cyrilzakka/clinical-trials huggingface dataset:
Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus

Evaluation whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.


Eligibility Criteria:
Inclusion Criteria:

* T2DM diagnosed \> 3 months prior to the enrollment
* HbA1c \>= 6,5 %
* Capability of filling questionnaires by their own language
* Being able to use the devices provided
* Being cognitively able to participate

Exclusion Criteria:
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.

The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner.
* Diagnosis of asthma for at least 12 months (GINA 2011)
* Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
* Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment
* Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)

Exclusion Criteria:

* Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results
* Patients with recurrent, latent, or chronic infections
* Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
* Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
* Current smoker or smoking history of more than 20 pack years
Neurobiology of Language Recovery in Aphasia: Natural History and Treatment-Induced Recovery

The purpose of this study is to investigate the effects of treatment for specific language deficits in people with aphasia. In addition to language and cognitive measures, changes in brain function will also be gathered before and after the treatment is administered in order to track any changes resulting from receiving treatment.

Naming Impairments (Anomia):

The labs of Dr. Swathi Kiran (Boston University) and Dr. David Caplan (Harvard University, Massachusetts General Hospital) will be studying language recovery in adults with anomia (naming impairments) following a stroke. Participants will receive treatment focusing on the semantic features of common objects (e.g., that birds can fly). The study will examine how naming and other language abilities change in response to treatment, as well as how the brain changes, as measured by magnetic resonance imaging (MRI) and other techniques.

Spelling/Writing Impairments (Dysgraphia):

At Johns Hopkins University, the lab of Dr. Brenda Rapp will investigate the neurobiology of language recovery in individuals with dysgraphia (spelling/writing impairments) resulting from a stroke. In this study, treatment will focus on improving spelling ability. The study will examine how spelling and other language abilities change in response to treatment, as well as how the brain changes, as measured by magnetic resonance imaging (MRI) and other techniques.

Deficits in Sentence Comprehension \& Production:

Dr. Cynthia Thompson's lab at Northwestern University will investigate language recovery in individuals with deficits in sentence production and comprehension. Treatment focuses on production and comprehension of complex sentences. At baseline (week 0) and after the treatment period (at week 12), participants take part in language, eye-tracking, and MRI testing, in order to learn how the processing of language, as well as brain function, changes as a result of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aphasia following a stroke
* Stoke was at least 1 year ago
* Medically stable
* Right-handed
* Normal or 'corrected to normal' vision and hearing
* English as primary language
* At least a high school education

Exclusion Criteria:

* History of neurological disease, head trauma, psychiatric disorders, alcoholism, or developmental speech, language, or learning disabilities
Exposure-Based Treatment for Perfectionism

This study is examining the efficacy of a computerized, exposure-based, intervention for perfectionism.

The primary aim of this study is to evaluate the effects of a two-week computerized exposure-based treatment for perfectionism (ETP). Individuals with elevated perfectionism will be randomly assigned to ETP or a waitlist (WL) control condition. ETP will consist of three tasks in which they will repeatedly make mistakes, repeated for five sessions over a two-week period (one session every 3 days).

Eligibility Criteria:
Inclusion Criteria:

* Score of at least 29 on the Frost Multidimensional Perfectionism Scale- Concern over Mistakes subscale

Exclusion Criteria:

* Current moderate or severe substance use disorder, psychotic disorder, or bipolar disorder
* Current suicidal ideation (imminent risk)
* Currently participating in psychotherapy
* Any changes to psychotropic medications in the past four weeks
Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination

The aim of this study is to discover the immune and oncogenomic features that distinguish patients who respond to teclistamab from patients who are primarily resistant. Moreover, phenotypic and genotypic characteristics that occur with secondary resistance to teclistamab will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* With multiple myeloma
* Who receive Teclistamab
* Consent form signed

Exclusion Criteria:

* Patient under legal protection
Patient-Reported Outcome Study of Project ECHO for ILD

The study will assess whether patients of providers participating in Project ECHO for ILD experience reduced stress, including financial stress, based on their ability to receive timely and local care and services, The study will employ nested mixed-method design at baseline, at 6 months and at 12 months to answer the study question.

