cyrilzakka/clinical-trials huggingface dataset:
Effects of Chiropractic Care in Patients With Hip Osteoarthritis

The purpose of the study is to explore the short term effects of chiropractic care on pain and function in patients with hip osteoarthritis.

Research over the last years have reported a scarce of trails investigating chiropractic treatment of lower extremities. Osteoarthritis, also called joint failure, is a common rheumatic joint disease often affecting the hipjoint, contributing to pain, decreased mobility and loss of function. Individuals with osteoarthritis can also be affected in many other ways, e.g. economically, socially and emotionally.

Chiropractic care may be considered as a complement to the conventional allopathic treatment of hip osteoarthritis. Joint manipulation is a well-established treatment technique to restore optimal joint function of the locomotor system. The aim of the study is to explore the effects of chiropractic vs. continued conventional care (waiting list controls) on pain and function during a three week trail period among patients with hip osteoarthritis waiting for arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* waiting for first time unilateral arthroplasty on the affected side

Exclusion Criteria:

* documented osteoporosis, current pathology such as malignancy, infection, cardiovascular disease, stroke and femoral fractures on affected side
Community Based Cannabis Cessation Program

The study examined a community based cannabis cessation program in Norway (CCP). The CCP uses a combination of cognitive therapy and psychoeducation and covers the normal withdrawal period for cannabis smoking cessation (up to 8 weeks), comprising \~15 individual sessions. From 2005 onwards, the CCP was implemented as a low-threshold community-based program in several Norwegian municipalities, e.g., Kristiansand, Fredrikstad and Oslo. The study had an observational one-group pre- / post test design. Outcomes was changes in cannabis use, mental distress, well-being, social network and sense of coherence (SoC) measured post-intervention (T2) and at a 3 months follow-up (T3).


Eligibility Criteria:
Inclusion Criteria:

* Severity of Dependence Scale (SDS) score ≥4

Exclusion Criteria:

* polydrug use where cannabis was not the predominating substance of use
* psychiatric comorbidity that was perceived as too severe to handle at the community-based centers
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children

The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear infection) in children with a history of recurrent acute otitis media.


Eligibility Criteria:
Inclusion Criteria:

* Six months to five years of age
* General good health
* History of at least three episodes of AOM in previous 12 months, at least one of which occurred within the previous six months
* English or Spanish speaking

Exclusion Criteria:

* History of tympanostomy tubes
* Intestinal malabsorption or chronic diarrhea
* Diabetes mellitus
* Any inborn error of metabolism
* Parent/guardian unreachable by telephone
* Known allergy to any of the study solution components (xylitol, sorbitol, sodium carboxymethylcellulose, potato starch, glycerin, potassium sorbate, natural berry flavoring).
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant

The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an improved quality of life in these patients.

Lung or breathing problems can develop several months to years following a bone marrow transplant. In some cases, these breathing problems develop without any signs of germs or infection in the lungs. The name for this type of breathing problem is called "Sub-Acute Lung Injury". Sub-acute lung injury often develops many months, even years following a bone marrow transplant. It is often characterized by shortness of breath, cough, wheezing and fatigue.

Sub-acute lung injury can either lead to the formation of scar tissue in the lungs (making it difficult to take deep breaths), or it can cause the lungs to get weak (making people feel out of breath easily). Approximately 25 - 50% of patients with sub-acute lung injury may eventually die from the damage in their lungs. Typically, such patients die from infections that develop inside the damaged lungs.

In this study, treatment with an experimental drug called Etanercept will be used. (Enbrel). The physicians feel there is the possibility that Etanercept may help improve breathing. Breathing ability will be assessed prior to treatment as well as during and after treatment so that comparisons can be made.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of allogeneic bone marrow, cord blood, or peripheral blood stem cell transplants are eligible
* Age \>6 years and able to complete pulmonary function testing
* Patients with evidence of sub-acute, non-infectious pulmonary dysfunction (OLD or RLD)
* Recipients of sub-ablative transplant regimens are eligible
* Recipients of donor leukocyte infusions (DLI) post-transplant are eligible
* Patients must be \> 100 days post transplant

Exclusion Criteria:

