cyrilzakka/clinical-trials huggingface dataset:
Implementation of a Very Low Calorie Diet for Remission of Type 2 Diabetes in the Community

The complications associated with uncontrolled type-2 diabetes mellitus (T2DM) are numerous; reducing the quality of life for the patient and consuming a considerable portion of healthcare finances.

The Health of the Nation (HotN) 2011 study reported that 50% of the Barbadian population \>65years old had a diagnosis of T2DM and that two-thirds of the population were overweight - which is a risk factor for the development of T2DM.

Encouraged by the success of the Counterpoint study in the United Kingdom (UK), the Barbados Diabetes Reversal Study 1 (BDRS1) was established using a similar protocol; the aim of which was to evaluate the feasibility of implementing a very low calorie diet to reverse T2DM in Barbados. At the end of the 8-week intervention period, the 25 participants had achieved an average weight loss of 10.1kg (22lbs). This was accompanied by an increase in the number of participants whose fasting blood sugars were now within normal range despite being off of their diabetes medication; and a decrease in the number of participants taking blood pressure medication. Participants transitioned to a solid diet over a 4-week period, with guidance on health dietary habits and regular exercise routines. The benefits accrued during the intervention phase were preserved at the end of the transition period.

We now propose the Barbados Diabetes Remission Study 2 (BDRS2) as a sustainable community intervention - utilizing the local church as the community site. We hypothesize that this will enhance reach while reducing the cost of the study and will also facilitate the structures necessary for the social support of the participant.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 20 - 70 years old, all ethnicities
* Diagnosis of T2DM for \<6 years as defined by the American Diabetes Association
* Diagnosis of pre-diabetes as defined by the American Diabetes Association
* Body Mass index (BMI) of 27 kg/m2 and over

Exclusion Criteria:

* Insulin use
* Substance abuse
* Current cancer diagnosis
* myocardial infarction within last 6 month
* learning difficulties
* current treatment with anti-obesity drugs
* diagnosed eating disorder or purging
* HbA1c \> 10%
* pregnant/considering pregnancy
* evidence of liver disease (including liver enzymes \> 3 times above normal values)
* evidence of renal disease (creatinine of \> 150 mmol/l)
* persons who have required hospitalisation for depression, or are on antipsychotic drugs
Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor of morbidity and mortality in these patients. At present, studies that evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria of Bohan and Peter). However, previous works are old and retrospective; above all, they have almost always been performed (90% of cases) from cases reported to the hospital, leading to selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis in the general population.

Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based on the population of Normandy.


Eligibility Criteria:
Inclusion Criteria:

* patients with polymyositis / dermatomyositis, meeting the diagnostic criteria for ENMC;
* patient living Normandy ;
* patient has been informed and has given its verbal agreement ;

Exclusion Criteria:

* patients with myositis diagnosed before inclusion (including pathophysiology, clinical phenotype and therapeutic care are different from polymyositis / dermatomyositis)
Non-invasive Tumor Immunoglobulin Gene Next Generation Sequencing (IgNGS) in Diffuse Large B Cell Lymphoma (DLBCL)

This study will evaluate IgNGS at different time points in newly diagnosed DLBCL patients homogeneously treated (RCHOP) to address its correlation with conventional techniques (i.e., positron emission tomography/computed tomography imaging (PET/CT) and outcome.

In B-cell malignancies, every lymphocyte clone expresses a unique antigen receptor structure, therefore immunoglobulin gene rearrangements (the sequence of nucleotides at the V(D)J recombination site) serves as a specific marker for each clone. Methods of analysis have changed over time to improve the sensitivity and to allow its application in clinical settings.

Diffuse Large B-cell lymphoma (DLBCL) displays molecular heterogeneity. In this context, IgNGS allows for detection of tumor clonotype from plasma (ctDNA) (Liquid Biopsy-LB) of DLBCL patients with high sensitivity and specificity. ctDNA can be tracked with this methodology in the vast majority (\>90%) of patients, in contrast to NGS-methods based on genotyping for specific DLBCL mutations, which have overall low frequency. Furthermore, most newly discovered neoantigens in lymphoma derive from immunoglobulin variable sequences, supporting the relevance of the analysis of this particular region in contrast to the use of specific B-cell mutations. Importantly, preliminary studies on clonotype detection by IgNGS at the end of treatment correlate with outcome (poorer progression-free survival) and the persistence or reemergence of the tumor clonotype by ctDNA studies may anticipate the clinical relapse. We propose to evaluate IgNGS at different time points in newly diagnosed DLBCL patients treated with RCHOP to address its correlation with conventional techniques (i.e., PET/CT imaging) and outcome.

