cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

To evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent before the test and fully understand the test content, process and possible adverse reactions.
* Male and female subjects aged 40 to 80 years old (including the cut-off value).
* Body mass index (BMI) in the range of 18-30kg/m2 (including the critical value)
* Subjects have no pregnancy plan and voluntarily use effective contraception for at least 1 month from screening to the last use of the study drug.
* Diagnosed as a COPD patient according to the The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria.
* Able to conduct acceptable and reproducible lung function tests.
* COPD clinical stability within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit.
* Smoking history ≥ 10 pack years.

Exclusion Criteria:

* History of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation.
* Screening for COPD acute exacerbations that require systemic hormone therapy prior to the visit.
* Screening for hospitalization history due to COPD within the first 6 months.
* Use antibiotics for respiratory tract infections within 6 weeks prior to screening or randomization visit.
* Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD.
* Previous lung resection or lung reduction surgery.
* Pulmonary rehabilitation treatment.
* Previously received TQC3721 treatment.
* Patients who received immunotherapy within the first 4 weeks of the screening period.
* The patient has a history of diseases that are currently beyond their control.
* History or current evidence of cardiovascular disease with clinical significance.
* History of cured or untreated malignant tumors in any organ or system within the past 5 years.
* Screening for clinically significant safety laboratory test outliers determined by the researcher during the visit.
* Those who require oxygen therapy or intermittent oxygen therapy.
* Receive attenuated live vaccine within 28 days prior to randomization, inactivated vaccine within 7 days, or study.
* Planned vaccine recipients during the period.
* Individuals who have participated in any drug or medical device clinical trials prior to screening.
* Researchers believe that there are other situations that are not suitable for participation in the study.
Identification of Undiagnosed Gaucher Disease

Partners HealthCare maintains a Patient Data Registry (PDR) with information from all patient encounters at Partners HealthCare facilities. We intend to utilize the PDR to identify groups of patient who are of high clinical suspicion for undiagnosed Gaucher disease. A group of potential participants will be identified through the PDR. Detailed records will be requested to further narrow to ideal participants based upon previously existing diagnoses and symptoms. Participants will be invited to partake in the study via a letter from their Partners care provider with supporting study details. Study participants will be evaluated in a one-time visit. A complete family and medical history will be collected. A physical exam will be performed, and up to 20cc of blood will be drawn. All participants will be notified of their disease status via letter and phone call from the study staff. If the study participant is diagnosed with GD through this evaluation, proper follow-up recommendations and referrals will be provided. Our intent is to determine if existing patient data can successfully be utilized to aid in the identification of patients with rare genetic disease.


Eligibility Criteria:
Inclusion Criteria:

* Must have records available in the Partners HealthCare Patient Data Registry

Exclusion Criteria:

* Must not have a diagnosis of Gaucher disease
Measurement Properties of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS

The purpose of this study is to translate and culturally adapt the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) into Turkish, and to determine the measurement properties of the Turkish version.

Patellofemoral pain and patellofemoral osteoarthritis are highly prevalent knee disorders associated with pain and functional limitations. Patient-reported outcome measures (PROMs) are suggested for clinical and research use; however, there is a lack of objective disease-specific PROMs for patellofemoral pain and osteoarthritis. The purpose of this study is to translate and culturally adapt the subscale of the Knee Injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF) into Turkish, and to determine the measurement properties of the Turkish version.

Eligibility Criteria:
Inclusion Criteria:

* peripatellar or retropatellar knee pain persisting for at least 3 months and exacerbated by activities that load the patellofemoral joint;
* pain intensity of at least 3 mm according to the visual analogue scale (VAS)

Exclusion Criteria:

* diffuse or generalized knee pain
* severe trauma to the target knee in the previous year
* moderate to severe concomitant tibiofemoral osteoarthritis
* recent knee injection (within 3 months)
* systemic inflammatory conditions
Clinical and Molecular Characteristics of Histiocytic Disorders

This study is being done to collect medical and personal histories as well as a samples of blood, other body fluid and/or tumor/disease tissue for current and future research studies on histiocytic disorders.

PRIMARY OBJECTIVES:

I. Define molecular signature and genomic landscape of histiocytic disorders. II. Correlate genomic findings with transcriptional abnormalities. III. Identify promising prognostic alterations and potential therapeutic targets.

