cyrilzakka/clinical-trials huggingface dataset:
IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)

This study tests the efficacy of interpersonal psychotherapy (IPT) for major depression following perinatal loss (early and late fetal death and early neonatal death) in a sample of 274 women in Flint and Detroit, Michigan. The trial will be the first fully powered randomized trial of treatment for any psychiatric disorder following perinatal loss.

The goal of this study is to conduct a fully-powered randomized efficacy study of IPT for MDD following perinatal loss. Our perinatal-loss adapted group IPT will be compared to a standard depression intervention (CWD, also delivered in a group format) in a sample of 274 women experiencing MDD following perinatal loss. The proposed randomized controlled trial (RCT) will test the hypotheses that: (1) IPT for perinatal loss will result in reduced time to recovery from MDD (primary), depressive symptoms, and PTSD symptoms (secondary) relative to CWD; and that among women meeting criteria for PTSD, IPT will result in reduced time to recovery from PTSD; (2) IPT for perinatal loss will result in increased social support, social role functioning (including parental functioning for women with living children), and well-being, and decreased grief and fear of subsequent pregnancies, relative to CWD; and (3) social support and grief will mediate the effects of IPT on time to MDD recovery.

Eligibility Criteria:
Inclusion Criteria:

* women who meet current Diagnostic and Statistical Manual 5 (DSM-5) criteria for major depressive disorder (MDD)
* have experienced a perinatal loss (including early and late fetal death, death of a liveborn neonate within the first 28 days, and medically recommended termination) within the last 1-12 months
* are 18 to 50 years old
* speak and understand English well enough to understand questionnaires when they are read aloud
* can provide the name and contact information of at least two locator persons
* have access to a telephone through owning one, a relative/friend, or an agency

Exclusion Criteria:

* onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included)
* current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder
* primary diagnosis of current substance use disorder
* acute suicidal or homicidal risk
* non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 12 weeks)
* any IPT or cognitive-behavioral treatment in the previous 12 weeks
SMS Technology for the Promotion of Diabetes Education and Self-Management in Egypt

This study was conducted at the teaching hospital of Misr University for Science \& Technology. It aimed to examine the use of SMS technology in educating and monitoring diabetic patients in Egypt, and assess the impact of educational text messages on their glycemic control and self-management behaviors. Participants were randomized into an intervention and a control group. Intervention patients received an instruction booklet as well as daily educational and weekly reminder messages to better control their diabetes. Control patients received the same instruction booklet but no SMS messages. Both group patients took an HbA1c test at the beginning and end of the study period and were asked to measure their blood glucose once a week and record their readings into a monitoring table over 12 weeks. The primary outcome was the change in HbA1c levels, which was expected to be greater among intervention patients at the end of the study. Secondary outcomes included blood glucose levels, treatment and medication adherence, diabetes self-efficacy, rate of hospital/ER visits, frequency of blood glucose measurement, among others.


Eligibility Criteria:
Inclusion Criteria:

* has diabetes
* owns a mobile phone
* can read SMS messages or lives with someone that can read for them.

Exclusion Criteria:

* cannot read or not SMS familiar and lives alone
A Study of ALN-AAT02 in Healthy Participants and Participants With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease

The purpose of this study is to evaluate the safety and tolerability of single or multiple doses of ALN-AAT02. The study will be conducted in 2 sequential phases in which Part A will be a single-ascending dose (SAD) phase in healthy participants, and Part B will be a multiple-ascending dose (MAD) phase in participants with ZZ type alpha-1 antitrypsin deficiency (PiZZ) and biopsy-proven alpha-1 antitrypsin (AAT) deficiency-associated liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 65 years, inclusive;
* Has normal 12-lead electrocardiogram (ECG);
* Has body mass index (BMI) between 18 and 30 kg/m\^2, inclusive;
* Has been a nonsmoker for at least 5 years before screening;
* Part A only: Has Alpha-1 antitrypsin (AAT) levels within normal limits;
* Part A only: Has adequate Forced Expiratory Volume in 1 second (FEV1) and adequate FEV1/forced vital capacity ratio;
* Part B only: Has documented ZZ type AAT by genotype;
* Part B only: Has liver biopsy within 90 days of the first dose of study drug demonstrating ZZ type alpha-1 antitrypsin deficiency (PiZZ AATD) liver disease;
* Part B only: Has adequate post-bronchodilator FEV1 and adequate diffusing capacity of the lung for carbon monoxide;
* Part B only: If on any maintenance medication, is likely to be able to remain on a stable medication regimen for the duration of the study (no new medications within 30 days prior to first dose of study drug).

Exclusion Criteria:

* Has known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) infection;
* Has clinically significant abnormal laboratory results;
* Received an experimental drug within 30 days of dosing;
* Has a history of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc);
* Part A only: Has estimated glomerular filtration equal to or below 60 mL/min/1.73 m\^2 at screening;
* Part A only: Has a history of asthma or recurrent or chronic lung disease, excluding resolved childhood asthma;
* Part A only: Has a history of chronic liver disease;
* Part B only: Has estimated glomerular filtration equal to or below 45 mL/min/1.73 m\^2 at screening;
* Part B only: Received an augmentation therapy for AAT deficiency within 8 weeks of first dose of study drug;
* Part B only: Has a history of chronic liver disease from any known cause other than ZZ type AAT deficiency;
* Part B only: Has a history of hepatic encephalopathy;
* Part B only: Has a history of gastrointestinal bleeding or ascites.
Comparison Between Home Macular Perimeter and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with Age Related Macular Degeneration (AMD). However, the device has the ability to detect the development of the lesion post treatment and therefore to assess in determination of the next treatment.

The Optical Coherence Tomography (OCT) may be used as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can be used as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluating the size and the location of the treated lesions may serve as an additional tool.


Eligibility Criteria:
Inclusion Criteria:

* For naïve CNV lesion - diagnosed in less than 60 days. OR For re-activated CNV lesion - treated more than 4 month from the diagnosis.

  * Intent to treat the study eye (SE)
  * Corrected VA better than 6/45 (20/150) in SE
  * Subject is capable and willing to sign a consent form and participate in the study
  * Age \> 55 years
  * Subject declared that he or she knows how to operate a computer mouse

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in SE
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the SE by biomicroscopy
* Any ocular surgery performed within 3 months prior to study entry in the SE \* Participation in another study
A Study of Patients With AIDS Syndrome

The purpose of this study is to find out why cancers develop in HIV-positive patients.

Cancer is a leading cause of death in AIDS patients. Common cancers in HIV-infected patients include Kaposi's sarcoma (KS) and non-Hodgkin's lymphoma (NHL), a cancer of the immune system. Risk factors include certain chemicals, viruses, and perhaps even anti-HIV drugs. Doctors would like to find out which risk factors are most important and how they relate to cancer in AIDS patients.

AIDS-associated malignancy represents a model system for investigations of carcinogenesis. There are few human conditions in which cancer rates are of the magnitude they are in HIV infection. While studies have investigated pre-cancer markers in HIV-infected patients, they have not correlated these markers with tumor samples. This study contributes to understanding oncogenesis of HIV-associated malignancies by establishing a collection of tumors linked with pre-cancer sera and lymphocyte specimens, as well as prospective questionnaire data.

At study entry, patients receive a comprehensive physical exam. Clinic staff interview the patient to collect data regarding medication history (particularly antiretroviral exposure), diet, occupational history, substance abuse, and sexual practices. This information is used to identify behavioral and environmental factors contributing to oncogenesis. In addition, baseline blood samples are analyzed for HHV-8 and EBV levels, anti-EBV and anti-HHV-8 antibodies, CD23, Th2 cytokines, tumor growth factors, chromosomal translocations associated with NHL, and other potential predictors of malignancy. At Month 6 and annually thereafter, patient records are abstracted for data on vital status, AIDS-defining illnesses, medications, and most recent CD4+ T cell and HIV RNA levels. At Years 1, 2, and 3, patients undergo physical exams and blood tests for malignancy surveillance. Any malignancies are biopsied and analyzed for oncogene identification and virology. The medical records of patients who die on study are reviewed to determine the cause of death and to rule out unreported cancer. No treatment is provided by this study.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this trial if you:

* Are HIV-positive.
* Have a CD4+ cell count of 200 cells/mm3 or below.
* Are 18 years of age or older.

Exclusion Criteria

You will not be eligible for this trial if you:

* Are not available for follow-up for at least 3 years.
A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Used artificial tears for dry eye
* Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
* Herpes keratitis in the last 6 months
* Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months
Ventilation Associated Pneumonia and Covid-19

In December 2019, a new pandemic emerged, the COVID-19 disease caused by a SARS-Cov-2 virus. One of the most common symptoms of COVID-19 is mainly respiratory failure and patients requires assistance by mechanical ventilation. Ventilator-associated pneumonia (VAP) is a risk of this assistance. Since the beginning of the pandemic, Standard of care have evolved with new data. The prevalence of these VAPs seems significantly higher in the population of patients with ARDS COVID-19 (40-50%) and their ecology seems to have evolved over time, particularly in terms of bacterial resistance. Investigators want to describe and compare this evolution of bacterial and fungal ecology as well as identify potential risk factors that may be associated with these changes in ecology during different waves.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Positive SARS-Cov-2 polymerase chain reaction (PCR)
* healthcare associated pneumonia

Exclusion Criteria : Patient opposition to participate to the study
CLARITY Extension Study

The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.


Eligibility Criteria:
Inclusion Criteria:

* Randomized in Trial 25643 and satisfied one of the following:

  * Completed randomized treatment course and scheduled visits for the full 96 weeks; or
  * Did not complete the randomized treatment course in Trial 25643 but elected to receive rescue treatment with Rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
  * Did not complete the randomized treatment course in Trial 25643, declined rescue with Rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
  * Did not complete the randomized treatment course in Trial 25643, were not eligible for rescue option with Rebif®, and still completed scheduled clinic visits for the full 96 weeks
* Male or female, between 18 and 65 years of age (inclusive, at time of informed consent for Trial 25643)
* No medical history or evidence of latent tuberculosis infection (LTBI) or tuberculosis (TB), as evidenced by TB skin test or chest X-ray
* All of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study Day 1:

  * Hemoglobin = 11.6 to 16.2 gram per deciliter (g/dL)
  * Leukocytes (total white blood cell) = 4.1 to 12.3\*10\^3 per microliter
  * Absolute lymphocyte count (ALC) = 1.02 to 3.36\*10\^3 per microliter
  * Absolute neutrophil count (ANC) = 2.03 to 8.36\*10\^3 per microliter
  * Platelet count = 140 to 450\*10\^3 per microliter
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* Participants who were not enrolled in Trial 25643
* Participant has moderate to severe renal impairment
* Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since Trial 25643
* Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis at any time during and since Trial 25643
* Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1
Vaccine Hyporesponse in Healthy Elderly Participants (MK-0000-131 AM2)

This study evaluated whether it is possible in healthy elderly participants to generate baseline biomarker-based prediction rules (PdR) for vaccine response (post baseline absolute serum antibody titer) using each of the protocol selected vaccines separately; and examined the rank correlation coefficients of pairs of post vaccination antibody titers within the same elderly individuals.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 25 to 40 years old or 65 years of age or older at the prestudy (screening) visit
* Has no fever on day of screening
* Lacks Hepatitis B surface antigen seroreactivity
* If female 25 to 40 years of age, is not pregnant nor breastfeeding, and agrees to use effective contraception

Exclusion Criteria:

* Has a prior history of Hepatitis B Virus infection
* Has BMI (Body Mass Index) \>35
* If female 25 to 40 years of age, is pregnant, or expecting to conceive, donate eggs or breastfeed
* Has received immune globulin and/or blood products within 3 months prior to first dose received
* Has a history of immunosuppression resulting from disease (e.g., malignancy; human immunodeficiency virus \[HIV\] infection), or is currently taking corticosteroids or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation)
* Has an active neoplastic disease
* Has had any infection including upper respiratory viral syndrome in the 6 weeks prior to planned collection of baseline laboratory samples
* Has received a live virus vaccine or an inactivated vaccine or is scheduled to receive a live virus vaccine or an inactivated vaccine in the period from 6 weeks prior to receipt of the first vaccine through the completion of all study visits
Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar

The purpose of this study is to learn about the effects of smoking shisha on the lungs, when compared to the effects of smoking cigarettes or of not smoking. The investigators hope to learn more about how shisha smokers should be monitored and treated once diseased.

Traditional shisha smoking is practiced by \~10% of the Qatari adult population. Although based on tobacco leaves, shisha smoking exposes the airway epithelium to a chemical insult of intensity and duration different from that of cigarette smoking. This study, a collaboration between WCMC-Qatar and WCMC-New York and the Hamad Medical Corporation (HMC), is focused on defining the biology of the airway epithelium of shisha smokers compared to non-smokers. Using approved protocols, bronchoscopy will be used to sample the airway epithelium, the site of the earliest changes associated with smoking. The transcriptome of the recovered epithelium will be assessed in the genomic core WCMC-Qatar for gene expression using microarrays and complete RNA sequencing using massive parallel sequencing.Based on this information, the epithelial DNA will be assessed for relevant SNPs, copy number variations and methylation status. Parallel studies will be carried out in cigarette smokers, providing a comprehensive catalog of shisha smoking-induced changes compared to cigarette smokers and non-smokers in this population.

Eligibility Criteria:
Non-smoker

Inclusion Criteria:

* Population living in Qatar
* Must provide informed consent
* Individuals must also have smoked less than 100 cigarettes and/or less than 10 shisha pipes in their lifetime
* Has normal pulmonary function test
* Has normal chest xray
* No signs of acute lung infection

Exclusion Criteria:

* Medical history of significant illness or other significant medical issues
* Regular shisha smoker
* Regular cigarette smoker
* Simultaneous cigarette plus shisha smoking

Shisha smoker

Inclusion Criteria:

* Population living in Qatar
* Must provide informed consent
* Must have smoked 5 pipe-yr
* Must currently smoke 5 pipes/wk
* Has normal function tests
* Has normal chest xray
* No signs of acute lung infection

Exclusion Criteria:

* Medical history of significant illness or other significant medical issues
* Regular cigarette smoker
* Simultaneous cigarette plus shisha smoking

Cigarette smoker

Inclusion Criteria:

* Population living in Qatar
* Must provide informed consent
* Confirmation of smoking status by urine testing
* Confirmation of smoking status by assessment of carboxyhemoglobin
* Has normal function tests
* Has normal chest xray
* No signs of acute lung infection

Exclusion Criteria:

* Medical history of significant illness or other significant medical issues
* Regular shisha smoker
* Simultaneous cigarette plus shisha smoking
High-intensity Interval Training Combined with Muscle-strength Training in Older Women

Women generally live longer than men but often experience a faster muscle mass loss due to inactivity, which can lead to weakness and disability. Despite these risks, women, particularly older women, are less active than men. In England, less than one-third of women engage in sufficient aerobic activity, and less than 5% do enough muscle strength training. Common reasons for not exercising include lack of time and enjoyment.

High-intensity interval training (HIIT) is an efficient and effective way to exercise that many women find more enjoyable than longer workouts. HIIT has been shown to be effective in older women, helping them improve their fitness with less time commitment. Because HIIT is time-efficient, it can be combined with muscle strength training without significantly increasing the duration of the exercise session, which may lead to even better fitness results.

This study will assess how practical it is for older women to do HIIT and strength exercise combined training. It will also investigate whether this combined approach can improve overall fitness, muscle strength, aerobic fitness, and quality of life more than HIIT alone.


Eligibility Criteria:
Inclusion Criteria:

* Females (biologically at birth)
* At least 60 years of age at the time of signing the informed consent
* Non-smoker, including electronic cigarettes
* Not participating in routine high-intensity aerobic or muscle strength exercise training (≥ 75 min/week of structured vigorous aerobic exercise, or 2 times /week of structured muscle strength training)
* Able to perform a cardiopulmonary exercise testing (CPET) to exhaustion
* willing to complete baseline and follow-up measures, and attend prescribed exercise sessions at the University of Nottingham
* willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Diagnosed with cardiovascular disease, kidney disease, diabetes, obstructive pulmonary disease, or uncontrolled hypertension
* History or current neurological or psychiatric illness, or motor or cognitive restrictions
* Contraindications to symptom-limited cardiopulmonary exercise testing (CPET), including resting hypertension with systolic blood pressure \>200 mmHg or diastolic blood pressure \> 110 mmHg, uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, and hyperthyroidism, mental impairment with limited ability to cooperate, physical disability that precludes safe and adequate testing.
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.