cyrilzakka/clinical-trials huggingface dataset:
The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth

The purpose of this study is to determine the effect of probiotic supplemented yogurt in reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two yogurts will be administered, one containing a specific strain of probiotic in the Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized that subjects receiving the probiotic supplemented yogurt will experience reduced CTT and improved gastrointestinal comfort and quality of life compared to those receiving the non-probiotic supplemented yogurt.


Eligibility Criteria:
Inclusion Criteria:

* Being female
* Ability to speak and write English or Spanish
* Willingness to refrain from specified probiotic supplements, during the 12 week trial (a list of prohibited products will be provided)
* Have access to refrigeration and phone
* Have a history of straining during bowel movements
* Have a history of lumpy or hard stools

Exclusion Criteria:

* Presence of an allergy or intolerance to any ingredients in yogurt
* Morbid obesity, defined as a BMI\>40
* Having inflammatory bowel disease
* Having a history of malabsorption syndrome
* Immunodeficiency, such as HIV or currently receiving chemotherapy
* Consumption of any medications used to treat, prevent or cure diarrhea in the last month
* Consumption of any medications used to treat, prevent or cure constipation in the last month
* Diabetes mellitus
* Thyroid disorders, including hypo- or hyperthyroidism
* History of gastric, small bowel or colonic resection
* Documented history of gastric emptying disorder
* Consumption of narcotics, antipsychotic medications, or verapamil in the last month
* Known pelvic outlet obstruction
* Antibiotic usage within 4 weeks of enrollment
* Pregnancy
Calprotectin Levels in Necrotizing Enterocolitis

Necrotizing enterocolitis (NEC) is a serious condition that can affect premature babies, leading to complications like intestinal damage and infection. In our study, we measured specific markers (called calprotectin) in blood and stool to understand how severe NEC is and predict outcomes. We found that these markers were higher in babies with more severe NEC (stage 3), especially in those who needed surgery or sadly did not survive. This information can help doctors detect NEC earlier, understand its severity, and make better decisions for treating affected babies.


Eligibility Criteria:
Inclusion Criteria:

before 32 weeks of gestation with a birth weight of ≤1500 grams

Exclusion Criteria:

Infants whose families did not provide consent and those with congenital anomalies were excluded.
A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301

The purpose of this study is to evaluate the long-term safety and efficacy of EDIT-301 in participants with severe sickle cell disease (SCD) or transfusion-dependent β-thalassemia (TDT) who have received EDIT-301.

This is a non-interventional, multicenter study evaluating the long-term safety and efficacy of EDIT-301 in participants with severe sickle cell disease (SCD) or transfusion dependent b-thalassemia (TDT) who received EDIT-301 in parent studies EM-SCD-301-001 (NCT04853576) or EDIT-301-BThal-001 (NCT05444894). No investigational drug product will be administered in the LTFU study.

Eligibility Criteria:
Inclusion Criteria:

* Participant must have received an EDIT-301 infusion as part of a clinical study.
* Participant or legal representative/guardian (if applicable) must sign and date the informed consent form (ICF) or assent, if applicable for this long-term follow-up study.

Exclusion Criteria:

* Participant is still actively enrolled in an EDIT-301 treatment study and has not yet met eligibility for long term follow-up in this study.
The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance

The purpose of this study is to determined effects of BreatheMAX on secretion clearance.


Eligibility Criteria:
Inclusion Criteria:

* One sign of secretion accumulation in bronchi
* Stable cardiopulmonary function
* Good consciousness and good co-operation

Exclusion Criteria:

* Massive hemoptysis
* Pneumothorax (untreated)
Acute Presentation and Management of Abdominal Tuberculosis: A Ten-year Experience at a Tertiary Care Center in Pakistan

A prospective interventional study was conducted in Services Instituton of Medical Sciences all patients who underwent emergency laparotomy from 2008-2018 due to abdominal tuberculosis. Data were analyzed using SPSS version 21