OUTLINE: This is an observational study.

Patients complete questionnaires and undergo blood and tissue sample collection. Patients' medical records are also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* \* All patients diagnosed with histiocytic disorders and age ≥1 year

Exclusion Criteria:

* \* \< 1 years age
AF Stroke Substudy SL-ECG Versus 12lead ECG

The purpose of the study is to compare parameters obtained per SL-ECG with the values from 12lead-ECG measurement. Patients who undergo out- or inpatient treatment and who receive a 12lead-ECG are asked to participate in this examination. Furthermore, 50 patients without heart disease should be included (control group).

Atrial fibrillation is the most common cardiac arrhythmia in Germany. Clinical studies have shown that atrial fibrillation is associated with increased morbidity and mortality and reduced quality of life. Patients with atrial fibrillation have a three times higher risk of heart failure and a four to five times higher risk of ischemic stroke. In addition to these risks, atrial fibrillation is often asymptomatic and therefore more difficult to diagnose. It is estimated that about one third of all atrial fibrillation patients are asymptomatic.

For this reason, the study "Opportunistic Screening in Pharmacies for Atrial Fibrillation in Seniors" was conducted in Aachen. Within four weeks more than 7000 volunteers could be measured in participating pharmacies using a ECG hand-held diagnostic tool. Since the already measured subjects only have the SL-ECG measurement of the hand-held diagnostic tool, the aim of this substudy is to establish a reference group. In this reference group a 12lead-ECG is performed by routine ECG and a SL-ECG measurement by ECG hand-held diagnostic tool. The aim of the study is to compare the measured parameters and to optimize the algorithm to evaluate the remaining SL-ECGs of the main study.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years old, for minors the signature of the legal guardian is required.
* Understanding of the essence, meaning and scope of the study.
* Patients (in-/outpatient) who receive a 12lead ECG through Medical Clinic 1.
* Volunteers who are willing to have a 12lead ECG and an SL-ECG performed and provide medical information.
* Signed informed consent

Exclusion Criteria:

* Insufficient language skills
* Limited cognitive abilities
* Limited physical abilities (i.e. tremor)
Increased Early Pain Relief by Adding Vertebroplasty to SBRT

The goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain.


Eligibility Criteria:
Inclusion Criteria:

* Histological evidence of cancer.
* Spinal and vertebral bone metastases (T5 to L5) documented by imaging.
* Pain related to metastases ≥ 4 on a numerical scale 0-10.
* Karnofsky performance index \> 60 (ecog 0-2)
* Candidate for SBRT
* Less than 3 consecutive levels reached.
* Ability to complete follow-up questionnaires regarding pain, analgesics, and quality of life assessment.
* Potentially unstable lesions according to the spinal instability neoplastic score (SINS) scale (\> or = 7)

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Contraindications to MRI.
* Histology: myeloma, lymphoma or plasmacytoma.
* Radiotherapy prior to the level to be treated.
* Previous surgery at the site to be treated.
* Surgical indication:

spinal instability neoplastic score (SINS) \> 13 or according to tumor board consensus.

Bilsky score \> or = 2 Severe or progressive neurological signs (motor, incontinence).

* Lesion too large for safe vertebroplasty.
* High thoracic location not allowing safe visibility in fluoroscopy to perform vertebroplasty (T4 and above).
* Non-reversible coagulation disorders.
* Uncontrolled local or systemic infection.
* Estimated survival of less than 6 months.
* Inability or refusal to undergo SBRT treatment or vertebroplasty
A Randomized Trial to Evaluate the Effectiveness of Transferring the Flexor Hallucis Longus Tendon

The optimal surgical treatment for insertional Achilles tendinopathy remains unclear. The purpose of this study is to evaluate the long-term outcome of surgical treatment by comparing the patient reported outcomes of Insertional Achilles Tendinopathy; Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles with flexor hallucis longus (FHL) transfer and Achilles tendon debridement, excision calcaneal exostosis, Strayer procedure, secondary repair of Achilles without FHL transfer.


Eligibility Criteria:
Inclusion Criteria:

* Male and female 18 years or older
* Diagnosed with insertional Achilles tendinosis by history and physical exam
* Confirmed by x-ray and MRI
* Calcification at the Achilles insertion and gastrocnemius tightness.
* Failure of the following non-operative treatment for greater than 6 months: \*shoe modifications

  * physical therapy
  * immobilization
  * and home exercise program.
* In addition, participant must have an intact flexor hallucis longus tendon.

Exclusion Criteria:

* Patients who have failed surgery for the same and patients with diabetic neuropathy.
Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.

A randomized controlled trial will test a cognitive behavioral skills building intervention (COPE-P) in Black and Hispanic women experiencing emotional distress in two sites (New York and Ohio) to determine if the intervention leads to better health behaviors, better psychosocial health (anxiety, stress, and depressive symptoms), and improved birth and post-natal outcomes in women experiencing emotional distress. Developing scalable prenatal interventions designed to improve birth outcomes as well as maternal physical and psychosocial health is essential to decrease health disparities in pregnant minority women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 18-40 years old
* Pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks
* Self-identified as either Black or Hispanic
* Able to read and speak English.
* The child participants born to the participants will have their record accessed for data collection.

Exclusion Criteria:

* Women with chronic medical conditions (e.g., hypertension, or diabetes), are currently receiving treatment or therapy for a psychiatric diagnosis, or have participated in this study with a prior pregnancy.
* Women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

The purposes of this study are to determine:

* The safety of tirzepatide and any side effects that might be associated with it.
* How much tirzepatide gets into the bloodstream and how long it takes the body to remove it.
* How tirzepatide affects the levels of blood sugar.

This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.


Eligibility Criteria:
Inclusion Criteria:

* Have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase \[DPP\]-IV inhibitors)
* Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive

Exclusion Criteria:

* Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds
* Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
* Have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or any GI disease which impacts gastric emptying or could be aggravated by GLP-1 analogs or DPP-IV inhibitors
Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study was to investigate the 5cm\^2 and 10cm\^2 doses of rivastigmine transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's Disease (MMSE \[Mini Mental State Examination\] 10-20). A 52-week extension phase evaluated the safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients with probable Alzheimer's Disease (AD).

Patients were randomly assigned in a double-blind manner to one of the 3 treatment arms (placebo, rivastigmine 5 cm\^2 and rivastigmine 10 cm\^2) in a ratio of 1:1:1. During the Double-blind treatment phase, patients entered a 16-week Titration Period followed by an 8-week Maintenance Period. During the open-label extension phase, all patients started treatment with a 2.5 cm\^2 patch and the dose was increased to 10 cm\^2 over a 16-week titration period, followed by a maintenance period of 36 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
* A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
* An MMSE score of \> or = 10 and \< or = 20

Exclusion Criteria:

* A current DSM-IV diagnosis of major depression
* Taken rivastigmine in the past
* A score of \> 5 on the Modified Hachinski Ischemic Scale (MHIS) Other protocol-defined inclusion/exclusion criteria may apply

Other protocol-defined inclusion/exclusion criteria may apply

Extension Phase Eligibility Criteria

Inclusion Criteria:

* Patients who have completed the Double-blind Treatment Phase on study medication

Exclusion Criteria

* Patients who have any important protocol deviations until the completion of the Double-blind Treatment Phase
Measuring Parkinson's Disease With Tear Fluid

The purpose of this study is to assess whether tear secretion in patients with Parkinson's disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that will be reflected in changes in the protein composition of tear fluid, which can be measured relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected from Parkinson's patients, and through biochemical assays, the profile of proteins in tears will be characterized and compared to that from control subjects. The profiles will be analyzed with respect to any differences between Parkinson's patients and control subjects. If differences appear, the levels of these potential biomarkers in Parkinson's patients will be compared to the severity of their disease.


Eligibility Criteria:
Inclusion Criteria:

* established Parkinson's Disease for at least 6 months
* Healthy controls without neurological illness

Exclusion Criteria:

* currently taking anti-cholinergic medication
* dementia
* have an exposure to neuroleptic medications other than Quetiapine or Clozapine in the 6 months prior to screening
* have an active eye infection or have had eye surgery within 3 months prior to screening
* control subjects will be excluded if they have a history of neurological disease
* PD subjects will be excluded if they have an atypical Parkinsonian syndrome
Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient must voluntarily sign and date a patient authorization.
* Patient must be ≥ 18 years of age.
* Patient must have confirmed diagnosis of UC.
* Patient must have:

  1. a Mayo endoscopic sub score of 2 or 3 from endoscopic investigation in the previous 3-months that is closest to the baseline visit or
  2. a Mayo rectal bleeding subscore ≥ 2 and a calprotectin value greater than 250 µg/gr.
* Patient must have been prescribed adalimumab as part of his treatment by his treating physician.
* If the patient was previously treated with vedolizumab or any anti-TNF agent (except adalimumab), an appropriate washout has taken place as per routine practice.

Exclusion Criteria:

* Patient has previously received adalimumab.
* Patient has previously used infliximab or any anti-TNF agent and have not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
* Patient with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
* Patient with a current diagnosis of indeterminate colitis, ulcerative proctitis only, or with a current diagnosis and/or have a history of Crohn's disease.
* Patient with other tumor necrosis factor (TNF) immune-modulated disease.
* Patient has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
* A female patient is pregnant or breast-feeding.
* Patient is currently participating in another prospective study including controlled clinical trials and observational studies
Fatigue in Primary Sjögren's Syndrome

Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

While fatigue is seen with a prevalence of 7-8% in the normal population, it is more prevalent in Primary Sjögren's syndrome (PSS). In the studies conducted so far, the frequency of fatigue was seen at a frequency of over 30% in Primary Sjögren's syndrome. Although fatigue is so common in PSS, there is not enough data about the conditions in which fatigue develops in PSS. Other common conditions in PSS, apart from fatigue, are psychometric disorders such as common pain, depression and anxiety, and sleep disorders. In the studies conducted so far, each situation mentioned is common in PSS and seems to be related to each other. In the literature, there is no data on how many psychometric parameters, pain level, and insomnia affect fatigue and which are independent risk factors in PSS.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
* Healthy hospital staff

Exclusion Criteria:

* Pregnant women
* Cancer patients
* Those with other connective tissue diseases other than PSS
* Multiple sclerosis patients
* Chronic obstructive pulmonary disease
* Those with heart failure and adrenal insufficiency
* Those with renal failure: GFR \<60 ml/min
* Anemia: Hemoglobin \<11 g / dl in women, hemoglobin \<12 g / dl in men
* Hypothyroidism: TSH \>5 mu / L
* Those with electrolyte disturbance
Study Evaluating the Efficacy and Safety of WID-RGC20(Cariprazine) in Patients With Schizophrenia

This Study is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Fixed-Dose, Phase 3 Clinical Trial Evaluating the Efficacy and Safety of WID-RGC20 3 mg/day and 6 mg/day in Patients with Acute Psychotic Episode of Schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 19 ≤ age \< 65 years
* At least 1 year of schizophrenia diagnosed according to DSM-5 criteria(295.90)
* At least 1 psychotic episode within 1 year
* Current psychotic episode(acute exacerbation of schizophrenia) within 2 weeks
* 80 ≤ PANSS total score ≤ 120
* Rating of at least 4(moderate) on at least 2 of the following 4 PANSS positive symptoms
* CGI-S score ≥ 4
* Patients who can be hospitalized during the screening period and at least 3 weeks of the initial double-blind treatment phase

Exclusion Criteria:

1. Psychiatric Criteria

   * Medical history except schizophrenia specified in protocol
   * First-episode psychosis
   * Treatment-resistant schizophrenia within 2 years
   * Positive result from the blood alcohol concentration(BAC) test or the urine drug screen(UDS)
   * Have suicide risk
2. Treatment-related Criteria

   * Electroconvulsive therapy(ECT) within 12 weeks or Previous lack of response to ECT
   * Concomitant treatment with 3 or more antipsychotics within 12 weeks
   * Treatment with flunitrazepam or LAI antipsychotics less than 1 cycle or clozapine within 24 weeks
   * Treatment with CYP3A4 inducers or potent CYP3A4 inhibitors
   * Treatment with amiodarone or systemic corticosteroids for ≥ 12 weeks within 1 year
   * Required prohibited concomitant medication during the study period
   * Prior participation in any clinical trials of Cariprazine
3. Other

   * Ophthalmic medical findings or related history(ex. uncontrolled diabetes or hypertension)
   * Abnormal laboratory findings specified in protocol
   * Not suitable for any other reason, as judged by the investigator