cyrilzakka/clinical-trials huggingface dataset:
The Impact of the Covid-19 Pandemic on Schizophrenia Patients Registered With the Community Mental Health Center

This study aimed to examine the effect of the Covid-19 pandemic on schizophrenia patients registered to the Community Mental Health Center (CMHC) in terms of depression, suicide risk, and tendency to violence.

The study was conducted on patients registered to the Ministry of Health Kartal Dr. Lütfi Kırdar City Hospital Adatepe Community Mental Health Center and was followed up regularly. It was carried out on 108 individuals who met the diagnosis of schizophrenia according to the DSM-V (American Psychiatric Association 2013) and met the inclusion criteria. Individuals who were respectively classified as hospitalized group (HG) during the Covid-19 pandemic period (n=39), non-hospitalized with emergency care group (NHECG) without hospitalization (n=37), and non-hospitalized with non-emergency care group (NHNECG) (n=32). Individuals who had been diagnosed with schizophrenia for at least two years, were not in the active phase of the disease, did not have organic mental disorders, did not have any other psychiatric diseases were included in the study. In the study, the Socio-Demographic Questionnaire, the Calgary Depression Scale in Schizophrenia (CDSS), the Buss-perry Aggression Questionnaire (BPAQ), and the Suicide Probability Scale (SPS) were used.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-65,
* receiving service from Kartal Dr. Lütfi Kırdar City Hospital Adatepe CMHC,
* having been diagnosed with schizophrenia for at least two years,
* not being in the active phase of the disease,
* not having an organic mental disorder,
* not having an additional psychiatric illness, and
* being literate

Exclusion Criteria:

* Individuals with cognitive and physical dysfunction,
* mental retardation, different psychiatric diseases that would prevent interview or testing, and
* those who did not consent to participate in the study
Comparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients

The aim of the study is to compare an Infra-zygomatic Mini implant supported appliance with headgear in distalization and intrusion of maxillary dentition for treatment of growing patients with class II malocclusion (maxillary excess)

In this randomized trial, 2 groups will be included. The first group will receive an Infra-zygomatic Mini implant supported appliance. In the second group, the patient will receive a removable high pull headgear. the follow-up period will be 8 months or till class I canine or incisors relation is obtained. the assessment will be through a lateral cephalogram

Eligibility Criteria:
Inclusion Criteria:

1. Growing patients ( cervical vertebrae maturation stage cs2-cs3 )
2. Maxillary excess
3. Minimum overjet 4 mm
4. class II canines or incisors
5. Increased incisal show at rest and on smiling
6. Normal and increased vertical growth pattern
7. No previous orthodontic treatment
8. No congenitally messing teeth except third molars

Exclusion Criteria:

1. Inadequate incisal show
2. Class II with deficient mandible and normal maxilla
3. Patients with any syndrome
4. Patients with horizontal growth pattern
Mini Stem DEXA (Dual Energy X-ray Absorptiometry)

The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

The purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patient has hip disease that requires a total hip arthroplasty.
* Patient is willing to consent to participate in the study.
* Patient plans to be available for the study duration.
* Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.

Exclusion Criteria:

* Patient known to have insufficient bone stock.
* Patient has had major non-arthroscopic surgery to the study hip.
* Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
* Patient has a known sensitivity to materials in the device.
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c \<=6.5% at Week 24.


Eligibility Criteria:
Inclusion Criteria:

* Has a clinical diagnosis of type 2 diabetes mellitus
* Has an HbA1c \>7.0% and ≤10.0%
* Has a BMI of ≥25 kg/m\^2 and ≤50 kg/m\^2
* Has been on a regimen of insulin for less than 6 months and is taking less than 50 U total of insulin per day, OR has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy

Exclusion Criteria:

* Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months
* Requires the use of drugs that stimulate gastrointestinal motility
* Has been previously treated with Symlin (or has participated in a Symlin clinical study)
* Is currently being treated with any of the following medications: \*Over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat \[Xenical®\] and sibutramine \[Meridia®\]); \*Oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; \*Drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide \[Reglan®\]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; \*Investigational medications
* Has a history or presence of any of the following: \*Eating disorders (including anorexia and/or bulimia); \*Bariatric surgery (gastric bypass, gastric banding, or gastroplasty)
* Is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study
* Has donated blood within 30 days of study start or plans to donate blood during the duration of the study
Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease

OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease.

