cyrilzakka/clinical-trials huggingface dataset:
Kyphosis Evaluation Using SPINESCAN®

The purpose of this study is to evaluate the accuracy of SPINESCAN® with standard lateral x-rays of the spine in patients monitored for kyphosis.

Kyphosis is usually a developmental deformity of the spine in the sagittal plane. Once diagnosed, serial X-rays are used for followup. These are usually required at yearly intervals.

SPINESCAN® is a computerized digital inclinometer, design for evaluating angular spine deformities.

Patients examined in the spine clinic with recent X-rays will be examined with SPINESCAN® and it's results compared with the classical radiological assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patients examined in scoliosis clinic for kyphosis with recent lateral spine X-rays.
* Age: 7 years old and above.

Exclusion Criteria:

* Less than 7 years old.
* No informed consent.
PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma

Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan alone.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 80;
* patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia;
* agree to give written informed consent.

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding, and known gastric neoplasia;
* Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 s), impaired renal function (creatinine level \>1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
* Inability to provide informed consent
Use of Bispectral Index Monitoring to Detect Deep Sedation in Mechanically Ventilated Patients: Validity Study

In the previous study, the investigators obtained the cutoff value of Bispectral Index to detect early deep sedation in patients with mechanical ventilation. Bispectral Index monitoring can be used as an adjunct tool in screening and confirming deep sedation during the early period of mechanical ventilation. In present study, validation test will be carried out to clarify the sensitivity and specificity of obtained cutoff value in screening deep sedation in patients with mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients are intubated and ventilated within the previous 24 hours, are administered with continuous or intermittent intravenous sedatives and/or analgesics, and are expected to receive mechanical ventilation and sedation for longer than 24 hours

Exclusion Criteria:

* Age under 18 or over 65 years;
* Continuously infusion of muscle relaxants;
* Diagnosed or suspected brain diseases, which including brain trauma, intracranial hemorrhage, stroke, brain tumors, hypoxic-ischemic encephalopathy, epilepsy and meningitis;
* Diagnosed conditions that resulted in a decrease level of consciousness, which including hypoxemia with partial pressure of oxygen in arterial blood less than 60 mmHg, hypotension with systolic blood pressure less than 90 mmHg, hypoglycemia with blood glucose concentration less than 4.1 mmol/L, anemia with hemoglobin concentration less than 70 g/L, and body temperature below 36 °C.
Laparoscopic Management of Periappendicular Abscess

According to retrospective studies the conservative management of periappendicular abscess is associated with decreased complication and re-operation rate compared with open appendectomy. Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not possible because of anatomical position of the abscess and surgical treatment is needed. The purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the first-line treatment in patients with periappendicular abscess.

The hypothesis of the study is that laparoscopic management of periappendicular abscess is suitable for the first-line treatment and it does not increase time of hospitalization or complication rate compared with conservative management.


Eligibility Criteria:
Inclusion Criteria:

* Periappendicular abscess at least 2 cm in size

Exclusion Criteria:

* Missing written informed consent
* Antimicrobial therapy lasted over 24 hours before randomization
* Attempt of drainage before randomization
* Age over 80 years or under 18 years old
* Pregnancy
* Allergy to either Cefuroxime or Metronidazole
* Severe chronic disease, that substantially increases the risk for operative mortality
* Previous major intra-abdominal surgery, that may have caused intra-abdominal adhesions
* Carrier of a resistant bacterial strain
* Being institutionalized or hospitalized for at least 2 weeks before randomization
Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes

This is an observational study. Forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. Study participants will include free-cycling females and females following oral contraceptive therapy. All study appointments may be completed virtually.

Females, age 18-40 y.o., diagnosed with type 1 diabetes and currently using an insulin pump, will be provided a study continuous glucose monitor (CGM) in order to collect 3 full menstrual cycle data within 180 days. Enrollment may last from 3-5 months. Study participants will include free-cycling females and females following oral contraceptive therapy. Study CGMs and activity trackers will be provided for the entire data collection period. During data collection, all participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. The Clue app will be recommended to study participants to record dates of beginning of menses and ovulation (if applicable).

