cyrilzakka/clinical-trials huggingface dataset:
Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight

This study will determine whether the drug metformin improves the effects of traditional antidepressant medications in people who are overweight.

Current depression treatments are not effective for approximately one-half of overweight people, and depression eventually returns in approximately one-third of those overweight people whose initial treatment is effective. One possible reason for these treatment failures is that overweight people often experience a condition called insulin resistance (IR), which can lead to type 2 diabetes, an associated disease that might also affect depression treatment. IR results in elevated blood sugar levels that may interfere with medications used to treat depression. Metformin, a medication commonly used to treat diabetes, reduces blood sugar levels. This study will examine whether taking metformin with the antidepressant medication sertraline will enhance the effectiveness of sertraline in people who are overweight and depressed.

Participation in this study will last a total of 16 weeks and will include baseline testing and ten scheduled study visits. Participants will be randomly assigned to receive either sertraline and metformin or sertraline and placebo on a daily basis. The baseline visit will include the following tests and measures: an electrocardiogram (EKG), which will measure the electrical activity in the heart; an oral glucose tolerance test (OGTT), which will measure how a person's body breaks down glucose; a blood test, which will measure lipids, glycosylated hemoglobin (A1C), and other cardiometabolic risk factors; a dual energy x-ray absorptimetry (DEXA) scan, which will measure body fat; a pregnancy test for women; measurements of vital signs, height, weight, waist-to-hip ratio, and waist circumference; and questionnaires concerning health, medication use, physical activity, diet, and mood. Some of the questionnaires will be administered through interviews with a researcher. During the study visits, which will occur every 2 weeks, participants will complete questionnaires, unused medication will be collected, and new medication will be handed out. At Week 8, participants will provide an additional blood sample by finger stick.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) greater than 28.7
* Positive screening for depression
* Must live within 100 miles of the St. Louis metropolitan area

Exclusion Criteria:

* Pregnant or breastfeeding
* Known hypersensitivity to sertraline or metformin
* Recent history of heart attack or unstable heart disease
* Severe liver disease or kidney impairment, defined by a serum creatine level above 3 mg/dL
* Psychiatric disorder thought to affect management, such as schizophrenia, or alcohol or drug dependence
Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

This is an open label 8-week trial of modafinil up to 400 mg daily added to a stable antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in patients with chronic schizophrenia. We hypothesize that modafinil, a wake-promoting agent, will lead to improved cognition, increased wakefulness, and decreased weight in patients with schizophrenia who are on stable antipsychotic regimens

This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual-IV diagnosis of schizophrenia (all subtypes), illness duration greater than three years
* Auditory and visual acuity adequate to complete cognitive tests
* Stable dose of antipsychotics for at least 2 weeks prior to entry
* Good physical health determined by complete physical examination, laboratory tests, and EKG
* Capacity and willingness to give written informed consent.

Exclusion Criteria:

* Inability to read or speak English
* Documented disease of the central nervous system
* History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
* Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions;
* HIV positive
* Patients on antidepressants, including monoamine oxidase inhibitors
* Uncontrolled hypertension
* Pregnancy
* Patients with a current diagnosis of substance dependence
* Significant history of violence
* History of an eating disorder
* Ready for discharge within the following 8 weeks.
Exogenous Ketone Supplementation and Cognitive Function During Exercise

15 healthy trained males will volunteer to participate in this study. there will be 2 treatments: Ketone esters supplementation and iso-caloric carbohydrate. The purpose of this study is to evaluate the effect of ketone esters on cognitive function during exercise after induced mental fatigue

mental fatigue is often seen in sports of moderate to long duration. its onset is associated with detriments in cognitive function which leads to poor decision making and detriments in specific sport skills. Ketones can serve as a powerful brain fuel source so they may have the potential to delay/ revert the onset of mental fatigue. in this experiment, we will induce mental fatigue in individuals who will be performing 45 minutes of intermittent exercise right after. During exercise cognitive function will be measured under 2 condition, Ketone supplementation and placebo. The purpose of this study is to see if ketones can play a role in reverting that initial mental fatigue during exercise, compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in this study you must be a healthy male or female recreationally active individual, 18-35 year old.

