cyrilzakka/clinical-trials huggingface dataset:
Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States

This primary goals of this study are to: estimate the prevalence of Clostridium sordellii and Clostridium perfringens carriage in the rectum and/or vagina among women of reproductive age; estimate duration of carriage of the two clostridium species; and estimate the incidence of carriage at 2 weeks after a negative test.

Since 2000, clostridial pelvic infections have claimed the lives of at least 17 young, previously healthy women. The majority of infections detected by molecular methods were among women testing positive for Clostridium sordellii only; in 5 cases, deaths were due to Clostridium perfringens only; and in 3 cases, the women were positive for both. These deaths occurred among both non-pregnant and recently pregnant women. Clostridium has been isolated from the vagina in 4-18% of normal, health non-pregnant women, with Clostridium perfringens the most common isolate. Most studies do not differentiate the small percentage of other clostridia present in the vaginal microenvironment. The vaginal carriage rate for Clostridium sordellii remains unknown, but is probably very low, less than 1%.

The correlates of clostridial carriage are unknown, and data on the etiology and lethality of clostridial infection among women of reproductive age are insufficient to guide possible courses of safe and effective prevention. In women infected with strains of Clostridium perfringens and Clostridium sordellii that produce the lethal toxin, it is not clear whether there is an effective treatment.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Between ages 18 and 45

Exclusion Criteria:

-Seeking emergency or oncological care
Surgical and Non-surgical Treatment of Peri-implantitis

This study will compare surgical and non surgical treatments of peri-implantitis. Peri-implantitis is an inflammation around dental implants that can lead to the loss of the implant over time if no treatment is established. The signs of peri-implantitis included bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients presenting with these characteristics will be included at random to one of the treatment groups. Those allocated to the non-surgical group will received implant cleansing after local anesthesia using adequate instruments. In the surgical group, patients will be submitted to a surgical procedure around the implant for visualization and cleansing also after local anesthesia. All patients will be followed over a 12-month period. The hypothesis is that surgical treatment is better than non-surgical treatment regarding clinical, radiographic, microbiological, and immunological.characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with at least one dental implant with peri-implantitits
* Individuals with good general health conditions;
* Individuals presenting at least 10 natural teeth;
* Individuals with no signs of active periodontitis

Exclusion Criteria:

* Individuals who received periodontal treatment in the last three months
* Pregnant
* Systemic condition that interferes with treatment such as diabetes
* Individuals who are taking or have taken antibiotics or anti-inflammatory medication
CardioMEMS HF System Real-World Evidence Post-Approval Study

The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.

Subjects will be identified in Abbott's Merlin.net remote monitoring database. Merlin.net data will be linked to Medicare fee-for-service (FFS) claims data to longitudinally track outcomes. Each subject will be followed for a minimum of 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject implanted with a CardioMEMS PA Sensor and enrolled in Merlin.net
* Subject resides in the United States as documented in Merlin.net
* NYHA Class II or Class III as documented in Merlin.net at the time of CardioMEMS implant (only NYHA Class II subjects contribute to the Primary Cohort)
* Subject identified in Merlin.net data can be linked to Medicare FFS claims
* Subject is enrolled in Medicare Part A and B, and not enrolled in Medicare Part C, at implant and for 12 months prior to implant, to establish qualification for CardioMEMS
* Subject ≥18 years of age at time of CardioMEMS implant

Exclusion Criteria:

* Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant
An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma

To characterize the safety profile of acalabrutinib with and without dexamethasone in subjects with relapsed or refractory Multiple Myeloma (MM)


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age.
* A confirmed diagnosis of MM, which has relapsed after, or been refractory to ≥ 1 prior therapy for MM, and is progressing at the time of study entry.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria:

* A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, gastric bypass, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
* Breast feeding or pregnant
Effect of Infant Formula on Energy Balance

The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.

This is a randomized clinical trial of infants whose parents decided to formula feed them; mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The groups will differ in the composition of the formula fed to the infant during the first year of life.

Eligibility Criteria:
Inclusion Criteria

1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.
2. Birth weight between 2500 - 4500 grams.
3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).
4. Mother must be 18 years or older.
5. Infant must be consuming a standard cow's milk protein infant formula and have been receiving a standard cow's milk protein infant formula for at least the past 2 days prior to enrollment.

Exclusion Criteria

1. Mother had gestational diabetes during pregnancy
2. Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle.
3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation).
4. Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus).
5. Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases. For example, infant must not be receiving insulin or growth hormone.
6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.
The SwissPrEPared Study

Nested within the SwissPrEPared Program, the "SwissPrEPared Study" - a large, multicentric, nation-wide cohort study - aims to longitudinally follow individuals asking for PrEP prescription over a period of 3 years.

The main aims of the study will be:

1. To obtain epidemiological data on individuals asking for PrEP in Switzerland. We are particularly interested in:

   * Determining the extent of PrEP use in Switzerland;
   * Assessing and monitoring the occurrence of sexually transmitted infections (STIs) in this particular population.
2. To assess sexual health and sexual well-being in individuals asking for PrEP using a questionnaire specifically designed for the SwissPrEPared program.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the SwissPrEPared program
* Aged ≥16 years
* HIV negative

Exclusion Criteria:

* Individuals unable to follow program procedures (e.g. language barriers, mental or psychiatric disorders)
Brief Treatment for Trauma Nightmares in Trauma-exposed Adults With Bipolar Disorder

Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has shown strong support in reducing the number and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar disorder.

This pilot study will examine the efficacy of Exposure, Relaxation, \& Rescripting Therapy (ERRT) on chronic nightmares in trauma-exposed adults diagnosed with bipolar disorder (B-ERRT), as these individuals have been excluded from past clinical trials. Eligible participants will be assessed prior to starting treatment. B-ERRT will be conducted once a week for approximately five consecutive weeks for approximately two hours per session. Each treatment session focuses on one of the following topics/skills: psychoeducation regarding trauma, nightmares, and sleep disturbances on bipolar disorder, relaxation techniques, exposure to the trauma-nightmare, and relapse prevention. Participants will then be asked to complete two to three follow-up assessments, 1-week, 3-months, and potentially 1-year after the end of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Nightmares at least once per week for the past month
* Formal diagnosis of Bipolar disorder (I or II)
* Exposure to traumatic event (1+ months ago)
* Stable on bipolar medication for at least 2 months

Exclusion Criteria:

* A traumatic event within the last month
* Intellectual disability
* Current or recent mania/hypomania within the last 3 months
* Suicide attempt or hospitalization within the last 3 months
* Current or untreated substance use disorder within the past 6 months
Craniosacral Therapy in Patients With Chronic Low Back Pain

The purpose of the current randomized clinical trial was to analyze the effectiveness of craniosacral therapy on disability, pain intensity, kinesiophobia, quality of life, isometric endurance of trunk flexor muscles, mobility, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid in individuals with chronic low back pain.

Objective: To analyze the effects of craniosacral therapy on disability, pain intensity, quality of life, and mobility in patients with chronic low back pain.

Design: A single blinded randomized controlled trial. Setting: Clinical setting. Subjects: Sixty-four patients (42 females) with chronic low back pain. Interventions: Patients were randomly assigned to an experimental group (craniosacral therapy group) or a control group (classic massage group).

Main measures: Self-reported disability (Roland Morris Disability Questionnaire - primary outcome; and Oswestry Disability Index), pain intensity (a 10-point Numerical Pain Rating Scale), scale of kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade Test), lumbar mobility in flexion, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid.

Eligibility Criteria:
Inclusion Criteria:

1. LBP for/over three months.
2. age between 18 and 65 years.
3. score equal or superior of four points on the Roland Morris Disability Questionnaire.
4. not currently receiving physical therapy.

Exclusion Criteria:

1. presence of lumbar stenosis
2. diagnosis of spondylolisthesis
3. diagnosis of fibromyalgia
4. treatment with corticosteroid or oral medication within the past two weeks
5. a history of spinal surgery
6. disease of the central or peripheral nervous system
Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis
* Inadequate response to stably dosed methotrexate

Exclusion Criteria:

* Current therapy with any DMARD or biologic other than methotrexate
Role of Ivermectin Nanosuspension as Nasal Spray in Treatment of Persistant Post covid19 Anosmia

ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia

ivermectin is FDA approaved antiparasitic drug which is also claimed to be having potent in vitro antiviral effect,so we are tryying to study itsovid19 anosmia effect upon releiving post covid19 anosmia as one of the most characteresic symptoms of covid19 infection

Eligibility Criteria:
Inclusion Criteria:

* post covid19 anosmia
* negative swab test for covid19

Exclusion Criteria:

* other types of anosmia ,
* no local or central other causes of anosmia
* still active covid 19 pateints ( positive swab test )
Arabic Version of a New Tool Called HEAL-COMMAND to Evaluate Hearing Loss and Communication and Conversation Disability

Hearing loss is the fourth highest cause of disability globally. Current data suggest that approximately 5% of the world's population suffer from disabling hearing loss, Earlier studies have shown that persons with hearing loss experience a higher prevalence of associated adverse health effects than persons with normal hearing. Those conditions include social isolation, depression, diabetes, dementia, falling, cardiovascular disease, and reduced quality of life. A limitation to disability-based questionnaires related to hearing loss is the large number of instruments available and the lack of consensus on which questionnaires to use. To do so, applying the World Health Organization's International Classification of Functioning Disability and Health (ICF) framework was found to be an ideal design foundation. In the ICF, functioning refers to positive aspects of Body Functions, Activities, and Participation, while disability refers to impairments, activity limitations, and participation restrictions, in which both aspects can be influenced by a health condition(s) and or contextual (personal and environmental) factors. Previous studies showed that the operationalization of the ICF Core Sets for HL into a self-assessment tool can serve as the foundation for a comprehensive picture of health. To accommodate this need, a collaboration between group of researchers at Audiology Clinic, Auburn university, Alabama, USA have been conducted. This partnership resulted in creating an English and German version of questionnaire that comprehensively assesses and individuals hearing functioning profile according to ICF framework which is called HEAL-COMMAND Tool


Eligibility Criteria:
Inclusion Criteria:

1. Age between 30-80 years
2. New individuals who presented to the speech and hearing clinic with ear or hearing complaints and showed the following pattern/s:

   * Normal hearing with subjective hearing difficulties
   * Mild hearing Loss
   * Moderate hearing loss
   * New hearing aid users or experienced hearing aid users
3. Adequate cognitive and comprehension abilities to complete the questionnaire and cognitive interview session.
4. Ability to attend remote activities

Exclusion Criteria:

1. age under 30 or over 80 years
2. illiterate who can't complete the questionnaire or digital forms
3. clinical diagnosis with depression and cognitive decline or dementia
4. Above moderate hearing loss
Custom Guides for Total Knee Arthroplasty (TKA)

The goal of the study is to know if the reconstruction of the lower limb mechanical axis and the patient knee function is improved after Total Knee Arthroplasty (TKA) using patient specific instruments.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a TKA
* Informed signed consent
Genetic Markers in Patients With Colorectal Cancer

RATIONALE: Determination of genetic markers for colorectal cancer may improve the identification of patients who are at highest risk for relapse.

PURPOSE: This clinical trial is studying the importance of genetic markers for detecting relapse in patients with colorectal cancer.

OBJECTIVES:

* Determine the clinical and pathologic significance of unstable DNA elements in colorectal cancer (tumor microsatellite instability).
* Determine the clinical and pathologic significance of loss of heterozygosity for chromosomes 5, 8, 17, and 18 (as the primary targets) and of chromosomes 1, 14, and 22 (as the secondary targets) in colorectal cancer.

OUTLINE: DNA is examined for unstable elements (microsatellite instability and loss of heterozygosity) by analyzing at least 10 separate (CA)n-repeats localized to 5 separate chromosomes (5q, 8p, 15, 17p, and 18q). Loss of heterozygosity is analyzed for at least four chromosomal arms (5q, 8p, 17p, and 18q) and later other chromosomes (e.g., 1, 14, and 22). Immunohistochemistry is used to test for the presence or absence of the genes involved in DNA mismatch repair (hMLH1 and hMSH2).

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: This study will accrue up to 708 specimens.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Must have had a resectable adenocarcinoma of the colon or rectum and must have participated in one of the following NCCTG randomized clinical trials:

  * 784852: No Treatment Control Versus Levamisole Versus Levamisole Plus Fluorouracil (5-FU)
  * 794604: No Treatment Control Versus 5-FU by Portal Vein Infusion
  * 794751: Postoperative Radiation Versus Postoperative Radiation Plus Sequential Chemotherapy with Methyl CCNU and 5-FU
  * 844652: An Intergroup Study - An Evaluation of Levamisole Plus 5-FU as Surgical Adjuvant Treatment for Resectable Adenocarcinoma of the Colon
  * 864751: Phase III Protocol for Surgical Adjuvant Therapy of Rectal Carcinoma: A Controller Evaluation of (A) Protracted-Infusion 5-FU as a Radiation Enhancer and (B) 5-FU Plus Methyl-CCNU Chemotherapy
  * 874651: M/N - A Controller Evaluation of Recombinant Interferon-gamma (IFL GM) and 5-FU and Folinic Acid With or Without Levamisole as Adjuvant Treatment for Resectable Adenocarcinoma of the Colon
  * 894651: A Controller Phase III Evaluation of 5-FU Combined With Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer
* Tissue blocks from the primary colorectal cancer must have been received by the NCCTG operations office
The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa

The Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Family-in-Focus program
* Caregiver provided informed consent
* the age-eligible children were not involved in any other sort of ECD program (e.g. crèche or other day-care)

Exclusion Criteria:

* Enrollment in an ECD program
Post-operative Lower Eyelid Massage for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach

Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up.

* The massage technique was executed with the patient in a fully open-eyed state, maintaining an upward gaze. The lateral aspect of the distal phalanx of the index finger was employed, exerting pressure on the lower eyelid to bring its margin into contact with the upper eyelid margin for a duration of 10 seconds per repetition. This procedure comprises 10 repetitions per set, administered once hourly, spanning 10 hours daily. The massage instruction was provided either by the authors or plastic surgery residents.
* Facial fracture surgeries were conducted by experienced plastic surgeons and/or proficient 4th and 5th year plastic surgery residents at Chiang Mai University Hospital, utilizing the skin-muscle flap subciliary approach. All patients underwent surgery one week after injury to mitigate soft tissue swelling, which had subsided by that time.
* Consistent pre-operative, peri-operative, and post-operative care protocols were administered to both patient groups. Stitches at the subciliary incision site were extracted on post-operative day 5. Patients in the massage group were instructed to commence lower eyelid massage on the day when stitches were removed.
* The follow-up assessments were occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively. Evaluation criteria include the Grading of Lower Eyelid Scar Contracture (GLESCO). Additionally, grading of lower eyelid malpositioning, comfort scores, rate on a scale of 0-10, adapted from POSAS and Verbal Rating Scale, wound infection, dehiscence, eyelid comfort, and management related to the subciliary incision will be assessed and documented by the plastic surgeon (author) and plastic surgery resident.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with zygomatic and Lefort II fractures necessitating infraorbital rim fixation following motorcycle accidents, and presenting without external lower eyelid wounds.

Exclusion Criteria:

* Pre-existing lower eyelid retraction (from previous scar, neurogenic cause, myogenic cause or Graves' disease), incision alteration, communication barriers, inability to perform daily activities or lower eyelid massage (ECOG ≥ 2, PPS Adult Suandok ≤ 60), inability to attend follow-up visits, and patient refusal.
Assessment of Colonic Epithelial Integrity With Mucosal Impedance

In this study, the investigators propose to use mucosal impedance (MI), a minimally invasive technology, to detect mucosal damage (i.e. barrier dysfunction) based on mucosal conductivity changes in the colonic epithelium.

The intestinal epithelium functions to separate luminal contents from the interstitium. Increased intestinal permeability can represent compromise of the epithelium's integrity. Prior research has demonstrated that defects in intestinal barrier function are associated with inflammatory bowel disease (IBD) and increased intestinal permeability can be important in the maintenance of remission in IBD patients. There is currently not a convenient way to measure colonic epithelial barrier function in real time which could provide clinically relevant information .

Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 18 with a diagnosis of IBD (Ulcerative Colitis or Crohn's Disease)
* Men and women undergoing screening colonoscopy (typical age would be 50 or greater but there are exceptions)

Exclusion Criteria:

* Age less than 18 years old
* Patients unable to give informed consent
* Patients with history of colonic surgeries
* Patients with history of colonic motility disorder