II. Compare the differences in pruritus, weight gain, and liver function for both treatments.

PROTOCOL OUTLINE:

Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb). There is a 24-hour washout between each 4-week course of therapy.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Chronic cholestatic liver disease

Cystic fibrosis-associated liver disease

--Prior/Concurrent Therapy--

Usual and customary diet maintained throughout study, e.g., medium-chain triglyceride oil

--Patient Characteristics--

Pulmonary: No serious respiratory deficiency

No acute illness

No inability to swallow

No fertile women
Timing of Resistance Exercise in Type 1 Diabetes

The aims of the current study are

1. to compare the effects of acute morning and afternoon resistance exercise on blood glucose levels in people with type 1 diabetes.
2. to compare the effects of morning and afternoon resistance exercise training on cardiometabolic health outcomes in people with type 1 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Physician confirmed type 1 diabetes for at least 1 year
* Stable insulin therapy for 3 months prior to the study

Exclusion Criteria:

* BMI of 45 or higher
* BP of 160/100mmHg or higher
* autonomic neuropathy
* severe proliferative retinopathy
* joint or limb injuries preventing weight-bearing activity
* autonomic neuropathy
* severe proliferative retinopathy
* any other medical condition that prevents participants from exercising safely.
Fructose Extra-splanchnic Metabolism and Its Effects on Systemic Flux of Substrates (FruPP)

In parallel to the dramatic rise in metabolic diseases and diabetes observed over the past fifty years, the generalization of added sugar in processed food led to a marked increase in fructose consumption in almost all countries, and epidemiological studies demonstrated that the consumption of sugar-sweetened beverage (containing at least 50% of fructose) is associated with the development of diabetes, hepatic steatosis, dyslipidemia and obesity.

The objective of the study is to measure the amount of fructose that escape first-pass hepatic extraction after oral ingestion (fructose+glucose), and gain insights into its metabolic fates with the use of tracers.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 40 years
* Body Mass Index of 18.5 to 25 kg/m²
* Sex male of female

Exclusion Criteria:

* Fructose intolerance
* Antidiabetic and hypolipemic drugs
* Alcohol consumption \>10g/day
* Severe eating disorders
* Severe psychological problems
* Vegetarian diet or other specific diet
* Consumption of illicit substances
* Pregnancy
* Weight gain or weight loss \> 3 kg in the last 3 months
A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

This is a phase 3 study. All subjects arerecurrent or metastatic head and neck squamous Cell Carcinoma (R/M HNSCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combined with AK117 versus pembrolizumab combined with placebo in patients with R/M HNSCC whose tumors have programmed cell death-ligand 1 (PD-L1) positive \[Combined Positive Score (CPS) greater than or equal to 1\].


Eligibility Criteria:
Inclusion Criteria:

1. Be able and willing to provide written informed consent.
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Have a life expectancy of at least 3 months.
4. Has histologically confirmed diagnosis of R/M HNSCC primarily located in oropharynx, oral cavity, hypopharynx, or larynx, which is considered incurable by local therapies.
5. Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
6. No prior systemic treatment for R/M HNSCC.
7. At least one measurable noncerebral lesion according to RECIST 1.1.
8. PD-L1 positive (CPS ≥ 1).
9. Has adequate organ function.
10. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
11. Able to to comply with all requirements of study participation (including all study procedures).

Exclusion Criteria:

1. Has squamous cell carcinoma of the primary site, such as nasopharynx, nasal cavity, sinuses, salivary glands, thyroid or parathyroid, skin, or of unknown primary origin.
2. Had other malignant tumors within the 5 years prior to enrollment.
3. Has a significant risk of bleeding assessed by the investigator based on imaging.
4. Radiologically documented evidence of major blood vessel invasion or tumor invading organs or there is a risk of esophagotracheal or esophagopleural fistula, or major blood vessel encasement that the investigator determines will pose a significantly increased risk of bleeding.
5. Has known active central nervous system (CNS) metastases.
6. Has pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
7. Previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, and any other treatments targeting the immune mechanisms of tumors.
8. Previously received radiation therapy for head or neck within 8 weeks prior to enrollment, received palliative radiation therapy for non-head or non-neck within 3 weeks prior to enrollment.
9. Has a history severe bleeding tendency or coagulation dysfunction.
10. Has a history myocarditis, cardiomyopathy, and malignant arrhythmia.
11. Has a history arterial or venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to enrollment.
12. Pregnant or lactating female.
NICU-TECH RM9L-RS Probe ME Feasibility Study

Use of a new ultrasound device designed for babies to look at the catheters in veins and arteries as well as the blood vessel itself. An observational study to assess the the clinicians perception of the ultrasound image quality as a tool to detect catheters in vessels.

The intent of the study is to confirm the maximum penetration of the NICU-Tech RM9L-RS probe. The investigators collected images on patients with PIV (Peripheral Intra Venous)/PAC (Peripheral Arterial Catheter) and central line catheters. The investigators collected images of deep vessel structures for offline processing to improve NICU-Tech algorithms for vessel segmentation.

Eligibility Criteria:
Inclusion Criteria:

* Neonates that are 23 gestational weeks at birth (and greater than 500 grams) to a 6 month old born infant at term (maximum weight 7 kg) who already have one or more lines placed (PIV/PAC/UVC/UACs/PICC) as part of their medical care. NO INFANT WILL HAVE A LINE PLACE FOR THE PURPOSE OF THIS STUDY

Exclusion Criteria:

* Neonates that are less than 23 gestational weeks at birth
* Neonates that are 23 gestational weeks at birth but are less than 500 grams in weight
* Patients weighing more than 7 kg.-Patients older than 6 months
Electrotherapy Combined With Neck Exercises for Non-Specific Neck Pain

Objectives: The objective of this study is to compare the effectiveness of telerehabilitation versus a face-to-face program in the therapeutic approach to non-specific neck pain through exercise and analgesic electrotherapy.

Methods: Randomized clinical trial on 100 participants with nonspecific neck pain who will be randomized into two groups to receive analgesic electrotherapy combined with a cervical exercise program through telemedicine or face to face. A total of 20 sessions will be applied over 8 weeks. Demographic and clinical data, disability, pain intensity, kinesiophobia, isometric spinal muscle strength, quality of life, and cervical mobility will be collected. Assessments will be performed at the beginning of the study (baseline), at 8 weeks (post-treatment) and 6 months after the end of the intervention (follow-up).

Introduction: Neck pain is a common problem in the working-age population, with a high recurrence rate and one of the highest health costs globally. Exercise is considered one of the keys in the management of this pathology, and electrotherapy is consolidated as a safe and proven analgesic measure. Telemedicine facilitates access to health care by eliminating geographical barriers and reducing costs, allowing consultations from any location and favoring the patient's work-life balance. The widespread availability of smartphones, tablets and computers makes telerehabilitation more accessible than ever.

Objectives: The objective of this study is to compare the effectiveness of telerehabilitation versus a face-to-face program in the therapeutic approach to non-specific neck pain through exercise and analgesic electrotherapy.

Methods: Randomized clinical trial with 100 participants with nonspecific neck pain who will be randomized into two groups to receive analgesic electrotherapy combined with a cervical exercise program through telemedicine or face to face. A total of 20 sessions will be applied over 8 weeks. Demographic and clinical data, disability, pain intensity, kinesiophobia, isometric spinal muscle strength, quality of life, and cervical mobility will be collected. Assessments will be performed at the beginning of the study (baseline), at 8 weeks (post-treatment) and 6 months after the end of the intervention (follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 30 and 65, with a medical diagnosis of cervical pain of non-specific origin,

  * Acceptance and signature of informed consent for voluntary participation in the research study.
  * Not receiving physical therapy.
* Chronic cervical pain lasting 3 months or more and not receiving any other type of physiotherapy treatment.

Exclusion Criteria:

* Patients undergoing rehabilitation treatment for pathologies of cervical origin.
* Patients have osteosynthesis material at the cervical level and/or cardiac complications, epilepsy or tumors.
* Patients who have undergone radiotherapy in the last 6 months.
Research on the Application of AI Image Recognition-Based Smartphone Apps in Personalized Bowel Preparation

Colorectal cancer, as one of the most common malignant tumors of the digestive system, has a high incidence and mortality rate worldwide. High-quality colonoscopy is essential for the early detection and prevention of colorectal cancer and is key to improving the survival rates of patients. However, traditional colonoscopy faces numerous challenges in bowel preparation, such as inadequate preparation and a lack of personalized cleansing approaches. Therefore, it is particularly important to develop timely and efficient individualized bowel preparation methods. Artificial intelligence, especially deep learning technologies, has shown great potential in the medical field. This study aims to leverage the advantages of artificial intelligence to optimize the bowel preparation process before colonoscopy, creating a personalized bowel preparation plan that effectively improves the efficacy of colorectal cancer screening and diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent painless colonoscopy at the Digestive Endoscopy Center of the First Affiliated Hospital of Zhengzhou University and signed the informed consent for the clinical trial.

Individuals who use smartphones.

Exclusion Criteria:

* Patients with contraindications for colonoscopy. Individuals in whom successful cecal intubation could not be achieved.
No More Falls Injury Prevention Study

A randomized controlled multi-component fall prevention study for older adults. The study integrates fall prevention into an existing community-based public health program for older adults.

A randomized controlled multi-component fall prevention study for older adults. The study integrates fall prevention into an existing community-based public health program for older adults. The study will evaluate the effectiveness of a fall prevention intervention among 552 seniors attending Preventive Health Care for the Aging (PHCA) clinics in two counties: urban San Diego county and rural Humboldt county. The intervention includes four elements: education about fall risk factors, referrals to community exercise programs to increase strength and balance, medication review, and home modification to reduce home hazards. The goal of the intervention is to reduce incidence of falls requiring hospitalization by 10%. Results of the study, which are expected to be completed by October 2004, will help guide future efforts to develop multifaceted fall prevention programs.

Eligibility Criteria:
Inclusion Criteria: PHCA clients age 65+ -

Exclusion Criteria: Age \<65

-
Modulation of Dyspnea Perception During Exercise in COPD Patients Using Attentional Distraction

Chronic obstructive pulmonary disease (COPD) is a major health problem whose prevalence is increasing rapidly. The gradual decrease in exercise tolerance is one of the usual consequences of COPD that affects the functional independence and quality of life of patients.

In COPD patients, breathlessness and muscle fatigue are the main symptoms limiting exercise. Recent studies have shown that most of the physiological mechanisms of psychological factors such as emotions, motivation, memory, personality, expectations, or prior experience can greatly influence and modulate the perception of breathlessness. It has been proposed that the attentional distraction (visual or auditory) during exercise may be associated with a decrease in anxiety and shortness of breath and could improve exercise tolerance in COPD. We therefore propose to study the impact of attentional strategies of distraction on the perception of dyspnea and walking tolerance in patients with COPD.

The research hypotheses are:

i) Compared with exposure to a strategy of negative attentional distraction during exercise, exposure to a strategy of positive attentional distraction will improve walking exercise tolerance in patients with COPD;

ii) For a given level of effort, sensory perception and emotional perception will be enhanced by exposure to a strategy of positive attentional distraction.

Ten subjects with moderate to severe COPD will be recruited at the Research Center of the Institut Universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ). During an assessment visit, we will measure complete pulmonary function, body composition and maximal functional capacity during a maximal incremental test work performed on a treadmill.

During two subsequent experimental visits, and after spirometry control, participants will perform a walking test performed on a treadmill at an intensity corresponding to 75% of maximum effort during maximal incremental test. The test will be carried out in combination with a strategy of either positive attentional distraction, neutral attentional distraction or negative attentional distraction . The order of the condition will be randomized.


Eligibility Criteria:
Inclusion Criteria:

* Smoking history \> 10 pack-years
* Post-BD FEV1 \[30-80 % predicted value\]
* Post-BD FEV1/FVC \< 70 %
* Age \[50-80 yrs\]
* Voorips score \< 9

Exclusion Criteria:

* Exacerbation \< 4 weeks
* Asthma, Neoplasia, Cardiac failure, Diabetes
* Neuromuscular limitations
* Major depression or other psychiatric disorders
* BMI \> 30 kg/m2
* PaO2 \< 60 mmHg or oxygenotherapy
* Involvement in a structured and regular physical activity program