Exclusion Criteria:

* You will be excluded from this study if you:
* Are not involved in regular exercise (at least 2x week)
* Have symptoms or take medication for respiratory, cardiovascular, metabolic, neuromuscular disease
* Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
* Are taking part in another research study
* For women, if you are pregnant or become pregnant during the study.
* Have a history of concussion/head injuries.
* Have an excessive alcohol intake (\>2 drinks/day)
* Are consuming a ketogenic diet (for at least 2 weeks)
* Are a smoker
* \*\* Cannabis use is not a exclusion criteria; however, it must be avoided on experimental days.\*\*
Value of Infection Control Programs on Infection Associated with Urinary Tract Catheterization in Sohag University Hospital

The aim of this study is to evaluate the effectiveness of an infection control program implemented at Sohag University Hospital in reducing the incidence of catheter-associated urinary tract infections (CAUTIs) among patients requiring urinary catheterization.


Eligibility Criteria:
Inclusion Criteria:

Adult patients (≥ 18 years) who are catheterized during their hospitalization. Patients who provide informed consent to participate in the study.

Exclusion Criteria:

Patients with a known history of urinary tract infections prior to hospitalization.

Patients who have indwelling catheters for more than 14 days before the study. Patients with urinary tract anomalies or other conditions that may affect infection rates.
A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia

This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) compared with placebo and of UTTR1147A compared with placebo, in combination with standard of care (SOC), in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
* Peripheral capillary oxygen saturation (SpO2) ≤93% (on room air or supplemental oxygen) or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤300 millimetres of mercury (mmHg) or requiring supplemental oxygen to maintain SpO2 \>93% or requirement for supplemental oxygen to maintain SpO2 at an acceptable level per local standard of care

Exclusion Criteria:

* Pregnant or breastfeeding, or positive pregnancy test at screening
* Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
* In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Participating in another clinical drug trial
* Treatment with investigational therapy (other than for COVID-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug
* Use of Janus kinase (JAK) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening
* Have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to Day 1
* Known HIV infection with CD4 \<200 cells/microlitre (uL) or \<14% of all lymphocytes
* ALT or AST \>10 times the upper limit of normal (ULN) detected at screening
* History of anaplastic large-cell lymphoma or mantle-cell lymphoma
* History of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment
* Clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ECG, laboratory assessment, or echocardiographic data
* History of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment
Multimodal Imaging in Central Serous Chorioretinopathy

This study aims to assess the contribution of the multimodal imaging, combining a routine examination using Optical Coherence Tomography (OCT) with an imaging procedure using adaptive optics retinal camera.

This is a feasibility study with a limited number of patients.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Beneficiary/affiliated to French social security/social healthcare
* Active ou chronic Central Serous Chorioretinopathy on at least one eye
* Absence of other known ophthalmological pathology or of any ophthalmological conditions revealed during the examination

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Predictable poor adherence
* Subject without health insurance
* Pregnant or breatfeeding women
* Sujet étant dans la période d'exclusion d'une autre étude ou prévue par le "fichier national des volontaires"
* Presence of transparent medium opacity damaging images quality
* Previous photosensitivity
* Recent treatment with PhotoDynamic Therapy (PDT)
* Use of drugs inducing photosensitivity
Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study.

With the progressive aging of the population in industrialized countries, acute calculous cholecystitis (ACC) has been constantly increasing among elderly. Because ACC is the most common complication of biliary gallstone disease and the population will become older, ACC in elderly is expected to increase. In 2017, the incidence of gallstone disease in Italian population is was 18.8% in women and 9.5% in men; the prevalence was 15% and 24% at 70 years and 24% and 35% at 90 years for males and females respectively. Since the increase in age is often associated with an increase in comorbidity, fragility, surgery related complications, morbidity and mortality, the surgical indication for gallstone is still debated and often based on anesthetic risk. In order to avoid surgery for elderly and high-risk patients, alternative treatments to surgery have been developed. The present study aimed to compare two groups of patients with acute calculous cholecystitis undergone laparoscopic cholecystectomy, under and over 70 years old and to assess whether laparoscopy can offer the same safety and efficacy to older people.


Eligibility Criteria:
Inclusion Criteria:

* acute calculous cholecystitis

Exclusion Criteria:

* tumors of the biliary tract
Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)

Standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder (CDD).

The study will investigate whether targeting the gut-microbiota-brain axis in CDD patients can alleviate seizures and ameliorate other comorbidities.

CDD is a neurodevelopmental condition characterized by infantile-onset epilepsy, developmental delays, intellectual and motor disabilities, sleep disturbances, and cortical visual impairment. Currently, there is no treatment for CDD, and epilepsy is a prominent and severe feature of the disorder. Standard anti-seizure medications have limited efficacy in seizure control, leading to detrimental effects on cognitive and motor development in CDD.

The gut-brain axis has gained attention in epilepsy research, prompted by evidence of gastrointestinal (GI) symptoms in people with epilepsy. Studies have demonstrated significant changes in gut microbial composition in animal models and between individuals with epilepsy and healthy subjects. Notably, CDD patients experience GI problems, and we discovered that they exhibit alterations in their gut microbiota compared to healthy individuals. The study will investigate whether supplementing CDD patients with alpha-lactalbum and prebiotics alone or with post-biotics can improve neurological features and modulate microbiota composition.

Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis of CDD and demonstrated CDKL5 pathogenic variant; drug-resistant seizures; ensured participation of a caregiver; willingness to sign the informed consent.

Exclusion Criteria:

organic GI disorders (i.e., food allergies, celiac disease); special diets; percutaneous endoscopic gastrostomy tube; use of antibiotics or probiotics in the previous month.
Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases.

Retrospective analysis of a prospectively collected database of 170 patients between 2004 and 2020, who underwent liver resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital trying to determine rates and patterns of recurrence following liver resections for CRLM and concurrently, characterise clinical, pathological and treatment-related factors that could function as predictors of recurrence or survival, particularly neoadjuvant chemotherapy and tumour clearance.

This is a descriptive, observational study with retrospective analysis of a prospectively collated database. This database included all patients who underwent curative hepatic resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital (Adelaide, Australia) between December 2004 and October 2020.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a liver resection for CRLM at The Queen Elizabeth Hospital between December 2004 to September 2020

Exclusion Criteria:

* Patients whose procedures were abandoned due to unresectable tumour burden
Gasdermin D Expression in Generalized Vitiligo Patients After Narrow-band Ultraviolet B Therapy

The aim of this study is to:

1. Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
2. Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
3. Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.

The aim of this study is to:

1. Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
2. Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
3. Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable vitiligo of 6 months duration,
* Both sex and ages(10-75)

Exclusion Criteria:

* pregnancy,
* lactation,
* patients under or previous phototherapy,
* patients on other immunosuppressives,
* patients receiving topical or systemic therapy like antioxidants and vitamins were kept off treatment for 2 weeks prior to recruitment into the study.
Institut Paoli Calmettes Thyroid Cancer Database

Database of Institut Paoli-Calmettes patients diagnosed with thyroid cancer


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of thyroid cancer

Exclusion Criteria:

* Non applicable
A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects

The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.


Eligibility Criteria:
Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.
Meditation and Cancer, Pilot Feasibility Study (MAEva Pilot Study)

MAEVA, which stands for Meditation, Acceptance and Commitment towards Values, is an open and circular program, made up of 3 themed sessions, following a weekly rhythm. It is proposed here to study this program over a period of 3 months, which will give participants the opportunity to complete up to three complete cycles.

This program is based on the practice of and the processes of acceptance and commitment therapy. These approaches, used for several years, have proven their effectiveness in the management of stress, chronic anxiety, insomnia, chronic pain, distress in the face of chronic disease, as well as in the prevention of depressive relapses and management of impulsivity.

Unlike conventional 8-week meditation programs, the MAEva program allows patients to enter the study at any stage of the disease (within, outside the exclusion criteria) and from any session and to participate according to their possibilities.

The patient can participate in a weekly session of the program for 3 cycles. During the sessions, it will be proposed to train meditative practices and 3 different themes will be addressed (one theme per session): Meditation, Acceptance and Commitment to values.

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Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient with non-metastatic prostate or breast cancer
* Newly diagnosed patients or those undergoing treatment
* Patient able and willing to follow all study procedures in accordance with the protocol.
* Patient having understood, signed and dated the consent form.
* Patient affiliated to the social security system
* Patient able to remain in a sitting position during the 2-hour session

Exclusion Criteria:

* Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
* Presence of an acute psychiatric disorder: depression in acute phase, unstabilised bipolar disorder, psychotic disorders (delusions, hallucinations), etc.
* Presence of recurrent uncontrolled panic attacks (notably linked to hypochondriac concerns)
* Presence of latent or patent post-traumatic stress disorder
* Lack of motivation to meditate
* Insufficient attentional resources to meditate: major problems with attention, memory or reasoning
* Patient with metastatic cancer.
* Presence of cognitive and neurocognitive disorders and deficits
* Presence of deafness
* Membership in a meditation programme prior to inclusion
Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects With Retinitis Pigmentosa

This is an open-label, multiple ascending dose study to evaluate the safety, tolerability, and efficacy of EA-2353 in subjects with RP. Unilateral intravitreal injections (IVT) will be administered into the subject's Study Eye. There will be up to 4 cohorts.

This is an open-label, multiple ascending dose study to evaluate the safety, tolerability, and efficacy of EA-2353 in subjects with RP. There will be up to 4 cohorts. Each of the first three cohorts will treat 3 subjects with 4 weekly injections of EA-2353.

Unilateral intravitreal injections (IVT) will be administered into the subject's Study Eye, which is determined as the eye with worse vision based on the BCVA. Eligible subjects will be enrolled into one of the following three cohorts in an ascending sequential fashion:

* Cohort 1 (low dose)
* Cohort 2 (mid dose)
* Cohort 3 (high dose)
* Cohort 4 (maximum tolerated dose)

Patient participation will last for approximately 25 months.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥ 18 years of age.
2. Have a clinical and molecular diagnosis of RP.
3. Understand the language of the informed consent and are willing and able to provide written informed consent prior to any study procedures.
4. Are willing to comply with the protocol and follow the instructions including attendance at all scheduled study visits.
5. BCVA in the worse eye between 20/50 and able to count fingers (CF)
6. Have clear ocular media.
7. Have pupillary dilation sufficient to allow for quality images.

Exclusion Criteria:

1. Subjects who are pregnant or suspected to be pregnant and subjects who are lactating or intend to breastfeed. Female subjects of childbearing potential are required to have a negative urine pregnancy test at screening and prior to each injection, and must agree to use an acceptable method of contraception from the time of signing informed consent until the end of the study.
2. Have any uncontrolled systemic disease or non-ocular disorder which would put the subject at risk due to study treatment or procedures, influence the results of the study, or impact the subject's ability to participate in the study (e.g., infection, uncontrolled elevated blood pressure, cardiovascular disease, and inability to maintain glycemic control).
3. Presence of a significant ocular disease or disorder in the Study Eye.
4. Have a history of any vitreoretinal surgery ever in the Study Eye.
5. Have received any prior cell or gene therapy for RP.
6. Have history or current abuse of alcohol and/or drugs.