* Patients with hypotension requiring inotropic agents other than dopamine \< 5mcg/ kg/ minute for blood pressure support.
* Patients with a positive quantitative bacterial culture from the BAL fluid (≥ 104 CFU/ ml is considered positive)
* Patients whose BAL fluid is positive for significant bacterial pathogens or pathogenic nonbacterial microorganisms (as defined by protocol) by special stain, culture or PCR analysis
* Patients who are enrolled on a phase I or phase II trial for the prophylaxis or treatment of GVHD (acute or chronic) within 7 days of study entry.
* Patients with known hypersensitivity to etanercept.
* Patients who are pregnant.
* Patients with CMV seropositivity at the time of study entry. Testing may include wither CMV PCR analysis or CMV pp65 testing.
* Evidence for multi-system organ failure.
A Clinical Data Collection Study of Verily Patch

This is a single center, prospective, non-randomized prospective observational data collection study of the Verily Patch. The Verily Patch is an investigational wearable, continuous temperature sensor which will be evaluated against reference oral and axillary temperature measurements to support development activities for the Verily Patch.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Able to read and speak English
* Able to read and understand the Informed Consent Form
* Willing to wear Verily Patch in the axillary region
* Willing to comply with repeated self-measurement of oral and axillary temperatures and willing to record temperature readings
* Have a working smartphone device and willing to use it for study activities
* Willing to install study apps on their personal smartphone
* Willing to comply with all study-related procedures

Exclusion Criteria:

* Pregnant or breastfeeding during study participation
* Have known allergies to medical grade adhesives
* Have known cutaneous hypersensitivity
* Have infection in both axilla
* Have open injury or rash where the study device will be worn
* Have a cardiac pacemaker or other implanted electronic medical device(s)
* Have any additional condition or situation that, in the opinion of the investigator, makes the subject inappropriate for participation in the study
Greek Physiotherapy Students' Attitudes Towards Psychiatry and Mental Health

The main purpose of this study will be to investigate what are the attitudes of Greek physiotherapy students who belong to one of the Higher Educational Institutions of Greece and the correlation of these attitudes with certain demographic characteristics that will be defined.

A link will be created via google forms, which will be made available to undergraduate physiotherapy students of all the departments of the country's universities. The Attitudes Towards Psychiatry - 30 scale will be used to explore students' attitudes towards psychiatry and mental health. Participants through a mandatory field will consent to participate in the study, having read all the necessary information at the beginning. Then the necessary section will be created in which the participant will answer the questions of the assessment scale. The Attitudes Towards Psychiatry - 30 scale has not been standardized in Greek and for this reason it will be translated forward and backward by 2 independent researchers. After the completion of the study, the researchers will collect the results and draw conclusions based on the necessary statistical analyses. The data collection will be done for about one month, the duration of data processing and archiving will be about 6 months.

Eligibility Criteria:
Inclusion Criteria:

* physiotherapy student in one of the Universities of Greece

Exclusion Criteria:

* not a physiotherapy student at one of the country's Universities
U-Act-After: An Observational Study on Long-Term Efficacy of Tight Control RoActemra/Actemra (Tocilizumab) and/or Methotrexate in Patients With Early Rheumatoid Arthritis Who Have Participated in the U-Act-Early Study (ML22497)

This non-interventional, observational, open-label multi-center follow-up study of patients from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in patients early in the disease followed by treatment according to standard of care in routine clinical practice in a three year follow-up, independently of what treatment the patient will be receiving.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have participated in the U-Act-Early trial (ML22497); these are adult patients (\> 20 years of age) with rheumatoid arthritis.
* Patients must be willing to give written informed consent

Exclusion Criteria:

* Patients who did not participate in the U-Act-Early trial
* Patients who are drop-outs in the U-Act-Early trial due to withdrawal of consent, are lost to follow-up or are serious protocol violators
Platelet Activation and Circadian Rhythms of Clotting-Fibrinolysis Factors in Patients With Sleep Apnea Syndrome

The objective of the study is to define and compare clotting- fibrinolysis patterns, platelet function markers and endothelial dysfunction in patients with SAHS before and after treatment and normal controls age and weight matched.

The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have higher risk of cardiovascular mortality during the night.

Respiratory alterations (hypoxia, hypoxia- reoxygenation) that these patients suffer during the sleep may induce modifications in platelet function, clotting-fibrinolysis factors and endothelial function, that may accelerate cardiovascular events during the night

DESIGN: Prospective and controlled study

METHODS: 20 SAHS patients and 20 controls will be studied. The study includes:

a) medical history; b) anthropometric variables (weight, height, body mass index, waist-hip ratio); c) sleepiness tested by Epworth scale; d) conventional polysomnography (PSG); e) testing every 4 hours for a 24 hours period: clotting-fibrinolysis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); platelet activation markers (CD62, CD63 and GPIIb/IIIa) and endothelial dysfunction markers (endothelins, nitrites/nitrates and asymmetrical dimethyl-arginine); f) basic biochemical profile and hemogram. Patients will be revaluated after 6 months of CPAP treatment.

Eligibility Criteria:
Inclusion Criteria:

* Apnea-Hypopnea Index \> 15

Exclusion Criteria:

* Presence of any chronic disease
* Presence of cardiovascular disease
* Refusal to sign informed consent
* Drug addiction and/or alcoholism
* Any medication two weeks before
A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis (i.e., Preventive Treatment) for Venous Thromboembolism (VTE, i.e., Blood Clots in the Veins) and Bleeding Event Risk in a Population With Acute Medical Illness

Venous Thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with an increase in risk of mortality and long-term disability and is a major contributor to global disease burden. Participants hospitalized with an acute medical illness are at increased risk of VTE.

This study a non-interventional study which analyzes data already collected in the Optum US clinical database. Its aim is to compare conventional versus extended duration prophylaxis with enoxaparin on the incidence of VTE and bleeding events in participants hospitalized for acute medical illness. The first date of enoxaparin treatment will be the index date.

The study population will be developed from the Optum Clinical database in the United States, representing routine clinical practice. Study population will comprise of participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization. The first date of enoxaparin treatment will be the index date. The study period will be from February 2010 to September 2021. Participants will be followed for 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization for the following acute conditions:

  * Infection
  * Respiratory insufficiency
  * Inflammatory condition
  * Cancer
  * Heart failure
  * Ischemic stroke
* Initiation of enoxaparin prophylaxis during hospitalization (index date)
* Age ≥40 years

Exclusion Criteria:

* Symptomatic VTE or major bleeding event 90-days prior to index date
* Major surgery within (+1,-90) days from index date
* Ongoing anticoagulation therapy (medication supply within \[-2,-32\] days from index date)
* Atrial fibrillation
* Chronic kidney disease (CKD) stages IV and V, or dialysis

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Cleancision IntRaoperative Contamination prEvention Study

This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate contamination at the wound incision site when the CleanCision is used during surgery.

This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate bacterial contamination at the wound incision site when the CleanCision is used during surgery. The CleanCision is a surgical tool that is designed to be used for the primary purpose of protecting the wound from contamination that occurs to the incision site during surgery ultimately reducing the occurrence of Surgical Site Infections (SSI).

This is a prospective, multi-center, single-arm (non-randomized) clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* BMI 15-45, inclusive
* Colorectal surgery patient, planned resection
* Incision length meets labeling requirements
* Written informed consent using the governing IRB approved form

Exclusion Criteria:

* Patients with a pre-existing stoma
* Patients undergoing emergent colorectal surgery
* Known history of contact hypersensitivity or allergy to device materials
* Prior laparotomy or abdominal surgery within a timeframe that may present a safety risk or compromise study results
* Active infection, sepsis or systemic antibiotic therapy within timeframe that may impact safety or study results
* Active participation in any other clinical study of an experimental drug or device that may impact safety or study results
* Postsurgical life expectancy is less than the study follow up period
* Subject is pregnant or lactating
* Subject is under incarceration
* Subject considered to be inoperable following exploratory surgery
A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients

The purpose of this study is to examine how the immune systems of HIV-infected patients react to 2 anti-HIV drug combinations.

Patients are randomized to two study arms for at least 48 weeks of treatment. Arm A receives SQV SGC plus RTV plus two NRTIs of choice. Arm B receives EFV plus two NRTIs of choice. NRTIs approved for study use are stavudine (d4T), didanosine (ddI), zidovudine (AZT), lamivudine (3TC), Combivir, and zalcitabine (ddC). Abacavir is excluded. The following immunology variables and HIV-1 viral characteristics will be evaluated during study visits: CD4 and CD8 cell counts; naive and memory T-cells; T-cell activation markers (HLA-DR and CD38); T-cells expressing T helper 1- (TH1-) and T helper 2- (TH2-) associated intracytoplasmic cytokines; anti-CD3 T-cell activation responses; T-cell receptor V Beta repertoire; cytotoxic T-lymphocyte (CTL) activity levels; lymph node histology (optional); HIV-1 qualitative microcultures and viral phenotyping for non-syncytium-inducing (NSI) and syncytium-inducing (SI) viral isolates. Laboratory determinations, adverse effects, neurological exams (including mental status evaluations), and lipodystrophy parameters (including fasting lipid profile and physical parameters) also are evaluated.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load of at least 5,000 copies/ml and a CD4 cell count greater than 75 cells/mm3.
* Are at least 16 (need consent of parent or guardian if under 18).
* Are able to complete the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have ever taken anti-HIV medications.
* Are pregnant or breast-feeding.
Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery

This study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study.

The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months (i.e., the difference between preoperative visual acuity and visual acuity 3 months after surgery) in pseudophakic or aphakic patients who have undergone successful surgical intervention (reattachment of the retina) through vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD).

120 patients will be enrolled and randomized in two groups:

* the experimental arm "UDCA Group," with oral administration of ursodeoxycholic acid (Ursolvan®)
* the control group "Placebo Group," with oral administration of the placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older,
2. Scheduled to undergo surgical intervention through vitrectomy,
3. Aphakic or pseudophakic patients,
4. Experiencing rhegmatogenous retinal detachment affecting 2 quadrants or more,
5. Presenting with macula OFF (raised macula) for 7 days or less before the onset of symptoms,
6. Has signed a consent form,
7. Affiliated with a health insurance plan.

Exclusion Criteria:

1. Patients who have previously undergone vitrectomy for retinal detachment,
2. Patients with vitreous hemorrhage or any other associated retinal pathologies,
3. Monophthalmic patients,
4. Women of childbearing age without effective contraceptive methods,
5. Pregnant or lactating women,
6. Hypersensitivity to the active substance, bile acids, or any of the excipients in Ursolvan® (see §6.1.1 of this protocol),
7. Patients with peptic ulcers, acute or chronic liver disease, acute infection or inflammation of the gallbladder or bile ducts, recurrent gallstones, or obstruction of the bile ducts (common bile duct or cystic duct obstruction),
8. Patients with radiopaque calcified gallstones,
9. Patients with severe pancreatic disorders,
10. Patients with Crohn's disease, ulcerative colitis, or other intestinal diseases that may alter the enterohepatic circulation of bile acids,
11. Patients on oral treatment with cholestyramine, colestipol, antacids containing aluminum or magnesium hydroxide and/or smectite (aluminum oxide), cyclosporine, ciprofloxacin, nitrendipine, or dapsone,
12. Patients with galactose intolerance, Lapp lactase deficiency, or glucose and galactose malabsorption syndrome (rare hereditary diseases),
13. Patients participating or in the exclusion period following an interventional research with the use of prohibited medications in this study,
14. Patients under protective custody.
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).


Eligibility Criteria:
Inclusion Criteria:

* Women or men with histologically or cytologically confirmed carcinoma of the breast
* Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
* Documented HER2-negative tumor according to ASCO/CAP guidelines
* De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
* Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
* Confirmation of biomarker eligibility
* Consent to provide fresh or archival tumor tissue specimen
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Exclusion Criteria:

* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
* Metaplastic breast cancer
* Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
* Any history of leptomeningeal disease or carcinomatous meningitis
* Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
* Symptomatic active lung disease
* History of or active inflammatory bowel disease
* Any active bowel inflammation
* Prior hematopoietic stem cell or bone marrow transplantation
* Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment