cyrilzakka/clinical-trials huggingface dataset:
Proper Nutrition, Physical Exercise and Appropriate Weight in Individuals With Long Term Mental Illness

Based on previous findings that mentally ill inpatients are interested in losing treatment associate weight gain and are capable of adhering to a weight reduction program, this study will investigate the effects of participation in nutrition intervention, physical exercise and will monitor measurement of metabolic profiles (cholesterol, triglycerides and glucose). Hypothesis: participants will reduce weight, maintain weight loss and experience reduction in metabolic values and will experience improved quality of life.

Study sample: 50 chronic psychiatric inpatients with DSM_IV diagnosis of schizophrenia or schizoaffective disorder, aged 18 or older. Exclusion criteria - pregnancy, severe physical illness, refusal to participate.

Study instruments: Q-LES-Q-18 (quality of life): Positive and Negative Syndrome Scale; Laboratory test- glucose levels, metabolic profiles (cholesterol, triglycerides). Measurements: Weight, BMI, pulse Intervention: Weekly group therapy, lectures on nutrition, physical exercise Duration of study: 3 months

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and older
* Men or women
* Schizophrenia or schizoaffective disorder
* BMI greater than 26
* Agreement to participate and capacity to provide written informed consent

Exclusion Criteria:

* Pregnancy
* Severe physical illness
* Refusal to participate
UF-BMT-HSCT-001: A Non-Interventional Study Evaluating Diet in HSCT Survivors

This is a single center, cross-sectional, non-interventional study aimed at the nutritional intake of long-term health of allogeneic or autologous hematopoietic stem cell transplant (HSCT) survivors.

Higher rates of comorbidity among hematopoietic stem cell transplant (HSCT) survivors support the need for lifestyle interventions that target this vulnerable population. Comprehensive evaluation of the nutrient intake will provide adequate information necessary for develop of a targeted nutritional intervention in order to achieve specific nutritional need and improve long-term health of HSCT survivors. The cross-sectional design of this study has been selected for the timely collection of subject reported nutrient intake data. The intended study is strictly observational.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures for subjects enrolled from the cancer registry.
* Both males and females ≥ 18 years of age.
* A medical history of allogeneic or autologous hematopoietic stem cell transplant (HSCT), irrespective of the disease. For the purpose of this study, HSCT survivor is defined as subjects one or more years after allogeneic or autologous HSCT without disease relapse, active graft-versus-host disease, or active infection. Subjects with chronic graft versus host disease who are on stable dose of immunosuppressant (or being tapered off of immunosuppressant) over the past 3 months will be eligible.
* Study participants must have the ability to complete the questionnaires through one of the previously stated mechanisms.
* English speaking due to the logistics of the questionnaires and phone contact included in this study.

Exclusion Criteria:

* Subjects demonstrating an inability to comply with the study procedures.
Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures

Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes during wound healing in human subjects.

Vestibuloplasty is the common name of those procedures designed to widen the zone of attached gingiva. The apically repositioned split thickness flap with a xenogeneic collagen matrix or with a combination of strip gingival graft and a xenogeneic collagen matrix are frequently used surgical techniques, however no data are available, how these graft tissues affect the microcirculation of the healing gingiva.

LSCI is a non-invasive, two dimensional method to evaluate microcirculation of different tissues. This new method let us monitor the entire surgical area real-time during the healing period.

The aim of the present study is to define blood flow patterns, which might characterize the wound healing of such surgical procedures during the first 6 months of healing in order to facilitate treatment.

Eligibility Criteria:
Ages Eligible for Study: 18 Years to 45 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• clinical diagnosis of inadequate width of keratinized gingiva at the mandibular front region

Exclusion Criteria:

* pregnancy
* heavy smoking
* general diseases
* taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, anti-inflammatory drugs)
* taking any other medications in the last three months (except contraceptives)
Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy

This study is being done with a new therapy called "Selective Internal Radiation Therapy" (known as SIRT). Radiation is an effective treatment for destroying tumors. It is widely used in cancer treatment. However, radiation can harm normal tissue. SIR-Spheres are tiny plastic beads. They contain a radioactive agent called Yttrium-90. These beads can be delivered through a small tube inserted into the blood vessel that goes directly to the tumor. The radiation goes directly to the tumor. This spares healthy parts of your liver.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of colorectal cancer.
* Unequivocal imaging of hepatic metastases.
* Dominant Liver metastases. (Small amount extrahepatic disease allowed.)
* Unresectable liver metastases.
* Liver Metastases non-eligible for, or progressed after ablation
* Failed prior HAC.
* ECOG performance status 0 - 1
* WBC \> or = to 1.5 x 109/L
* Platelets \> or = to 50 x 109/L
* Creatinine ≤ 1.5 mg/dl
* Bilirubin ≤ 1.5 mg/dl
* Age \> or = to 18 years
* Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active, must agree to use an acceptable method of contraception.
* Male patients must be surgically sterile, or if sexually active, must agree to use an acceptable method of contraception.
* Life expectancy of at least 3 months without any active treatment.
* No chemotherapy regimen administration for at least 4 weeks prior to SIRT administration

Exclusion Criteria:

* Evidence of severe cirrhosis (CHILDS B and C), portal hypertension with gastroesophageal varices and liver failure as determined by clinical, radiologic or laboratory assessment.
* Previous radiotherapy delivered to the liver.
* Pregnant or breast-feeding.
* Any of the following are contraindications to the use of Yttrium-90 microspheres, and are therefore exclusion criteria:

  * With a Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy that shows any disposition to the gastrointestinal tract that cannot be corrected by angiographic and embolization techniques.
  * With more than 20% shunting of blood to the lungs as estimated in the Lung Scintigram performed after the intraarterial injection of Tc MAA. Radiation pneumonitis has been seen in patients receiving doses of Yttrium-90 greater than 30 Gy in a single treatment. This corresponds to the shunt over 20% presence of vascular abnormalities, bleeding diathesis, making catheterization of the hepatic artery contraindication.
The Influence of Hip Replacement on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient

Explore the influence of hip replacement on lower extremity hemodynamics in Crowe Ⅳ hip dysplasia patient.

Changes of limb length after total hip replacement is common, especially for Crowe Ⅳ hip dysplasia patient. Such change potentially increases tension of vessel and influence lower extremity hemodynamics. Till now, little is known in this area.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral Crow IV hip dysplasia;
* Bilateral Crow IV hip dysplasia without osteoarthritis on the other side

Exclusion Criteria:

* Patients with serious medical disease;
* Patients with lower extremity vascular disease; 3. Patients with severe mental illness.
A Study of Three Modified-Release Formulations of RO4917523 in Healthy Volunteers

This single-center, open label, randomized, 3-period cross-over study will compare 3 modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized to one of six sequences to receive single oral doses of RO4917523 slow, target and fast release modified release (MR) capsules along with a reference intravenous microdose with the target capsule. A washout period of at least 21 days will occur between treatments.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers, 18 - 55 years of age inclusive Healthy status will be defined by absence in evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Body mass index (BMI) of 18 to 30 kg/m2, inclusive, and body weight of at least 50 kg
* Females of child-bearing potential must agree to use effective contraception as defined by protocol
* Non-smoker for at least 90 days prior to dosing on Day 1

Exclusion Criteria:

* History or presence of a clinically significant psychiatric condition as defined by protocol
* Participation in an clinical study with an investigational drug within 60 days or 5 times the half-life (whichever is longer) preceding first administration of study drug. Participation in more than 3 other drug studies within 10 months preceding first administration of study drug.
* Clinically significant disease or disorder
* Personal or family history of long QT syndrome or sudden death
* Any suspicion or history of alcohol and/or other substance abuse or dependence in the last 6 months
* Subject likely to need concomitant medication during the study (including for dental conditions), except for hormonal contraception or HRT
* Pregnant or lactating women, or women who intend to become pregnant during the course of the study
* Positive for hepatitis B, hepatitis C or HIV infection
* Any confirmed significant allergic reactions against any drug, or multiple allergies
Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD according to the NINCDS-ADRDA criteria.
* Able to give informed consent. Patient' s caregiver must consent to participate in the study.

Exclusion Criteria:

* Use of medications for cognitive enhancement within 3 months of baseline.
* Significant neurologic disease other than AD that may affect cognition.
Acute Myocardial Dysfunction and Chest Trauma - The Strainy Trauma Study

This study aims to investigate whether the identification of acute myocardial dysfunction by 2D-strain transthoracic sonography in the first week following trauma would allow to better diagnose occult and severe patterns of myocardial contusion, in order to identify a subpopulation at higher risk of complications.

