cyrilzakka/clinical-trials huggingface dataset:
Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App

The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs),


Eligibility Criteria:
Inclusion Criteria:

* US Military Veterans / Service Members
* diagnosis of PTSD as measured by a Posttraumatic Symptom Checklist for DSM-5 (PCL-5) score of \>33
* history of combat trauma and/or military service in an imminent danger pay area
* be fluent in English.
* be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
* have access to a SmartPhone or tablet to utilize the mobile health app and/OR access the virtual classroom.
* agree to undergo psychometric testing and participate in ongoing assessments throughout the study duration.
* be willing to comply with all study procedures, able to complete all assessments independently, and available for the duration of the study.

Exclusion Criteria:

* Active suicidal ideation as assessed by the Investigator at screening or as identified during the study.
* Clinically significant history of psychotic disorder, bipolar spectrum disorder, or neurodegenerative disease/dementia as assessed by the Investigator.
* Active severe substance abuse as assessed by the investigator in accordance with DSM-5 Substance Abuse Disorder criteria, an AUDIT score \> 15, or partial Brief Addiction Monitor (BAM) indicating the presence of illicit substance use other than cannabis (\< 3 times weekly).
* They are currently undergoing another form of treatment other than supportive therapy (\> 2 times per month).
* Engaged in active trauma-focused therapy including Cognitive Processing Therapy (CPT)Prolonged Exposure (PE), or Eye Movement Desensitization and Reprocessing (EMDR).
* Any other condition/situation that the Investigator believes may interfere with participant safety, study conduct, or interpretation of study data.
Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?

Anemia is a common condition during chemotherapy administration. Treatment options usually include oral iron supplementation and blood transfusion. However, oral iron has gastrointestinal side effects, which affects patient compliance, and only a small amount of oral iron can be absorbed from the gastrointestinal tract. Intravenous iron may overcome a block of iron absorption and iron recycling induced by hepcidin. Therefore, it may increase hemoglobin level and reduced blood transfusion in cancer patients receiving chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-70 years
* Good performance status (Zubrod score \< 2)
* No serious underlying disease
* Normal renal function test
* Normal liver function test
* Platinum based chemotherapy is the first line regimen
* No prior or receiving radiotherapy

Exclusion Criteria:

* Iron hypersensitivity
* Underlying disease which has the risk of iron overload such as chronic kidney disease, major thalassemia
* Progressive disease
* Bone marrow metastasis
Obesity Index That Better Predict Ovarian Response

This study is designed to assess the accuracy of Body Mass Index ,Waist Circumference ,Waist Hip Ratio or Waist Height Ratio as a predictor of ovarian response in women undergoing ICSI.

Obesity is an increasingly serious health concern worldwide, and its association with many diseases has been demonstrated. Obesity as it relates to infertility is also being studied All these studies used body mass index (BMI) to determine obesity. Although it is the most commonly used parameter to measure obesity, BMI does not provide an accurate measure of a person's body composition, including body fat.

Almost all studies conducted on this subject used body mass index (BMI) as the measure of obesity; however, using only BMI might be the wrong strategy. Interestingly, some studies on the cardiovascular system found protective effects of BMI and as a result a new term, 'obesity paradox,' emerged. Later studies used waist-to-hip (W/H) ratio and wrist circumference (WC) as a measure of obesity, and showed the exact effect of body fat distribution and obesity on the cardiovascular system

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for ICSI

Exclusion Criteria:

* Poor Responders.
* Poly cystic ovary syndrome.
* Previous ovarian surgeries.
* Patients with ovarian cysts
* patients with endometriosis
* women age more than 35 years
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
* Systemic Sclerosis patients with moderate to sever skin sclerosis

Exclusion Criteria:

* Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease
* Patients with a diseases that could interfere with assessment of Systemic Scleorosis
* Patients with body weight less than 30.0kg
* Pregnant or lactating women.
Recognizing and Treating Psychosocial Stress Among Children With Complex Heart Problems

This research project has two goals. The first goal is to find one or more questionnaires that can accurately identify children who are experiencing high levels of stress or emotional health issues during a regular clinic visit. The second goal is to find out whether children who are experiencing stress or emotional health problems are able to attend a day camp programme and complete activities at home that are designed to help them cope better with stress. We also want to find out if the day camp and home activities are helpful.

This research will investigate the psychological stress experienced by children who have had surgery for a complex heart problem. Measures of quality of life among children with heart problems indicate that those 8 to 12 years of age have lower quality of life scores than younger or older children.

