old
* followed up at the clinic for at least 6 months

Exclusion Criteria:

* illiterate patients,
* patients with mental or physical comorbidities that compromise their participation
Follicular Flushing in Patients With Suboptimal Responses

The aim of the present study is to determine the effect of follicular flushing on the ongoing pregnancy rate in patients who developed four or fewer follicles of 14mm following standard ovarian stimulation for IVF.

Oocyte aspiration under the guidance of transvaginal ultrasound is an integral part in IVF treatment. Follicular flushing has been advocated. However, subsequent data from randomized trials failed to demonstrate any benefits with routine follicular flushing in normally responding patients. Instead, it has been shown to prolong the operating time, increase the procedure-related pain and analgesics requirement. Most of the IVF centers no longer perform routine follicular flushing in normally responding patients.

The potential role of follicular flushing in patients with a limited number of developing follicles is conflicting based on the recently published randomized trials. The aim of the present study is to determine the effect of follicular flushing on the ongoing pregnancy rate in patients who developed four or fewer follicles of 14mm following standard ovarian stimulation for IVF.

Eligibility Criteria:
Inclusion Criteria:

1. Age of women \<43 years
2. Normal uterine cavity on saline sonogram
3. Endometrial thickness \>=8mm on the day of hCG

Exclusion Criteria:

1. Planned not to have fresh embryo transfer
2. Cycle cancelled prior to hCG administration
3. Natural cycle IVF
4. Presence of hydrosalpinges on scanning which are not surgically treated
5. Presence of endometrial polyps on scanning
6. Undergoing preimplantation genetic diagnosis
Effect of Xen Implantation on the Aqueous Humor Proteome

The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma.

The purpose of this study is to determine how the aqueous humor proteome changes after implantation of a Xen microstent for treatment of glaucoma using liquid chromatography mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of any racial or ethnic origin, 18 years or older
* Able to provide written informed consent.
* Scheduled to undergo Xen implantation for open angle glaucoma or already has an aqueous shunt

Exclusion Criteria:

* History of conjunctivitis or any ocular infection within the past 3 weeks.
* Any active inflammation of the cornea or the anterior chamber (uveitis)
N-Terminal Pro-brain Natriuretic Peptide Hormone and Persistent Pulmonary Hypertension

Babies who are suspected of having persistent pulmonary hypertension (PPHN) will be included in this study. PPHN is a condition in which the blood is restricted from flowing to the lungs in a normal way making it hard for babies to breath and placing strain on the heart. This study will observe whether certain hormones that measure stress (N-terminal pro-brain natriuretic peptide) can help determine how well a baby will do when they have PPHN.

PPHN occurs in infant \> or = 34 weeks gestation and is characterized by an elevation in pulmonary vascular resistance (PVR) and right-to-left shunting of the blood at the atrial, ductal, and pulmonary levels, leading to hypoxemia. Management of these infants is complex (and the clinical course) is often difficult to predict.

Brain natriuretic peptide (BNP) is a cardiac hormone that is secreted from cardiac myocytes and cardiac fibroblasts. Upon activation, the prohormone is cleaved into a biologically active BNP and an inactive N-terminal proBNP (NT-proBNP). BNP and NT-proBNP levels are increasingly being used for diagnostic purpose in adults and have been correlated to adult pulmonary hypertension. Multiples studies have been performed to determine normal values for NT-proBNP in the pediatric population. One study measured NT-proBNP levels in umbilical cord blood during the second trimester and at delivery of uncomplicated pregnancies and determined normal reference values of NT-proBNP. It is thought that NT-proBNP has potential for use in term infants with PPHN.

The objective of this research is to correlate NT-proBNP levels to left ventricular dysfunction in term infants with PPHN. Secondarily, we want to assess the possible use of NT-proBNP to predict response to inhaled nitric oxide and the ability to successfully wean off inhaled nitric oxide.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 34 weeks gestation at birth
* clinical diagnosis of PPHN

Exclusion Criteria:

* newborns with evidence of structural heart disease, congenital anomalies and prior use of inhaled nitric oxide.
Natural History Protocol for Movement Disorders

Background:

A movement disorder is a condition that causes a person s body to move in ways that are not normal. There are different types. Some disorders cause movements people can t control, such as tics or shaking. Some cause reduced or slow movements. Movement disorders can cause disability in people. Sometimes members of the same family will have the same disorder. Researchers want to learn more about how people develop these disorders. This research could lead to better treatments.

Objective:

This natural history study will collect data on people with different types of movement disorders. It will also collect data on their family members. The data will support further research.

Eligibility:

Children and adults aged 2 years and older who have a movement disorder. Family members of people with movement disorders are also needed.

Design:

Participants will undergo screening. They will have a physical exam. Researchers will look at their existing medical images. Any photographs or videos of their movements will also be reviewed.

Most participants will come to the NIH clinic for only 1 visit. They will answer questions about their condition. They will have normal tests used to diagnose their condition. They may have blood tests and different types of imaging scans. They may have tests to see how well their nerves function. The tests used will depend on the type of disorder they have.