Eligibility Criteria:
Inclusion Criteria: patients diagnosed with de novo DLBCL, all ages, treated with R-CHOP. Patients with DLBCL not otherwise specified (NOS) according to World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues (WHO) 2016 would be included. In addition, those with "high-grade B cell lymphoma (including both NOS and those with Myc and bcl2 and/or bcl6 alterations) will be also included.

Exclusion Criteria:

* Primary mediastinal DLBCL.
* Transformed DLBCL
* Patients HIV+
* Central Nervous System (CNS) DLBCL
* All other DLBCL not included under "NOS" classification, according to WHO 2016 (except those specifically indicated in "inclusion criteria").
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)

The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.

A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Subject, male or female, must be between the ages of birth to 48 months inclusive at the time of consent.
* Subject must have experienced at least one previous episode or have a history of reactive airways disease.
* Subject must have an Oxygen saturation ≥ 90% at room air or with no more than 2 L/min supplemental Oxygen.

Exclusion Criteria:

* Subject who has participated in an investigational drug study within 30 days prior to study start, or who has previously participated in this study.
* Subject with a known sensitivity to levalbuterol or racemic albuterol, including Ventolin® or any of the excipients contained in any of these formulations.
* Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.

For additional information please call: 1-800-718-1021

Eligibility Criteria:
Inclusion Criteria:

* subjects with elevated cholesterol

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Intolerance to statin therapy resulting in withdrawal
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study
a Retrospective Study on the Systemic Treatment of LPP and FFA

This retrospective study aims to assess the effectiveness of systemic treatments for lichen planopilaris (LPP) and frontal fibrosing alopecia (FFA) in patients treated at the Erasmus MC University Medical Center. LPP and FFA are chronic inflammatory hair disorders leading to irreversible hair loss. The study evaluates treatment responses to systemic medications, including hydroxychloroquine, methotrexate, cyclosporine A, and retinoids.

Cicatricial alopecia, also known as scarring alopecia, refers to a group of rare chronic inflammatory hair disorders resulting in irreversible hair loss. Lichen planopilaris (LPP) and frontal fibrosing alopecia (FFA) are the most common forms of primary lymphocytic cicatricial alopecia, affecting predominantly postmenopausal women. These conditions lead to significant quality of life impairment due to their chronic nature and the lack of effective, standardized treatment protocols. The study aimed to address the gap in evidence-based treatment guidelines by investigating the effectiveness of various systemic therapies currently used in clinical practice. The retrospective cohort study reviewed medical records of patients diagnosed with LPP or FFA at the Department of Dermatology, Erasmus MC University Medical Center, from July 2016 to July 2022.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of LPP or FFA
* 18 years or older

Exclusion Criteria:

* Other forms of cicatricial alopecia than LPP or FFA
Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery

The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic cholecystectomy

Exclusion Criteria:

* bile duct stones
* ileus
* conditions affecting gastric emptying
* severe, organ-specific disorders
* HIV
* inherited metabolic disorders
* known intolerance against or allergy to any component of the investigational feeds
Translating an Efficacious Illness Management Intervention for Youth With Asthma

The propose of the study is to test the effectiveness of Reach for Control (RFC) as compared to Michigan MATCH to improve asthma symptoms, asthma management and lung functioning and to decrease ED visits and admissions for youth with poorly controlled asthma when integrated into hospital emergency departments and delivered by community health workers. The study is a hybrid implementation-effectiveness design and will test RFC for use in real world, public healthcare settings.

The study was conducted in the emergency department at Children's Hospital of Michigan; CHM). 170 adolescents with poorly controlled asthma and their primary caregivers will be enrolled. Prior to the COVID-19 pandemic, families were randomly assigned to six months of home-based family treatment consisting of either RFC or Michigan MATCH , a model program endorsed by the State of Michigan for treatment of poorly controlled asthma. Subsequently, all intervention content in both arms was delivered by telehealth. Treatment content of RFC consists of weekly sessions focusing on asthma education, asthma management skills, improving home-school community for asthma, access to care and case management. MATCH includes asthma education but is less intensive and does not focus on family management skills. Treatment was provided by community health workers (CHWs) employed by a community agency providing MATCH as their standard of care. Consent and data collection was completed at baseline with additional data collection visits at 6, 12 and 18 months after baseline. Data collection was completed by project research assistants and consists of questionnaires and interviews with the adolescent and parent to assess asthma management, asthma symptoms and hospital utilization. The data analyses were intent-to-treat, meaning that all randomized participants are included regardless of the intervention dose received. Trial data were analyzed using linear mixed effect models.