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Use of glucose sensor in the last 6 months
* Use of insulin pump in the last 6 months
* Age ≥18 to ≤40 years
* HbA1c ≤8.5% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately 200 mg/dL or less
* Absence of perimenopausal/menopausal symptoms
* Willingness to keep track of beginning of menstrual cycle
* Willingness to keep track of ingested carbohydrates
* Willingness to not become pregnant during study participation
* Regularly menstruating (at least every month with no missed cycles)
* Only free-cycling participants: willingness to use ovulation kits to confirm ovulation
* Only participants under oral contraceptive therapy: use of monophasic pill, with 3 weeks of active pill and 1 week of placebo
* Willingness to use the study Dexcom G6 during the study
* Participants must have Internet access and a computer system that meets the requirements for uploading the study equipment

Exclusion Criteria:

* Pregnancy
* Hormonal birth control therapy except monophasic pill contraceptive
* Polycystic ovary syndrome (PCOS) diagnosis
* Current use of steroids
* Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas, metformin)
* Uncontrolled thyroid disease
* Active fertility treatment
* Concomitant disease or condition that may compromise patient safety or ability to follow the protocol including: planned or current dialysis treatment; moderate to advanced nephropathy; known or suspected allergy to medical grade adhesives.
* Severe hypoglycemia or diabetes ketoacidosis (DKA) in the previous 6 months
The Mitopure Challenge to Detect Levels of Urolithin A in Dried Blood Spots

Open labelled, virtual home based study to assess the test repeatability and the failure/rejection rate of the samples collected at home by participants.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 18 to 80 years of age;
2. Is in general good health, as determined by the research team;
3. Willingness to consume the investigation product, complete questionnaires and to complete the study;
4. Have given voluntary, electronic, informed consent to be a participant in the study.

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
2. Volunteers who plan to donate blood during the study or within 30 days of completing the study;
3. Subject has a known allergy to the test material's active or inactive ingredients;
4. Subjects with unstable medical conditions;
5. Participation in a clinical research trial within 30 days prior to randomization;
6. Allergy or sensitivity to study ingredients;
7. Individuals who are cognitively impaired and/or who are unable to give informed consent;
8. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject;
9. Has taken antibiotics within the previous 30 days.
Young-Onset Colorectal Cancer

This study investigates the genetic factors that may influence the risk of developing colorectal cancer at a young age. Finding genetic markers for colorectal may help identify patients who are at risk of colorectal cancer. Studying individuals and families at high risk of cancer may help identify cancer genes and other persons at risk.

PRIMARY OBJECTIVES:

I. To define the clinical phenotype of young-onset versus (vs.) later onset colorectal cancer (CRC), including clinicopathologic characteristics, tumor molecular markers, family history, and associated lifestyle/environmental factors.

II. To examine germline genetic alterations in patients with young-onset (diagnosed between age 18 and 50), CRC and those of their first-degree relatives, in comparison to those in patients with later-onset (diagnosed at age 51 or older) CRC.

III. To determine the frequency of the mutations and pattern of inheritance of the mutations identified above in this patient population.

IV. To correlate molecular findings to clinical endpoints of survival and disease recurrence and/or progression in patients with young-onset vs. later-onset CRC.

V. To compare the treatments received by patients with young-onset vs. later-onset CRC and their subsequent survivorship experiences.

OUTLINE:

PATIENTS: Patients complete questionnaires over 30-50 minutes about work, family history, medical history, health habits, and experience as a cancer survivor (quality of life, well-being, concerns, types of health care, and follow-up care received). Active patients, who have undergone treatment at MD Anderson Cancer Center within the past year, complete additional questionnaires at enrollment, 6 months, 12 months after treatment completion, and then every years for up to 6 years. Also, active patients who are consented to the study more than 5 years from surgery, they may complete the survivorship questionnaire once. Patients medical records are also reviewed.

FAMILY MEMBERS: Participants complete questionnaires over 10-15 minutes. Participants also undergo collection of blood or saliva samples once.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS: MDACC patients who have adenocarcinoma of the colon or rectum, diagnosed between ages 18 through 50 (young-onset), or diagnosed at age 51 through 80 (later-onset)
* PATIENTS: Patient must have sufficient command of the English language and mental capacity to provide consent
* FAMILY MEMBERS: Be a parent, sibling or child (first degree blood relative) of a registered MDACC patient meeting eligibility criteria above
* FAMILY MEMBERS: Have sufficient command of the English language and mental capacity to provide consent
* FAMILY MEMBERS: Family member must be at least 18 years of age at the time of study registration
Study to Test a Computer-assisted Support System to Improve Patient-centered Care and Symptom Relief in Cancer Patients

Patient-provider shared decision making and the inclusion of patients' illness experiences and preferences in patient care are prioritized areas in health care. CHOICE is a computer-based support system for patient-centered symptom management of cancer patients developed for this purpose. In this randomized clinical trial at Rikshospitalet- Radiumhospitalet HF 145 adult stem-cell transplantation and newly diagnosed lymphoma and leukemia patients used CHOICE for assessments of their symptoms, problems and priorities for care at in-and outpatient visits during treatment and rehabilitation. In the experimental group this information was shared with physicians an nurses for subsequent care planning, but not in the control group.

This study tested effects of CHOICE on symptom- related patient care and outcomes of symptom relief, patients' needs for care over time and patient satisfaction;(2) analyzed how patients' symptoms, needs for care varied during illness/treatment stages; and (3) evaluated CHOICE' ease of use and user satisfaction. Controlling for gender, age, diagnosis, and type/stage of treatment, education, depression, health related quality of life, and social support, repeated measurement models were used to test differences and variations in outcome variables within and between groups and over time.

as above

Eligibility Criteria:
Inclusion Criteria:

* Starting treatment for a newly diagnosed acute myelogenous leukemia (AML), lymphatic leukemia (ALL), Hodgkin or non-Hodgkin lymphoma, or
* starting treatment for a recurrence of the disease;
* starting treatment with allogenous or autologous Stem Cell Transplantation (SCT).
* above 18 years of age.

Exclusion Criteria:

* having received radiation on the brain
Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients

The purpose of this study is to investigate the effects of a Buteyko-based breathing technique on physiological and psychological parameters in adults with asthma

The investigators explore the effects of a Buteyko-based breathing technique training using a treatment group vs. control group design and a repeated measures design with follow-up measurements 3 and 6 months after the intervention. The sample size calculation was made for an effect of d = .20 with repeated measures, a power of 1- β = .80 and α = .05. Additionally the investigators plan to take measurements (only once) from healthy volunteers matching them (age and gender) with the asthma patients.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, regular intake of prescribed asthma medication according to the AWMF scheme level 1, native speaker of german

Exclusion Criteria:

* Participation in another study, comorbidities (heart diseases, cancer still under treatment, psychiatric diseases)
Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS

A multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients with Essential Hypertension Inadequately Controlled with AGLS


Eligibility Criteria:
Inclusion Criteria:

* Hypertension patient who satisfied below condition at Visit 1.

  * patient who takes antihypertensive drug

    * 140mmHg \<= MSSBP \< 200mmHg
    * 130mmHg \<= MSSBP \< 200mmHg at or before visit 1(In high-risk patients)
  * patient who doesn't take antihypertensive drug

    * 160mmHg \<= MSSBP \< 200mmHg
* Hypertension patient who satisfied below condition at Visit 2.

  * 140mmHg \<= MSSBP \< 200mmHg at Visit 2
  * 130mmHg \<= MSSBP \< 200mmHg at or before Visit 1(In high-risk patients)

Exclusion Criteria:

* Patient who have received 4 or more antihypertensive drug
* Patient with 20mmHg\>= of difference in MSSBP or 10mmHg\>= of difference in MSDBP between 2 times of BP measuring at Visit 1
* Patient with MSDBP \>= 120mmHg at Visit 1 or 2
* Patient with secondary hypertension(including past medical history)
Estimation of Injection Volume for Caudal Epidural Block Using Dynamic US Imaging in Children

Caudal epidural block is the most commonly used technique for analgesia in pediatric patients. Although there are clinically used doses of local anesthetics for caudal epidural block, we do not know exactly how much levels are blocked in young children. Thus, we aimed to identify the spreading of injection of local anesthetics for caudal epidural block using ultrasound imaging in young children.


Eligibility Criteria:
Inclusion Criteria:

* age: 6-24months
* ASA 1-3
* body weight: 5-20kg

Exclusion Criteria:

* patients who refuse to participate
* local site infection, pilonidal cyst, spina bifida
* spinal/meningeal abnormality
* patients who discharge after surgery without admission
* patients who is judged ineligible for other reasons by the authors
Bigfoot Unity Real World Study

This study is observational, designed to collect real world use and safety data for those using the Bigfoot Unity Diabetes Management System for 12 months. Participants will be those with a prescription to use the Bigfoot Unity System. Medical practices prescribing Bigfoot Unity and Sponsor representatives will provide information about the study to current users and individuals considering initiation of the Bigfoot Unity System. During the course of the study, participants will be asked to use the Bigfoot Unity System in accordance with the prescription provided by their healthcare professional (HCP).


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 or type 2 diabetes diagnosis
2. HCP-prescribed, registered Bigfoot Unity users who have used the Bigfoot Unity System 2 weeks or less
3. Age 12 years or older at time of electronic informed consent
4. Using both long-acting and rapid-acting insulins that are compatible for use with the Bigfoot Unity System
5. Using long-acting insulin no more than 1 time per day
6. Must have baseline HbA1c collected within 90 days prior to starting the Bigfoot Unity System
7. Able to read and understand English
8. Participant or legally authorized representative for minors has the capacity to provide electronic informed consent
9. Resident of the United States
10. Persons who are using a phone that is compatible with Bigfoot Unity and not shared with a family member or a caregiver

Exclusion Criteria:

1. Females who are pregnant or intending to become pregnant during participation in the study
2. Persons with implantable medical devices such as pacemakers
3. Persons on dialysis or other serious medical conditions that would impact the ability to use the device or manage their diabetes
4. Persons taking or expected to be taking \>500mg Vitamin C supplements on routine basis
5. Persons employed by the Sponsor or JCHR
Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)

This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion.

The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour weekly, every other week, or every three week infusion in participants with advanced cancer will be generally safe and tolerated at a dose which achieves a trough concentration ≥3 μg/mL.

Trial Duration of Treatment: Participants can be treated for up to two years if their disease has not progressed and they are not having unmanageable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Participant has metastatic or locally advanced solid tumor or multiple myeloma
* Tumor specimen has IGF-1R expression
* Participant agrees to use birth control throughout study

Exclusion Criteria:

* Participant must not be recovering from antineoplastic therapy in the last 4 weeks
* Participant has participated in a clinical trial in the last 4 weeks
* Participant has a history of heart problems such as congestive heart failure, angina, heart attack or stroke in the last 3 months
* Participant is taking growth hormone or growth hormone inhibitors
* If female, participant is pregnant or breastfeeding
* Participant is human immunodeficiency virus (HIV) positive
* Participant has a history of hepatitis B or C
Visanne Study to Assess Safety in Adolescents

A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.


Eligibility Criteria:
Inclusion Criteria:

* Female adolescents after menarche (12 - less than 18 years of age) at screening. For Finland: Adolescents aged 12 - 14 years old who present with clinical features of endometriosis will only be enrolled into the study if their diagnosis of endometriosis has been confirmed by laparoscopy.
* Dysmenorrhea of at least moderate intensity, with or without chronic pelvic pain, for at least 2 cycles in the previous 4 months and one of the following conditions:

  * Clinically suspected endometriosis based on the presence of pelvic pain incompletely relieved by non steroidal anti-inflammatory drugs and/or oral contraceptives
  * Any abdominal pain associated with ultrasound findings suggestive of endometriosis (abdominal, vaginal or rectal; only after additional specific consent and assent)
  * Failure of surgical treatment for endometriosis (with cyclic or chronic pelvic pain of at least 4 months duration postsurgery)
  * Threshold for endometriosis-associated pelvic pain (EAPP) score: at least 30 on a 100 units visual analog scale retrospectively evaluated at screening for the last 4 weeks

Exclusion Criteria:

* Absence of endometriosis at laparoscopy
* Previous application of hormonal agents including oral contraceptives within 2 months, progestins, danazol within 3 months, and Gonadotropin Releasing Hormone (GnRH) agonists within 6 months prior to start of treatment
* Chronic pelvic pain that might be related to genitourinary disease or to chronic or recurrent gastrointestinal disease, including irritable bowel syndrome (defined as a disease characterized by pain relieved by defecation and irregular defecation patterns lasting at least 3 months)
* Clinically established need for primary surgical treatment of endometriosis
92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus

To compare the efficacy of intramuscular injection of two anti-inflammatory drugs, Traumeel and Dexamethasone, used in the control of postoperative complications pain, edema and trismus after third molar extraction mandibular


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication of asymptomatic bilateral extractions of lower third molars;
* Aged 18 years or older;
* Have a good health and no disease.

Exclusion Criteria:

• Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation
Effects of Gum Arabic Ingestion on Hormonal and Metabolic Changes in Patients With Polycystic Ovary Syndrome

To assess the effects on hormonal and metabolic changes in the PCOs patients after ingestion of Arabic gum

Polycystic ovary syndrome (PCOS) affects 5-20% of women of reproductive age worldwide it increases the risk for type 2 diabetes mellitus, cerebrovascular and cardiovascular events and not to mention it is one of the main causes of infertility. in the management of PCOS life style modification like weight reduction is necessary and recently it was discovered that GA ingestion causes significant reduction in BMI and body fat percentage among healthy adult females.so if GA could also affect the hormones and the metabolic changes in PCOs is going to be useful in decreasing the comorbidities and even treating PCOs.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with PCO by independent Gynecologist

Exclusion Criteria:

* Diabetic patients
* Menopausal women
* History of allergy to Gum Arabic