Eligibility Criteria:
Inclusion Criteria:

* Both sexes and age between years and 90 years
* Patients presenting with acute abdomen and who underwent exploratory laparotomy
* Patients who diagnosis confirmed on biopsy (caseating granulomas)

Exclusion Criteria:

* Peritoneal tuberculosis
* Other causes of acute abdomen (Typhoid perforation)
* Patients diagnosed with abdominal tuberculosis and on conservative management
The Effectiveness of Bibliotherapy on Emotional Distress, Coping Strategies and Resilience of Adolescents With Cancer

Adolescents with cancer who were diagnosed within two years suffered severe emotional distress. Bibliotherapy therapy uses healing materials as a medium to enable individuals experiencing emotional distress to obtain emotional healing through story situations, thereby enhancing resilience. However, there is a lack of research on bibliotherapy in adolescents with cancer. Therefore, the investigators would like to evaluate the effectiveness of interactive bibliotherapy in improving emotional distress and coping strategies and enhancing the resilience of adolescents with cancer compared to reading bibliotherapy.

A multicenter randomized controlled trial will be conducted. Adolescents aged 10 to 19 years and diagnosed with cancer or relapse during the first two years will be included in the study. Seventy participants from three medical centers in northern Taiwan will be assigned to experimental or comparison groups through blocked randomization. The experimental group will receive the interactive bibliotherapy twice, and the comparison group will receive the reading bibliotherapy twice. The Positive and Negative Affect Schedule, Pediatric Cancer Coping Scale, and Haase Adolescent Resilience in Illness Scale will be used to measure participants' emotional distress, coping strategies and resilience at the time points of pre-intervention, after the intervention, and follow-up for a month after the intervention. An interview will be conducted over the intervention for a month. The generalized estimating equation will be used to analyze the two groups' emotional distress, coping strategies, and resilience. The content analysis will be performed to analyze the interview data. It is hoped that the results of this study can prove that bibliotherapy has the potential to improve emotional distress and coping strategies and enhance resilience in adolescents with cancer. This study is expected to provide health providers with novel evidence on the effectiveness of an intervention to take care of patients with cancer. Furthermore, this study provides an interdisciplinary intervention of nursing and other domain, and it may be extended to further research to improve patient care quality through cross-disciplinary coordination.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 10 to 19 years.
* Adolescents were diagnosed with leukemia or osteosarcoma.
* Adolescents were diagnosed with cancer or relapsed during the first two years.
* Adolescents who have received cancer treatment.
* Adolescents who can read picture books and communicate with Chinese.

Exclusion Criteria:

* Adolescents who have psychiatric history.
Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration

The objectives of this study are:

* to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration;
* and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-65 years of age
* If female: non-lactating; non-pregnant; and incapable of becoming pregnant, or taking specific precautions to avoid becoming pregnant before and during study
* Normal clinical laboratory parameters
* Adequate venous access in both upper extremities
* Agreeing to refrain from smoking and from ingesting any alcohol or caffeine-containing products before and during the study
* Good health based on medical history, physical examination and laboratory tests
* Non-smoking; or smoking less than 10 cigarettes per day and willing to refrain from use of nicotine products before and during study

Exclusion Criteria:

* Received a cephalosporin within the 21 days prior to study or anticipated to receive non-study cephalosporin during study
* Pregnant or breast-feeding.
* Previously exposed to a hyaluronidase drug product
* Medical condition presenting unacceptable safety risk or likely to prevent completion of study
* Known hypersensitivity to hyaluronidase or any other ingredient in HYLENEX recombinant
* Contraindication to ceftriaxone, including known allergy to beta-lactam antibiotics
* Local condition precluding subcutaneous injection or injection site evaluation
* History of gastrointestinal disease (in particular colitis)
* Consumption of caffeine- or other methylxanthine-containing beverage within 24 hours before and/or during the PK sampling period
* Participation in study of any investigational drug or device within 30 days before this study
* Serum hemoglobin \<12 g/dL.
* Blood donation or significant loss of blood within 56 days, or plasma donation within 7 days, prior to study
* Medical history/condition, screening physical examination finding or clinical laboratory result precluding safe participation in study, or which might adversely effect interpretation of study results
* History of drug or alcohol abuse within 2 years prior to study
Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma

This is a proof of concept study designed to assess the effects of a single intravenous dose of etokimab compared to placebo in adult participants with severe eosinophilic asthma. This study will also assess the safety and tolerability of etokimab in adult participants with severe eosinophilic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a confirmed clinical diagnosis of eosinophilic asthma
* History of diagnosis of eosinophilic asthma
* Severe asthma diagnosed according to the Global Initiative for Asthma (GINA) 2016
* Body mass index (BMI) of 18 to 38 kilograms per squared meters (kg/m\^2) (inclusive) and total body weight \> 50 kg (110 pounds)
* Women of childbearing potential must have a negative serum pregnancy test at screening and be willing to use highly effective methods of contraception throughout the study
* Male participants must be willing to use effective methods of contraception during the entire study period.
* Participant must be on high dose inhaled corticosteroids (ICS) plus long-acting beta-2-agonists (LABA)
* Willing and able to comply with the study protocol requirements
* Have the ability to read and understand the study procedures and can communicate meaningfully with the Investigator and staff

Exclusion Criteria:

* Have concomitant medical condition(s) which may interfere with the Investigator's ability to evaluate the participant's response to the investigational product (IP)
* Have experienced severe life threatening anaphylactic reactions
* Have received any IP within a period of 3 months or 5 half lives of an IP
* Have received high dose systemic corticosteroids
* Have received treatment with biologics, such as mepolizumab or omalizumab, within 3 months or 5 half lives (whichever is longer) before screening
* Abnormal electrocardiogram (ECG) assessment at screening
* Uncontrolled hypertension, or acute ischemic cardiovascular diseases
* If female, is pregnant or lactating, or intend to become pregnant during the study period
* History (or suspected history) of alcohol or substance abuse within 2 years before screening
* Any comorbidity that the Investigator believes is a contraindication to study participation
* Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments
* Planned surgery during the study or 30 days before screening
* History of malignancy within 5 years, except non melanoma skin cancer which has been fully treated with no current active disease
Pharmacokinetics of Oral Calcium Carbonate in Parturients

This study investigates the time course of change in calcium in the blood after a pregnant subject takes an oral dose of calcium carbonate (commonly marketed as "Tums"). This information is important for trials investigating whether calcium can reduce postpartum hemorrhage, bleeding after delivery.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant female subjects at the study institution, admitted for labor (spontaneous, augmented, or induced)

Exclusion Criteria:

1. severe range blood pressure (BP \>160/\>110) within the 48 hours prior to delivery
2. patient age \<18 years or \>45 years
3. renal dysfunction with a documented serum Cr \> 1.0 mg/dL
4. known history of congenital or acquired cardiac disease or history of arrhythmia
5. patient taking digoxin
6. patient currently taking a calcium channel blocker
7. Weight \<55kg or \>100kg, or
8. receiving magnesium infusion within 24 hours prior to or during cesarean delivery
9. Prior or planned administration of calcium by the obstetric or anesthesiology teams for clinical indications within 24 hours of study enrollment
10. Patient took a calcium supplement in the past 48 hours
11. Patient status is NPO (nothing by mouth) as ordered by the clinical team
The Moving 2 Mindful (M2M) Study: Mindfulness Group + Ecological Momentary Intervention

This study will evaluate the feasibility and acceptability of Learning to BREATHE (a mindfulness intervention for adolescents) plus an ecological momentary intervention (Learning to Breathe Plus), and will examine the extent to which mindfulness reduces dysregulated stress physiology, perceived stress, and anxiety in adolescents from high conflict homes.

Adolescents from homes with interparental conflict will be randomly assigned to Learning to BREATHE Plus (the standard group program designed to increase mindfulness, plus a multi-method adaptive intervention that will be comprised of an ecological momentary intervention and online library of mindfulness practices) or to a health and wellness active control condition to determine feasibility, acceptability, and potential effectiveness of Learning to BREATHE Plus.

Eligibility Criteria:
Inclusion Criteria:

* two parents in the home
* an adolescent who is between 14 and 18 years of age
* marital distress and/or problematic interparental conflict (based on parent or youth reports)
* youth reports of stress or anxiety

Exclusion Criteria:

* two parents in the home, but they are pursuing legal divorce or separation
* parents are not willing to receive marital education/support
* adolescents are severely clinically depressed or report suicidal ideation at baseline
A Research Study for Patients With Overactive Bladder

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Must be between 18-85 years old
* Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
* Must weigh at least 50 kg (110 lbs)
* Must be willing and able to record information regarding bladder function into a diary (provided)
* Must be willing and able to complete the entire course of the study

Exclusion Criteria:

* Cannot currently be catheterizing as a way to control incontinence
* Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition
Study of Mental Care in Spain

Non-interventional, multicenter, cross-sectional study to evaluate the mental care received by schizophrenic patients and their caregivers in Spain irrespective of the drug prescribed.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia (DSM-IV criteria)
* Attended to the mental care units for the first time in 2006

Exclusion Criteria:

* Participation in another clinical trial
* Other criteria that according to the medical criteria make difficult the normal development of the study
Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment

Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment


Eligibility Criteria:
Inclusion criteria:

* patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention
* patients with mild or moderate renal impairment
* age \>= 18 years at enrollment

Exclusion criteria:

- severe renal impairment (Creatinine Clearance \< 30 ml/min)
Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis

This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.


Eligibility Criteria:
Inclusion Criteria:

- Participants with rheumatoid arthritis receiving tocilizumab as per product label

Exclusion Criteria:

- No specific exclusion criteria were specified for this non-interventional trial
Identification of Specific Molecular Signatures in Pediatric, Adolescent, and Young Adult Rhabdomyosarcoma Through Spatial Proteome Analysis Using Mass Spectrometry

This non-interventional study aims to develop spatial proteomics for analyzing small FFPE tumor samples in rhabdomyosarcoma. It will identify molecular signatures linked to tumor regions, subtypes, survival, and treatment resistance, using pre-existing samples and data.

This is a non-interventional, monocentric, retrospective cohort study aimed at developing a spatial proteomics analysis method for small tumor samples (FFPE) to precisely characterize proteins at the tissue level in rhabdomyosarcoma (RMS). Using mass spectrometry, the study will identify molecular signatures associated with different tumor regions, histological subtypes, patient survival, and treatment resistance. The goal is to identify potential protein biomarkers and therapeutic targets. Data from clinical samples will be analyzed to find biomarkers correlated with survival and resistance to treatment. No patient intervention is required, as the study uses pre-existing biological samples and clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Age between 0 and 25 years at the time of initial diagnosis
* Diagnosis of rhabdomyosarcoma confirmed histologically
* Care at the Oscar Lambret Center between January 2005 and November 2024
* No objection to the re-use of data and biological samples collected as part of care for research activities.

Exclusion Criteria:

* Unavailability of biological sample in FFPE from biopsy and/or surgical specimen for diagnosis at Centre Oscar Lambret;
* Patient under guardianship or trusteeship.
Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion

Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to provide an effective medication and solution for the treatment of acute exacerbation of chronic obstructive pulmonary disease, and to provide data for the development of the further application of Qingcheng Pingxian Granules.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of AECOPD.
2. Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence
3. 40 years old ≤ age ≤ 90 years old
4. Patients who signed the informed consent form and volunteered to participate in the study

Exclusion Criteria:

1. Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc.
2. Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases.
3. Pregnant or lactating patients.
4. Allergic to the clinical trial drugs.