Family members will have some of the same tests as people with disorders.

Participants will not receive any new treatments.

Some participants may be asked to return for a follow-up visit.

Up to 4000 people may participate.

Study Description:

This is a Natural History and Screening protocol for movement disorders, no research procedures will be done but the resulting data will be used for research.

Objectives:

Primary Objective: To collect data as part of standard of care evaluation of patients who have or are suspected to have a movement disorder and their family members for use in future secondary research.

Endpoints:

Collection of data from clinical/routine care that will contribute to/be used for future research.

Eligibility Criteria:
* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 2 and above
* Either one of these:

  * Have or suspected to have a diagnosis of a movement disorder.
  * Family member of someone who has or is suspected of having a diagnosis of a movement disorder.
* Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

An individual who meets the following criteria will be excluded from participation in this study:

-Being \< 2 years old.
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures


Eligibility Criteria:
Inclusion Criteria:

* Completion of study A9451162 (NCT00603473)

Exclusion Criteria:

* Seizures related to drugs or acute medical illness
* History of any serious medical or psychiatric disorder
A Study of Tooth Erosion in People With Esophagogastric Cancer

The researchers are doing this study to find out more about what may lead to the loss of tooth enamel (the thin outer covering of the tooth) and how often it happens in people with esophagogastric cancer, colorectal cancer, pancreatic cancer, breast cancer, head and neck cancer, or non-small cell lung cancer, or a healthy volunteer.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to provide written informed consent.
* Patients with a history of esophagogastric, HNSCC, PDAC, CRC, or NSCLC or healthy controls
* Patients must be able to fully comprehend and complete the survey and be willing to have pictures taken of their teeth with a camera or intra-oral camera.
* Patients must be able to understand English language or have access to adequate translation services.
* Age ≥ 18 years old.

Exclusion Criteria:

* Subjects without evaluable molars or with significant molar dental work precluding dentists from assessing enamel status, Note: evaluable is defined as having bilateral assessable mandibular molars, or erosions present in the remaining assessable quadrants.
* For healthy controls only, patients cannot have a non-skin cancer history nor presenting for a procedure evaluating reflux symptoms.
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine

Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.

The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.

The primary objective for the IgG adsorber GLOBAFFIN® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Informed consent signed and dated by study patient and investigator/authorised physician
* Ability to understand the nature and requirements of the study
* Treatment with one of the immunoadsorber system GLOBAFFIN® according to the intended use.

Exclusion Criteria:

General:

* Any condition which could interfere with the patient's ability to comply with the study
* In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required)
* Participation in an interventional clinical study during the preceding 30 days.
* Participation in an interventional clinical study with pharmacological active substances (e.g. therapeutic antibodies) during the preceding 60 days.
* Any deviation from the intended use

Study-specific:

Any contraindication listed in the valid instruction for use:

* Hypersensitivity or allergy against any materials used in either the immunoadsorber column or the extracorporeal circuit
* Inability to withstand the stress of an extracorporeal treatment procedure due to their age, their physical developments or their clinical constitution
* Previously demonstrated hypersensitivity associated with therapeutic apheresis
* No suitable anticoagulation treatment, such as due to known hypersensitivity to heparin or ACD-A
* Haemorrhagic diathesis in which extracorporeal apheresis procedures and anticoagulation performed have a high bleeding hazard
* Severe cardiovascular disease, so that extracorporeal treatment is not possible
* Acute, systemic infection
A Single Mindfulness Meditation Session in Preoperative Anxiety : Effects on the Autonomous Nervous System

Anxiety is an emotional disorder. It's a painful concern caused by uncertainty. It is a complex phenomenon misunderstood in spite of medical progress. Relaxation is a technical for reduce anxiety and is effective and safe. Previous study demonstrated the impact of session relaxation on the autonomous nervous system by the heart rate variability.

Primary objective of this new study is to demonstrate a link between heart rate variability and reduced anxiety during relaxation session.

It is monocentric, prospective and interventional study. This study will be proposed at the patients who will have an orthopedic surgery in full hospitalization. These patients are anxious because of surgery too. The day before surgery anesthetist save heart rate variability and value of the partial pressure of carbon dioxide during relaxation session.

Eligibility Criteria:
Inclusion Criteria:

* Affiliated or entitled to a social security
* Have signed consent before their participation in the study
* Aged over 18 years
* Patients who will have an orthopedic surgery in full hospitalization
* Patients anxious on visual analogic scale of anxiety (\>5)

Exclusion Criteria:

* Different disorder : disability to understand instructions, respiratory insufficiency, obesity, sleep apnea, wearing a pacemaker
* Medical history of schizophrenia or bipolar disorder
Efficacy Study of Nebulized Morphine and Intravenous Morphine in Post Traumatic Pain

In the emergency department, 60% of patients have an acute pain. Appropriate management of acute pain is a public health priority according to who recommendations. Nebulized morphine has been extensively studied in children but less well in adults.