Children who survive a critical illness requiring a multi-day stay in a pediatric intensive care unit are at risk for a variety of psychiatric morbidities. Depression, anxiety and post-traumatic stress disorder occur in 7% to 28% of patients.

A systematic review of psychological adjustment among children with heart problems indicates that parent reports (but not child self-reports) are useful in detecting problems with psychological adjustment. While parent reports tend to identify increased social and behaviour problems, child self-reports indicate more frequent symptoms of depression compared to healthy peers.

Eligibility Criteria:
Inclusion Criteria:

* children who have had surgery for a complex heart problem
* children with heart problems requiring on-going medical care
* age 6 to 12 years

Exclusion Criteria:

* the child has had an intervention (catheterization or surgery) within the previous 6 months,
* the child has an identified cognitive or emotional health disability,
* the child or parents do not speak English sufficiently well to respond to the screening instruments, or
* the child's clinic visit is for an acute illness or change in health status.
Local Anaesthetic Effects of Transcutaneous Amitriptyline

The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on the skin of human volunteers, considering the differential effects on mechanic and thermic sensitivity, the local and general tolerance, and the systemic absorption of the drug. The solution used for dilution of amitriptyline is the only one known to allow transcutaneous absorption of the drug \[1\]. Considering that the peripheral sensitive fibre is a possible site of action of tricyclic antidepressants for relieving neuropathic pain \[2,3\], this is a first step study before further assessment of the therapeutic effects of transcutaneous amitriptyline.

Sixteen male healthy volunteers are enrolled for this study. They receive in a randomised order on six regions of dorsal skin (after previous targetting by ink marks) the six following treatments : lidocaïne-prilocaïne anaesthetic cream (EMLA (R)), normal saline, amityptiline hydrochloride diluted in solution of water (%), isopropanol (%) , glycerol (%), titrated with sodium hydroxide for pH=8.5, at four different concentrations (0,25, 50 and 100 mM). The person in charge of local application does not participate to further examination. Immediately after one hour of application, the volunteer is examined, and then every 2 hours during 8 hours, and 24 hours after the end if application. Every trial includes, for every treated area, (a) measurement of sensitive and nociceptive threshold to Von Frey hair application, (b) assessment of sensation induced by cold and heat after Rolltemp TM application, (c) measurement of sensitive threshold to cold, then sensitive and nociceptive thresholds to heat with Thermotest TM, (d) clinical evaluation of tolerance to the treatment, (e) blood sampling for measuring amitriptylinemia (HPLC). The possible residual anaesthetic effects of the treatment are assessed one and three weeks after the application, by measurement of sensitive and nociceptive threshold to Von Frey hair application. The statistical analysis will use two-way ANOVA, considering the following factors : treatment, time, order, subject, subject/order.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* history of intolerance to amitriptyline, lidocaine or prilocaine
* cardiac predisposition to intolerance to tricyclic antidepressants
Multidisciplinary Intervention for Mild Cognitive Impairment

The purpose of this investigation is to conduct a series of case studies on the impact of a novel functional medicine approach to improving cognitive skills, brain structure, and daily functioning for participants with Mild Cognitive Impairment (MCI).

Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from a combination of optimized diet, exercise, nutritional supplements, and cognitive training across domains on standardized measures used to monitor treatment effectiveness for Mild Cognitive Impairment (MCI).

Eligibility Criteria:
Inclusion Criteria:

* Age 50+ previously diagnosed with MCI
* Living in the greater Colorado Springs area

Exclusion Criteria:

* No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging
Pain and Sensation After Regional Anesthesia - Pilot Study

This study aims to determine spinal resolution and pain levels after the placement of a lumbar plexus block (LPB) and spinal for total hip replacement procedure. This is a pilot study that looks to collect information in order to design a larger, more significant study comparing Quadratus Lumborum blocks (QLB) and Lumbar Plexus blocks.

The Quadratus Lumborum block (QLB) is a newer regional analgesic technique that may be as effective as Lumbar Plexus blocks (LPB) at providing pain control following direct anterior approach (DAA) hip arthroplasty. The purpose of this study is to collect pilot data to help the design of a future randomized study, comparing a QLB to a LPB for DAA procedures. The investigators will assess for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels. This will help determine if pain scores collected at 6hrs reflect analgesia provided by the preoperative LPB alone or if the data is confounded by the presence of spinal anesthesia. This data will help us determine if 6hrs is a feasible primary endpoint to assess pain scores. Additionally, assuming that spinal regression is complete by 6hrs, the VAS pain scores obtained will then be used to perform a power analysis to determine the necessary study size when comparing QLB to LPB for DAA hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have elective total hip arthroplasty with DAA at Davie Medical Center.

Exclusion Criteria:

* Patients will be excluded if they do not receive a lumbar plexus block and spinal anesthesia.
* and/or if they have peripheral neuropathy affecting their feet.
Pathophysiological Mechanisms of Hypertensive LVH:Optimising Regression

Uncontrolled high blood pressure can cause heart muscle 'thickening', and this increases the likelihood of complications and death. The high blood pressure explains some but not all of this increase in heart size. This study will investigate the other causes, and will measure the heart muscle 'thickness' very accurately using the latest and most accurate technique called cardiac magnetic resonance imaging (MRI). The best way to treat this heart thickening remains to be determined. We hope to be able to show that by specifically targeting the cause of heart muscle thickening we can reduce its occurrence more effectively than by other standard means of blood pressure treatment


Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed essential hypertension (within 6 months).
* Age 25 to 80 years; Weight \< 100kg.
* Sinus rhythm without significant ventricular or atrial ectopy.

Exclusion Criteria:

* Current angiotensin II receptor antagonist or ACE Inhibitor treatment.
* Contra-indication to any of the protocol anti-hypertensive agents.
* Angina requiring treatment with a Beta blocker or calcium antagonist
* Any disease affecting the autonomic nervous system e.g. congestive cardiac failure, diabetes, neurological disease, malignancy, pregnancy.
* Contraindication to MRI (pacemaker, intra-orbital debris, intra-auricular implants, intra-cranial clips, history of claustrophobia, inability to lie supine for 15 minutes etc).
Collection of Ocular Surface Impressions Cytology of the Living Eye From Patients With Dry Eyes or Limbal Stem Cell Deficiency.

In order to develop innovative biomarkers for the diagnosis of two ocular surface pathologies, Dry Syndrome (DS) and Limbic Stem Cell Deficiency (LSCD), human cells from the ocular surface will be collected in order to test these biomarkers ex vivo.

To collect them, cytological fingerprints of the ocular surface are made using filter paper applied to the surface using a commercially available EC (European Conformity)-marked medical device, called EYEPRIM.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security scheme
* Age 18 years or older
* Presenting a Dry Syndrome, a limbic stem cell deficiency (clinical diagnosis) or another pathology (control).
* Signature of Consent

Exclusion Criteria:

* Major blepharospasm making examination impossible
* Pregnant women
* Breastfeeding women
* Protected Persons
Weight Gain Management in Patients With Schizophrenia

Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine for at least two months and evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent adverse events, changes in vital signs, laboratory results and extrapyramidal effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients, men or women, with age of 18 to 65 years
* Patients must have schizophrenia that meets disease diagnostic criteria as defined in DSM-IV Sections 295.10, 295.20, 295.30, or 295.90 and not to be in a clinically acute phase, in accordance with the judgment of the investigator
* Patients in use of 5 mg/day and 20 mg/day of olanzapine for a period not less than 2 months and not greater than 6 months and that have increased at least 5% of their corporal weight since the beginning of the treatment with olanzapine.
* The individuals must be trustworthy, and have a level of understanding enough to carry out all the tests and examinations demanded for the protocol, to understand the nature of the study and to have signed the informed consent
* Women with potential to become pregnant must be using a medically acceptable and reliable means of birth control.

Exclusion Criteria:

* Participation in a clinical study of another drug in investigation within a period of 1 month (30 days) before the entrance in the study (Visit 1)
* People who have used clozapine within a period of 12 months before the beginning of the study
* People with diagnosis of diabetes mellitus types I or II without adjusted clinical control or have initiated the medication use for glycemic control in the last 6 months
* DSM-IV substance (except nicotine and caffeine) dependence within the past 30 days
* Current participation in programs of weight loss
The Study of Long-term Deterioration of Kidney Transplants.

This study is being done to create a kidney transplant database with information from many transplant centers for the purpose of studying ways to help improve transplant outcomes and the care of transplant recipients. This is also being done to learn why kidney transplant recipients have worsening of their kidney function, and whether there are specific findings that could result in future treatments.

Data will be collected from the participant's medical records, local health care providers and participant's to clarify or add any information. Participants will have samples of blood, and urine obtained during their routine visits, that will be saved for testing in this study. In addition, participant's receiving a kidney biopsy performed as a part of their clinical care, will have a piece of the biopsy used for the study. This study will be followed for five years.

Eligibility Criteria:
In the prospective group, all participants who will be receiving a kidney transplant are eligible. In the retrospective group, kidney transplant recipients who are undergoing a kidney biopsy to determine the cause of change in their serum creatine level.
Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia

The purpose of this study is to determine the Optimal dose for safety and efficacy in the treatment of cervical dystonia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18\~75
* Have no clinically significant medical condition
* Cervical dystonia

Exclusion Criteria:

* Pregnant or lactation
* Subjects who have been administered the following drugs within the previous 1 month
MRD in High-risk EBC

This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed
* Age ≥18 years old
* Undergoing breast surgery, the surgical specimen was diagnosed as invasive breast cancer by the central laboratory and met any of the following conditions:

  1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4;
  2. HER2-positive breast cancer, lymph node metastasis≥4;
  3. Triple negative breast cancer, the number of lymph node metastases ≥ 1;
* ECOG 0-1
* Willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance

Exclusion Criteria:

* Confirmed distant metastases site
* History of other malignancy
* Psychopaths or other reasons unable to comply with treatment
* Concomitant uncontrolled lung disease, severe liver and kidney disease, severe infection, active peptic ulcer requiring treatment, coagulation disorders, connective tissue disease, or bone marrow suppression, and cannot tolerate chemotherapy and other related treatments
* HIV carrier or HBC/HCV infected
* Current or recent (within 30 days prior to enrollment) use of participation in another investigational program or use of another investigational drug
Thoracic Lymphatic Pump Techniques for Reducing Lung Volumes in Persons With Chronic Obstructive Pulmonary Disease

The primary goal of this line of research is to see if realistic manipulative protocols can be developed to produce sustained reductions in residual volume and improve pulmonary function parameters in people with Chronic Obstructive Pulmonary Disease (COPD).

This study is a prospective randomized crossover study to evaluate the effects of two different manipulation techniques on pulmonary function parameters in persons with COPD. Thirty-six (36) subjects will be enrolled in the study in order to complete the study with at least 30 subjects. Pulmonary function measures will include spirometry and lung volume. The pulmonary function testing will be done baseline, 30 minutes post-treatment, and 3 hours post-treatment. The study protocol treatment consists of a five-minute treatment session of one of the two studied treatment techniques given in a random order. After a washout period of at least four weeks, the subject will return for a second treatment session using the other technique.

Eligibility Criteria:
Inclusion Criteria:All subjects must be age 50 or older, have a history consistent with the diagnosis of COPD, and have documented airflow obstruction and an increased residual volume on pulmonary function testing. Airflow obstruction is defined as an FEV1/FVC ratio of 70 percent or less of the predicted value and a RV of 120 percent or greater of the predicted value.

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Exclusion Criteria:Subjects will be excluded if they have received any form of manipulative treatment in the 3 months prior to enrolling in the study. Subjects with acute respiratory illness, such as an exacerbation of COPD, acute bronchitis, or pneumonia will be excluded from the study. Persons unable to cooperate and follow instructions to complete pulmonary function testing due to dementia or other cognitive disorders will be excluded as will persons with spinal scoliosis greater than 25 degrees, significant chest wall deformity, and acute rib or compression fracture of the vertebra, unstable angina, or unstable congestive heart failure.

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Immunity and Infections in the Psychiatric Population

The main objective of this multicenter cohort study is to determine the degree of COVID19 infection immunization of a population of psychiatric patients.

The secondary objective of this cohort follow-up is to:

1. Clinically characterize COVID patients who are positive for serological testing
2. Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis
3. Immunologically characterize COVID patients who are positive for serological testing
4. Exploring the links between susceptibility to COVID19 and erythrocytic blood groups

All patients accepting to participate will be included in participating psychiatry services and will have a COVID Serological Test for Inclusion with confirmation at J15 including immune-genetics data.

A Comparison of COVID patients versus no COVID patients will be based on a clinical examination (psychiatric, somatic) and blood samples collected at J0 and J15.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Hospitalized in one of the participating psychiatric wards during the inclusion period
* Signed informed consent

Exclusion Criteria:

* Inability to obtain the consent of the patient or legal representative, if applicable
* Patient under safeguard of justice