cyrilzakka/clinical-trials huggingface dataset:
Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers

The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric volume, motor and sensory effects in healthy patients.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
2. No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
3. Body mass index of 18-35 kg/m²
4. Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female subjects unable to bear children must have this documented in the medical record (i.e., tubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of one year since the last menstrual period\]).

Exclusion Criteria:

1. Unable or unwilling to provide informed consent or to comply with study procedures
2. Diagnosis of gastrointestinal diseases
3. Structural or metabolic diseases that affect the GI system
4. Unable to avoid the following over- the- counter medications 48 hours prior to the baseline period and throughout the study:

   1. Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin,
   2. Analgesic drugs including NSAIDs and COX-2 inhibitors NOTE: stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception as drug-interactions with birth control have not been conducted) are permissible.
5. History of recent surgery (within 60 days of screening)
6. Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.
7. Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the Investigator
8. Acute GI illness within 48 hours of initiation of the baseline period
9. Females who are pregnant or breastfeeding
10. History of excessive alcohol use or substance abuse
11. Participation in an investigational study within the 30 days prior to dosing in the present study
12. Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study
Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India

The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving package of iron and other micronutrients, to treat infants with iron deficiency anemia in India. Results have implications for programs using Sprinkles worldwide because lower doses of iron may have fewer side effects.

Iron deficiency anemia affects two thirds of children in most developing nations, and even mild anemia can have serious implications for child development. In India, government programs within India have been ineffective in controlling this public health problem due to the lack of effective iron supplements reaching children.

Our research group developed 'Sprinkles', an inexpensive micronutrient supplement which is a single-serve sachet of tasteless powder that contain encapsulated iron and other micronutrients. Parents can be easily instructed to mix the contents of one sachet into a bowl of any complementary food.

This study is part of a partnership and capacity development between interdisciplinary research groups at The Hospital for Sick Children, University of Toronto, Canada and the King Edward Memorial Hospital in India, aimed at developing a long-term program of research that will address iron deficiency anemia among infants and young children in India. For Sprinkles to be implemented into national programs in India, a comprehensive strategy is needed which includes a single, safe and effective iron dose for the Indian population.

This specific study is to conduct a community-based, randomized clinical trial in India to determine the appropriate dose of supplementation required for the target age group.

Eligibility Criteria:
Inclusion Criteria:

* 6-18 months of age
* anemic (Hb 70-100g/L)
* ingesting weaning food in addition to breast milk
* free from major illness (including symptomatic for malaria) and afebrile
* living within study area for the next two months
* parental consent obtained
* only one child per household in the study

Exclusion Criteria:

* Hb \< 70 or ≥ 100 g/L
* Not receiving any complementary foods
* Receiving an iron supplement within two weeks of the date of enrolment
* chronic illness
* severely malnourished: weight for age z-score \< -3.0
* another child in the household is a subject in this study
MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

This is a pilot trial to assess feasibility and acceptability of MyVoice:Rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care.

• Hypothesis: MyVoice:Rheum will be feasible and acceptable to patients who receive rheumatology care.

The pilot will demonstrate if the MyVoice:Rheum decision aid can be feasibly and acceptably implemented into the rheumatology context and inform operational procedures for a future hybrid effectiveness-implementation trial. Women in the intervention arm will receive the MyVoice:Rheum decision aid (n=30). Women in the control arm (n=9) will receive a widely-accessible paper-based pamphlet about pregnancy, which, similarly to MyVoice:Rheum, targets women with a broad range of rheumatic diseases.

Eligibility Criteria:
Inclusion Criteria:

Patients must have at least one of four rheumatic diseases diagnosed by a rheumatologist: rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis, Sjogren's syndrome, vasculitis, spondyloarthritis, and systemic lupus erythematosus (SLE).

Patients must read and speak in English as a Spanish-language version of the tool has not yet been developed

Access to a smart phone, personal computer, or tablet.

Exclusion Criteria:

* Women who have had prior hysterectomy or sterilization, or are pregnant.
Study on the Impact of Electroacupuncture Combined with Self-Acupressure on the Quality of Life of Patients with Early-Stage Breast Cancer Undergoing Chemotherapy

This randomized controlled clinical trial aims to evaluate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy.

This study is a parallel-group, blinded (participant, evaluator, and statisticians), randomized controlled trial to investigate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy. Patients in each group will receive electroacupuncture or sham electroacupuncture during the first week of the chemotherapy cycle. They will receive self-acupressure or sham acupressure during the second and third weeks of the chemotherapy cycle. Participants will be asked to complete the EQ-5D-5L and FACT-B scales. Primary and secondary outcomes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older and aged 75 years or younger, inclusive. with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
2. Patients who have not received prior chemotherapy and are scheduled to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy or combination targeted therapy;
3. Normal organ function with platelets ≥ 100\*10\^9/ L, hemoglobin ≥ 90 g/L, serum creatinine ≤ 1.5 mg/dl (133 mmol/L), or creatinine clearance ≥ 60 ml/min, total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase ≤ 2.5 times ULN, and aspartate aminotransferase ≤ 2.5 times ULN;
4. Premenopausal women need appropriate contraception;
5. Ability to understand the study well and complete the study questionnaire.

Exclusion Criteria:

1. Patients with needle phobia or allergy to stainless steel needles; and
2. Current diagnosis of mental illness (e.g., major depression, obsessive-compulsive disorder, or schizophrenia);
3. History of autoimmune diseases, blood disorders, or organ transplantation, or long-term use of hormones or immunosuppressants;
4. Comorbid bleeding disorders or thyroid dysfunction;
5. Implantation of a pacemaker; pregnancy or breastfeeding;
6. A plan for adjuvant radiotherapy in the upcoming chemotherapy cycle;
7. Current active infection;
8. Acupuncture treatment within the last four weeks;
9. Patients who are allergic to the drugs used;
10. Use of other Traditional Chinese Medicine (TCM) techniques such as Chinese herbs in the next chemotherapy cycle.
Empathy in Post-traumatic Stress Disorder in Comparaison to a Control Population

It has been shown in the literature that the symptoms of post-traumatic stress disorder influence the quality of life of patients, in particular through the cognitive alterations they can cause. Social cognition is also itself impacted. It refers to the perception, interpretation and processing of information relating to the social environment and relationships. It is affected by the symptomatology of PTSD both in terms of the response to emotional stimuli, the perception of self and others, and the quality of intimate relationships. These elements lead to reflection on the origin of these alterations, in particular the impact of PTSD on the patient's empathy capacity, defined as the recognition and understanding of the feelings and emotions of another individual. This parameter is also little studied in the literature, only a study dating from 2010 finds a correlation between PTSD and empathy. It is in this context that the realization of a new study studying the capacity for empathy of patients with PTSD in comparison with a control group with a larger and more representative population was envisaged. The primary outcome of this study is to analyze the post-traumatic stress disorder's repercussions on empathy by passing the Interpersonal Reactivity Index (IRI) on patients in comparison with a control group. The first hypothesis is a lower total score but a higher personal distress sub-score in the PTSD population. The secondary outcomes are to describe the cofactors that can influence empathy in association or not with post-traumatic stress disorder: sociodemographic data (age, sex, education level...), traumatic event type determined through the "Inventory of Traumatogenic Events", human intervention, duration and severity of the disorder (evaluated by the Impact of Events Scale) ... The number of subjects required was calculated at 19 patients and 19 controls.


Eligibility Criteria:
Any patient or controls who score positively off the diagnostic criteria for comorbidities such as major depressive episode, generalized anxiety disorder, psychotic disorder and autism spectrum disorder are not included. These criteria will be assessed through the MINI diagnostic interview and the Autism Spectrum Quotient.
Effects of Therapeutic Music Combined With Loaded Sit-to-Stand Resistance Exercise for Children With Spastic Diplegia

The purpose of study is to investigate the effects of PSE Music with a "home-based" loaded STS exercise program on the functional strength, gross motor function, daily participation, exercise involvement, motor control, and gait speed for children with spastic diplegia.


Eligibility Criteria:
Inclusion Criteria:

* children with SD, aged 5 to 13 year-old, and GMFCS level between I to III
* able to stand up from a chair independently and maintain standing for more than 2 seconds without falling
* able to follow verbal instructions

Exclusion Criteria:

* have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within 6 months
* have orthopedic problems or other medical conditions preventing the child from joining the resistance exercise program, such as obvious LE joint contractures, uncontrolled epilepsy, or cardiopulmonary problems
* hearing loss or using hearing aid
* have mental disorders, such as pervasive developmental disorders and attention-deficit and disruptive behavior disorders
Evaluation of the Presence of Enthesitis in Patients With Acne Vulgaris

Acne vulgaris is an inflammatory disease of the pilosebaceous unit, affecting about 85% of the young population. In the studies p. acne is a potent stimulator of the release of IFN-gamma (IFN-)) and IL-17 from CD4 + T cells, and the presence of IL-17 + cells in the perifollicular infiltrate has been shown in biopsies of inflammatory acne lesions. Therefore, acne is thought to be a Th17-related disease (1).

This study was aimed to evaluate the presence of enthesitis in patients with acne vulgaris.

Patients with acne vulgaris and healthy controls aged between 18-25 who admitted to Hitit University Erol Olcok Education and Research Hostpital Dermatology policlinic will be icluded. Patients with rheumatic, neurological diseases, history of trauma and previous fractures will be excluded from the study. After all the participants were evaluated by the dermatologist and demographic data will be recorded, the participants will be examined by the physical medicine and rehabilitation specialist and the short form-36 (sf-36), hospital anxiety and depression scale will be completed. Bilateral lower extremity tendon thicknesses and the presence of erosion, bursitis, etc. will be evaluated according to the criteria of Guess (Glasgow Ultrasound Enthesitis Scoring System) and Guess score will be determined for all participants. A total of 48 participants, 24 patients with acne vulgaris and 24 healthy controls, will be included in the study (2).

Eligibility Criteria:
Inclusion Criteira:

* Patients with acne vulgaris and healthy controls aged between 18-25

Exclusion Criteria:

* Participants with rheumatic and neurologic disease, history of trauma ,
Pharmacodynamic Trial on Rocuronium in Obese Patients

Aim: To optimize the use of rocuronium (a neuromuscular blocking agent) in obese patients undergoing gastric bypass or gastric banding.

Background: During general anaesthesia, a neuromuscular blocking agent is needed to allow surgery and airway management. Optimal dosing is important in order to avoid inadequately muscle relaxation, but also to avoid overdosage, which can result in prolonged anaesthesia and respiratory complications.

Main hypothesis: Rocuronium dosed according to ideal body weight results in shorter duration of action compared to rocuronium dosed according to corrected body weight without prolonged onset time or compromised airway management or surgical demands for muscle relaxation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years.
* Elective laparoscopic gastric banding or gastric bypass.

Exclusion Criteria:

* Expected difficult endotracheal intubation based on anatomic or pathologic findings or history.
* Known or suspected neuromuscular disease, known to affect the neuromuscular blockade.
* Severely impaired renal or hepatic function, as evaluated by the investigator.
* Known or suspected allergy to drugs used in the trial.
* Daily or expected use during the trial of the following drugs, known to affect neuromuscular transmission: Inhalational anaesthetics, magnesiumsalts, clindamycin, polymyxins and aminoglycosides (gentamicin, neomycin, netilmicin, streptomycin og tobramycin).
Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ages 18 to 70 years
* HCV-Infected Genotype 1 Null responders to current standard of care
* Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.

Exclusion Criteria:

* Evidence of a medical condition associate with chronic liver disease other than HCV
* History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
* History of Cancer within 5 years of enrollment
* History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
* History of clinically significant cardiac disease
* History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Documented cirrhosis within 12 months prior to dosing
* Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
* Pregnant
The Effect of Intranasally Administered Nitroglycerin on Hemodynamic Response to Laryngoscopy and Intubation Among Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery

Numerous preventive medications have been used to lessen the cardiovascular response to laryngoscopy and intubation. Though some advantages have been noted, most of these treatments have not been found to be completely satisfying. However, nitroglycerin is the most widely utilized medicine due to its fast effect, short half-life, and absence of sedative qualities.

The circulatory system under compromise is less resilient to the effects of general anaesthesia. Inducing anaesthesia is a crucial step for cardiac patients because their impaired circulatory systems are less tolerant to depression. During coronary artery bypass grafting surgery, the primary objective of general anesthesia is to reduce sympathetic response to uncomfortable stimuli, including laryngoscopy, intubation, skin incision, sternal splitting, and spreading. A rise in blood pressure is one of the hemodynamic reactions that is typically associated with tracheal intubation and laryngoscopy. The impact of intra nasally delivered nitroglycerin on blood pressure response to laryngoscopy and intubation in patients having non-cardiac surgery is currently contentious; however, this study focus on coronary artery bypass grafting surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Patients undergoing coronary artery bypass grafting surgery.
* Patients aged 35-60 years.
* Ejection Fraction between 50-60%.
* American Society of Anesthesiologists Classification 3-4.

Exclusion Criteria:

* Known hypersensitivity to nitroglycerin.
* Anticipated difficult airway.
* Emergency surgery.
A Retrospective Study on the Treatment of Intermediate and Advanced Liver Cancer.

To evaluate the effectiveness of TACE combined with immunotherapy and targeted therapy versus TACE alone in patients with intermediate and advanced liver cancer.

To evaluate the efficacy and safety of TACE combined with immunotherapy and targeted therapy in patients with intermediate and advanced liver cancer. Explore the factors affecting the prognosis of liver cancer treated with TACE combined with immunotherapy and targeted therapy and establish a specific individualized prognostic score and risk stratification model.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old, both men and women
* primary liver cancer confirmed by liver biopsy or history of hepatitis B, AFP, and typical imaging findings
* patients with liver function Child-Pugh A or B (≤8 points)
* BCLC stage B and stage C
* expected survival time ≥8 weeks
* patients with generally good performance status (ECOG PS score 0 or 1)

Exclusion Criteria:

* The patient's key data is missing
* liver metastatic cancer confirmed by histology or cytology
* patients who interrupt treatment due to intolerance of adverse drug reactions
* combined with primary malignant tumors of other organs within 5 years; combined with other serious diseases, such as severe heart disease, renal insufficiency, severe infection, bleeding, etc.
* combined with systemic infection, autoimmune disease, or other types of tumors; previous allogeneic bone marrow transplantation or solid organ transplantation
* study participants known to have mental illness
* situations such as drug use or substance abuse
Effect of a Probiotic-based Product on Blood Pressure

The aim of the present study was to examine the efficacy of a probiotic-based product on either reducing hypertension or preventing a high normal blood pressure from reaching hypertensive levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals at the age of 40-75 years.
* Blood-pressure \>140/90 mmHg that has been confirmed at 2-3 separate occasions or represents the mean value of a 24-hour measurement.
* Triglycerides \>1,7 mmol/L and/or HDL \<1 mmol/L (men)/1,29 mmol/L (women).
* Fasting plasma glucose levels \>5,6 mmol/L and/or waist circumference \>102 cm (men)/88 cm (women).
* BMI \<40.

Exclusion Criteria:

* Medically treated allergy or allergy to any of the ingredients of the study product.
* Medication for high levels of blood lipids.
* Metabolic disease, such as type one diabetes.
* Confirmed diseases of the heart, liver of kidneys.
* Chronic inflammatory disease requiring medication.
* Pregnant or nursing.
* Regular intake of other probiotic products (5-7 days per week during the last three months before inclusion into the study).
Effects of an Early Wheelchair Reconditionong Program on Functional Independence in Spinal Cord-inured Individuals

Reconditioning program during the chronic phase of the spinal cord-injury is well known for its beneficial effects, but there is no investigation in early rehabilitation consequences. Nevertheless, it may be justified : to increase oxygen uptake; to decrease the risks of medical complications; or to improve the mobility. The restrictive autonomy is due to different factors: firstly wheelchair users reduce their movement because they need technical or human help to achieve transfers; and secondly, locomotion is performed by the upper limbs. Without specific practice, the upper limbs mechanical and physiological properties do not permit exercises that are long and intense. Then, the purpose of this research is to evaluate the effects of an 8 weeks interval training program on wheelchair independance during inpatient early rehabilitation for spinal cord injury (3 to 6 months post injury) compared to a control group (classical rehabilitation program in a physical medicine and rehabilitation department).


Eligibility Criteria:
Inclusion Criteria:

* Acute spinal cord injury (SCI) from trauma , medical or surgical pathology at levels between C7 and L1.
* Categories A or B as defined by the American Spinal Injury Association (ASIA) Impairment Scale
* Male or female
* 18 to 60 years old.
* No ability to walk independently with or without an assistive device
* 3 to 6 months post-SCI in early phase of rehabilitation in a physical medicine and rehabilitation unit.
* Subject affiliated to a social security regime and registered at the healthcare department
* Written informed consent obtained from each subject

Exclusion Criteria:

* Symptomatic syringomyelia that may complicate the evaluation procedures
* Disabled pathology before the SCI
* Cardiopulmonary disease, degenerative disorders, upper limb disorders, bones inury or other significant medical complications that would prohibit or alter compliance with a wheelchair training protocol.
* Psychological incapacity to follow a training protocol during 8 weeks.
* Surgery or intrathecal injection planned.
* Reject to give written informed consent.