It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than intravenous (IV) method.


Eligibility Criteria:
Inclusion Criteria:

* Post-traumatic pain with visual analog pain scale( VAPS) ≥ 50%
* Age between 8 and 50 years.

Exclusion Criteria:

* Glasgow coma scale (GCS)\< 14,
* Severe injury ,
* Hypotension : blood systolic pressure \< 90 mmhg,
* Bradypnea \< 12 cpm or SaO2\< 90%,
* Chronic pain treatment,
* Aspirin or paracetamol treatment within 6 hours of emergency presentation,
* Nasal trauma, rhinitis, nasal obstruction,
* Incapacity to cooperate,
* Opiate allergy,
* Drug addiction,
* Pregnancy, breast feeding,
* Severe renal and liver failure and chronic obstructive pulmonary disease(COPD)
Effect Study of Modified Transoesophageal Echocardiography on Cerebral Embolization After Cardiothoracic Surgery

Patients undergoing cardiac surgery frequently develop neurologic complications, ranging from subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of complications is commonly caused by embolization in the brain due to manipulation of atherosclerotic parts of the aorta ascendens (AA) during surgery. Timely detection of AA atherosclerosis before surgery enables the surgeon to consider changes of the surgical plan, to reduce the risk of embolization and thus subsequent neurologic complications.

Various methods exist to visualize the AA to detect atherosclerosis. Epiaortic ultrasound scanning has become the gold standard, but is seldom used as it interferes often with surgical plan and can only be used after sternotomy. Transesophageal echocardiography (TEE) is a widely used imaging method permitting evaluation of the aorta preoperatively, but assessment of distal AA is hampered by interposition of air-filled trachea between esophagus and AA. The A-View® (Aortic-view) method, a modification of conventional TEE using a fluidfilled balloon, overcomes this limitation. The safety and diagnostic accuracy of the A-View® have successfully been shown in previous studies. The hypothesis of this study is that the use of A-View will reduce cerebral embolization secondary to a change of surgical technique.


Eligibility Criteria:
Inclusion Criteria:

* Isolated CABG
* Elective surgery
* Stroke Risk Index \<75(Newman, '96)

Exclusion Criteria:

* Other than isolated CABG
* Contra-indication for TEE
* Contra-indication for A-View
* Contra-indication for MRI
Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease

The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years inclusive at the time of signing the ICF
* Allogeneic SCT 90 to 180 days prior to enrollment
* Able to comprehend and willing to provide informed consent
* Willing and able to complete participant-assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel

Exclusion Criteria:

* There are no exclusion criteria for this study
A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator

This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
* Males and Females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
* HbA1c must be ≥7.5% and ≤10% at screening
* Fasting Plasma Glucose must be \<240 mg/dL at screening

Exclusion Criteria:

* History of type 1 diabetes
* History of diabetic ketoacidosis
* NYHA Class III or IV cardiac status or hospitalization for congestive heart failure within 6 weeks prior to Visit 1
* Treatment with any non-peroxisome proliferator-activated receptor (non-PPAR) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
* Treatment with rosiglitazone, pioglitazone, or any PPAR investigational antidiabetic agent within 6 month prior to screening
* Body mass index \>45 kg/m2
* Fasting triglycerides \>500 mg/dL
* Uncontrolled hypertension (sitting systolic blood pressure \>160 mmHg and/or sitting diastolic blood pressure \>100 mmHg
* Presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)
Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)

This will be a randomized clinical trial examining the efficacy and safety of ARAT (intervention group) in patients with chronic GERD symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months.

Patients must have a positive pH test and a negative manometry (no treatment) procedure.


Eligibility Criteria:
Inclusion Criteria:

* Chronic GERD symptoms (at least 1 typical symptom of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for last 6 months
* Objective evidence of reflux disease (positive ambulatory pH study.)

Exclusion Criteria:

* Patients unable to or unwilling to participate or consent.
* Age \<18 years or \>80 years.
* Allergic or intolerant to PPI medications.
* Large hiatal hernia \> 3 cm and Hill grade IV.
* Barrett's esophagus.
* Esophageal stricture with any prior intervention.
* Major motility disorder.
* Eosinophilic esophagitis.
* Gastroparesis documented by abnormal gastric emptying time.
* Previous fundoplication, myotomy or LINX surgery.
* Cirrhosis with esophageal and/or gastric varices.
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.

This study consists of a 12-week Treatment Period followed by 4-week Randomized Withdrawal (RW) Period.

Eligibility Criteria:
Inclusion Criteria:

* Patient has no clinically significant findings on a physical examination and clinical laboratory tests
* Female patients of childbearing potential must agree to use one of the following methods of birth control:

  1. Hormonal contraception
  2. Double-barrier birth control
  3. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy
* Patient meets protocol criteria for diagnosis of IBS-C
* Patient demonstrates continued IBS-C symptoms through Pretreatment Period
* Patient maintains a minimum level of compliance with daily diary

Exclusion Criteria:

* Patient has history of loose or watery stools
* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments