cyrilzakka/clinical-trials huggingface dataset:
Meru Health Program for Cancer Patients With Depression and Anxiety

The primary objective of this study is to evaluate clinical outcomes among people with cancer who participate in a 12-week therapist-supported digital mental health intervention (DMHI) called the Meru Health Program (MHP). Study participants (N=20) will be referred to the MHP through the Cancer Support Community (CSC) Helpline and network of Gilda's Club locations. The main outcomes will be depression symptoms, anxiety symptoms, health-related quality of life (HRQoL), intervention adherence, and intervention satisfaction. The secondary objective will be to determine the acceptability of the screening and referral process from the CSC networks into the MHP. Data pertaining to implementability will be collected from study participants, MHP clinicians, and CSC staff.

The goal of this single-arm intervention study is to test the feasibility of the Meru Health Program (MHP) in reducing symptoms of depression and anxiety among 20 people with cancer referred from the Cancer Support Community (CSC). The MHP is a 12-week digital mental health intervention delivered via a smartphone app. The intervention focuses on cognitive behavioral techniques and mindfulness skills with the aim of improving mental health symptoms. The platform provides informational videos, skills practices, group discussion, and messaging with a licensed clinician employed by Meru Health. The licensed clinician supports patients as needed and reviews engagement logs within the app. As part of the intervention, depression and anxiety symptoms are measured on a biweekly basis over 12 weeks. For this study, self-reported surveys will be administered at baseline, week 12, and 2-months post-treatment to measure health-related quality of life and intervention satisfaction. In-depth interviews will be conducted with patients. Two focus groups will be conducted with MHP clinicians and CSC navigators to understand barriers and facilitators to the screening processes and intervention delivery.

Eligibility Criteria:
Inclusion Criteria:

* Positive screen (score \>= 3 out of 8) on the anxiety or depression subscale of the CSS 15+ Questionnaire
* PHQ-9 and/or GAD-7 score \>= 5 at clinical intake
* Willing to commit to the Meru Health Program if selected
* Proficient in the English language
* At least 18 years of age at the time of enrollment
* Has a valid mailing address
* Owns 1 of the 3 past versions of an Apple or Android mobile phone operating system
* Currently in active cancer treatment at the time of enrollment

Exclusion Criteria:

* Active suicide intent with plan to act
* Substance use disorder in the past 3 months
* Lifetime bipolar disorder
* Lifetime psychotic disorder
* Currently pregnant
* Less than 3 months postpartum
Wind Instruments' Fungal Contamination

On the basis of 2 cases of immunologically-induced lung disease in 2 saxophonists, the investigators supposed that wind reed instruments could be contaminated with molds. The investigators led a study on 40 musicians playing a wind reed instrument to analyze instruments' fungal contamination and its immunological and clinical consequences for musicians.


Eligibility Criteria:
Inclusion Criteria:

* must be 18 year old or more
* must play a wind reed instrument (saxophone, clarinet, bassoon or oboe) one hour per week or more

Exclusion Criteria:

* refuse to sign consent
Swelling or Malrotation of Metacarpal Shaft Fractures in the Evaluation of Rotational Deformity

Rotational deformity or malunion causes the most significant functional deficit in these common fractures. The evaluation of the rotation may be performed with the metacarpophalangeal joints flexed although postoperative swelling may not enable this examination with flexion of the fingers. Furthermore, it has been shown that swelling may cause rotation of the digit itself. The investigators propose that the swelling may cause a mistake in the estimation of rotation, during surgery and early follow up period. This is of special importance when open reduction and rigid fixation is performed.

Methods:

Prospective analysis of XX isolated metacarpal fractures treated, in YY patients was performed. End-on view of the finger-nail was taken with a digital camera on the day of OR, at 2 weeks and at 1 year. The photos were taken on a standard apparatus and from a distance of XX cm and evaluated using ZZ software in comparison with photos taken of the other hand, according to the involved digit. Range of motion, type of fracture and type of fixation were compared.


Eligibility Criteria:
Inclusion Criteria:

1. isolated metacarpal fractures in one hand- fingers 2, 3, 4, 5
2. treated with cast or surgical treatment , closed or open reduction

Exclusion Criteria:

1. multiple fractures simultaneously
2. fractures in both hands
3. former fracture in one of the fingers, two palms,metacarpal,proximal phalanx (with exception of the thumb)
4. open fracture, open wounds, infection
5. pregnancy, inability performing full x-ray follow up
An Algorithmic Approach to Preoxygenation

The aim of this randomized controlled trial is to evaluate an algorithmic approach to gradually adding pressure-supported ventilation and end-tidal positive pressure when conventional tidal volume breathing is insufficient for adequate preoxygenation. The main question it aims to answer is:

* Will the proportion of patients receiving preoxygenation increase?
* Will the duration of preoxygenation decrease?

Participants will;

* 200 patients who were planned to undergo general anesthesia for elective surgeries
* aged between 18 and 65 years
* ASA 1-2 physical status
* ETO2 \<90% at the end of the 3rd minute with spontaneous tidal volume breathing

The patients were randomly assigned to one of two groups (Group TVB and Group PSV) according to a computer-generated randomisation table. In the patients included in Group TVB, the tidal volume breathing was maintained for a further two minutes. Group PSV received inspiratory pressure support of 6 cm H2O for +1 min. At the end of four minutes, patients whose ETO₂ value had not reached a minimum of 90% were randomly divided once more into two groups. One group continued with PSV, while the other was administered 4 cm H₂O PEEP in addition to PSV (Group PSV+PEEP).

When adequate preoxygenation was achieved, the duration of preoxygenation, SpO2, end-tidal carbon dioxide (ETCO2), arterial blood pressures and heart rate values were recorded. Any adverse effects such as discomfort or gastric distension were noted.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgeries general anaesthesia was planned for a patient aged 18-65 years with ASA 1-2 physical condition.

Exclusion Criteria:

* Haemodynamically unstable, preoperative oxygen support such as increased intracranial or intraocular pressure, to be operated on by thoracic surgery have conditions in which positive pressure ventilation may be indirectly harmful, BMI≥35 kg/m2, pregnant, undergoing emergency surgery and causing leakage in mask ventilation bearded male patients were not included in the study.
Birmingham Access to Care Study

The purpose of this study is to determine whether a modified form of the ARTAS (Antiretroviral Treatment and Access to Services) intervention, adapted for HIV patients who have fallen out of care, can be successful in re-engaging patients in care and reducing HIV-1 viral load.


Eligibility Criteria:
Inclusion Criteria:

* HIV patient with at least one primary care appointment since 1/1/10 but currently lost to follow-up defined as 1) currently out of care for greater than 7 months or 2) does NOT have two or more completed clinic visits separated by three or more months in time during a 12-month observation period (HRSA-HAB measure of retention in care) or 3) has 2 or more "no shows" - scheduled visits for which the patient has not arrived or canceled - in the past 12 months.
* 19 years or older
* Be able and willing to provide informed consent
* Be willing to provide locator information
* Be willing to sign a HIPAA authorization form/medical record release form to facilitate medical record abstraction
* Report living in the vicinity
* Be able to communicate in English.

Exclusion Criteria:

* Not meeting one of the above inclusion criteria
* Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
* Incarcerated at the time of potential enrollment
* Are terminated via site PI decision
Association Between the Adenomyosis and the Clinical Outcomes of Vaginal Repair of CesareanSectionScar Defects

To examine the correlation between the occurrence of adenomyosis and the outcome of vaginal repair of cesarean section scar defects (CSD), women with CSD will be enrolled in this retrospective observational cohort study. According to preoperative magnetic resonance imaging (MRI) findings, patients will be divided into two groups, the adenomyosis group and the non-adenomyosis group. They all will have vaginal excision and suture of CSD and will be required to undergo examinations at 3- and 6-months after surgery. Preoperative and postoperative clinical information will be collected.

Women with CSD will be enrolled in this study. According to preoperative magnetic resonance imaging (MRI) findings, patients will be divided into two groups, the adenomyosis group and the non-adenomyosis group. They all underwent vaginal excision and suture of CSD and will be required to undergo examinations at 3- and 6-months after surgery. Preoperative and postoperative clinical information will be collected. Optimal healing was defined as a duration of menstruation of no more than 7 days and a TRM of no less than 5.30 mm after vaginal repair

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are non-pregnant patients who had one or more cesarean sections, patients who had intermenstrual spotting after the cesarean section or those in which the TRM was less than 3.0 mm at the preoperative stage, and patients who underwent MRI and TVS to evaluate the size of the defect and the TRM before surgery

Exclusion Criteria:

* Patients who had a history of chronic diseases (such as cerebro-cardiovascular diseases, malignancies and diabetes mellitus), endocrine disorders, menstrual irregularities before cesarean section, coagulation disorders, use of intrauterine devices, sub-mucous myoma, endometrial diseases, endometrial cysts, uterine fibroids, and adenomyosis after cesarean section
A Hepatic Impairment Study for PF-04965842.

This is a Phase 1 non randomized, open label, single dose, parallel cohort study to investigate the effect of hepatic impairment on the PK, safety and tolerability of PF 04965842.

A minimum of 24 subjects with normal, mild or moderate hepatic function will be enrolled into the study, with approximately 8 subjects in each cohort. The Child Pugh classification score will be utilized to assess entry criteria and to assign subjects into the appropriate hepatic impairment group. For individual subjects, the total maximum duration of study participation from the Screening visit to the end of clinical research unit (CRU) stay is approximately 31 days and approximately 63 days from the Screening visit to the Follow up contact.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 pounds).
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Additional Inclusion Criteria for subjects with hepatic impairment:

* Satisfy the criteria for Class A or Class B of the Child Pugh classification (mild: Child Pugh Scores 5 to 6 points, and moderate: Child Pugh Scores 7 to 9 points), within 14 days of investigational product administration.
* A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or magnetic resonance imaging (MRI).

Exclusion Criteria:

* Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days, history of disseminated herpes simplex infection or recurrent (\>1 episode) or disseminated herpes zoster.
* Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.

Additional exclusion criteria for subjects with hepatic impairment:

* Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as less than 1 year).
* Subjects who have previously had a transplanted kidney, liver, or heart.
* At Screening, persistent severe, uncontrolled hypertension.
Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry

The goal of this clinical trial is to learn how different materials used in dental implants affect the surrounding gum tissue in adults who need dental implants. The main questions it aims to answer are:

How do different materials (titanium, PEEK, zirconia, and lithium disilicate) affect inflammation around dental implants? What changes occur in inflammation markers in the gum tissue after 3 and 6 months? Researchers will compare the different materials to see which one causes the least amount of inflammation.

Participants will:

Receive dental implants made from different materials. Have samples of fluid from around their implants collected for analysis at 3 and 6 months.

Undergo regular dental check-ups to measure gum health, such as bleeding and pocket depth around the implants.

The study will involve a total of 40 edentulous patients, each missing four teeth in the posterior region of the mandible or maxillae. Each patient will receive four dental implants and single crowns made from different materials. The primary objectives are to evaluate biomarkers in peri-implant crevicular fluid and to assess the changes in these biomarkers after three and six months of loading. This research will help determine the biocompatibility of the materials and their potential to cause peri-implantitis.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years or older.
* Participants must be edentulous with at least four missing teeth in the posterior region of the mandible or maxillae.
* Participants must have appropriate oral hygiene and periodontal status of natural teeth, with a pocket depth of 4mm or less and no bleeding.
* Dental implants must be fully integrated with no bone resorption or inflammation after three months of implant placement, confirmed by X-ray and clinical examination.
* Implant placement must be into natural bone without additional procedures such as sinus lift or bone augmentation.
* The procedure must be a standard implantation with no immediate implant placement.
* The height of the gingiva must be at least 3mm or more.

Exclusion Criteria:

* Patients with systemic diseases such as malignancy, diabetes, osteoporosis, or rheumatoid arthritis.
* Patients with a history of periodontal treatment.
* Patients who smoke or use tobacco.
* Patients who have received antibiotic treatment within three months prior to implantation.
* Pregnant individuals.
The Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis

Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no prospective studies in gentamicin irrigation in chronic rhinosinusitis.

Chronic rhinosinusitis (CRS) is characterized by symptoms \> 12 weeks.Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure reduction or loss of smell).

Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics. Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis. Gentamicin irrigation should be helpful in chronic rhinosinusitis.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic rhinosinusitis and/or recurrent acute/subacute sinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between December 4, 2012, and December 3, 2016

Exclusion Criteria:

1. Patients who used antibiotic prophylaxis within within 1 year before and 6 months after started gentamicin nasal irrigation
2. Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
3. Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
4. Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
5. Patient who have mental retardation
6. Patient who have aminoglycosides hypersensitivity reactions
7. Pregnancy women and Lactation period
8. Patient who have abnormal hearing test before started gentamicin nasal irrigation
9. Patient who have chronic rhinosinusitis with nasal polyp
Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Non-Fasting Conditions

The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under non-fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers

To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.


Eligibility Criteria:
Inclusion Criteria:

Any patient with data in the RADARS system

Exclusion Criteria:

None
State of Obesity Care in Canada Evaluation Registry

The purpose of this study is to see whether care gap(s) exist in the management of obesity and its related conditions in obese patients seen by primary care physicians and specialists. The study will also look at whether there is a compliance and adherence gap that exists in patients prescribed medication for obesity management.

Obesity currently affects over 15% of the adult population in Canada. The economic burden associated with obesity is estimated at $4.3 billion or 2.2% of the total health care costs in Canada. Despite increasing recognition as a public health problem, clinical management of obese patients in Canada has received little attention. This study will collect information on the current status, characteristics and management of subjects with obesity. The design of the study will mirror real-life management of these subjects.There are three goals in this study: the primary goal is to document appropriate obesity management strategies aimed at reducing and maintaining a healthy body weight by participating primary care physicians and specialists. The second goal is to explore factors that determine patients compliance and adherence to anti-obesity medication when prescribed. Obesity management is currently not a priority in tertiary care centres in Canada. An exception being the Bariatric Clinic located at McMaster University, which is one of the few academic centers dedicated to obesity management in Canada. The primary goal of the Bariatric Clinic Substudy is to evaluate the management, compliance and adherence of patients seen at a tertiary care obesity clinic compared to those of primary care physicians and specialists.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older and is able to provide informed consent
* Has not been enrolled in this study at an earlier office visit; and
* Provides signed informed consent
* BMI \> = 27 kg/m

Exclusion Criteria:

* Participation in a clinical trial
* Hospitalized patient
* Subject expected to have difficulties to come back at follow-up visits
* Pregnant or nursing
First Time in Man Study of Finafloxacin Hydrochloride

The purpose of this study is to study the safety of single doses and multiple doses of Finafloxacin hydrochloride in healthy volunteers. The level of Finafloxacin hydrochloride will be measured in the subjects blood and urine. One part of the study will assess if Finafloxacin hydrochloride eradicates Helicobacter pylori, a stomach bacteria. Another part of the study will assess the activity of the drug in urine.

New antibiotics are needed due to the increasing resistance of bacteria to existing antibiotics. Helicobacter pylori (H. pylori) is a bacteria of the stomach and has been shown to cause peptic ulcers and is implicated in gastric cancer. Up to 40% of the population has H. pylori. Current treatments used to eradicate H. pylori are a combination of a number of drugs including antibiotics and drugs which reduce the acid in the stomach. These treatments are complicated and some H. pylori is resistant to the antibiotics used.

This study is the first use of Finafloxacin hydrochloride in man and will examine its safety and make a preliminary study of its effectiveness as a single agent in eradicating H. pylori. The urine of subjects will also be used to test its effectiveness in killing the bacteria which cause urinary tract infections.

Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy subjects
* 18-55 years of age
* In good health
* For part C only, Helicobacter pylori carrier status as assessed by a positive result of the urease breath test at screening.

Exclusion Criteria:

* Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.