cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder.

Poststroke depression is seen with a frequency of up to 30%. Drug options for depression and accompanying sleep problems are limited; In addition, effective doses cannot be increased depending on the comorbidities of the patients and the side effect profiles and drug interactions of the drugs used. Acupuncture has been used in Chinese traditional medicine for more than 2000 years and there are findings that it has positive effects in post-stroke depression and anxiety disorders.

The aim of this study is to examine the effectiveness and reliability of acupuncture treatment in depression and anxiety disorders developing after stroke and to reduce the need for multiple drugs and / or high-dose medication in the treatment of these complications.

The hypothesis of the study: Acupuncture is an effective and reliable treatment method for depression and anxiety disorders in stroke patients.

Patients who receive inpatient stroke rehabilitation at Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, will be included in the study by the inclusion and exclusion criteria. Their informed consent will be received. Initially, clinical and demographic data of all patients will be noted. Participants who volunteered for the study will be separated into the acupuncture treatment group and the control group by simple random sampling. Both the acupuncture treatment group and the control group will be included in the conventional rehabilitation program 2 hours a day, 7 days a week, for 8 weeks. In addition the acupuncture treatment group will get acupuncture treatment which will be applied to Baihui (DU20), Yintang (EX-HN3) points and bilateral Tai Chong (LR3), Hegu (LI4) points for 4 weeks, twice a week. During the application, the feeling of De Qi will be taken and the application will take 20 minutes. Measurements; Hamilton Depression Rating Scales, Hamilton Anxiety Rating Scales, Pittsburg Sleep Quality Index, Barthel Index, and change in psychiatric drug use will be assessed at baseline (week 0), 4th and 8th week post-treatment. The adverse events observed during the study will be noted and the compliance of patients in each application will be questioned by visual analog scale.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 2 months maximum 6 months after stroke
* Volunteering for study
* Mini-Mental State Examination \>17
* Patients with Hamilton Depression Rating Scale\> 7 and/or Hamilton Anxiety Rating Scale\> 4 assessed by the psychiatrist

Exclusion Criteria:

* Insomnia and depression before a stroke
* Aphasic patients
* Sleep Apnea Syndrome
* Psychiatric Disorders (Learning disabilities, Mental disorder, Autism)
* Decompensated cardiac, kidney, hepatic failure
* Infection on Acupuncture Points
* Pregnancy
Learning Efficacy and Motivation of Medical Students in Clinical Training With Virtual Reality

We created a curriculum based on clinical events with 360° camera on an interactive learning platform. We hypothesize that medical students will learn better and be motivated with the immersive 360 video and virtual reality headset during the clinical training.

We created a curriculum based on rapid sequence induction before anesthesia induction with 360° camera and put it on an interactive learning platform. We hypothesize that medical students will have better learning efficacy and motivation with the immersive 360 video and virtual reality headset. Moreover, the learning engagement will be translated into clinical skills acquisition and medical knowledge retention.

Eligibility Criteria:
Inclusion Criteria:

* Medical students undergoing clinical rotation

Exclusion Criteria:

* Unable to wear virtual reality headset
Effects of Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors

Clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body health.

This is one randomized, double-blind, placebo-controlled study. The purpose of the present study is to evaluate and/or elucidate the role of the natural supplement, containing chlorogenic acid (10-12%) and luteinyl-7-glucoside (2-4%), on cardio-metabolic risk factors.

The research hypothesis is to evaluate whether natural supplement containing chlorogenic acid and luteolin (Puraltilix, BIONAP SRL, Catania, Italy) may improve several cardio-metabolic parameters in subjects with the metabolic syndrome.

All subjects will be evaluated at baseline and after 6 months of treatment (with natural supplement or placebo).

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \>18 years with the metabolic syndrome (as defined by the international criteria: Alberti KG, et al. Circulation. 2009; 120: 1640-5);
* BMI\> 25 kg/m\^2;
* Subjects able to swallow whole tablets;
* Informed consent obtained prior to any study-related activities.

Exclusion Criteria:

* Pregnancy or willingness to become pregnant;
* Severe liver dysfunction (ALT \>2.5 times upper limit of normal);
* Severe renal failure (eGFR\<60 mL/min/1.73 m2 using the MDRD formula);
* Severe infections at the discretion of the investigator (such as HIV, HBV and HCV);
* History or presence of malignant neoplasms within the last 5 years.
Comparison of Phicogenic vs. Xenogeneic Biomaterial for Maxillary Sinus Floor Elevation

The study aims to evaluate the clinical and radiological behavior, the histological and morphometrical components, the expression of proteins related to bone formation, and the analysis of markers of reparative mesenchymal stromal cells, after using a biphasic phicogenic biomaterial in comparison with anorganic bovine bone.

A randomized split-mouth clinical study is designed to include patients in need of two-stage bilateral maxillary sinus floor elevation. Patients are assigned to receive a mix of autogenous bone and a biphasic phycogenic biomaterial in one maxillary sinus and a mix of autogenous bone and xenograft bovine hydroxyapatite in the other maxillary sinus. Cone-beam computerized tomography (CBCT) scans are performed before sinus floor elevation and 6 months after the procedure to assess the bone gain. Bone core biopsies are obtained at the site of implant placement 6 months after the floor elevation. Histological sections are subjected to histomorphometric and immunohistochemical evaluation of differentiation markers.


Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous patients.
* Kennedy class I in the upper jaw.
* Less than 5 mm of residual crestal bone to the maxillary sinus.
* Need for the replacement of teeth with dental implants.

Exclusion Criteria:

* Sinus pathology (sinusitis, mucocele, cysts).
* Smokers.
* Previous long-term (\>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.
The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic

To determine the safety and efficacy of erythropoietin administered to patients with AIDS or advanced AIDS related complex ARC and anemia.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.
* AIDS-related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.

Concurrent Medication:

Excluded:

* Zidovudine (AZT) during the double-blind phase of the study.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.
* Zidovudine (AZT) and during double-blind phase of study.

Clinical diagnosis of AIDS related anemia.

* Clinical diagnosis of AIDS or advanced AIDS related complex (ARC).
* Clinically stable for 1 month preceding study entry.

Substance abuse.
Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers

Multiple Ascending Dose Study


Eligibility Criteria:
Inclusion Criteria:

* Provision of Informed Consent
* Healthy male subjects and female subjects (of non-child bearing potential)

  * with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* Inability to understand or cooperate with given information
* Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
* History of seizure (including infancy febrile seizures) or family history of seizure
Protandim and the Metabolic Syndrome

Protandim will decrease markers of oxidative stress/inflammation in subjects with metabolic syndrome and proteomics will identify protein profiles that correlate with markers or/changes in oxidative stress.

Evaluate the effects of Protandim on protein profile changes and markers of inflammation and oxidation in subjects (40-60 years of age) with the Metabolic Syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age = 40-60 years of age
* Meets at least 3 of the 5 criteria for the metabolic syndrome (as defined by NCEP/ATP III criteria)

NCEP/ATP III criteria

* Central obesity as measured by waist circumference:

  * Men - Greater than 40 inches
  * Women - Greater than 35 inches
* Fasting blood triglycerides greater than or equal to 150 mg/dL
* Blood HDL cholesterol:

  * Men - Less than 40 mg/dL
  * Women - Less than 50 mg/dL
* Blood pressure greater than or equal to 130/85 mmHg or on anti-hypertensive Rx
* Fasting glucose greater than or equal to 100 but \< 125 mg/dL

Exclusion Criteria:

* Women taking hormone replacement therapy for post menopause
* Signs or symptoms of acute coronary syndrome
* History of congestive heart failure (prior myocardial infarction, coronary artery disease including stent placement, coronary artery bypass graft, EBCT calcium score of at least 100, or a positive stress test)
* Serum creatinine \> 1.5 mg/dL, AST or ALT \> 2 times ULN, HgA1c \>6.5%, severely depressed or elevated blood cell lines, triglycerides \> 500, TSH outside of normal range, elevated calcium, blood pressure \> 160/100, urine protein \> 30 ,g/dl.
* Concurrent medical conditions/illnesses in which expected life expectancy is 2 years or less and/or are likely to require frequent hospitalizations and treatment adjustments (e.g., cirrhosis, active malignancy, , or highly active rheumatologic condition, lupus, rheumatoid arthritis or chronic obstructive pulmonary disease and diabetes).
* Participation in any other investigational substance or medical device study within 30 days before this trial and/or participation in such entity during this trial.
* Known pregnancy.
* Supplementation with nutraceuticals or if so one month washout before initiating the study before initiating this trial.
* Taking statins or fibrates to lower cholesterol
* Inability or unwillingness to provide written informed consent
FDA Cigarette Warning Labels: Eye Tracking Study

The purpose of this study is to examine the effect of cigarette pictorial warning label content (lesser-known vs well-known risks) on visual engagement, recall, and knowledge of tobacco use harms.

This laboratory-based study will aim to enroll 120 current cigarette users to complete a 1-day randomized, parallel design protocol.

The participants will be randomized to one of two conditions, pictorial warning labels (PWLs) with well-known or lesser-known tobacco harms. After completing a baseline questionnaire, the participants will view 4 warning labels from the assigned group and complete a follow-up questionnaire. Eye-tracking will provide data on visual processing of the warning labels and the effect of these labels on knowledge, attitudes, and beliefs about smoking will be supplemented by self-report.

Eligibility Criteria:
Inclusion Criteria:

* Current cigarette smokers using only filtered commercially manufactured cigarettes; smoking at least 5 cigarettes daily and smoking for at least last 1 year.
* Participants must physically present a pack of their preferred brand of cigarettes at the lab session to confirm their status as a cigarette smoker.
* Not currently undergoing smoking cessation treatment or planning to quit smoking currently or in the next month.
* Plan to live in the area for the duration of the study.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined Informed Consent and HIPAA form.
* Able to communicate fluently in English (i.e., speaking, writing, and reading) as determined by the research assistant.

Exclusion Criteria:

* Use of any nicotine-containing products other than cigarettes. Participants reporting isolated use of other nicotine-containing products less than 5 times per month are eligible to participate.
* Not actively trying to quit smoking currently and had not made a quit attempt in the past month.
* Self-report current alcohol consumption that exceeds 25 standard drinks/week.
* Self-report current pregnancy or breastfeeding.
* Any self-reported impairment - visual (colorblindness or impairments such as glass eye), physical, and/or neurological impairments preventing the proper completion of the study procedures.
* Serious or unstable medical condition.
* Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.
* Current use or discontinuation of anti-psychotic medications within the last 6 months.
* Current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate.
* Inability to provide informed consent or complete any of the study tasks as determined by the principal investigator.
Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

This study is designed to identify the predictive biomarker for immunotherapy using patient samples (tumor tissue, blood, fecal material) who treated with immune checkpoint inhibitor.

\[Sample acquisition\]

* Informed consent is waived for those who agree to donate samples left over from other clinical trials or acquired for other purposes to be used for other research by the sign to master agreement in advance.
* The study will be conducted based on the purposes indicated in the master agreement signed by tissue donator \[Clinical data acquisition\]
* Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals)
* Lung cancer treatment history: diagnosed date, treatment history (surgery, radiation therapy, chemotherapy, immunotherapy treatment history, and responses), general performance, metastatic sites
* Lung cancer histologic information: pathology, histologic subtype, EGFR mutation profile, ALK-rearrangement result

Eligibility Criteria:
Inclusion Criteria:

1. aged above or equal to 18
2. Histologically confirmed lung cancer patients
3. Patient treated with immune checkpoint inhibitor

Exculsion Criteria:

NA
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Have participated in and completed Study NBI-98854-TS2003
2. Have a clinical diagnosis of Tourette Syndrome (TS)
3. If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder \[OCD\], Attention-Deficit Hyperactivity Disorder \[ADHD\]), be on stable doses
4. Be in good general health
5. Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
6. Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

Exclusion Criteria:

1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
2. Have a known history of long QT syndrome or cardiac arrhythmia
3. Have a known history of neuroleptic malignant syndrome
4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
5. Have an allergy, hypersensitivity, or intolerance to vesicular monoamine transporter 2 (VMAT2) inhibitors
6. Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline
7. Have a known history of substance (drug) dependence, or substance or alcohol abuse
8. Have a significant risk of suicidal or violent behavior
9. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
Which Needle Length for Injecting Insulin

Background and aims:

* In the Netherlands most patients with diabetes mellitus that are treated with insulin, use an insulin pen for insulin administration. The injection technique can influence the absorption rate of insulin.
* The aim of this study is to compare the effect of insulin injections using a 5 mm insulin needle with insulin injections using a longer needle, on HbA1c, bloodglucose levels, hypoglycaemic events, bleeding, bruising, insulin leakage and pain perception.
* Study Hypothesis: 'Insulin injected with needles of 5 mm can be given without a skinfold. The length of the needle will not influence HbA1c levels and bloodglucose levels'.

* In this randomised, clinical trial with cross-over design, 52 patients with Diabetes type 1 and 2 using a 8 or 12 mm needle, are randomised into two groups.
* Group I starts using 5 mm needles for insulin administration, after 13 weeks group I returns to their previously used 8 or 12 mm needle
* Group II continues using their own 8 or 12 mm needle, after 13 weeks group II starts using 5 mm needles for insulin administration.
* During each visit the HbA1c level is measured and a copy is made of the logbook of the patient with the blood glucose measurements.
* Insulin doses and number of experienced hypoglycaemic events are registered at each visit.
* The opinion and experiences of the patients regarding the different needles are obtained by using a questionnaire.
* Within-group analyses are computed, using the Wilcoxon signed Ranks Test. Between-group analyses are computed using the Mann-Whitney U test.

Eligibility Criteria:
Inclusion Criteria:

* males and females diagnosed with diabetes Type 1 or 2
* using insulin for at least one year
* using an insulin pen and a needle of 8-mm or longer
* 18 years or older
* capable of reading the written information
* prepared to, and capable of signing an informed consent

Exclusion Criteria:

patients that

* change their own insulin dosage and don't keep an administration of these changes
* had an HbA1c that varied more than 15 % in the past year
* use a needle of 5 or 6-mm
* have hypoglycaemia unawareness
* are pregnant or wanted to become pregnant
* have a BMI \< 18
* have a skinfold thickness of 10 mm or less at the injection sites (abdomen and thigh)
* had hemoglobinopathies which could limit the ability of haemoglobin to be glycated
* had skin problems like lipodystrofie
A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor

The primary purpose of the study is to evaluate safety and tolerability of E7389 liposomal formulation (E7389-LF) in combination with nivolumab and to determine the recommended Phase 2 dose (RP2D) in Phase 1b part and to evaluate objective response rate (ORR) of E7389-LF and nivolumab using RP2D in each tumor type in Phase 2 part.


Eligibility Criteria:
Inclusion Criteria:

1. Phase 1b part only: Participants with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists (participants who will be the candidate of treatment by nivolumab monotherapy as standard therapy is acceptable)
2. Phase 2 part only: Participants with a confirmed diagnosis of nonresectable gastric cancer (GC), esophageal cancer (EGC) or small cell lung cancer (SCLC) who showed disease progression based on investigator's assessment during or after first line chemotherapy (second-line chemotherapy for GC) and did not receive any other systemic chemotherapy to advanced/recurrent disease
3. Participants who meet the following criteria for biopsy; Phase 1b part: Participants who have accessible tumors for biopsy and agree to tumor biopsy for pre- and post-treatment of study drug (If a pre-treatment biopsy cannot be obtained due to safety issue, then an archival tumor tissue sample may be submitted.) Phase 2 part: Participants who have accessible tumors for biopsy and agree with tumor biopsy for pre and post treatment of study drug (As an alternative to pre-treatment biopsy, tumor tissue sample taken from recurrent or advanced disease may be submitted). However, if the sponsor and the investigator discuss and agree in advance, and the participants agree to submission of archival tumor tissue, then these participants are eligible regardless of accessible tumors, and consent to biopsy is not necessary
4. Life expectancy of greater than or equal to (\>=) 12 weeks
5. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) 0-1
6. Phase 2 part only: At least one measurable lesion based on RECIST 1.1 (Lesions that have had radiotherapy or loco-regional therapies must show evidence of progressive disease to be deemed a measurable lesion)

Exclusion Criteria:

1. Diagnosed with meningeal carcinomatosis
2. Participants with brain or subdural metastases or invasion are not eligible
3. Active, known, or suspected autoimmune disease