Project ECHO (Extension for Community Healthcare Outcomes) is a knowledge-sharing model to expand the capacity of the health care workforce so that more people can get high quality care for their health conditions in or near the communities where they live. The model brings specialty disease expertise to community providers through its hub-and-spoke networks. The model relies on videoconferencing to connect local providers in non-urban or underserved communities (spoke sites) with an interdisciplinary team of specialist providers at academic medical centers (hubs) during virtual "teleECHO" clinic sessions, which include brief educational lectures and case-based, experiential learning.

The ECHO model addresses barriers of long wait times for a first appointment, the time and expense associated with long distance travel, and the disinclination to follow through on repeated care appointments in the face of these persistent barriers, all with the additional objective of achieving health equity. Most patients perceive the diagnostic and care pathways in ILDs as a major struggle because of lack of awareness about the diseases, delayed access to specialty centers, providers' focus on disease- versus patient-centered care, and lack of reliable information and education about the diseases and supportive care resources.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of interstitial lung disease
* Not be currently followed by an ILD specialist at an academic institution or must live more than 50 miles away from an academic ILD center

Exclusion Criteria:

-
A Double Blind Study for the Treatment of Acute Ulcerative Colitis

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).

This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
* Female patients need to be postmenopausal or using adequate contraception.

Exclusion Criteria:

* Patients with isolated proctitis
* Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.
Lithium Water in Gun Violence Prevention

The word lithium frequently conjures images of catatonic psychiatric patients and side effects so severe that premature death is commonplace. But naturally occurring lithium is a far cry from pharmaceutical grades. Found in the soil, water and certain foods, it is an essential mineral for maintaining physical and mental health. When exposure is low, suicide rates, mental illness and violent crime increase

Lithium has a long history of use in the treatment of mental disorders. However, it hasn't been until recently that scientists began exploring the psychiatric implications of naturally occurring lithium in the water supply.

As stated in the article, Foods Rich in Lithium And Lithium Supplements:

"Research suggests that locations with the highest concentration of lithium tend to have the lowest rates of depression and violent crime. These studies have been conducted across the globe in different climates with different natural habits and diets. Researchers have therefore concluded that this phenomenon is fairly universal."

A study in the United States agrees with these findings. According to Everything Addiction:

"In a 1990 study of 27 Texas counties, researchers found an "inverse association of tap water lithium content in areas of Texas with the rates of mental hospital admissions, suicides, homicides, and certain other crimes." It was also discovered that young men incarcerated for violent crimes in some parts of Texas had disproportionately low lithium levels. Schrauzer and Shrestha discovered that the negative correlation was confirmed," especially in the south-central region of the state where high suicide mortality rates correspond to low lithium concentrations."'

Another study published in the British Journal of Psychiatry had similar results. Researchers at Oita University examined the suicide rates in Japan's Oita prefecture. The team discovered that cities with higher levels of natural lithium in the public water supply had lower rates of suicide overall.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 14-60.
* Existence of alcoholism, substance abuse, violence antecedent, suicide history Answered all questions in the pre-treatment safety questionnaire. Gave their oral and written consent to participate in the trial.

Exclusion Criteria:

Patients with renal failure, cardiovascular insufficiency, Addison's disease and untreated hypothyroidism.

Pregnancy. Patients who have vomiting or diarrhea or if fluid or salt (sodium) intake is increased or decreased.

Inadequate communication with examiner. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.