Eligibility Criteria:
Inclusion Criteria:

Adolescent/Parent:

1. Child aged 12 years, 0 months to 16 years, 11 months
2. Moderate to severe persistent asthma
3. Child seen in the CHM emergency department for treatment of asthma exacerbation
4. Child has experienced 2 or more ED visits and/ or inpatient admissions in prior 12 months (i.e. poorly controlled asthma)
5. Parent/ legal guardian willing to participate in home-based family treatment
6. Child and family resides within 20 miles of CHM (allows for home-based data collection and intervention)

Exclusion Criteria:

Adolescent/Parent:

1. Child is currently in an out-of-home placement
2. Schizophrenia or other psychosis on the part of the youth or parent
3. Current suicidality or homicidality on the part of the youth or parent
4. Cognitive impairment or learning disability that prevents comprehension of research measures on the part of parent or youth
Iron Absorption in Haiti

The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.


Eligibility Criteria:
Mother-child pairs will be recruited!

Inclusion criteria for mothers :

* Women of reproductive age (18 to 45 years)
* Generally healthy
* Consenting to study participation

Exclusion criteria for mothers :

* Pregnancy or lactation
* Weight \>65 kg
* Chronic illnesses which may influence iron absorption
* Severe anemia (Hb\<10 g/dl)

Inclusion criteria for children:

* Age 4 years +/- 12 months
* Generally healthy

Exclusion criteria for children :

* Severe anemia (Hb\<10 g/dl)
* Weight for height \< -2 Z scores (wasting)
* Height of age \< -2 Z score (stunting)

Furthermore, the following exclusion criteria apply to both mothers and children :

* Chronic illnesses or medication which may influence iron absorption (will be judged by investigator)
* Consumption of vitamin or mineral supplement (unless they agree to discontinue using them two weeks before beginning of the study until the las visit)
* Allergies or intolerances relevant to the test meal (gluten)
* Blood donation or major blood losses during the 2 months prior to the study
* Illness during the 4 weeks prior to the study (will be judged by investigator)
Multimodal Brain Monitoring as a Prognostic Tool for Intracerebral Hemorrhage

To verify if there is an association between advanced multimodal brain monitoring parameters in the first 48h and fist 7 days of admission with intrahospital and six-months functional outcome, even when controlled to other factors that may influence the outcome. Secondary Goals: To describe multimodal neuromonitoring parameters variation in the first seven days of ICH and identify any trends.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous Intracerebral Hemorrhage
* ICU admission in the first 24hours
* Need for intraparenchymal Neuromonitoring
* Over 18 years old

Exclusion Criteria:

* Tumour, Trauma or known Vascular Lesion
* Pregnancy
Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection

The aim of this study was to investigate the association between oral Helicobacter pylori infection and gastric Helicobacter pylori infection. Patients who were tested for gastric Helicobacter pylori were tested for oral Helicobacter pylori at the same time, and were divided into four groups according to the test results to compare the positive rate of oral Helicobacter pylori.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18\~70 ,both gender.
2. Initial diagnosis of stomach Helicobacter pylori infection or never had Helicobacter pylori infection.
3. Have not received dental care or systemic periodontal basic treatment in the past 1 year.

Exclusion Criteria:

1. There is serious organ damage and complications (such as cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
2. Ongoing use of antiulcer medications (including PPIs taken within 2 weeks before Helicobacter pylori infection testing), antibiotics, or bismuth complexes (more than 3 times/week before screening).
3. Those with severe oral diseases and malignant tumors of the mouth.
4. Previously had upper gastrointestinal surgery.
5. Refusal to sign informed consent.
Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first signs and symptoms of disease to a physician prior to randomization.


Eligibility Criteria:
Inclusion Criteria:

* Randomization after 12 weeks but within 12 months from first doctor visit for symptoms or signs of diabetes
* Diagnosis of type 1 diabetes mellitus
* Currently receiving insulin therapy
* Detectable fasting or stimulated C-peptide level at screening
* One positive autoantibody test result at screening: Islet-cell autoantibodies (ICA512)/islet antigen-2 (IA-2),Glutamic acid decarboxylase (GAD) autoantibodies, or Insulin autoantibodies

Exclusion Criteria:

* Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
* Previous treatment with monoclonal antibody
* Current treatment with oral antidiabetic agents
* Evidence of active infection
Effects of Colour-By-Number Mandalas ın Children Hospitalised Due to A Chronic Disease

Purpose: This study was conducted to find out the effects of colour by number mandala in decreasing the stress of hospitalized children with chronic disease.

Design: A randomized controlled study. Methods: This study was conducted with 120 children between the ages of 8 and 11. 60 children formed the experimental group, while 60 children formed the control group. Descriptive Information Form and Perceived Stress Scale were used in data collection.

Experimental group: The children, along with their parents, were interviewed by one of the researchers on their first day of hospitalisation. The parents were informed about the Descriptive Information Form and the Perceived Stress Scale for Children, which the researcher filled out in the presence of the children and their parents. The children were then given a colour-by-number mandala and colouring pencils. A different colour-by-number mandala was given to each participant every day; the mean length of hospital stay was 3 days. At the end of the third day, the same researcher interviewed the children and filled out again the Perceived Stress Scale for Children.

Eligibility Criteria:
Inclusion Criteria:

* parents who agreed to participate in the study

Exclusion Criteria:

* visually impaired child
* mentally retarded child
* speech impaired children
Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application

Comparative pharmacokinetics study after single subcutaneous application of AFOLIA and the reference product (Gonal-f®).

Objective: To demonstrate equivalence within the 80%-125% margin of the reference product for the area under the curve (AUC) of AFOLIA compared to (Gonal-f®).


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers
* Age between 18-38 years
* Body mass index 17-29 kg/m2
* Woman of child bearing potential must agree to practice effective barrier methods for birth control
* Use of oral contraceptives for at least 3 months before study entry
* Regular menstruation cycle (25-34 days) before initiation of oral contraception
* Presence of both ovaries
* Normal findings in medical history and physical and gynaecological examination unless the investigator considers an abnormality to be clinically irrelevant for this study
* Signed informed consent

Exclusion Criteria:

* Polycystic ovary syndrome (PCOS)
* History of hypersensitivity to FSH (Ovary Hyperstimulation Syndrome, OHSS)
* Impaired thyroid function (treated or untreated)
* History of malignant disease
* AST and/or ALAT \> 2 x ULN
* Other clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
* Smoking habits of more than 5 cigarettes per day
* Abuse of alcoholic beverages and drugs
* Participation in a clinical trial within 3 weeks prior to the study
* Foreseen inability to attend to scheduled study visits
* Symptoms of a clinically relevant illness during 3 weeks prior the first study day
* Pregnancy or lactation period
* Any medical condition that, in the opinion of the investigator, would interfere with safety of the subject or interference of the objectives of the study
Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block

The perioperative management of pain following lower abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.

One method used in this multimodal approach is the transversus abdominis plane block. This block, as first described by Rafi. in 2001, provides analgesia to the anterolateral abdominal wall. In 2007, McDonnell et al. further studied this technique in patients undergoing large-bowel resection. He discovered a reduction in postoperative pain and morphine consumption in the first 24 hours postoperatively, resulting in fewer opioid mediated side effects. In this same year, Hebbard et al. described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve transversus abdominis plane block accuracy. In 2008, Hebbard. described the subcostal approach of transversus abdominis plane block, to target the nerves of the upper abdomen. Transversus abdominis plane blocks continue to be studied and developed as an effective method for providing analgesia for numerous types of transverses abdominis plane block duration is limited to effect of administered local anesthetics.The use of an infusion catheter to administer local anesthetics is an option to prolong the block's duration. Recently, adjuvant medications were added to local anesthetics to prolong the effect of transverses abdominis plane block .

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status II-III,
* scheduled for uncomplicated elective paraumbilical hernia repair.

Exclusion Criteria:

1. Patient refusal to participate in the study
2. Patients with coagulopathy or under anticoagulation therapy.
3. Infection near the site of needle insertion.
4. Body mass index \> 40kg/m2
5. Patients with any neurological or neuromuscular disorder or history of seizures.