cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients

This study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries.

Eye pressure will be measured at protocol specified intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects undergoing prolonged procedures (scheduled \>3hr) in steep Trendelenburg position (eg. robotic prostatectomy, hysterectomy, cystectomy)
2. Morbidly obese subjects: BMI ≥ 35 kg/m2
3. Thin subjects: BMI ≤ 30 kg/m2
4. Age 18-70
5. ASA (American Society of Anesthesiologists) physical status classification I, II, or III

Exclusion Criteria:

1. Known history of glaucoma
2. Note:if initial IOP is noted to be \>21mmHg (millimeters of mercury), patient will be excluded from study and an ophthalmology consultation will be obtained.Surgery will not be postponed.
3. Recent use of IOP lowering topical ophthalmic agents
4. Allergy to latex or proparacaine hydrochloride ophthalmic solution
5. Patients with active corneal epithelial defects or history of recurrent corneal erosion
6. Patients with underlying disorders that can directly increase intraocular pressure (thyroid eye disease, intra orbital tumors, orbital vascular malformation, Sturge-Weber disease, carotid or dural cavernous arteriovenous malformation, cavernous sinus pathology)
7. History of corneal surgery, to include LASIK (laser-assisted in-situ keratomileusis)
8. Any eye surgery within prior 1 month
9. Known pregnancy
10. Cognitive impairment
Acupuncture for Pain During Injection of Local Anaesthetic

Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and distress in children receiving an injection of a local anaesthetic (LA). Children scheduled for dental treatment using local anesthesia as a standard treatment, received bilateral acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the patients stimulated the needles by massage. Two different treatment regimes were compared: a standardized LA injection given 5 minutes after acupuncture, and an LA injection without acupuncture. The order of treatment was randomised, with the two treatments performed on different days. Pain intensity during LA injection, assessed by the patient with the Verbal Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction with the received therapy were also recorded.


Eligibility Criteria:
Inclusion Criteria:

* children with an American Society of Anesthesiologists (ASA) physical status of I or II
* scheduled for at least two dental treatments for caries requiring local anaesthesia

Exclusion Criteria:

* history of analgesic medication, psychiatric disease, or local or systemic infection
* necessity to change their treatment schedule
Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection

Purpose: To prove the feasibility of sentinel node navigation surgery (SNNS) in early gastric cancer patients with the risk of lymph node metastasis after endoscopic resection and preparation of multicenter phase 3 trial of stomach preserving surgery in these patients.

Contents: The number of enrollment is 247 patients. The patients underwent endoscopic resection for early gastric cancer, and the tumor was defined to be out of indication for endoscopic resection pathologically. So, additional gastrectomy is recommended for them.

The investigators will enroll patients who agree this study. After general anesthesia, Tc99m-Phytate with indocyanine green will be injected with endoscopy. Then sentinel basin will be detected using gamma probe and laparoscopic basin dissection will be done. Sentinel lymph node will be identify in back table dissection, and patients will undergo conventional gastrectomy. Detection rate and false negative rate will be evaluated by pathological review.

Sentinel basin dissection method

1. endoscopic tracer injection after general anesthesia
2. Tracer : Tc99m-phytate 3cc and indocyanine green 3cc mix --\> Injection of the probe (1cc/site, 4 sites) around endoscopic submucosal dissection ulcer scar
3. Sentinel basin identification with laparoscopic probe
4. Dissection of the sentinel basin
5. Sentinel node dissection at back table
6. Conventional laparoscopic gastrectomy

Eligibility Criteria:
Inclusion Criteria:

* No limitation for age if the patient is available for gastrectomy
* Patient who underwent endoscopic submucosal dissection and the tumor was defined as out of indication.

The expanded criteria for endoscopic resection are as follows

* criterion I: intramucosal tumor without ulcerative findings and of differentiated type with size \> 2 cm
* criterion II: intramucosal tumor with ulcerative findings and of differentiated type with size ≤ 3 cm
* criterion III: intramucosal tumor without ulcerative findings and of undifferentiated type with size \< 2 cm
* criterion IV, submucosal invasion \< 500 mm and of differentiated type with size ≤ 3 cm)
* Eastern Cooperative Oncology Group (ECOG) performance scale 0 or 1

Exclusion Criteria:

* Inoperative due to severe cardiovascular or pulmonary disease
* Pregnant
* Patients who had previous gastric surgery
* Patients who had previous upper abdomen surgery except cholecystectomy, or radiation therapy on upper abdomen, or hypersensitivity to any medicine
Study of Oral Fampridine-SR in Multiple Sclerosis

To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.

Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in subjects with MS.

Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of multiple sclerosis
* Are able to walk with or without an assistive device

Exclusion Criteria:

* Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
* Participating in other investigational drug trials
* A medical history or clinical findings that preclude entry into the study
* A medication history that precludes entry into the study
* Previously treated with 4-aminopyridine (4-AP)
OCT Agreement and Crossed Precision Study

The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.


Eligibility Criteria:
Inclusion Criteria: NORMAL EYES

* Subjects who do not have pathology in both eyes

Inclusion Criteria: GLAUCOMA

* Subjects who have a glaucoma diagnosis

Inclusion Criteria: RETINAL

* Subjects who have a retinal diagnosis including but not limited to:

  1. Diabetic macular edema
  2. Dry age related macular degeneration
  3. Wet age related macular degeneration
  4. Cystoid macular edema
  5. Epiretinal membrane
  6. Macular hole

Inclusion Criteria: CORNEAL

* Subjects who has one of these diagnosis:

  1. Post status LASIK surgery
  2. Keratoconus
  3. Other corneal dystrophies or degenerations.

Exclusion Criteria: ALL EYES

* Subjects who have any of the following conditions

  1. Diabetes mellitus (DM) and/or diabetic retinopathy
  2. Uncontrolled Hypertension (HT)
  3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
  4. Cardiac, hepatic, renal and hematologic diseases
  5. A current condition requiring systemic administration of steroid
  6. A history of, or currently receiving, anticancer therapy
  7. Epileptic seizures which are optically induced
  8. Dementia
* Subjects who have other life threatening and debilitating systemic diseases

Note: Additional criteria may apply
The Effects of Texture Modified Diets on Dietary Intake and Appetite Responses in Older Adults

This study aims to investigate the effects of equicaloric texture modified and regular meals that are either fortified with protein or not on dietary intake and satiety in older adults (65+) living in the United Kingdom (UK).

* To investigate whether there are any differences in appetite responses following a texture modified meal compared to a standard meal.
* To investigate whether protein-enriched versions of a texture modified meal and/or standard meal affects satiety and subsequent intake in healthy older adults.
* To investigate the effects of a texture modified diet, standard diet and their protein-enriched versions on gastric emptying in healthy older adults.

Eligibility Criteria:
Inclusion Criteria:

* aged 65 years or over (no upper age limit);
* be within body mass index range (18.5-34.9kg/m2 );
* regularly consume 3 meals a day (breakfast by 11am, lunch and dinner);
* be able to accept test meals provided;
* be able to feed themselves;
* be able to give informed consent; i.e not lacking mental capacity;
* Have access to a kitchen, freezer and fridge.
* Have access to a telephone.
* understand English.

Exclusion Criteria:

* Diagnosed with coronavirus (COVID-19) or have had it in the last 4 weeks.
* have any existing neurological or gastrointestinal condition;
* have Cancer;
* have no current chewing or swallowing difficulties (such as dysphagia);
* have no existing cognitive or psychiatric disorder;
* taking medications that can significantly affect taste changes, appetite or gastric emptying;
* be on a special or therapeutic diet;
* have any food allergies or intolerances that will be worsened with meals provided in the study;
* have a history of drug or alcohol misuse;
* smoke more than 10 cigarettes a day.
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment

The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with varying degrees of liver function to see if they respond differently to the study drug.


Eligibility Criteria:
Key Inclusion Criteria:

1. Relapsed or progressive advanced malignancies (solid tumors or hematologic malignancies)
2. At least ≥ 2 prior treatment regimens for the underlying malignancy
3. Confirmed advanced solid tumor or hematologic malignancy
4. Measurable or evaluable disease
5. Clinical diagnosis of chronic hepatic impairment that is stable with no acute worsening of liver failure within one month prior to enrollment. Hepatic impairment will be assessed as per National Cancer Institute Organ Dysfunction Working Group Criteria (NCI-ODWG) schema and will fall into one of the following three categories:

   * Cohort 2 (mild): Bilirubin \> 1-1.5 × upper limit of the normal range (ULN) or aspartate aminotransferase (AST) \> ULN, but bilirubin ≤ ULN
   * Cohort 3 (moderate): ≥ 1.6-3 × ULN; any AST
   * Cohort 4 (severe): Bilirubin \> 3 × ULN; any AST

   Exception to Inclusion Criterion #5 for Subjects with Normal Hepatic Function:

   All subjects enrolled with normal hepatic function (N=10) must meet all inclusion criteria as outlined with the exception of Inclusion Criterion

   #5, which should be substituted with the following criterion to be enrolled into the study:

   - Cohort 1 (normal hepatic function): Bilirubin ≤ ULN; AST ≤ ULN
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
7. Left ventricular ejection fraction (LVEF) ≥ 40%
8. Adequate renal function (calculated creatinine clearance ≥ 30 mL/min)
9. Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment

Key Exclusion Criteria:

1. Subjects with symptomatic brain metastasis or central nervous system (CNS) disease
2. Significant neurotoxicity (Grade 2 with pain or higher) at the time of enrolment
3. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection (Exception: Subjects with chronic or cleared HBV and HCV infection and stable liver function tests \[bilirubin, AST\] will be allowed)
Circadian Intervention to Improve Cardiometabolic Health

The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

The study is a randomized controlled trial with control and circadian intervention groups. Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment. The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and complete all food consumption at least 4 hours before bedtime. Participants randomized to control will maintain their habitual food intake and sleep habits in their home environment for \~8 weeks. Both groups will have equal contact time with the study team.

Prior to enrollment participants will complete an clinical overnight sleep disorders screening. Baseline consists of an \~1-week ambulatory real-world monitoring segment. Following baseline participants will be randomized to the control or intervention groups for the 8 week experimental segment. Throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. At the end of the baseline and experimental segments participants will complete overnight laboratory visits to assess insulin sensitivity and circadian timing by oral glucose tolerance test and dim light melatonin onset, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-45 years old; equal numbers of men and women
2. Body mass index (BMI): 25.0-34.9 kg/m2,
3. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months

Exclusion Criteria:

1. Clinically diagnosed sleep disorder or major psychiatric illness
2. Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)
3. Use of prescription drugs or substances known to influence sleep or glucose metabolism
4. Shift-work: current or history of within last year
5. Weight change: \>10% of body weight over prior six months
6. Experiencing menopause or post-menopausal
7. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
8. Currently pregnant or planning to become pregnant, or currently lactating.
9. Currently smoking
10. Alcohol intake \>3 drinks per day or \>14 drinks per week
Effect of Music on Pain and Comfort Levels After Laparoscopic Abdominal Surgery

It is planned to examine the effects of local music on pain and comfort levels in patients undergoing laparoscopic abdominal surgery and to make a comparison between Turkey and Iran with the results obtained.

The hypotheses of the study are as follows:

H1-0: Music has no effect on reducing pain in patients undergoing laparoscopic abdominal surgery.

H1-1: Music has an effect on reducing pain in patients undergoing laparoscopic abdominal surgery.

H2-0: Music has no effect on increasing comfort in patients undergoing laparoscopic abdominal surgery.

H2-1: Music has an effect on increasing comfort in patients undergoing laparoscopic abdominal surgery.

As part of the pre-test, the patient introduction form, comfort and pain scales will be applied to the experimental group patients. Music will be played in the patient room 2 hours after the patients are transferred from the post-operative care unit to the clinic, which is the most appropriate time after surgery, when vital signs are stable and clinical compliance is achieved. Music will be played for 20 minutes. As part of the post-test, the comfort and pain scales will be applied to the experimental group patients again.

As part of the pre-test, the patient introduction form, comfort and pain scales will be applied to the control group patients. No intervention will be applied to the control group patients and the clinic's routine practices will continue. As part of the post-test, the comfort and pain scales will be applied to the control group patients again.

Eligibility Criteria:
Inclusion Criteria:

* Must be over 18 years old
* Must not have communication problems

Exclusion Criteria:

* Having any hearing or mental problems
* Laparoscopic surgery converted to open surgery
Colour Vision Impairment During Acute Hypobaric Hypoxia

This study analyses the impairment of colour vision during hypobaric hypoxia in volunteers of different groups.

This study analyses the impairment of colour vision during hypobaric hypoxia in volunteers of different groups.

Five different Groups were analysed:

* ground control binocular (n=12, Bi/GC)
* ground control monocular (n=11, Mo/GC)
* 10,000 ft, 60 min, monocular (n=10, Mo/60/10,000)
* 15,000 ft, 15 min, binocular (n=11, Bi/15/15,000)
* 15,000 ft, 60 min, monocular (n=10, Mo/60/15,000)

Eligibility Criteria:
Inclusion Criteria:

* volunteers from 18 years old

Exclusion Criteria:

* cardiovascular, pulmonary, neurological, or ear, nose, and throat disease
* pregnant or suffering from cold symptoms
How Variations in Pharmacogenomic Profiles Affect Pain and Narcotic Needs Following Total Knee Arthroplasty (TKA)

The purpose of the study is to gain a better understanding of how genetic variations can affect pain experience and the need and type of pain control medication after a total knee replacement.

The purpose of the study is to gain a better understanding of how genetic variations can affect pain experience and the need and type of pain control medication after a total knee replacement. People experience pain differently. The type and amount of medication required to control pain varies. Post-operative pain often requires narcotics to keep patients comfortable. It has been shown that there is a genetic difference in how people respond to pain and how they respond to the medications used for the relief of pain. Opioids are often used to relieve pain after surgery. These medications can be abused and have had a role in the current opioid crisis.

Pharmacogenomics is the study of how patients respond to and metabolize drugs and medications based on their genetic profiles. This study will collect data on the pain experienced by participants and the narcotics used after total knee replacements. This will be correlated with the participants' pharmacogenomic profiles obtained though DNA testing. There are no treatment interventions in this study. Although a pharmacogenomic profile will be obtained at the first post-operative visit and reported approximately 3 weeks later, the subject will have completed the need for pain relief. The study is expected to last 2 years with 300 subjects enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Unilateral primary Total Knee Arthroscopy (TKA)
* Knee Osteoarthritis
* Planned discharge to home

Exclusion Criteria:

* Unicompartmental Total Knee Arthroscopy (TKA)
* Revision Total Knee Arthroscopy (TKA)
* Knee flexion contracture \> 15°
* Axial deformity \> 15°
* Previous or current chronic narcotic use for pain \> 3 months
* Previous or current substance abuse
* Any chronic pain condition
* Any dementia or cognitive disorder
* Discharge to Skilled Nursing Facility
* Rheumatoid arthritis
* Potential difficulty completing daily pain scores and medication use
* Previous NorthShore genotyping
* Currently taking CYP2D6 inhibitors (list in appendix)
* Currently taking CYP2D6 inducers (list in appendix)
Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients

The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, but some problems related to early mortality are still of concern, mainly in resources-limited settings. There are several published reports showing that such patients are at a significantly higher risk of death during the first months of treatment, in comparison with the observed outcomes in developed countries. One of the consistently detected risks for early mortality across these reports is the baseline low CD4 count, although it does not seem to be the only reason for such outcome. In Brazil and other developing countries, there is still a large proportion of AIDS patients who are diagnosed with AIDS, or only seek health care for HIV infection late in the course of disease. Dolutegravir (DTG), the first HIV-1 integrase inhibitor, is a potent and safe ARV drug. The available evidence suggest it promotes a faster decline in HIV-1 plasma viremia, and a higher increase in CD4 cells count, in comparison with those in Efavirenz (EFV) arm. The investigators propose to compare the impact of DTG versus EFV in the early mortality rates for severely ill (CD4+ cells count \<50 cells/mm3) patients starting ARV therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA \>1,000 copies/ml)
* No previous use of any ARV drug (drug-naïve patients)
* Presence of clinical symptoms according to Rio de Janeiro / Caracas´ AIDS definition (Asthenia, Cachexia/Wasting, Cough, Dermatitis, persistent, Diarrhea, Fever, Lymphadenopathy, Candidiasis, oral, or hairy leukoplasia, Central nervous system dysfunction, Herpes zoster in individual younger than 60 years of age)), and/or any active AIDS-defining condition
* Baseline CD4+ cells count equal or lower than 50 cells/mm3
* Age equal or higher than 18 years
* HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml

Exclusion Criteria:

* Undetectable plasma viral load at screening
* CD4 cells count\>50 cells/mm3
* Asymptomatic individuals