cyrilzakka/clinical-trials huggingface dataset:
Exercise Exposure Data Collection in Patients Undergoing Tumor Molecular Profiling

This study will recruit approximately 5,000 patients with histologically confirmed cancer who have successfully completed MSK-IMPACT panel testing and collect information about tumor genetic results and patient exercise behavior history.

The purpose of the study is to create a registry to collect exercise behavior history in patients who had IMPACT genetic panel testing on protocol IRB #12-245 "Genomic Profiling in Cancer Patients", IRB #06-107 "Storage and Research Use of Human Biospecimens," or IRB #09-141 "Collection of Human Biological Specimens from Patients for Research Studies." The investigators want to find a way to create an exercise database. This database will collect information about tumor genetic results and patient exercise behavior history.


Eligibility Criteria:
Cohort 1: IMPACT Cohort

Inclusion Criteria:

* Histologically-confirmed cancer.
* IMPACT testing with completed genomic profile completed within three years of initial recruitment approach
* Registered to Memorial Sloan Kettering Cancer Center protocol IRB# 12-245 and/or IRB #06-107 and/or IRB # 09-141
* ≥ 18 years of age
* ECOG Performance Status of 0 or 1

Exclusion Criteria:

* Unable to speak and read English
* Not willing to provide informed consent
Multilevel System Intervention Based on Information Platform to Reduce Ischemic Stroke Recurrence Rate

A prospective, multicenter and cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multilevel system intervention based on information platform, whereas hospitals in the control arm will receive no intervention. The randomisation will be conducted after baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, and the number of acute ischemic stroke (AIS) patients within 7 days of stroke onset. Hospitals with \<250 AIS cases per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the one-year stroke recurrence rate on the follow-up stage (post-intervention).


Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years or older.
* Patients admitted with neurological deficit consistent with ischemic stroke within 7 days of of symptoms onset. (\*Symptom onset is defined by the "last seen normal" principle)
* Confirmation of new ischemic stroke by objective modality of CT scan and MRI (had relevant lesions on DWI).
* Informed consent from patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated).

Exclusion Criteria:

* Patients refuse to participate in this study.
* Patients who losing his medical record of having the incomplete medical record
Interval Intraocular Pressure in Intravitreal Injection Study

This is a prospective study of IOP in Intravitreal injections to evaluate:

1. IOP effect of intravitreal injection
2. IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods
3. IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities

Study design: A prospective study Sample size: 60 patients (180 readings) Recruitment: Patients will be recruited at the intravitreal injection clinic in Grantham Hospital.

Randomization:

Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol

There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly.

Injection doctors masked to treatments given.

Study visits:

1. Injection visit

   * Record the anti-VFGF injection to be given
   * Macula disease involved
   * Record no. of previous injections
   * Prophylactic eye drops will be given according to treatment group 1 hour prior injection
   * IOP immediately before injection (without speculum while sitting on table)
   * IOP immediately after injection (without speculum while sitting on table)
   * IOP 30 minutes after injection via iCare
   * Slitlamp examination, document inflammation or complications if any
2. Day 1 follow-up visit

   * IOP via iCare (sitting)
   * Slitlamp examination, document inflammation or complications if any
3. Week 1 follow-up visit

   * IOP via iCare (sitting)
   * Slitlamp examination, document inflammation or complications if any Visit a, b and c will be repeated for 2nd and 3rd injections.

Eligibility Criteria:
Inclusion Criteria:

* AMD patients requiring multiple intravitreal injections (Eylea or Lucentis), not necessarily 3 month loading.
* Age \>50
* Chinese patients with ability to read Chinese ICF

Exclusion Criteria:

1. Known glaucoma
2. Corneal disease e.g. corneal scarring or opacity preventing fundal view
3. On steroid or anti glaucoma eye drops
4. Prior vitrectomy or glaucoma surgery
5. Recent intraocular surgery i.e. cataracts surgery
6. Pseudophakic with anterior chamber IOL
7. History of ocular inflammatory disease e.g. uveitis
8. Previous laser iridotomy
9. Recent intravitreal injection of steroid
10. Inability for regular follow-up
Managerial Database II

This study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of HIV positive adolescents receiving care at the ATN sites.

The proposed study is a cross sectional study intended to be conducted at each of the 15 Adolescent Medicine Trials Units (AMTUs) participating in the ATN and to enroll all participating patients followed at each site. This approach will allow for the examination of the broad spectrum of youth participating in the ATN, including those newly entered into care.

Psychosocial and risk-taking behavioral data will be collected using Audio Compute-Assisted Self-Interview (ACASI); biomedical information will be collected through medical chart abstraction.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory evidence of HIV-1 infection documented by a positive result on any of the following licensed tests at any time: Any HIV-1 antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA PCR, or plasma HIV-1 RNA PCR \> 1,000 copies/ml;
* Knowledge of HIV positive diagnoses;
* Age 12 years through 24 years, inclusive;
* Engaged in care at the AMTU or its affiliate and/or partnering clinic. Individuals will be considered to be engaged in care if:
* Diagnosed less than or equal to 12 months prior to the date of approval to generate the master list and has attended a minimum of one visit since diagnosis for the management of HIV disease or its sequelae; or
* Diagnosed more than 12 months prior to the date of approval to generate the master list and has had a minimum of one visit, as described above, within the past 12 months.
* Ability to understand written and/or verbal English
* Ability and willingness to provide signed consent/assent;
* Parental/legal guardian permission (if applicable)

Exclusion Criteria:

* Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individuals' ability to complete the study measures;
* Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior); or
* Intoxicated or under the influence of alcohol or other substances at the time of consent/assent.
Atomoxetine in Patients With Tourette's Syndrome

The purpose of this pilot study is to evaluate the effects of Atomoxetine, a selective noradrenaline reuptake inhibitor, on impulsivity in patients with Tourette's syndrome.

High impulsivity characterizes severe forms of Tourette's syndrome, in which motor and vocal tics are associated with various neuropsychiatric disorders as compulsive disorders, difficult to manage and impairing quality of life of patients and their family. Previous preclinical study and clinical studies in attention-deficit hyperactivity disorder and Parkinson's disease demonstrate that atomoxetine, a selective noradrenaline reuptake inhibitor, improves response inhibition in high impulsive individuals. However, there is no suffisant data in Tourette's syndrome. The purpose of this pilot study is to evaluate the effects of Atomoxetine on impulsivity in 10 to 35 years old patients with Tourette's syndrome.

Eligibility Criteria:
Inclusion Criteria:

* High impulsive patients, aged 10-35 years old, diagnosed for Tourette's syndrome as defined by the DSM-IV, never treated by Atomoxetine
* The use of effective contraception or abstinence for subjects of reproductive age
* Written informed consent

Exclusion Criteria:

* Patients with mental retardation, psychotic disorders as schizophrenia, autism spectrum disorders, chronic tics which do not respond to Tourette's syndrome criteria.
* Actual severe depression
* Allergy to one of the constituents
* Severe cardiovascular or cerebrovascular diseases, Pheochromocytoma, uncontrolled hyperthyroidism, closed angle glaucoma
* IMAO treatment discontinued less than 2 months or contra-indicated associated treatment
Rapid Administration of Insulin in Sepsis

The purpose of this study is to determine if a glucose-insulin-potassium (GIK) solution can be safely administered to patients with septic shock. GIK has been used in thousands of critically ill patients in research studies with very few safety concerns. However, there is a lack of data in regards to patients with septic shock. There are many reasons to believe that GIK would be beneficial in sepsis, including improving heart function and decreasing inflammation. This study will administer intravenous GIK for 12 hours continuously and monitor 10 subjects for 24 hours. A control arm will be used and 10 patients will receive the same monitoring but will not receive GIK.


Eligibility Criteria:
Inclusion Criteria:

1. Suspected or confirmed infection;
2. Any two of four criteria of systemic inflammatory response:

   * Temperature \> 100.4° or \< 96.8° F
   * Heart rate \> 90 beats/minute
   * Respiratory rate \> 20 breaths/min. or PaCO2 \< 32 mm Hg
   * WBC \>12,000 or \< 4000 cells/µL or \> 10% bands
3. Initiation of quantitative resuscitation protocol in the ED;
4. Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock

Exclusion Criteria:

1. Age \<18 years;
2. Pregnancy;
3. Any primary diagnosis other than sepsis;
4. Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
5. Known hyperkalemia (serum potassium \>5.5);
6. Dialysis-dependent renal failure;
7. Anticipated requirement for immediate surgery (within 24 hours);
8. Active participation in another interventional study;
9. Transferred from another hospital setting with sepsis therapy initiated;
10. Inability to obtain informed consent;
11. Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
12. Active malignancy currently under treatment (chemo- or radiation therapy);
13. Known systemic allergy to insulin;
14. History of periodic paralysis associated with carbohydrate loading;
15. Receiving continuous intravenous inotropic support (including dobutamine, milrinone, amrinone, and levosimendan).
Analysis of Foot Plantar Pressure Behavior of Children With Obstetric Brachial Plexus Paralysis

The aim of this study was to investigate the foot plantar pressure behavior alterations during gait for children with obstetric brachial plexus (OBBP). 19 children with OBBP and 10 healthy children will be included in the study. The inclusion criteria of the study were to be between the ages of 7-15, not have a history of surgery or botox in the last 6 months, and not have any other disease. Foot plantar pressures of all participants will be analyzed with a pedobarography device. For arm swing analysis, a video camera will be recorded during walking and arm flexion/extension angles will be measured with Kinovea software.


Eligibility Criteria:
Inclusion Criteria:

- Between the ages of 7-15. No other disease

Exclusion Criteria:

- Having undergone surgery or botox intervention for orthopedic problems in the last 6 months.

Having health problems in the unaffected extremity or adversely affecting general body health.

The participant's parent has not signed the consent form.
Fatigue and Sleep Quality in Multiple Sclerosis Patients

This study was planned to examine the effect of reiki application on fatigue and sleep quality in patients with multiple sclerosis.

Fatigue and Sleep Quality in Multiple Sclerosis Patients: Does Reiki Application Affect?

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Volunteering to participate in the research
* Having the ability to use technological tools
* Not using Reiki and similar integrative treatment methods
* Not having a verbal communication disability (hearing and speaking)
* Not having a diagnosed psychiatric disorder
* Patients who have been treated for MS for more than three months
* Having a scale score of \>5 on the Piper Fatigue Scale
* A score of \>5 on the Pittsburgh Sleep Quality Scale

Exclusion Criteria:

* None
Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia

Physical activity has been used for a number of years in the treatment of fibromyalgia (FM). The main objective of this study is to compare the effects of physical activity on two groups of women diagnosed with fibromyalgia (FM) in terms of pain, quality of life and the impact of the condition on their daily lives. Methods: this was a randomized clinical trial to assess the effects of physical activity performed by subjects assigned to one of two groups on the scores of three questionnaires (the pain Visual Analogue Scale, the FIQ questionnaire and the SF-36 health questionnaire) administered before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

Women

* Ages of 40 and 75
* Diagnosis fibromyalgia (code M79.7)
* Anoia region

Exclusion Criteria:

* Pregnant
* Unable to participate in the physical activity program.
Clinical Study of Depo Provera Comparing Lay Health Workers and Clinically-trained Health Workers

This is a randomized controlled trial comparing lay Lady Health Workers (Lay Health Workers) with Family Welfare Workers (Clinically- trained Health Workers) on quantitative measures of safety and effectiveness of Depo Provera and Sayana Press provision in a clinic setting. This comparative trial will test the non-inferiority hypothesis that Lady Health Workers are just as competent as clinically-trained Family Welfare Workers in screening and counseling first-time injectable users. These first time users will also be randomly assigned to receive intramuscular or subcutaneous injections of DMPA.

FHI 360 and Jhpiego in collaboration with USAID, Aga Khan University (AKU) and the Government of Sindh province propose a randomized controlled trial (RCT) to provide evidence that could change current policies in Pakistan that forbid initiation of DMPA by Lady Health Workers (LHWs). Positive findings on the safety and effectiveness of LHW-initiation of DMPA may also prompt the WHO to consider modifying the recommendation for targeted M\&E for lay health worker provision of intramuscular injectable contraceptives. The trial will compare the screening and counseling of (LHWs)-the main lay health worker cadre--with that of Family Welfare Workers (FWWs) who are clinically-trained. The Government of Sindh province also expressed interest in introducing Pfizer's subcutaneous form of Depo Provera, Sayana Press® (SP) in Pakistan, which could simplify administration of injectable contraceptives. As such, an SP arm will be included in the trial, which will be facilitated by relevant training of LHWs and FWWs by Jhpiego and stocks provided by a special USAID procurement, since the registration process for SP in Pakistan is ongoing. A successful RCT demonstrating the non-inferiority of LHWs vis á vis FWWs on first-dose initiation of Depo Provera IM (DMPA IM) and (SP) would facilitate efforts to expand CBA2I in Pakistan, and in turn improve access to family planning services for a potentially large number of underserved women.

Eligibility Criteria:
Inclusion Criteria:

* Women who voluntarily accept DMPA

Exclusion Criteria:

* Women unable to provide informed consent
* Women with contraindications to DMPA
* Women who are pregnant
The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers

Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices.

The main objectives of this study are:

1. To verify that the investigational devices and the reference medical devices have a reasonable deviation value.
2. To verify the consistency of repeated measurements of investigational devices.

This Study carried out in accordance with the ISO 80601-2-56: 2017, which included definitions for the age groups and sample sizes, the definition of fever, the flowchart for relevant procedures, and statistical methods for clinical performance.

All subjects were measured by the reference device (electronic thermometer MT-B231) and three investigational devices under test evaluation (infrared forehead thermometer GE-TF03, infrared ear thermometer GE-TE06, and electronic thermometer MT-B321FB). For each subject, the reference device measured one time and each investigational device measured three times respectively.

Eligibility Criteria:
Inclusion Criteria:

* Newborn to 80 years old adult
* Male or Female
* The subject or parent/guardian can talk to the researcher, understand the content of the study after researcher's explanation and agree to sign the subject's consent form, and is willing to accept the trial procedure.

Exclusion Criteria:

* Currently have signs or symptoms of infection or inflammation at the temperature measurement site (axillary, forehead, ear canal)
* The forehead cannot be fully exposed to the environment for more than 15 minutes
* Using cooling blankets, fans, or placing ice cubes on the forehead
* There is a catheter placed in the ear
* Use of antipyretics (such as aspirin, ibuprofen), barbiturates, antipsychotics in the past 2 hours
* Received thyroxine, corticosteroids or immunotherapy in the past 7 days
* Subject has been diagnosed with cognitive impairment or has a history of dementia, mental illness, mental illness, pervasive developmental disorder, illicit drug use or alcoholism, etc.
* Pregnant women
* The researcher considers that the subject is not suitable for participating in this trial, such as taking any drugs that may change body temperature
* Participated in clinical trials of investigational drugs within the last 30 days
* The subject is unwilling to sign the subject's consent form
Safety and Efficacy of a Single Dose of a Polyphenol-enriched Brown Seaweed Powder in Human

The primary endpoint of this trial will be to evaluate the safety of a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a test meal. The secondary endpoint of this trial will be to evaluate if a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder is able to reduce the rate of carbohydrate absorption as measured by following postprandial glycemia and insulinemia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* BMI between 20 and 30
* Non-smoking

Exclusion Criteria:

* Iodine allergy
* Diabetes
* Use of dietary supplements for duration of study
* History of major surgeries or surgeries of the stomach or digestive tract
Interest of the Pleth Variability Index in Neurosurgery

This clinical trial aims to study the interest of the Pleth Variability Index (PVI) to evaluate perioperative fluid responsiveness in neurosurgery in adults.

The main question it aims to answer is:

• Does the Pleth variability index predict fluid responsiveness in neurosurgery? Researchers will compare the Pleth variability index to dela PP to see if it predicts fluid responsiveness in neurosurgery.

Once participants give their consent, they will be randomly assigned to one of two groups. In one group, fluid responsiveness will be monitored using the Pleth Variability Index, while in the other group, it will be monitored using delta PP.


Eligibility Criteria:
Inclusion Criteria:

1. Patients proposed for intracranial surgery
2. Must be aged 18 and over
3. Must be classified as ASA I, ASA II, and ASA III according to the American Society of Anesthesiologists classification

Exclusion Criteria:

1. Non-consenting patients
2. Patients classified ASA IV or higher
3. Cardiac arrhythmia
4. Heart disease with left ventricular ejection fraction less than 45%
5. Obesity with a BMI greater than 40 Kg/m2.
6. Peripheral vascular disease
7. Severe lung disease
8. End-stage renal disease
9. Intraoperative cardiac arrhythmia
10. The occurrence of cardiac arrest
11. The occurrence of hemorrhagic shock
12. Intraoperative use of low tidal volumes or high respiratory rates.
Effect of Ramosetron on Post-discharge Nausea and Vomiting

Nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea or vomiting occurs. Thus, It is necessary to prevent these symptoms beforehand. Patients who underwent gynecologic surgery will be treated with prophylactic ramosetron to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo hysteroscopic surgery and are discharged on the day of surgery.

Exclusion Criteria:

* American Society of Anesthesiologists physical statue 3 or more
* Planned admission after surgery
* Intravenous anesthesia
* During chemotherapy
* Pregnancy or breastfeeding
* Abnormal liver or kidney function