cyrilzakka/clinical-trials huggingface dataset:
Psychosocial Intervention for Suicidal Ideation in Individuals With FEP: A Feasibility Trial

To check the feasibility and acceptability of Culturally adapted Cognitive Behavioral Therapy for Psychosis (CaCBTp) and Culturally Adapted Manual Assisted Brief Psychological Intervention for Self-harm (CMAP), which we have provisionally called (CMAP Plus) for individuals experiencing Suicidal Ideation (SI) in First Episode Psychosis (FEP).

Psychosis is one of the 20 leading causes of disability worldwide, affecting 29 million people. First Episode Psychosis (FEP) occurs at a young age and is thought to be a critical period, influencing the long-term course of the disorder. The early course of psychosis is characterised by repeated relapses with up to 80 % relapsing within five years of an initial episode. It has been reported that individuals diagnosed with psychosis disorders are also identified with developing experiences of self-harm, completed suicide or suicide attempt. A systematic review on identification of correlation between self-harm/suicidality and FEP, also suggested association of suicidal ideation or self-injurious behavior though additional research is highly recommended in this particular subject Psychological therapies are widely used in the high-income countries, but very limited in LMIC like Pakistan due to factors including lack of trained mental health workers and inadequate infrastructure to support secondary mental health services. These factors, amongst others, contribute to the significant treatment gap in LMICs like Pakistan. There are currently no early intervention services in Pakistan and given the shortage of appropriately trained clinicians to deliver psychosocial interventions novel approaches are needed. We have culturally adapted Cognitive Behavior therapy which demonstrated feasibility and acceptability for psychosis in Pakistan. To address suicide specific symptoms, content will be integrated from the life after self-harm manual (CMAP. It is a CBT based problem solving intervention for self-harm which has been adapted in Pakistan in a feasibility trial and a recently completed MRC funded large multicenter trial (n=901)

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with, Schizophrenia or Schizoaffective disorder according to DSM-V, confirmed by treating consultant.
* Age 18 and above years able to understand written and spoken Urdu.
* A score of 1 (Mild- Frequent thoughts of being better off dead, or occasional thoughts of suicide.) on the Calgary depression Scale item 8 (Suicide) "Have you felt that life wasn't worth living? Did you ever feel like ending it all? What did you think you might do? Did you actually try?"
* Individuals with a score of 3 or more on any of the positive symptoms on the Positive and Negative Syndrome Scale (PANSS) (e.g., delusions, hallucination).

Exclusion Criteria:

* Any evidence of organic brain disease, clinically significant comorbid illness or learning disability. Participants deemed actively suicidal by their designated health professional.
* Those scoring \>1 on Calgary depression Scale will be excluded and be referred to a psychiatric service.
Energy Devices for Rejuvenation

Non-ablative and ablative devices are the most commonly used minimally-invasive treatments for skin rejuvenation. Current devices on the market for rejuvenation include the lasers such as the Fraxel Restore, the Halo, the Helios III, the Pico, the ThermiVa and the DiVa which have all been shown to have efficacy for the rejuvenation of the face, décolletage, hands and vagina. In this study we propose to compare the efficacy and side effect profile of these devices for skin rejuvenation of various areas of the body including the face, décolletage, hands, trunk, upper and lower extremities, and vagina.


Eligibility Criteria:
Inclusion Criteria:

1. Exhibit skin aging and will benefit from skin rejuvenation treatment of the face, neck/décolletage, trunk, hands, upper and lower extremities and/or vagina as determined by the investigator/physician.
2. Subjects between the ages of 18-85 years old, at the time of consent.
3. Subjects may be male or female.
4. Subjects with Fitzpatrick Skin type I-III (Fraxel Restore, Helios III, Pico) or I-VI (Halo, ThermiVa, DiVa).
5. Subjects must be able and willing to give written informed consent and to comply with the requirements of this protocol. The consent form has been standardized in English. For those patients who do not read and understand English, a consent form will be standardized and provided in a language that they read and understand if possible.

Exclusion Criteria:

1. Children and adolescents (less than 18 years old).
2. Subjects who are not willing or able to provide written consent.
3. Individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician.
4. Subjects on any substances affecting blood coagulation (including but not limited to aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin E, fish oil, heparin, low-molecular weight heparin, novel anti-coagulants).
5. Subjects with known blood coagulopathies.
6. Subjects with a compromise of local blood supply (including but not limited to recent surgery, severe scarring, autoimmune diseases involving the face, neck/décolletage, trunk, hands or lower extremities such as lupus, morphea, sarcoid or mixed connective tissue disease) (dependent on their treatment group).
7. Subjects who have received energy-based rejuvenation treatment of the face, neck/décolletage, trunk, hands, upper and lower extremities, and/or vagina within the past 3 months (dependent on the area they are planning to treat).
8. Subjects who meet any of the contraindication criteria listed in the product information for the device the subject will be treated with.
9. Subjects who are self-reported to be currently pregnant or lactating at the time of treatment.
Phone-based Smoking Cessation Intervention for Patients With Chronic Pancreatitis.(START)

This study aims to explore whether regular telephone intervention in patients with chronic pancreatitis can improve their smoking cessation rate.

Chronic pancreatitis（CP） is a chronically progressive disease characterized by pancreatic fibrosis and inflammation, and its basic pathological features include chronic inflammatory damage to the pancreatic parenchyma, interstitial fibrosis, pancreatic parenchymal calcification, pancreatic duct dilation, and pancreatic duct stones.

Environmental factors such as alcoholism，smoking and genetic factors are the main causative factors of CP. Clinical studies have found that smoking can not only accelerate the course of CP, but also increase the risk of CP-related complications. Some scholars believe that smoking cessation may be a potential way to prevent the progression of CP and improve the prognosis of CP. Although there is no evidence to verify whether smoking cessation will improve the clinical course of CP, the latest ACG Clinical Guideline strongly recommends CP patients quit smoking.

In 2016，a prospective study of smoking cessation interventions in CP patients showed that 27 enrolled patients had a smoking cessation rate of 0% after 6 months of smoking cessation intervention, indicating that smoking cessation is a huge challenge for CP patients.

The investigators propose to conduct a randomized controlled trial to investigate the effects of telephone intervention on smoking cessation in patients with CP and explore the impact of smoking cessation on their clinical course and prognosis.

Eligibility Criteria:
Inclusion Criteria:

1.18 years of age and older living; 2.Patients diagnosed as chronic pancreatitis; 3.Self-reported smoking ≥ 5 cigarettes; 4.Urine cotinine levels ≥ 200 ng/mL; 5.Owning a phone; 6.Willing to provide informed consent to participate in the study.

Exclusion Criteria:

1. Patients diagnosed as pancreatic cancer within 2 years after diagnosing chronic pancreatitis; Patients diagnosed as groove pancreatitis or autoimmune pancreatitis;
2. Pregnant or lactating women;
3. Patients with life expectancy ≤ 12 months;
4. Comorbidities such as Alzheimer's disease, end-stage cancer, HIV, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease, uncompensated cirrhosis, renal failure;
5. Smoking e-cigarettes or other forms of non-burning tobacco.
6. Patients refused to participate.
Is Hip Range of Motion Relevant in the Treatment of Chronic Low Back Pain?

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. A total of 60 subjects aged between 18 and 35 with non.specific low back pain will be selected and randomized in two interventions.

The control group will carry out a specific strengthening program for the gluteus maximus and the experimental group will carry out the same strengthening program in addition to receiving a specific manual therapy program for both hips.

The total duration of the treatments will be 8 weeks, with on-treatment evaluations at 4 and 8 weeks, with a follow-up after 1 month.

The objective will be to determine the efficacy of manual therapy on the coxofemoral joint together with a protocol of gluteus maximus strengthening exercises in patients with non-specific chronic low back pain, in comparison with the same protocol of gluteus maximus strengthening exercises performed in isolation, in patients with non-specific chronic low back pain.

Detailed Description has not been entered.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-specific low back pain, with a score of more than 2 on the visual analogue scale.
* Pain with a course of more than 12 weeks, of a chronic nature.

Exclusion Criteria:

* Patients with neurological signs and symptoms or severe psychiatric illnesses.
* Subjects with a history of severe trauma, fracture or previous surgery on the lumbar spine or hip.
* Subjects with a history of musculoskeletal and/or rheumatologic disease.
* Patients with low back pain attributable to dysmenorrhoea.
* Pregnant patients.
* Individuals with fibromyalgia, autoimmune disorders.
* Subjects with a history of oncological processes.
Effects of Propofol on Oxidative Stress and Liver Regeneration After Partial Hepatectomy

Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic vessels during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to this ischemia-reperfusion phenomenon, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.

The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic vessels clamping. The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.

Propofol is an anaesthetic agent that showed in vitro and in vivo anti oxidant properties. No data are available concerning the potential benefit of a total anaesthesia with propofol in partial hepatic surgery. Patients who undergo partial hepatic resection have frequent liver insufficiency that could be related in part to the oxidative stress induced by clamping the hepatic hilum during the surgical intervention. Our hypothesis is that propofol, by increasing liver resistance to ischemic-reperfusion injury, could improve the remaining liver function recovery, and therefore could reduce post surgical morbidity.

The aim of the study is to evaluate the anti oxidant effects of propofol compared to another widely used anaesthetic agent, inhaled desflurane, during and after partial hepatic resection with hepatic hilum clamping.

The primary endpoint will be the level of malondialdehyde (a plasmatic marker of oxidative stress), 30 minutes after the end of hepatic clamping.

The evolution over time of other markers of oxidative stress will be studied (glutathione, myeloperoxidase, nitric oxide), as well as functional and biological markers of liver regeneration.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18
* Need for partial hepatic resection requiring heptic clamping
* Resection of 4 liver segments or less
* In case of cirrhosis, child A
* Written informed consent

Non-inclusion Criteria:

* Hemochromatosis
* chemotherapy in the previous week before inclusion
* Thrombosis of the portal vein or the hepatic artery
* Absence of contraception among fertil woman
* Concomitant treatment that could have potential interaction with propofol
* Concomitant treatment known to have antioxidant properties
* Inclusion in another study protocol using a medication incompatible with the present study
* Patient in which the follow up seems impossible
TMJ Fibrocartilage Detection Using MRI

Objective: The aims of this study will be to detect the fibrocartilage layer (FC) of the human temporomandibular joint (TMJ) using 3D SPGR (Spoiled GRASS sequence) (T1 WATS) sequence and to compare these results with those of conventional magnetic resonance imaging (DP, T2 MRI) sequences in patients with temporomandibular disorders (TMD).

This prospective and observational study will focused on analyzing morphological characteristics of the fibrocartilage layer of the TMJ based on the MRI scans of 59 patients. All 118 TMJs of these patients will be suitable for analysis, (range: 18-60 years old), females and males affected by TMD and did not undergo previous TMJ treatment.

Eligibility Criteria:
Inclusion Criteria:

\* Internal derangement in theTMJ

Exclusion Criteria:

* Cardiac pacemaker
* Cochlear implant
* Intracranial vascular clips
* Metal particles in the orbit
* Head or face trauma
* Gout
* Generalized osteoarthrosis
* Joint hyperlaxity
* Congenital malformity
* Facial cysts
* Facial tumors
* Previous TMJ surgery
Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women

Polycystic ovarian syndrome (PCOS) is a heterogeneous, multifaceted and complex disorder characterized by insulin resistance (IR), hyperinsulinemia, and hyperandrogenism leading ovarian disfunction and infertility. Given the central pathogenic role of IR in the endocrine, reproductive, and metabolic disturbances of PCOS, several pharmacological and non-pharmacological approaches have been proposed to counteract the hyper insulinemic IR typical of the syndrome. Two Inositol stereoisomers, Myo-Inositol (MI) and D-chiro-inositol (DCI), captured the attention of researchers for their insulin-sensitizing actions, which configure them as proper candidates for the treatment of PCOS.

Very few studies reported on spontaneous clinical pregnancy rates, none were powered for this outcome, and none reported on the clinically relevant outcome of live birth. Therefore, data about clinical pregnancy rate, live birth rate, and miscarriage rate comparing inositols with placebo are limited.

Nevertheless, regarding infertility the primary outcomes that should be considered are clinical pregnancy rate, miscarriage rate and live birth rate. Although many studies showed improved hormonal and metabolic profile and improved ovulation rate and higher quality and number of oocyte retrieved in Assisted Reproductive Technology (ART) in PCOS women after inositols administration, data about clinical pregnancy rate, live birth rate, and miscarriage rate are limited with several concerns regarding interpretation of the studies.

Furthermore, independently by the effect on PCOS related infertility, few data are available about the role of inositol on obstetrics outcomes of pregnancies conceived after treatment with inositol and/or orally supplemented during pregnancy. Considering that the combination of MI and DCI alleviate many of the metabolic dysregulations typical of PCOS thanks to insulin-sensitizing actions, it is plausible consider a beneficial effects on pregnancy complications such as gestational diabetes and preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy spontaneously conceived in women with PCOS diagnosed by Rotterdam criteria that starts oral supplementation before conception.

Exclusion Criteria:

* Any kwon pre-pregnancy disease.
* Any other pharmacological, non-pharmacological or nutraceutical treatment (beside oral folic acid supplementation) more than 3 months before the enrollment (wash-out period) or during the trial, or until the development or pregnancy-induced/related diseases requiring pharmacological treatments.
The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

Study Description

The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are:

* 1. Whether there is intestinal flora in the stool of premature infants.
* 2. Are there dysregulated intestinal flora and their metabolic products in premature infants diagnosed as necrotizing enterocolitis.
* 3. The detailed role and underlying mechanism of the intestinal dysbacteriosis and the metabolic products in premature infants diagnosed as necrotizing enterocolitis.

Participants, premature infants diagnosed as necrotizing enterocolitis (NEC group), will be asked to collect stool (usually 2 times) for intestinal flora analysis.

If there is a comparison group: Researchers will compare premature infants without necrotizing enterocolitis (control group) to see if their intestinal flora and the metabolic products also changed as their NEC counterparts.

When the patients is hospitalized in neonatology, we screen the premature infants according to the selection criteria and exclusion criteria. After sighed the informed consent, they are classified into two groups: premature infants diagnosed as necrotizing enterocolitis (NEC group) and premature infants without necrotizing enterocolitis (control group). Their stool and blood (usually 2 times ) are collected for intestinal flora and FABP (including L-FABP and I-FABP) analysis, respectively.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Necrotizing Enterocolitis,
* gestational age \<37 weeks,
* body weight 1,000-2,500 g,
* postnatal Apgar score ≥7,
* initial oral feeding tolerance.

Exclusion Criteria:

* serious hereditary or other serious diseases, such as heart, lung and abdominal malformations ,
* early or late onset septicemia,
* early use of antibiotics in the newborn,
* serious adverse reactions caused by probiotics.
Characterization of the Use of Antipsychotics in PTSD During the Past Seven Years

The primary objective is to examine the percentage of patients with PTSD who were prescribed an antipsychotic over the past seven years in the VA Network 7 (AL, GA, SC) and compare the percentage on an annual basis. We will also determine the type and dose of antipsychotics received. We hypothesize that there has been a significant increase in antipsychotic use, especially atypical antipsychotics, prescribed for patients with PTSD over the last 7 years

This study is a retrospective electronic review of the VISN 7 Data Warehouse to determine what have been the emerging trends in prescriptions of atypical antipsychotic medications over the past seven years for the treatment of posttraumatic stress disorder (PTSD) in the VA

This study is a retrospective electronic review of patients of the VISN 7 Data Warehouse of patients with a diagnosis of PTSD treated with antipsychotics as monotherapy or adjunctive therapy at a VA Medical Center or VA clinic in VISN 7 (GA, SC, and AL). The data will be retrieved from a computerized list of patients treated in VA VISN 7 for PTSD from 1998-2005 and cross-referenced with the electronic pharmacy file for having received a prescription of an antipsychotic medication. No personal identifiers will be collected. The data will then be examined to determine what type of antipsychotics were prescribed and the dose and duration of the antipsychotics. In addition, demographics and clinical characteristics available through the Data Warehouse will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, any race or ethnic origin at least 19 years of age.
* Patients with a diagnosis of PTSD
* Treated with an antipsychotic as a monotherapy or adjunctive therapy
* Patient must have been seen at a VA medical center or clinic within VISN 7 during the study period.

Exclusion Criteria:

* Patients not diagnosed with PTSD
* Not treated with an antipsychotic as a monotherapy or adjunctive therapy
* Patients outside of Network 7
* Patients with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected chronic obstructive pulmonary disease (COPD)
* 3 or more positive answers in COPD questionnaire
* Age over 40 years

Exclusion Criteria:

* Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
* Patient treated with Spiriva in the past year
* Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva Patient with known narrow-angle glaucoma Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance\<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics
Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance

The purpose of this study is to evaluate the longitudinal test performance of an array of conventional biomarkers of glycemia, including Hemoglobin A1c (HbA1c), and novel metabolomic biomarkers for identifying progression of glucose tolerance (normal to prediabetes or prediabetes to diabetes) in an overweight and obese pediatric cohort.


Eligibility Criteria:
Inclusion Criteria:

* Groups 1 and 2 (overweight and obese groups):
* Age 8-17 years for the visits #1 and #2, individuals can be as old as 22 years for follow-up visits #3 and 4
* Overweight or obese, as defined by a BMI ≥ 85th% \& \<95th% or BMI ≥ 95th%, respectively by age and sex, and for those 16 years and older, BMI ≥25 and \<30 and BMI ≥30
* For Group 2 only: previously completed visits 1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes
* Group 3 (Normal weight controls):
* Age 8-17 years
* Healthy weight, as defined by a BMI ≥ 5th percentile \& \< 85th percentile, respectively by age and sex

Exclusion Criteria:

* Previous diagnosis of type 1 diabetes
* Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin)
* Verbal report of Pregnancy