cyrilzakka/clinical-trials huggingface dataset:
Therapy for Depression With Co-occurring Panic or Anxiety Symptoms

This 6-month study, with a 3-month follow up period, will compare the effectiveness of new and traditional psychotherapies for depression with panic or anxiety symptoms.

Many depressed patients also experience significant symptoms of panic or anxiety. This study will compare the effectiveness of a new therapy called interpersonal psychotherapy for depression with panic or anxiety symptoms (IPT-PS) with that of traditional interpersonal psychotherapy for depression (IPT).

Participants are randomly assigned to receive up to 24 weeks of treatment with either IPT-PS or traditional IPT. Improvements in interpersonal functioning, quality of life, and symptoms of depression and anxiety will be assessed at the end of therapy and at a 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of major depression with co-existing panic or anxiety symptoms.

Exclusion Criteria:

* History of manic episode(s). Patients who have had hypomanic episodes in the past will be accepted into the study, provided they meet other admission criteria and are not presenting in a current hypomanic or mixed episode.
* History of schizophrenia or schizoaffective disorder.
* Organic affective syndrome.
* Unspecified functional psychosis.
* Anorexia nervosa or bulimia nervosa. Patients meeting criteria for an eating disorder not otherwise specified will not be excluded.
* Chronic drug or alcohol abuse/dependence within the past 2 years. Patients with abuse related to episodes will not be excluded.
* DSM-IV criteria for borderline or antisocial personality disorder. Patients who meet criteria for other Axis II disorders will not be excluded.
* Inpatient treatment due to suicide risk or psychotic symptoms.
* Index episode secondary to the effect of medically prescribed drugs.
* Significant or untreated medical illness, including cardiovascular disorder, renal or liver disease, epilepsy, untreated hypertension, or unstabilized endocrine disease.
* Medical illness that would interfere with the best treatment strategy for the potential participant.
* Current treatment with an antidepressant. Patients on a stable dose of anxiolytics for at least 3 months prior to study participation who are able to maintain this dosage throughout the study will not be excluded.
* Pregnant and breast-feeding women will be accepted into the study, but will not be prescribed adjunctive medications.
Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is generally safe and well tolerated in adolescents with schizophrenia. This is an extension of base study P05896 (NCT01190254), which means participants must have completed participation in the 8-week base study in order to qualify for this extension study P05897. Participants in this extension study will receive open-label asenapine for 26 weeks. Throughout the study, observations will be made on each participant at various times to assess the long-term safety, tolerability and efficacy of the study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Each participant must be between 12 and 17 years of age at the time of entry on this study, however, participants in the 8-week base study (P05896 \[NCT01190254\]) who reach 18 years of age while on P05896 may be enrolled in this extension study provided all other inclusion/exclusion criteria are met.
* Must have completed the 8-week efficacy and safety trial (P05896 \[NCT01190254\]) and, according to the investigator's judgment, would benefit from long-term treatment.
* Must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the 8-week trial (P05896 \[NCT01190254\]), in the opinion of the investigator.

Exclusion Criteria:

* A female participant must not be pregnant and must not have the intention to become pregnant during the trial.
* A participant must not be at imminent risk of self-harm or harm to others.
* A participant must not currently be under involuntary inpatient commitment.
Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities

There are very few studies on emotion management in chronically ill patients. They usually include small sample size (less than 30 persons) and are not randomized controlled trials. However, emotion management is an essential coping skill in mental well-being and quality of life and is the subject of numerous studies in psychology.The investigators hypothesized that a creative and physical activities combination in chronically ill will promote the strengthening of emotion management skill. The investigators will conduct an innovating study combining quantitative and qualitative variables in a randomized controlled trial to confirm our hypothesis.

1. Surveyors will conduct a first interview with patients (within an association "La Fabrique Créative de Santé" that provides free activities to chronically ill) , in order to collect data on emotion management and quality of life perception and to assess expectations regarding the activities. At the end of the interview, patients will be randomized in two groups.
2. In arm 1, patients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during the following six months.
3. In arm 2, patients will follow the same pattern but will start activities 6 months later.
4. After 6 months data on patients emotion management and quality of life perception will be collected again and interviews will be conducted regarding their overall satisfaction of the activities.
5. Every six months during one year, data will be collected by mail or e-mail.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and over
* Chronical illness
* Followed by a physician from Nantes University hospital

Exclusion Criteria:

* Having already taken part in activities within the association "La Fabrique Créative de Santé"
* Mental illness
mNGS for Detection of Pathogens for Pulmonary Infection

Pulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases. Metagenomic Next-generation Sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. The study is designed observationally to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional paradigm of serial tests wil be performed.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary infection as the primary diagnosis
* Bronchoalveolar lavage fluid can be obtained

Exclusion Criteria:

* when the primary diagnosis is tumor or connective tissue diseases
* microbiological diagnosis is confirmed before bronchoalveolar lavage
* not enough bronchoalveolar lavage fluid for mNGS
New Treatment of Alopecia Areata

Abstract: Alopecia areata is believed to be an autoimmune disease resulting from a breach in the immune privilege of the hair follicles causing non scarring hair loss.

Methods: our study included 40 patients from may 2019 to july 2022 diagnosed clinically, dermatoscopically and pathologically as alopecia areata Data were enrolled from department of dermatology and venereology, Al-Hussein hospital.

For each patient the following will be done :

1. History taking including ( age, sex, disease duration, family history, history of drug intake, smoking and history of any associated disease ).
2. All patients will give a written, informed consent for induction.
3. Basic photographs will be taken to assess site, size (by cm), number, Extent of the patch using D5300 camera with lens (18-55).
4. Patients will be subjected to 3 session of trichloroacetic acid (TCA) 35% one month apart.
5. serial photographs and dermoscopic examination every month will be done and patient will be score.
6. Efficacy will be assessed using prognostic scoring system for density, pigmentation, and texture of growing hair.
7. histopathological examination will be done before the first session and one month after third session.

Eligibility Criteria:
Inclusion Criteria:

* Alopecia areata multilocularis and alopecia totalis. Age from 16-60 years old. Ophiasis pattern alopecia areata.

Exclusion Criteria:

* Age less than 16 and more than 60years old. Alopecia areata of the face.
* Patient under treatment.
the Possible Effect of the Antiviral Inhibitors for Treatment of Hepatitis C Virus Infection in Cardiac Function

It has been known for many years that the heart and the liver are intimately related. There is a mutual interaction between the function of the heart and the liver and a broad spectrum of acute and chronic entities that affect both the heart and the liver. Chronic hepatitis C virus infection affects more than 3% (170 million) of the world's population.

Assessment of systolic function by echocardiography will be done to 100 hepatitis C virus infected patients who receive antiviral treatment (sofosbuvir and daclatasvir) by biplane simpson's method and by speckle tracking.

Assessment of diastolic function by echocardiography to 30 hepatitis C virus infected patients who will not receive antiviral treatment, by left atrium volume , mitral inflow pattern , tissue doppler annular early and late diastolic velocities .

Eligibility Criteria:
Inclusion Criteria:

1. patients on continuous regimen (Sofosbuvir and daclatasvir) for 3 months
2. normal baseline trans thoracic echocardiography
3. normal Electrocardiography

Exclusion Criteria:

1 - Diabetes mellitus, hypertension and chronic kidney disease. 2- Hepatitis C virus patients with any baseline Electrocardiography abnormality.

3- Patients with underlying any structural heart disease.
Improving Caries Risk Using Propolis-containing Versus Fluoride-containing Toothpastes in High Caries Risk Patients

This study will be conducted to evaluate the effect of Propolis-containing toothpaste in comparison to Fluoride-containing Toothpaste by caries risk assessment in high caries risk patients.

A total of 40 patients will be assigned in this study. Patients will be randomly divided into two groups according to type of Toothpaste (A) where group A1 patients will use propolis containing toothpaste twice daily while group A2 patients will use fluoride containing toothpaste twice daily as control with 20 patients in each group. Each group will be further divided into three groups according to caries risk assessment times (T) where T0 represents caries risk assessment of patients before application of propolis and fluoride toothpastes and T1 represents caries risk assessment of patients after three months of application of propolis and fluoride toothpastes, T2 represents caries risk assessment of patients after six months of application of propolis and fluoride toothpastes.

Both Propolis containing toothpaste and fluoride containing toothpaste will be placed in concealed tubes. The tubes will completely wrapped by plain white tape to conceal the formulation of toothpaste. Participants are given the tubes of toothpaste and soft brush with a coloured mark at 2 cm length of the bristle surface. The technique can be summarised in four steps:

1. 2 cm of the toothpaste will be squeezed over the wet toothbrush bristles
2. The upper and lower teeth will be brushed for 2 min;
3. After brushing, the remaining toothpaste foam and saliva "slurry" will be swished around the dentition with active movements of the cheeks, lips and tongue, forcing the slurry in between the teeth for about 20 seconds before expectorating the slurry
4. No post-brushing water rinsing will be carried out All these steps will be presented in a reminder card and all patients will put a tick mark for every step.

Eligibility Criteria:
Inclusion Criteria:

* Participants should be over 18 years of age.
* Participants should be high caries risk.
* Systematically healthy.
* Not taking any medication interfering with saliva secretion.
* Participants who signed informed consent.

Exclusion criteria:

* Participants with a compromised medical history.
* Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
* Severe or active periodontal disease.
* History of allergies or other adverse reactions to propolis, or oral care product or their ingredient.
Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE

A Study to Investigate the Tolerability, Safety,Pharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus ； GR1603 injection is a monoclonal antibody targeting IFNAR1, which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus.

This is a Phase Ib/Ⅱ,double blind, multiple-dose study to evaluate the pharmacokinetics (PK), safety，tolerability and efficacy of intravenously administered GR1603 in participants with active SLE despite receiving standard of care .

Phase Ib is a multi-dose escalation phase in which 16 subjects are scheduled to enroll.

A total of 120 subjects were randomly assigned to GR1603 injection low dose group, high dose group or placebo group in phase Ⅱ.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE according to the ACR 1997 ≥24 weeks
* Active moderate to severe SLE
* At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.

Exclusion Criteria:

* Active severe or unstable neuropsychiatric SLE
* Clinically significant laboratory test
* Clinically significant active infection
Hydrocephalus Treatment on Persistent Disorder of Consciousness

After acute brain injury or haemorrhagic stroke, hydrocephalus might participate to consciousness disorder. We plan to explore whether ventriculoperitoneal shunt insertion improves consciousness in patients with vegetative or minimally conscious state and hydrocephalus. Patients with acute brain injury, persistent consciousness disorder and hydrocephalus will be shunted with a detailed follow-up at 3 months combining: clinical evaluation, FluoroDésoxyGlucose positron emission tomography imaging, high density electroencephalogram, electrocardiogram Holter and sympathetic activity by microneurography.

Persistent disorder of consciousness following acute brain injury is a major public health problem. Advances in intensive care allow a growing number of patients to survive after acute brain injury. However, one third of patients in coma following acute brain injury will not recover a consciousness. To date, no specific treatment has shown its effectiveness in the cognitive recovery of those patients. Few clinical cases suggest that hydrocephalus, which is the impairment of cerebrospinal fluid circulation in the brain, may participate to prolonged disorder of consciousness. Hence treating hydrocephalus with a shunt might improve disorders of consciousness. It is possible to gauge intracranial fluid circulation, that is hydrodynamics quantification, and measure resistance to cerebrospinal fluid outflow. Demonstration of an altered hydrodynamics favours the implantation of a shunt to improve cerebrospinal fluid circulation that might modulate brain region involved in the emergence of consciousness. The study hypothesis is that shunting a patient with persistent disorder of consciousness due to acute brain injury and hydrocephalus might improve his state of consciousness. The neural processes underlying will be assessed through comparative analyses of brain metabolic and electrophysiological signatures.

Eligibility Criteria:
Inclusion Criteria:

* adult, post brain injury persistent disorder of consciousness, hydrocephalus requiring ventriculo-peritoneal shunt.

Exclusion Criteria:

* pregnancy, no consent
Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet

Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?

The gut microbiota is increasingly being implicated in disease. However, due to difficulty accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid), the small bowel microbiota is infrequently evaluated in any studies of this nature. The small bowel microbiota continues to remain an unexplored area of the gastrointestinal tract. Characterization of the microbial community and its function is the first step in determining how it potentially affects health and disease.

Eligibility Criteria:
Inclusion Criteria:

* Adults between (and including) 18-65 years old.
* On a baseline healthy diet characterized by:

  * High fiber of ≥ 14 g/1000 calories/day
  * \< 10% of daily calories from added sugar
  * At least 5 servings of fruit and vegetables per day
  * \< or = 13% of daily calories from saturated fat

Exclusion Criteria:

* Patients who do not meet the above diet requirements.
* Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions.
* Presence of abdominal symptoms based on baseline questionnaire.
* Commercial oral antibiotic or probiotic use within the past 4 weeks.
* Pregnancy or plans to become pregnant within the study time frame
* Vulnerable adults
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
Sublingual Microcirculation and Postoperative Ileus

The aim of this pilot study is to establish if a correlation between sub-lingual microcirculation measured by Orthogonal polarization spectral (OPS) imaging and symptoms of postoperative ileus exist in patients undergoing elective colorectal surgery.

AIM OF THE STUDY This observational study will assess whether perioperative microcirculatory changes can be correlated with symptoms associated with primary POI.

