cyrilzakka/clinical-trials huggingface dataset:
Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay

MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.

In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.

Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states.


Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years
* spontaneous sinus rhythm
* signed informed consent
* indication to heart surgery

Exclusion Criteria:

* age lower than 18 years
* absence of sinus rhythm
* pregnancy
* impossibility of informed consent
Effect of Glossopharyngeal Versus Diaphragmatic Breathing Exercise on Pulmonary Function After Decortication Surgery

This study will be conducted to compare between the effect of glossopharyngeal and diaphragmatic breathing exercises on pulmonary functions after decortication surgery

Lung decortication is a well-known procedure for the treatment of empyema. Persistent lung collapse and non-expansion of the lung parenchyma are frequently noticed in the postoperative period after decortications, chest physiotherapy plays a crucial role in the re-expansion of underlying parenchyma.

There is an increased flow of patients after decortication surgery to hospitals who suffer from decreased lung volumes so the hospitalization period for them increases which puts an economical burden on health insurance services with a decreased level of quality of life that is the most concern to improve patient status and relieve this burden. So this study aims to improve patient's lung volumes and arterial blood gas parameters which improves patient status through two various forms of breathing exercises.

Eligibility Criteria:
Inclusion Criteria:

* The participant's body mass index (BMI) will be ranged from 25- 29.9 kg/m2
* The patient will receive treatment after 24 hours after decortication
* The study will be in the intensive care unit (ICU).
* The patients have unilateral lung decortication
* Their vital capacity is 70% or less.

Exclusion Criteria:

* Cancerous patient.
* Inability to comprehend and follow instructions as in dementia
* paralytic involvement of thorax muscle
* Abdominal diseases that affect diaphragmatic function
* Diaphragmatic paralysis
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.

This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening.
3. Agrees to use required birth control methods during the entire length of participation in the study.
4. Subject has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 38 days within the Screening Period, prior to Day 1

Exclusion Criteria:

1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
2. Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).
3. Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
5. Subject has a history of osteoporosis or other metabolic bone disease.
6. Subject has a current history of undiagnosed abnormal genital bleeding.
To Comapre The Effectiveness of Two Lasers in The Treamment of Unwanted Hair

A total of 60 female patients (30 patients in each group) with unwanted facial hair diagnosed by a consultant dermatologist were included in this study. In Group A patients were subjected to intense pulse light therapy while patients in Group B were subjected to diode laser for three sessions one month apart. Effectiveness in both groups was ascertained in terms of hair reduction, less adverse effects, side effects and patients' satisfactory response at the end of final session.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with hirsuitism were included in the study.

Exclusion Criteria:

* tendency to develop hypertrophic scarring/keloid,
* underwent any treatment for unwanted facial hair in last two years
* pregnant/lactating women
* with hormonal imbalance and PCOS were also not in included in the study.
Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance

Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. The effect on eating habits for engraftment of microbiome by FMT is unknown.

The purpose of this study is to investigate whether FMT relieves FODMAP diet extension without worsening intestinal symptoms in IBS patients.

This is a plasebo controlled study in which we study the effect and safety of FMT in patients who have IBS and have used FODMAP diet. FMT is assessed by colonoscopy route and therafter the patietns receive twice FMT enema from healthy donor or plasebo..

Eligibility Criteria:
Inclusion Criteria:

* Adults, age 18-75 years, knowledge of the Finnish language
* IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial
* The patient must consume low FODMAP diet to control IBS symptoms
* Patient must sign the informed consent

Exclusion Criteria:

* Diagnosed allergies to food components in the study dietary protocol
* Pregnancy and breastfeeding
* Antibiotic treatment less than three months prior enrolment
* Faecal incontinence, i.e., inability to retain enema
* Abuse of drugs, alcohol or medications
* Other diagnosis besides IBS causing GI symptoms, these include IBD, microscopic colitis, coeliac disease and bile acid diarrhoea.
* Severe psychiatric or neurologic condition decreasing patient's compliance
Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis

Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.

Diabetes mellitus may be present in patients with cystic fibrosis (mucoviscidosis) starting in the second decade of life. The prevalence increases rapidly with increasing age. As life-expectancy increases in CF, CF-related diabetes will be diagnosed more frequently in the future. Negative consequences of secondary diabetes in cystic fibrosis include:

* Catabolic metabolism
* Weight loss
* More frequent / more severe infections
* Deterioration of pulmonary function
* Reduced life-expectancy
* Diabetic micro vascular complications (retinopathy, nephropathy, neuropathy)

Up to date, no data are available to answer the question, whether secondary diabetes in CF should always be treated by insulin therapy. Several centres report the successful management of CF-related diabetes using oral anti-diabetic drugs at least for some years. Oral therapies would be less invasive for a patient group which is highly traumatised by a very demanding therapy (multiple drugs including antibiotics, pancreas enzymes, bronchodilators, mucolysis, in addition to physiotherapy, regular inpatient iv-antibiotic therapy etc, finally lung transplants in a subgroup of patients).

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for the Screening:

* Diagnosed cystic fibrosis
* Age 10 years and older

Inclusion Criteria for the therapeutic part of the study:

* Newly diagnosed Diabetes mellitus in the screening

Exclusion Criteria:

Exclusion Criteria for Screening:

* Diabetic keto-acidosis (blood glucose \> 350 mg/dl and arterial pH \< 7.25)
* Already treated Diabetes mellitus by oral antidiabetic medication or insulin

Exclusion Criteria for the therapeutic part of the study:

* Systemic steroid therapy during the last 3 months
* Transplantation (status post TX or on the waiting list for TX)
* Beginning pulmonary insufficiency, FEV1 \< 35% at pulmonary function test in stable condition
* Pregnancy
* Already diagnosed and treated diabetes mellitus
* Patients with diabetic keto-acidosis (blood glucose \> 350 mg/dl and arterial pH \< 7.25) with or without diabetic coma
* Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value \< 70% which is a contraindication to use Repaglinide)
* Treatment with an indispensable important drug which contraindicates Repaglinide
* PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study
* CF-patients with type 1 diabetes
* Not patient's consent to randomisation and therapeutic trial
* Participation on other medical trial
Nonopioid Analgesia After Rotator Cuff Repair

This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen

Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.

Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia

Primary endpoints is reduction in pain as measured by visual analogue scale and Patient-Reported Outcomes Measurement Information System. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.

Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair

Exclusion Criteria:

* Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff
Clinical Feature and Treatment of Microsporidial Keratoconjunctivitis

The purpose of this project was to analysis the causes, pathogenesis, diagnostic modalities and treatment outcomes of microsporidial keratoconjunctivitis.

Microsporidia comprise a diverse group of obligate spore-forming intracellular eukaryotic pathogens first described in immunocompromised patients. Many species of microsporidia are found in aquatic environments, and they are considered as waterborne pathogens.Microsporidia are opportunistic pathogens that are reported to cause infections in various organs, including the eyes. The ocular appearance of this infection can manifest as corneal stromal keratitis or a superficial punctate keratoconjunctivitis. In particular, the characteristic feature of microsporidial keratoconjunctivitis is multiple whitish, slightly elevated epithelial lesions in conjunction with acute conjunctivitis. Awareness of microsporidial keratoconjunctivitis is increasing, and the number of cases reported is on the rise. This study was a retrospective case series of patients diagnosed as microsporidial keratoconjunctivitis. The purpose of this project was to analysis the causes, pathogenesis, diagnostic modalities and treatment outcomes of microsporidial keratoconjunctivitis

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as microsporidial keratoconjunctivitis

Exclusion Criteria:

* Patients diagnosed as bacterial or viral keratoconjunctivitis
Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children

This study hypothesizes that supplementation of omega-3 fatty acids (OM3) can increase physical activity, inhibit rapid gain in body weight and BMI in both sedentary and normally active 8 year old children. The purpose is secondarily to explore patterns of associations between OM3 supplementation, baseline and follow-up levels in all studied parameters. The study also aims to study if basal levels of OM3 are correlated with physical activity and to study if there is an association between basal levels of OM3 and the effect of OM3 supplementation on physical activity. To study if there is an effect of OM3 supplementation on triglyceride and LDL cholesterol levels and to study if there are more pronounced effects on children with higher levels. To study if OM3 supplementation, compared with placebo reduce weight increase among children at risk to become overweight. To study if there is an association between effects of OM3 on physical activity, weight and risk markers in blood. To study if there are any gender differences.


Eligibility Criteria:
Inclusion Criteria:

* Children in second grade of Swedish primary school willing to participate
Balance Function in Patients Post Corona Virus Disease 2019 (COVID-19)

The purpose of this study is to describe balance deficits in patients post COVID-19. The information the investigators learn may help influence balance training exercises for patients post-COVID-19. Participants will have a primary or secondary diagnosis of COVID-19 during hospitalization and off COVID-19 isolation and be receiving care in an acute inpatient hospital. Following consent, participants will complete balance assessments and questionnaires about balance and dizziness in a single session. Vital signs will be monitored during the session.The greatest risks of this study include shortness of breath, and a risk of falling or musculoskeletal soreness.These risks are no greater than those experienced during a usual physical therapy visit.

Heart rate (HR), respiratory rate (RR), blood pressure (BP), and oxygen saturation (SpO2) will be measured at rest and after all outcome measures are completed. Rate of Perceived Exertion (RPE) (0-10 per modified Borg scale) will be measured after each outcome measure. In addition, HR will be measured after each outcome measure. SpO2 will be continually monitored via pulse oximetry. Fraction of inspired oxygen (FiO2) will be titrated per MD orders. If SpO2 drops below MD-specified parameters, patients will first be given a 3-minute seated rest break. If SpO2 recovers above MD-specified parameters after rest break, activity will resume. If SpO2 remains below MD-specified parameters after rest break or continues to drop with activity, FiO2 will be titrated to maintain SpO2 within MD-specified parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Primary or secondary diagnosis of COVID- 19 during hospitalization and off COVID-19 isolation
* Receiving care in acute inpatient
* Ability to ambulate 20' with or without an assistive device without dropping \>10% of resting oxygen saturation (determined from existing physical therapy evaluation)
* Ability to stand with no more than contact guard assistance (determined from existing physical therapy evaluation)
* Not requiring use of mechanical ventilation
* Minimum resting oxygen saturation of 88% with or without supplemental oxygen
* No neurological or orthopedic dysfunction that would affect balance
* Cognitively intact and able to follow directions and provide consent

Exclusion Criteria:

* History of 2 or more falls in the year prior to COVID-19 diagnosis or history of balance dysfunction
Cerebrospinal Fluid (CSF) Raltegravir Substudy

The purpose of this study is to measure concentrations of Raltegravir in cerebrospinal fluid.

The hypotheses are:

* Raltegravir concentrations in CSF will be measurable
* Raltegravir concentrations in CSF will remain constant, while plasma concentrations vary widely leading to highly variable CSF-to-plasma ratios.
* Following at least 4 weeks of Raltegravir-containing combination therapy, HIV RNA levels in CSF will be below 50 copies/mL in all subjects.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in a raltegravir parent protocol at UCSD.
* Willing to undergo lumbar puncture.
* Able to give informed consent. If cognitively impaired, a test will be administered to ensure adequate comprehension of the consent document and procedure.

Exclusion Criteria:

* Relative or absolute contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets\<50,000/µL), hemophilia, or use of anticoagulant medication.
* Psychiatric disease that would interfere with study participation, in the opinion of the investigator.
* No major opportunistic infections within 30 days.
* Moderate or severe cognitive impairment. The proposed study does not have a neuropsychological objective.
Omega-3 Fatty Acids for Treatment of Depression in Adolescents

Adolescence is the highest risk period for depression onset. More than 1.3 million youths suffer from major depression annually in the United States, and there is evidence for an increasing trend. Because many adolescents have their first depressive episode in adolescence and adolescent depression often leads to recurrent mood disorders in adults, effective treatment during early illness can minimize the negative consequences of initial and repeated episodes. Although some antidepressants (particularly Selective serotonin reuptake inhibitors (SSRIs)) are effective treatments for juvenile depression, recent warnings about suicide and the use of SSRls highlight the need for new and safe treatment for juvenile depression. Data in adults suggest that supplementation with polyunsaturated fatty acids (PUFA) might be useful for the treatment of depression. The purpose of this study is to investigate the safety and efficacy of PUFA for the treatment of adolescent depression.


Eligibility Criteria:
Inclusion Criteria:

1. Adolescents between the ages of 13 and 21 currently under standard of care treatment at the Child Division of the Department of Psychiatry at CSMC
2. Diagnosed with major depressive disorder using the DSM-IV diagnostic criteria

Exclusion Criteria:

1. Active suicidal ideation, with a current plan and/ or a recent suicide attempt
2. Severe psychotic symptoms (presence of distressing or common hallucinations and/ or delusions)
3. History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, or autism
4. Potential subjects using psychotropic medication(s), alcohol, and/ or drugs within 2 weeks prior to entry into the study (8 weeks for fluoxetine and MAOIs - monoamine oxidase inhibitors)
5. Pregnant or lactating females, or those who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy) and become pregnant
6. Seizure or other neurological disorders
7. Dermatological conditions
8. Unstable cardiac, pulmonary, endocrine, or renal disorder
9. Adolescents who are currently being effectively treated with antidepressants