The measurement of myocardial strain (2D-strain) by transthoracic sonography is a robust tool to assess the myocardial function.

The investigators strongly suppose that the 2D-strain would allow to better identify subclinical MC in chest trauma, as well as the severe patterns that are associated with more organs dysfunctions and a worst outcome.

Thoracic trauma is the cause of significant morbidity and accounts for 25% of trauma-related deaths.

The myocardial contusion (MC) is a distinct injury, which has a prevalence increasing with the severity of the trauma. The diagnostic tool is a major factor to vary the prevalence of MC (i.e. clinical exam, biology, electrocardiogram), with the highest values for autopsy series, until 24% of patients. It does not exist therefore of gold standard for the diagnosis of MC in clinical practice leading to a modest knowledge of this nosological entity. In clinical practice, troponin plasma level determines the diagnostic.

Otherwise, the measurement of myocardial strain (2D-strain) by transthoracic echocardiography (TTE) is a robust tool to assess the myocardial function. This ultrasound analysis allows an objective and topographical quantification of an acute myocardial dysfunction, be it global or segmental. 2D-strain has been thus has been validated for the diagnosis of myocardial dysfunction in medical setting. Its use in trauma setting has never been reported.

Eligibility Criteria:
Inclusion Criteria:

* severe trauma patients with blunt chest trauma
* (AIS Thorax score ≥ 1)
* admitted in our trauma intensive care unit
* and included within the 24 first hours following trauma

Exclusion Criteria:

* Imminent death
* Recovered cardiocirculatory arrest following trauma
* Critical patient : AIS score ≥5 on 1 lesion, requiring ECLS (extracorporeal life support) or REBOA (resuscitative endovascular balloon occlusion of the aorta)
* Refractory hypovolaemia
* Arrhythmia, atrial fibrillation
* Congenital heart disease, ischemic cardiomyopathy, moderate or severe pre-existing valvular heart disease, pulmonary arterial hypertension (PAH)
* Valve prosthesis or pacemaker
* Insufficient quality of ultrasound image to allow correct assessment of 2D-strain
* Pregnant woman and underage patients
Acute Effects of Ultra-processed Versus Unprocessed Foods on Glucocorticoid Secretion in Healthy Individuals

The investigators aim to understand whether the acute cortisol response to food differs between differently processed foods.

In this monocentric, randomized, cross-over, open-label study, 20 healthy volunteers will receive two differently processed meals of similar caloric content and composition. The study will primarily focus on changes in blood cortisol levels, but other metabolic parameters will also be compared.

Obesity is one of the most serious health problems of the 21st century, with ultra-processed diets being a major driver of the current obesity pandemic. Understanding how these diets affect body weight is critical to identifying new treatment targets. Current evidence suggests that the degree of food processing may affect cortisol secretion, a hormone that plays a key role in body weight regulation by increasing with acute food intake and promoting energy storage in adipose tissue. However, whether ultra-processed foods enhance cortisol response has not been thoroughly investigated.

Here, the investigators aim to understand the reaction of GCs in response to different processed foods in healthy volunteers. No medication will be used in this study.

Participants will be asked to refrain from strenuous physical activity and alcohol consumption for 24 hours prior to the study. They will fast for 12 hours before consuming a high-calorie, low-processed meal. After fasting again, participants will consume a high-calorie, ultra-processed meal on a second study day. The order of the meals is not fixed. The study will include a screening visit and two study visits.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18 to 40 years
* BMI 18.5-29.9 kg/m2

Exclusion Criteria:

* Severe acute or chronic disease
* Lactose intolerance
* Severe food allergy
* Casual smoking (more than six cigarettes per day)
* Frequent, heavy alcohol consumption (more than 30g/day)
* Frequent, heavy caffeine consumption (more than 4 caffeinated drinks/day)
* Regular physical exercise (more than 4hrs per week)
* Shift work
* Previous enrollment in a clinical trial within the past two months
* Intake of any steroid-containing drugs, including topical steroids and inhalers, within four weeks of the study initiation
* Contradictions to undergo the investigated intervention
* Inability or unwillingness to provide informed consent
Intrathecal Morphine for Cesarean Delivery

This is a randomized double blinded non-inferiority study comparing the duration of pain relief when patients receive one of three doses of spinal morphine. Enrolled patients will be randomly assigned to receive either 50 mcg, 150 mcg, or 250 mcg. All patients will receive standardized postoperative care, including multimodal analgesia. The primary outcome will be the time until the patient requests additional opioid pain medications.