PRIMARY RESEARCH QUESTION Is there a correlation between peri-operative microcirculatory flow measurements and the incidence of symptomatic primary POI?

SECONDARY RESEARCH QUESTIONS

1. Is there a correlation between peri-operative microcirculatory flow measurements and the duration of symptomatic primary POI?
2. If any correlation is observed, which anatomic location (sublingual mucosa vs bowel serosa) yields microcirculatory flow measurements that are more strongly associated with the incidence and/or duration of symptomatic primary POI?
3. Can either intraoperative sublingual mucosa or intraoperative bowel serosa microcirculatory flow measurements predict symptoms of primary POI? Are these two anatomic locations equivalent in their ability to predict this complication?

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 yo undergoing elective laparoscopic colorectal surgery with an Enhanced Recovery Program (ERP) at the Montreal General Hospital

Exclusion Criteria:

* Any patient who refuses enrolment
Home Mechanical Ventilation Effectiveness and Air Leaks

Non invasive ventilation (NIV) usually presents air leaks that may determine the result of this treatment. The clinical usefulness of analyzing (and quantifying) these leaks during the adaptation period to NIV has not been evaluated in prospective clinical studies as a predictive data of treatment effectiveness. Our hypothesis is that air leaks are correlated to a successful adaptation to NIV. And air leak magnitude may predict early failures of this treatment. And also, as we do not know if air leaks change during the adaptation period to NIV, we do not know whether early detection of air leaks plays a role in the therapeutic outcome. Our objective is to evaluate the clinical usefulness of quantifying air leaks during the adaptation period to NIV as a predictor of effectiveness of this treatment. We also want to evaluate the correlation between air leaks and clinical-functional patients' profile, and the ventilatory parameters selected and to evaluate air leaks variability during the adaptation period to NIV. Method: We will determine the air leak magnitude in twenty patients during adaptation to NIV. We will use VPAP III ventilators (ResMed, Australia), commercial nasal masks (Mirage o Ultra Mirage) and VPAP III/ResLinkTM (ResMed, North Ryde, Australia), a device that includes a monitoring system coupled with the VPAP III ventilator. This device allows to record air leaks and other ventilation parameters. We will perform four VPAP III/ResLinkTM recordings in each patient (the last night in hospital during the adaptation period, the first night at home, and one and two months later, after the initiation of NIV treatment). We will also perform a complete pulmonary function test, quality-of-life questionnaire (SF36), and a tolerance to NIV questionnaire in all patients at the onset of NIV treatment and two months later. We will evaluate which patients will need to change treatment at the end of the adaptation period to NIV. We also will analyze and compare air leaks magnitude in each of the four recordings stated above.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a restrictive pulmonary disease (slow evolution neuromuscular or thorax cage diseases, obesity or nocturnal hypoventilation) and hypercapnic chronic respiratory failure with standard criteria for NIV.
* COPD patients who need NIV because of another reason (obesity, nocturnal hyperventilation or nocturnal hypercapnic response to oxygen).
* PaCO2 ≥ de 50 mmHg.
* Clinically stable (at least for one month).
* Possibility to fit a nasal mask for NIV treatment (ultra mirage, mirage).

Exclusion Criteria:

* Rapid evolution neuromuscular disease (Amyotrophic Lateral Sclerosis).
* Serious comorbidity.
* Lack of patients comprehension or collaboration.
* Inability to fit a nasal mask for NIV treatment (ultra mirage, mirage).
* Treatment compliance \< 4h/d.
Evaluation of the Effects of Chemotherapy on the Uptake and Retention of Carbon 11 Methionine in Prostate Cancer Patients

The purpose of this study is to better understand a new type of radiology test called positron emission tomography (PET) with carbon 11 methionine to determine which patients have a beneficial effect from anti-cancer therapy with the drug docetaxel.

In the week before the patients first dose of chemotherapy they will receive a C11 methionine PET scan which takes about 90 minutes. C11 methionine is a radioactively labeled amino acid that is given to the patient intravenously.

Eighteen to twenty days after the patients first dose of docetaxel chemotherapy, they will have another C11 methionine PET scan which is identical to the first scan.

At the end of three cycles of docetaxel chemotherapy (about 2 and 1/2 months on study) another C11 methionine PET scan will be done.

The PET scans will show how well the tumor is taking up methionine.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic hormone-refractory prostate cancer patients who are planned to begin every 3-week docetaxel chemotherapy
* Progression after androgen deprivation therapy
* Serum testosterone \< 50ng/ml
* 18 years of age or older

Exclusion Criteria:

* Prior taxane therapy