cyrilzakka/clinical-trials huggingface dataset:
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Painful osteoarthritis
* Able to discontinue anti-inflammatory drugs and analgesics
* Must be ambulatory without assistive walking devices

Exclusion Criteria:

* Chronic pain conditions other than knee osteoarthritis
* Treatment with corticosteroids in the study knee within 12 weeks
* Treatment with hyaluronic acid in the study knee within 24 weeks
* Previous treatment with any botulinum toxin for any reason
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Clinical Trial With PRECIZON Presbyopic

The purpose of this clinical trial is to evaluate the effectiveness of the PRECIZON Presbyopic.

Prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. The PRECIZON Presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. The main objective is to evaluate the ability of the PRECIZON Presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / Clear Lens Exchange (CLE) and intraocular lens implantation. Study results will be used for CE-approval and registration and marketing purposes.

Eligibility Criteria:
Inclusion Criteria:

* Presbyopic
* Cataract patient or Clear Lens Extraction (CLE) candidate
* Patients wishes to be spectacle independent for near and far vision
* Patient lifestyle and outlook fit with multifocal IOL implantation
* Qualifies for bilateral implantation
* Patient must have a calculated IOL power within the available diopter range
* Expected best corrected visual acuity of 0.5 Snellen decimal or better after IOL implantation.
* No secondary surgical procedure planned during the course of the study
* Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study
* Patients must provide written informed consent
* The predicted keratometric postoperative astigmatism (calculated with respect to the surgical induced astigmatism) must be \<1.0 D.

Exclusion Criteria:

* Ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g. anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders)
* Acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject
* Endothelial cell count \<1500 cells/mm2
* Amblyopia
* Congenital eye abnormalities
* Previous ocular surgery that might confound the outcome of the investigation or increase risk to patient
* Concurrent participation or participation during the last 30 days in any other clinical trial
* Patient must not be pregnant or has another condition with associated fluctuation of hormones that could lead to refractive changes
Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study)

N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different intravenous DMT boluses over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects.

N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (\<20 min). However, to date no clinical study has investigated dose-response effects over a broad range of different doses of DMT within the same patient. The aim of the present study is to experimentally test different intravenous DMT bolus doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of DMT in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 25 and 65 years old
2. Sufficient understanding of the German language
3. Understanding of procedures and risks associated with the study
4. Willing to adhere to the protocol and signing of the consent form
5. Willing to refrain from the consumption of illicit psychoactive substances during the study
6. Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions
7. Willing not to operate heavy machinery within 6 h of DMT administration
8. Willing to use double-barrier birth control throughout study participation
9. Body mass index between 18-29 kg/m2.

Exclusion Criteria:

1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
6. Pregnancy or current breastfeeding
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medication that may interfere with the effects of the study medication
9. Tobacco smoking (\>10 cigarettes/day)
10. Consumption of alcoholic beverages (\>20 drinks/week)
Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers

The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon

The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon, packed in a swallow-able capsule, in healthy subjects with 30 \< BMI≤ 35.

Eligibility Criteria:
Inclusion Criteria:

* 21 ≤ Age \<65 years
* 30 \< BMI ≤ 35 kg/m2
* Healthy without any medication;
* No history of weight reduction of more than 5% of total body weight in the past 6 months;
* Normal blood count and chemistry;
* Hemoglobin level over 11;
* At least 3 bowel movements per week;
* Subject declares that he/she is able to go through gastroscopic examination;
* Subject is able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria:

* Any history or evidence of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results;
* History or evidence of any active liver disease. (abnormal liver functions: \>1.5 times upper limit);
* History or symptoms of thyroid disease which is not controlled by medication;
* Abnormal gastrointestinal findings: Diaphragmatic hernia \> 3 cm; Active peptic ulcer; Erosive gastritis; Gastric outlet obstruction;
* Subject with IBD
* Significant swallowing disorders;
* Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy);
* Malabsorption disorders.
* Is taking medications that reduce gastric acidity
* Currently using pharmaceutical agents or food supplements for weight loss;
* History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
* History of food Allergy;
* Subject with poor venous access;
* Is taking chronic aspirin or other non-steroidal anti-inflammatory agents, or other medications known to be gastric irritants;
* Have any coagulation problem and/or taking any anticoagulant medications;
* Evidence of current malignant disease;
* Have history of any acute disease (viral, bacterial, pain, accident) in the last 6 weeks.
* Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study;
* Inability to give written informed consent;
* History of alcohol or drug abuse within 6 months of screening;
* Mental disorders;
* Currently participating in an ongoing clinical study
* Any reasons making the patient a poor candidate in the opinion of the investigator.
An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function

This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body weight ≥ 45 kg and ≤ 120 kg and BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
* Heart rate ≥ 50 bpm and \< 95 bpm
* Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of study treatment

Exclusion Criteria:

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
* History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches
* History of migraine or cluster headaches

Other protocol defined inclusion/exclusion criteria could apply
The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients

This is a prospective cohort study to investigate differences in the bladder environment (i.e. urinary microbiome) amongst women with interstitial cystitis (IC) before and after undergoing mindfulness-based stress reduction (MBSR) treatment, including yoga and meditation practices.

Interstitial cystitis (IC), or Painful Bladder Syndrome (PBS) is a debilitating condition of the bladder that is estimated to affect 3-8 million women in the United States. The pathophysiology of the disease is poorly understood, and thus treatment modalities and treatment efficacy vary widely. Lately, much attention has shifted toward investigating how the bladder 'environment' differs amongst women with IC compared to those who do not suffer from IC.

Mindfulness-based stress reduction (MBSR), a complementary alternative medicine (CAM)-based therapy, is a standardized program including components of meditation and yoga. Recent studies show that MBSR improves symptoms in the IC patient population.

The purpose of this study is to compare measurable differences in the urinary microbiome among women with IC before and after MBSR treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* English-speaking
* Established patient of Cincinnati Urogynecology Associates, TriHealth Inc.
* Current diagnosis of IC/PBS, as defined by the American Urological Association (AUA)
* Negative urinalysis or urine culture within 2 months of enrollment
* Currently undergoing first or second-line treatment for IC, as defined by the AUA
* Willingness to participate in study

Exclusion Criteria:

* Non-English speaking
* Unwillingness to participate in study
* Pregnancy or breastfeeding
* Physical or mental impairment that would affect the subject's ability to participate in the MBSR treatment, including patients with Dementia, Parkinsonism, or those who have impaired mobility or hearing
* Current or expected prolonged catheterization
* Expected travel or surgery that would hinder the ability to attend all eight MBSR sessions
* Undergoing third-, fourth-, fifth-, or sixth-line treatment for IC as defined by the AUA
* Subjects on antibiotics currently or prior use within one week of consenting
Nystagmus Assessment for Patients Consulting in the Emergency Department for Acute Vertigo

This pilot study is perfomed to validate and document faisability of the use of Frenzel lens and the use of a diagnostic algorithm for the assessment of a special sign (nystagmus) observe in the eyes of patients consulting in the emergency department (ED) for an acute episode of vertigo/dizziness/imbalance.

This pilot study is a randomized controlled trial 2 by 2 design to allocated randomly the Frenzel lens and the diagnostic algorithm. There is no use of sham lens. The usual care opposed to the diagnostic algorithm will be questioned only on the perception of nystagmus by the clinician and the use of repositioning particles technique. The only blinding will be the patients about the use of the algorithm and the outcomes assessor about the use or not of Frenzel lens and the use or not of the diagnostic algorithm.

Eligibility Criteria:
Inclusion Criteria:

* New episode of acute vertigo/dizziness/imbalance occuring during the 28 last days
* Must be able to consent.

Exclusion Criteria:

* No traumatic context before symptoms onset
* No intoxication context
* Glycemia ≤ 3,0 mmol/L
* Only one participation is permitted
* Not able to speak adequately in French or English.
* Reachable for 3 month follow-up
A Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma

A study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma.

To evaluate the progression free survival of intestinal probiotics in immunotherapy for urothelial carcinoma. Changes in fecal flora abundance before and after treatment were assessed to identify subjects most likely to benefit from enteric probiotics treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with urothelial carcinoma and undergoing immunotherapy ;
2. Age ≥ 18 years;
3. Expected survival time is greater than 12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or 2;
5. Organ function level must meet the following requirements:

   Hematological indexes: neutrophil count \>= 1.5x10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 9.0 g/dl (can be maintained by symptomatic treatment); Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=2.5 ULN (can be maintained by symptomatic treatment);
6. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;
7. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Receive live attenuated vaccine within 4 weeks before treatment or during the study period;
2. Active, known or suspected autoimmune diseases;
3. Cannot take orally or are allergic to probiotics ;
4. History of primary immunodeficiency ;
5. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
6. Pregnant or lactating female patients;
7. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
8. Uncontrolled concurrent diseases, including but not limited to:

HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension \[hypertension greater than or equal to conmon terminology criteria for adverse events （CTCAE） grade 2 after drug treatment\]); Patients with active bleeding or new thrombotic disease.
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).

Eligibility Criteria:
Main Inclusion Criteria:

* Age 40 or older.
* Positive diagnostic imaging of the affected shoulder indicating full thickness Massive RCT (according to Cofield classification) or long involving more than one tendon.
* Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

* Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of gleno-humeral instability
* Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Partial-thickness tears of the rotator cuff
Hyper-Personalized Medicine Using Patient Derived Xenografts (PDXovo) for Metastatic Solid Tumors

The Investigators will use novel PDX (patient-derived xenograft) technology to form xenografts using material from metastatic solid tumor patients. Xenografts will be treated with a panel of drugs to determine which agent(s) yield the greatest anti-tumor effect on the xenograft.

The goal is to use PDXovos, which are chick embryos cultivated in an ex ovo fashion that will act as a xenograft host, for drug paneling. Chick embryos as a PDX host model system offer multiple advantages, such as increased tumor take rates, rapid drug testing, a short evaluation timeframe, and an undeveloped adaptive immune system. Collectively, these advantages allow for implantation of tumor xenografts, subsequent growth in vivo, subsequent drug challenge, and subsequent evaluation for anti-tumor effects.

Patients with metastatic forms of solid tumors will be enrolled regardless of subtype. Metastases will be provided either via metastasectomy or needle core biopsy of metastatic deposits. Spinal and intracranial metastases will be included. Thoracentesis and paracentesis fluid samples yielding tumor tissue will also be included.

Tissue will be processed and briefly cultured in vitro. Upon authentication and expansion to a suitable number of cells, xenografts will be formed in the chick embryo pre-clinical model. After implantation (2 days later), drug treatments will be applied topically to each xenograft's surface. Drug treatments are: sunitinib, pazopanib, axitinib, temsirolimus, cabozantinib, gemcitabine (N\>18/treatment group).

Evaluation of xenografts for anti-tumor effects will be performed via ultrasound imaging (changes in tumor volume and tumor vascularity) and confirmed by histology (H\&E, TUNEL, CD31+ microvessel density). Treatments will be compared to vehicle control (5% DMSO in saline) treated xenografts. ANOVA (2-way, p\<0.01, bon ferroni alpha corrected) analysis will be performed to identify treatments that lead to the greatest decrease in tumor volume and tumor vascularity (ultrasound imaging metrics). Agents identified will not be used to intervene in clinical care. Objective response rates with clinically chosen drug in each patient will be compared to the corresponding PDX drug panel results using kappa analysis.

Eligibility Criteria:
Patient eligibility:

Localized solid tumor inclusion criteria:

i) Age 18+ ii) localized solid tumor irrespective of subtype undergoing curative surgery iii) Consent to provide tumor tissue for this research

Metastatic cancer inclusion criteria:

i) Age 18+ ii) metastatic cancer irrespective of subtype undergoing a needle biopsy or resection of lung, liver or brain as part of their routine clinical care.

iii) metastatic cancer irrespective of disease site undergoing a thoracentesis or paracentesis as part of their routine clinical care.

iv) measurable disease as per RECIST 1.1 criteria v) Consent to provide tumor tissue for this research
Clinical Performance of Two Fissure Sealants

Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant that has been on the market for years in children


Eligibility Criteria:
Inclusion Criteria:

participants

* ASA Status 1
* all dentinal lesions are restored
* consent of parents and patient
* instruction and demonstration of oral hygiene

teeth:

* first and second molars of the permanent dentition
* healthy teeth without caries
* molars with primary lesions

Exclusion Criteria:

participants

* no consent
* allergies to methacrylates or other ingredients of dental products

teeth:

* molars with occlusal cavities (UniViSS score occlusal \> M)
* Molars with untreated dentinal lesions
* premolars, incisors, deciduous teeth
* teeth with huge occlusal restorations
* hypomineralized teeth or other defects
Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb)

Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France in 2016.

Study of seroprevalence of hepatitis E among patient followed and treated in "centre Hospitalier de la Côte Basque" for HIV infections. Study of acquisition of hepatitis E , and determination of liver status using fibrotest in co-infected patients with hepatis C and / or B.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive \> 18

Exclusion Criteria:

* patient refusal for participation
Hospital at Home at EOL in Heme Malignancies

This study is evaluating an intervention, which the investigators call "Optimize End of Life (EOL) Care at Home," that entails remote patient monitoring and home-based supportive care for patients with advanced hematologic malignancies.

This research study is a single arm pilot feasibility study, which is the first-time investigators are examining this care at home intervention in patients with advanced hematologic malignancies.

The research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs) and hospital care at home (e.g. providing maximal supportive care to to address and manage patients' symptoms) and structured communications oncology clinicians to optimize end of life care for patients with advanced hematologic malignancies.

Participants will include 3 groups:

1) Enrolled patients with advanced hematologic malignancies receiving the end of life (EOL) care at home intervention; 2) caregivers of these patients; and 3) oncology clinicians caring for these patients.

Participants will be in this research study for approximately six months after consent. It is expected that about 30 patients, 30 caregivers, and 15 oncology clinicians will take part in this research study.

Medically Home company is supporting this research study by providing funding.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* diagnosed with relapsed or refractory hematologic malignancy
* must be receiving treatment with non-curative intent or supportive care alone based on the intent of chemotherapy as reported in order entry or Electronic Health Record
* deemed eligible to receive EOL care at home based on the primary oncologist's assessment
* Able to communicate and respond to questionnaires in English or with the assistance of an interpreter.
* residing within 50 miles of MGH. Of note, patients requiring supportive transfusions in the oncology clinic will still be eligible to participate.

Exclusion Criteria:

* Those with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written informed consent as determined by the primary oncologist.