cyrilzakka/clinical-trials huggingface dataset:
The Impact of the SPIKES Protocol With IVF Patients

The purpose of this study is to determine if the utilization of the SPIKES protocol for delivering bad news is perceived to be more compassionate and effective than the current standard of care for IVF patients receiving negative pregnancy test results.

Presently, nurses at Boston IVF (BIVF) and Weill Cornell Medical Center Division of Reproductive Medicine (Cornell) do not have a scripted method to deliver negative pregnancy tests to in Vitro Fertilization (IVF) patients. This study will invite clinic nurses to assist in the research protocol; half of the nurses will be randomized to be trained on a compassionate way to deliver bad news following the SPIKES protocol, while the other half will continue with the current standard of care of news delivery. The patients who receive the negative test phone calls from participating nurses will be surveyed to see if the method of which the news was delivered was scored as more compassionate, as well as if it was associated with reduced participants reported level of distress and depression.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age \>18
* Underwent an embryo or blastocyst transfer using their own eggs at participating clinic
* Able to read and understand English
* Access to email
* Received a negative pregnancy test result phone call from a nurse involved in the research study

Exclusion Criteria:

* Partners of patients undergoing treatment
A Trial of HR021618 in Postsurgical Pain Management

The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective Orthopaedic surgery
3. Male or female
4. Meet the weight standard
5. Conform to the ASA Physical Status Classification Postoperative randomization criteria Exclusion Criteria

1、 Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery

Exclusion Criteria:

1. History of major surgery
2. History of active or high-risk bleeding disorders
3. History of myocardial infarction or coronary artery bypass
4. History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
5. Abnormal values in the laboratory
6. Have a known allergy to meloxicam or any excipient of HR021618, , aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study
7. Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives
8. Planned/actual admission to the intensive care unit
9. Pregnant or nursing women
10. No birth control during the specified period of time
11. Participated in clinical trials of other drugs (received experimental drugs)
12. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Effect of Muscular Imbalance Between Flexors and Extensors of the Fingers and Wrist on Upper Limb Injuries in Climbers

Climbing is a booming sport with an increasing number of participants. When practicing this sport, there is a muscular imbalance between the flexor and extensor systems (especially in the fingers), with the flexors of the fingers exerting greater force than the extensors. In addition, upper limb injuries, particularly the fingers, are very common.

The study will be carried out on club-licensed climbers, as they are better supervised. They will be recruited through requests sent to various clubs. The measurements will be taken during different climbing sessions, after the warm-up.

The study will include measurements on different climbers. Informed consent and personal data will be collected from the climbers before the measurements are taken. The strength values of the flexors and extensors of the fingers and wrist will be measured using a dynamometer. The climbers will then continue their usual training for 1 year. For 1 year after the measurements, the climbers will be contacted every month by telephone to collect the different injuries they may have suffered in relation to climbing, as well as the number of hours they have spent climbing in the past month. After 1 year, the annual number of hours of climbing and the annual number of injuries can be calculated for each climber. Injury is defined as any medically diagnosed lesion of the musculoskeletal system of the upper limb or pain that prevents the practice of a sport whose aetiology is climbing. These data are used to calculate the "athlete exposure" (A-E), i.e. the incidence of injury per 1000 hours of practice. As the study population is large, this allows for variations in exposure between subjects.


Eligibility Criteria:
* A male or female climber who has been a member of a climbing club for at least 1 year;
* Have a level of 6a "on sight" or higher;
* Fluent in spoken and written French;
* Over 18 years of age.

Exclusion Criteria:

* Declaration of a medically diagnosed upper limb injury at the time of testing;
* Presence of any pathology that prevents climbing or taking finger or wrist measurements;
* Volunteers for whom it is impossible to collect data by telephone.
High Fiber Rye Foods for Weight and Body Fat Reduction

The overall aim of this study is to investigate whether a diet rich in rye fiber from wholegrain rye, compared to refined wheat, as part of a hypocaloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention. Furthermore the study will investigate the effect on appetite as a potential underlying mechanism for differences in weight loss and body fat reduction.


Eligibility Criteria:
Inclusion Criteria:

* BMI 27-35 kg/m2
* Hb≥120g/l
* Serum thyroid stimulating hormone (TSH) ≤4.00 mIU/L
* Plasma low density lipoprotein cholesterol \<5.3 mmol/L
* Plasma triglycerides ≤1.8 mmol/L
* Signed informed consent
* Freezer capacity for 2 weeks bread provision

Exclusion Criteria:

* Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
* Unable to complete satisfactorily the 3-day weighted food record at screening visit 2.
* Unable to lose 0.5 kg or more during the run-in period for men and women not having menstruation during the run in period
* Increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period.
* Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)
* Using e-cigarettes (regardless of nicotine content)
* Following any weight reduction program or having followed one during the last 6 months prior to visit 1
* Diastolic blood pressure 105 mm Hg at visit 1
* Systolic blood pressure 160 mm at visit 1
* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
* More than 10 hours physical activity per week
* History of heart failure or heart attack within 1 year prior to screening
* Have type I diabetes
* Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol)
* Previous gastrointestinal surgery
* Thyroid disorder
* History of drug or alcohol abuse
* Stroke or transient ischemic attack (TIA) within 1 year prior to screening
* Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician (will be included in the list of allowed/disallowed medications)
* Pregnant or lactating or wish to become pregnant during the period of the study.
* Food allergies or intolerances
* Vegetarian (due to the standardized meals for appetite measurements)
* Unable to understand written and spoken Swedish
* Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI.
Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib

A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of metastatic breast cancer HER2-positive phenotype (confirmed by IHC 3 + or FISH positive)
* Older than 18 years
* Progressed to at least one prior treatment line for MBC with trastuzumab and / or lapatinib, either as monotherapy or in combination with chemotherapy or hormonal therapy schemes
* Having the patient's complete medical history that contains all lines antiHER2 therapy treatment
* Being a patient who initiated the combination of trastuzumab and lapatinib between January 2005 and December 2011
* Inform the patient and get the signature of the informed consent

Exclusion Criteria:

* Not having phenotypic classification of the tumor by IHC or FISH test for HER2
* Being a patient with HER2-negative phenotype(FISH negative or IHC in range \[0-2 +\] without FISH)
* Being a patient who received the trastuzumab and/or lapatinib treatment (TL) in combination with chemotherapy
* Being a patient who, since January 2012, began TL therapy for metastatic disease.
Accuracy of Various Virtual Articulator Mounting Procedures: An in Vivo Study

the aim of this study was to evaluate the accuracy of the various virtual articulator mounting procedures.

The purpose of the present study was to evaluate the accuracy of various virtual articulator mounting procedures. For this purpose, 7 kinds of virtual mounting procedures were investigated:(1) indirect virtual mounting in MS VA by using an average facebow; (2) virtual mounting in MS VA by using average values; (3) virtual mounting in MS VA by using professional facial scanner; (4) virtual mounting in MS VA by using smartphone facial scanner; (5) virtual mounting in MS VA by using CBCT located in Bergstrom's point; (6) virtual mounting in MS VA by using CBCT located in the medial poles of the condyles; (7) virtual mounting in CA VA by using JMA，as the group to compare with the other mounting procedures. The null hypothesis is that no difference would be found in the static measurements taken virtually when comparing these 7 procedures for virtual mounting.

Eligibility Criteria:
Inclusion Criteria:

* 1.without any symptoms and signs of the temporomandibular joint 2.Willing to participate and to sign a written informed consent form 3.in good health and had no past history of any serious illness

Exclusion Criteria:

* emporomandibular or craniocervical disorders
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 2 years of age and older
* Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
* Nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for AD or for whom those treatments are not advisable
* Subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing

Exclusion Criteria:

* Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
* Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg, clinically infected AD)
* Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations
* History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris)
* History or presence of:
* basal cell carcinoma of skin effectively treated more than 2 years ago
* carcinoma of cervix effectively treated more than 5 years ago
* immunological deficiencies or diseases, HIV, or serious recurrent infection
* clinically significant severe renal insufficiency or severe hepatic disorders
* Current or recent serious infection
Nashville Early Diagnosis Lung Cancer Project

This screening study will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiological and imaging strategies.

The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular analysis of biological specimens including those from bronchoscopy (bronchial brushings and biopsies) may contribute to the refinement of high-risk populations and allow an earlier clinical diagnosis.

The goal of the investigators study is to provide screening for lung cancer in a high-risk population. In this prospective cohort it will be tested whether repeated measure of biomarkers of risk allows early detection of lung cancer.

It is proposed to test the hypotheses in a screening study of high risk individuals (characterized by an established prediction rule). The expected prevalence of lung cancer in this high risk group is estimated to be 2% per year. All individuals benefit from clinic visit, low-dose Chest CT, spirometry and auto-fluorescence bronchoscopy at baseline, Chest CT, follow-up doctor visit, and auto-fluorescence bronchoscopy at least at year 2 and 5.

Eligibility Criteria:
Inclusion Criteria:

* 55 - 80 years of age
* Current smoker or former smoker. If former smoker, must have quit smoking less than 15 years ago
* \>/= 30 pack year of smoking history

Exclusion Criteria:

* History of diagnosis/treatment of lung cancer in the past 2 years
* History of head/neck or esophageal cancer in the last 1 year
* Inability to provide informed consent
* Participants in whom stopping anti-platelet or anti-coagulation therapy would have an adverse effect (DVT, mechanical heart valves, unstable coronary syndrome, etc.)
Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 1 or 2
* Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months

Exclusion Criteria:

* Major Depression
* Uncontrolled diabetes
Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission in Ulcerative Colitis in remission.


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis with confirmed diagnosis by histology and endoscopy AND in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) OR having a mild disease.
* A negative pregnancy test

Exclusion Criteria:

* No history or diagnosis of any of the following conditions: Crohn's disease, bleeding disorders, gastrointestinal or colonic malignancy, Kidney disease, including kidney "stones" or hypercalcemia, Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin.
* Ingested certain medications (Calcium, Vitamin D, fiber supplements and Non-steroidal anti-inflammatory drugs - NSAIDs) within 30 days of study start.
Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals

Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study

Interventional, Multicentric, Randomized Controlled Study in Two Parallel Groups of 530 Healthcare Professionals working in the Intensive Care Unit Exposed to Risk of COVID19 Infection Taking Hydroxychloroquine (HCQ) (200 mg/day) VS Placebo

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19 (-)
* Works in a medical intensive care unit exposed to COVID-19 infection
* 18 years old \< age \< 65 years old
* Having given written consent for their participation in the study.

Exclusion Criteria:

* Diagnosis of COVID-19+
* Retinopathies,
* Hydroxychloroquine or other prophylactic treatments for VIDOC19 within one month prior to inclusion and throughout the study.
* Hypersensitivity to chloroquine or hydroxychloroquine or 4-aminoquinolines or any of the other components of this drug,
* Contraindication to prophylactic use of chloroquine, e.g. liver failure, known epilepsy, creatinine clearance \< 30 ml/min.
* Inability to be monitored during the trial period
* Pregnancy and breastfeeding
* Psoriasis
Rainbow Extension Study

The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)

This was a multicenter, open-label extension study where the Visual Acuity (VA) assessment at the child's 5th birthday visit was performed. The study had 2 distinct periods (Epochs). Treatment with study ranibizumab (either as retreatment after ranibizumab had already been injected in the same eye or as switch ranibizumab treatment from study laser therapy administered in the core study) was permitted for eligible eyes with recurrence/worsening of ROP up to and including Week 40 from the baseline visit in the core study (Epoch 1). The remainder of the extension study up to the 5th birthday visit (Epoch 2) was observational, with no study treatment planned to be administered.

In the core study, patients were randomized to 1 of the 3 treatment arms (ranibizumab 0.2 mg, ranibizumab 0.1 mg, and laser). Treatment arm assignment and patient identifier in the extension study remained the same as in the core study.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
* The patient successfully completed the core study H2301, as defined by providing assessments at the Visit 112 (the last scheduled visit in the core study) or, if appropriate, at the last of the additional assessment visits as per protocol in H2301, whichever was latest
* The patient received study treatment in both eyes at baseline of study H2301

Exclusion Criteria:

* Patient had a medical condition or personal circumstance which precluded study participation or compliance with study procedures, as assessed by the Investigator
* Patient had been discontinued from the core study H2301 at any time
Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with schizophrenia in accordance with DSM-5
* BMI over 24
* Accepting antipsychotics stable treatment for more then 2 months

Exclusion Criteria:

* Diagnosed with other mental disease in accordance with DSM-5
* Comorbid with other severe physiological disease
* Used antipsychotic, antidepressants, mood stabilizer, or other psychoactive substances before
* Drug or alcohol abuse
* Pregnant or lactating Contraindication to rTMS
Virtual Reality to Alleviate Claustrophobia During MRI

This study evaluates if our Virtual Reality (VR) simulation inside the MRI efficiently alleviates symptoms of claustrophobia for patients during the MRI examination.

Anxiety of claustrophobic patients during MRI scan leads to movements of patients (which cause imaging artefacts), interruptions or even abortions of imaging scans, eventually requiring to reschedule the examination. Improving these symptoms by creating a VR experiences adapted to the physical constraints of the MRI environment, such as "disappearing the scanner", not only improves the subjective experience of the participant, but has immediate impacts the time spent on the examination, on personnel costs, and resource availability (scanner time).

This study aims at comparing claustrophobic patients in an A\|B group design with or without VR intervention. Primary outcomes include subjective reports from patients (Acceptability and Demand) and practitioners (Implementation, Practicality, Adaptation, Integration, Expansion). Secondary outcomes include scanning efficacy based e.g. on the imaging quality, number of times a scan is interrupted by the user and the total duration of a scan. Another non-claustrophobic patients' group will be tested for for obtaining feedback on the general benefit of VR immersion on patients' experience.

Eligibility Criteria:
Inclusion Criteria:

* indicating suffering from claustrophobia
* Be aged between 18 and 40 year-old
* Being able to give consent
* Being able to understand and speak French or English
* Being MRI-compatible

Exclusion Criteria:

* Epilepsy or illnesses affecting the brain, such as HIV, Lyme disease or meningitis
* Psychiatric disorders, such as schizophrenia, autism, obsessive compulsive disorder.
* History of 1 year or more of addiction to drugs such as cannabis, alcohol, cocain, heroine, LSD.
* Taking sleeping pills or anti-anxiety medication before the exam