Inability to sign a consent form.
Efficacy and Safety of Modified Gegen Qinlian Decoction for Diarrhea-predominant Irritable Boewl Syndrome

Diarrhea-predominant irritable boewl syndrome(IBS-D) seriously affect the quality of life in patients. Clinically, it is effective to apply therapeutic method of clearing heat and promoting diuresis to the common syndrome of dampness-heat. Dysbiosis of intestinal microbiota is closely related to the immune imbalance and intestinal mucosal barrier injury. C1orf106/CYTH-1/ARF6 signal pathway, which derive from intestinal micro environment changes,is the mainly cause of intestinal mucosal barrier injury, and this is may be the common pathogenesis of dampness-heat syndrome in IBS-D . Based on the clinic, the project is to study the effect and mechanism of Chinese compound formula of clearing heat and promoting dieresis in modulating intestinal microbiota dysbiosis, repairing intestinal mucosal barrier and reconstructing intestinal microenvironment. With the combination of metagenomics and metabonomics, the study compare the differences of co-metabolites of intestinal microbiota and host within the healthy people, IBS-D patients with dampness-heat syndrome, to explore the relevance between intestinal flora and host co-metabolites. Furthermore, the experimental study is to clarify the drug targets via C1orf106/ CYTH-1/ARF6 signal pathway.Through the study of association between dampness-heat syndrome in IBS-D and intestinal microbiota, it is of important academic significance to reveal the Chinese theory intension of "homotherapy for heteropathy ".


Eligibility Criteria:
Inclusion Criteria:

1. It meets the diagnostic criteria of diarrhea-predominant irritable boewl syndrome and meets the diagnostic criteria for damp-heat syndrome.
2. Age between 18 and 70 years old.
3. Not taking antibiotics, steroids and other hormones, Chinese herbal preparations in the past week (including) Probiotics such as oral and intravenous), microecological preparations or yogurt.
4. The subject informed and voluntarily signed the informed consent form. ;
5. Have a certain reading ability

Exclusion Criteria:

1. Patients with severe organ, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental illness;
2. combined with other digestive systemic lesions (such as peptic ulcer), or systemic diseases affecting digestive tract motility (eg hyperthyroidism, diabetes);
3. Those who are or need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anxiolytics, intestinal flora regulators, antibiotics, etc.);
4. Those with a history of allergic reactions to related drugs and a history of severe food allergies.
A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers

This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects aged 18 to 55 years
2. A standardized body mass index
3. General good health as determined by the Investigator
4. Normal organ function as per the Investigator's judgement
5. Must be non-smokers, or ex-smokers who have not smoked within the previous 6 months from the screening visit
6. Female subjects must:

   * Not be lactating; not be pregnant
   * Agree to use an acceptable contraceptive method or be of non-childbearing potential
7. Male subjects must refrain from donating sperm or fathering a child during the study and until 3 months after the last study drug

Exclusion Criteria:

1. Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other related component
2. Presence of antibodies to polyethylene glycol at screening
3. Positive result for cotinine (\>500 ng/mL) or drugs of abuse at screening or on admission
4. Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator
5. Donation of blood (≥500 mL) or plasma within the previous 3 months
6. History of unexplained syncopal episodes;
7. Any disorder that, in the Investigator's opinion, may interfere with study compliance
8. History of any cancer
9. History of pulmonary infiltrate or pneumonia within the previous 6 months from screening visit
10. Hereditary fructose and/or sorbitol intolerance
11. Absolute neutrophil count below 1500/mm3 or above 12000/mm3 at screening
12. Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 or 2
13. Any abnormality in 12-lead ECG that in the Investigator's opinion is clinically significant and/or suggestive of underlying cardiac abnormalities
14. A clinical diagnosis of hypertension, significant hypercholesterolemia as judged by the Investigator, or thyroid abnormalities
15. Family history of acute myeloid leukemia or subjects with splenomegaly at baseline, or with sickle cell disease
16. Any prescribed or over the counter medications including analgesics, herbal remedies, vitamin therapy must not be used from 7 days prior to the first administration of study drugs
Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings

The purpose of this study is to assess the impact of small intestine bacterial overgrowth (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Child previously enrolled in the FIELD STUDIES protocol (enrollments in both studies may occur simultaneously)
* Mother willing to sign informed consent form.
* Healthy infant aged less than 7 days old

Exclusion Criteria:

* Parents are not willing to have child's blood drawn, oral fluid collected, urine collected, or breath testing performed.
* History of seizures, other apparent neurologic disorders, or other congenital abnormalities involving major organ systems.
Cognitive Functions During Thyrotropin Suppressive Therapy in Patients With Differentiated Thyroid Carcinoma

Thyroid carcinoma is the common endocrine system malignant neoplasm. At present it has become the malignant neoplasm of fastest growing incidence rate. More than 90% thyroid carcinoma is thyroid differentiated carcinoma（DTC）. Postoperative oral L-thyroxine suppressing thyroid stimulating hormone (TSH) treatment is the standard therapy in DTC patients. While TSH-suppressive therapy with L-thyroxine can cause subclinical hyperthyroidism in treatment of patients with thyroid differentiated carcinoma. The impact of this therapy on cognitive functions and mood have not been systematically studied. The investigators infer the subclinical hyperthyroidism caused by TSH-suppressive therapy may impact cognitive function and mood disorders in DTC patients. The aim of this study is to explore the possible mechanism of cognitive function impairment in the course of TSH-suppressive therapy by rat model of total thyroidectomy + TSH-suppressive therapy and clinical trials. The result of this study may provide clinical and experimental basis for the side effects risk result form TSH-suppressive therapy in DTC patients.

1. Object:

   Patients aged 18-65 years; newly diagnosed differentiated thyroid carcinoma and undergone thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer; followed by TSH-suppressive therapy 6 /12 months.
2. Clinical information, examination data and neuropsychological assessments:

Information is obtained from medical record abstraction. Serum T3, T4, FT3, FT4, TSH, TG-ab, TPO-ab, TG levels and neuropsychological assessments are examined after TSH-suppressive therapy 6 /12 months. Cognitive complaints were assessed with the Mini-Mental State Examination (MMSE), Clock Drawing Test (CDT), Digit Symbol test (DST), Wechsler Memory Scale (WMS), Aphasia Battery of Chinese （ABC） and patient health questionnaire-9 (PHQ-9).

Healthy volunteers (normal T3, T4, FT3, FT4, TSH, TG-ab, TPO-ab, TG) are recruited to match the patients with age, gender, education level, etc.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed differentiated thyroid carcinoma.
* Undergo thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer.
* Followed by TSH-suppressive therapy 6 /12 months.

Exclusion Criteria:

* Current or past disorder/disease of the central nervous system or medical condition impacting cognitive functioning.
* Head trauma history with prolonged loss of consciousness.
* Epilepsy, dementia, or learning disability.
* Current or past psychotic-spectrum disorder or current major affective disorder.
* Current substance abuse/dependence.
* Daily tobacco and alcohol use.
* Whole brain irradiation or surgery.
* Prior cancer diagnosis or chemotherapy treatment.
* Active autoimmune disorder.
* Insulin-dependent diabetes.
* Uncontrolled allergic condition or asthma.
* Chronic use of oral steroid medication.
* Hormone therapy (estrogen, progestin compounds).
.German TTP-Registry (Thrombotic Thrombocytopenic Purpura)

Open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18 for 1.) prospective investigation of patients with TTP in an acute bout and during long-term follow and 2.) assessment of prevalence, course of disease, success of therapy, possible triggers for relapses and possibilities for better diagnosis and prognosis.

1.) Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry and 2.) Investigation of the pathophysiological processes in acute bouts and in remission by recording the clinical symptoms and diagnostics for a better understanding of the course of the disease, optimization of diagnostic procedures and their correlation with the clinical course, recording of therapy response of all therapeutic options in acute bouts, observation of current treatment options to evaluate outcome and prognostic markers and recording of clinical and laboratory chemical data during follow-up to assess long-term morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18.
* Patients incapable to give consent, who are accompanied by a legal representative during admission to the study, after the written informed consent of the legal representative.
* Written informed consent of the patient.

Exclusion Criteria:

* Patients who are not able to understand the German or English language.
* Patients who are permanently unable to communicate and who are not accompanied by a legal representative.