Prospective, randomized, double-blind, controlled trial, with a non-inferiority design. Patients will be randomly assigned to receive either intrathecal morphine 50 mcg, 150 mcg, or 250 mcg based on a pre-assigned randomization sequence. This medication will be administered as part of their spinal anesthesia for cesarean delivery. the patient, clinician who administers the spinal anesthesia, and investigator who follows the patient will all be blinded to the dose of medication.

All patients will receive standard of care for cesarean delivery and routine nursing care. This includes: preoperative intravenous catheter placement with preoperative IV fluid, standard American Society of Anesthesiologists monitoring, and neuraxial anesthesia placement (either spinal or combined spinal epidural) in sterile fashion. Each patient will receive standard cesarean induction dose of intrathecal medication consisting of 1.5ml of 0.75% hyperbaric bupivacaine, fentanyl 25 mcg. At end of surgery, all patients will receive standard dose of ketorolac 30 mg IV and acetaminophen 1 gm IV and continue with redosing every 6 and 8 hours (respectively) for 24 hours. On arrival to PACU, all patients will receive standard nursing care with standard monitoring of side effects. On discharge from PACU, patients will be transferred to postpartum floor and receive standard nursing care and monitoring.

Over the following 24 hours, the patient will receive all standard post-cesarean care. For treatment of breakthrough pain, medications will provided be per standard care: oxycodone 5-10 mg PO every four hours PRN for pain. If the patient is not comfortable after receiving oral oxycodone they will be assessed by an anesthesia provider for either regional nerve block or additional opioids, as a one-time dose or by patient controlled analgesia (PCA).

For treatment for side effects, medications will provided be per standard care: ondansetron 4mg IV as first-line for nausea/vomiting, promethazine 6.25 mg IV or Haloperidol 0.5-1mg IV for refractory nausea/vomiting. Naloxone 0.04 mg IV for refractory pruritus.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women (ASA 2)
* Between 18 and 45 years old
* Singleton term pregnancies
* Planned neuraxial anesthesia

Exclusion Criteria:

* Refusal to participate
* Known allergy or contraindication to any medication used in the study
* Significant medical or obstetrical disease (ASA ≥ 3)
* Opioid use disorder
* Chronic pain syndrome
* Daily or near daily opioid use within last 3 weeks.
* Patient receiving a Monoamine oxidase inhibitors (MOAi)
A Study of SHR-1316 and Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients

The purpose of this study is to evaluate the safety and efficacy of SHR-1316 in combination with Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age.
* Histologically or cytologically confirmed SCLC.
* Failed at least one prior line of platinum-based chemotherapy.
* Patients must have measurable disease as defined by RECIST v1.1.
* ECOG 0-1.
* Adequate hematologic and organ function
* Signed inform consent form

Exclusion Criteria:

* Active or untreated central nervous system (CNS) metastases
* Spinal cord compression not definitively treated with surgery and/or radiation .
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Malignancies other than SCLC within 5 years prior to randomization
* History of autoimmune disease
* Positive test result for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
* Severe infections
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.
* Significant cardiovascular disease
* Prior allogeneic bone marrow transplantation or solid organ transplant
* Treatment with systemic immunosuppressive medications prior to randomization
* Pregnant or lactating women
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects

Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18 and 65 years of age (inclusive).
2. Subjects who have given written consent.
3. Individuals in good health as per investigator judgement.

Exclusion Criteria:

1. If female, pregnancy or unwillingness to practice acceptable contraception.
2. If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.
3. Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.
4. Unable to comprehend and to follow all required study procedures for the whole period of the study.
5. Participating in any other clinical trial 30 days prior to first study visit.
6. History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization.
7. Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43.
8. Received any other vaccines within 2 weeks prior to enrollment in this study or plan to receive any vaccine within 4 weeks from the study vaccines.
9. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
10. Individuals who are part of study personnel or close family members conducting this study.
11. Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination.
12. Plans to travel within the next year to areas where Rabies and/or Japanese Encephalitis vaccine may be considered or offered. This includes but is not limited to India, Asia, Pacific-Rim, African countries.