cyrilzakka/clinical-trials huggingface dataset:
Chronic Effects of Estrogen in Microcirculation

This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention.

Estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen receptors. Traditionally, estrogen receptors have been recognized as transcription factors regulating the expression of target genes, however, numerous studies have revealed rapid actions of estrogen in different systems, so-called 'extranuclear actions'. At this level, estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular cell growth and migration, and confers protection to cardiomyocytes. Our aims are to investigate estrogen´s chronic effects on microcirculation.

The study will assess the potential benefits of estrogens on: chronic low-grade inflammation, metabolic profile, microcirculation and blood rheology. Postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion. At baseline and after intervention, nailfold videocapillaroscopy, laser-Doppler flowmetry and venous occlusion plethysmography, inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and anthropometrical measures will be assessed in all subjects.

Eligibility Criteria:
Inclusion Criteria:

* History of natural menopause defined by the absence of menses for at least 12 months and a serum concentration of FSH \> 35 IU/L
* BMI between 27 to 34.9 kg/m²
* Non-smokers
* Not on use of any hormones or supplements for a minimum of 6 months prior to the study
* No absolute contraindications to the use of physiological replacement doses of estrogen

Exclusion Criteria:

* Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases
* Diabetes mellitus, glucose intolerance or altered fasting glucose
Home-based Growth Charts in Indonesia

The investigators developed a home-based growth chart that offers a simple and inexpensive way for caregivers to have access to simple health and nutrition information guided by behavioural economics analysis as well as to track their child's linear growth, empowering them to act to improve their child's nutrition. Results from a pilot study conducted in rural Zambia suggest that growth charts installed in homes can increase awareness and reduce early-life growth deficits, particularly among children experiencing growth faltering. The main objective of this study is to assess the impact and cost-effectiveness of growth charts through a cluster-randomized trial in Indonesia. The primary outcome is child height-for-age z-score.

The study is divided into two phases. In the first phase, growth chart development activities will be conducted in two villages in each of Manggarai Timur and Trenggalek districts to ensure the chart design is compatible with the local context and chart information is understandable to caregivers. Focus group discussions (FGDs), key informant interviews (KIIs), and door-to-door user testing will be conducted in each village. Results from the FGDs and KIIs will inform a draft growth chart design that will then be user tested in 10 households in each village. Qualitative interviews will be conducted with each household approximately two weeks after chart installation to gather insights on the usability of the growth chart. The chart design will then be finalized for use in the second phase of the study.

In the second phase, 1,480 caregiver-child dyads will be recruited and enrolled in the study as part of a baseline survey. Dyads will be sampled using a two-stage procedure. 110 villages will be selected proportionate to national census population size. All sub-villages ("dusun") within selected villages will be randomly assigned into two groups: 1) Growth chart; and 2) Control. Eligible caregiver-child dyads with children between 9 and 14 months will be selected from each sub-village.

Eligibility Criteria:
Inclusion Criteria:

* Caregivers must be 19 - 55 years old
* One child of either gender, 9-14 months old
* Caregiver can have other children
* Caregiver of any occupation and income level
* Live in Manggarai Timur and Trenggalek during inception

Exclusion Criteria:

-Caregivers with a cognitive disability
Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome

Mycobacterial Lung Diseases in Virginia: sequencing and clinical determinants of relapse and outcome

Nontuberculous mycobacterial (NTM) lung diseases, primarily due to M. avium complex (MAC), are an increasing clinical problem nationwide and now overtake domestic TB in terms of morbidity and mortality. It is also harder to treat and results in poorer outcomes despite longer drug regimens. In this project we utilize a state-wide clinical cohort of NTM lung disease patients to understand what features of the organism (such as the species or subtype or drug resistance profile), the host (such as antibiotic drug absorption), and the environment (such as household exposure to NTM) are most important in predicting clinical outcome. The sum of this research will direct future therapies and management algorithms for this difficult disease.

First, we will perform whole genome sequencing of NTM isolates to discern relapse versus reinfection and the environmental sources of acquisition. Second, we will utilize a state-wide cohort of new and prior diagnosed NTM lung disease patients, starting initial therapy to correlate clinical outcomes with NTM species, drug susceptibility, other bacterial in vitro assays, and serum drug levels.

Eligibility Criteria:
Inclusion Criteria:

* All subjects:

  * Race/ethnicity: any
  * Subject has no history of active Tuberculosis in the last 2 years.
  * NTM culture positive from respiratory specimen (sputum or bronchial lavage fluid)
  * Subject must have an available sputum sample that was taken in the last 2 years. If a sample is not available, the subject must be willing and able to provide a sputum sample.
  * Meets the following Infectious Diseases Society of America (IDSA) criteria for NTM lung disease:

    * 2 or more sputum (or 1 bronchoscopy/biopsy) cultures positive for "Mycobacterium Avium Complex" or "Mycobacterium abscessus) within the last 2 years.
    * Nodules, cavities, and/or bronchiectasis on CT scan within the past 2 years
    * If if the above data are not available, but a patient's Infectious Disease or Pulmonary physician has documented the diagnosis of NTM lung disease in their notes, this will suffice

PK subjects:

* Newly diagnosed with NTM lung disease and beginning antibiotics for NTM within the last 3 months from enrollment.
* Prior diagnosis of NTM lung disease, and starting initial therapy within the last 3 months prior to enrollment.
* Consent to pharmacokinetic testing within one month of enrollment and at six months of therapy

Exclusion Criteria:

* List the criteria for exclusion

All subjects:

* Age \< 18 years
* Subject has cystic fibrosis or other inherited disorders of airway ciliary dysfunction (eg, primary ciliary dyskinesia)
* Unable to participate in follow-up requirements by phone or clinic visit

PK subjects:

• Unable to have blood drawn for pharmacokinetic testing
Antibacterial Effect of NaOCl With Etidronic Acid in Apical Periodontitis Treatment

Sodium hypochlorite (NaOCl), the most commonly used irrigation solution during chemomechanical preparation, plays a significant role in eliminating bacteria within root canals. Additionally, after preparation with different concentrations of NaOCl, 30% to 70% resistant bacteria were observed in the root canals. For this reason, new protocols have been developed to increase the effectiveness of NaOCl in chemomechanical preparation and to support disinfection within root canals. Recently, etidronic acid (1-hydroxyethane 1,1-diphosphonic acid \[HEDP\]), a biocompatible chelating agent, has emerged as an alternative irrigation solution. It has been suggested to combine and use this solution with NaOCl.

This study aims to evaluate the antimicrobial effectiveness of NaOCl in the root canal, which is used in combination with HEDP or sequentially with Ethylenediaminetetraacetic acid (EDTA) in the final irrigation after retreatment. Additionally, the effect of activation with Endoactivator (EA) on microbial reduction was assessed.


Eligibility Criteria:
Inclusion Criteria:

The study included teeth from patients aged 18-65 years who had no systemic disease and had not undergone antibiotic therapy in the past three months. To ensure standardization, all the treatments were performed by a single clinician.

1. A minimum of 2 years since the initial root canal treatment
2. Single rooted mandibular premolar with apical periodontitis (AP) and a canal filling within 4 mm from the apex on radiographic examination
3. The absence of pain on palpation and percussion, healthy periodontal tissues, and no mobility,
4. Presence of a coronal restoration (teeth that have not retained permanent restoration over the previous root canal treatment).

Exclusion Criteria:

1. Patients who have received antibiotic therapy in the last 3 months,
2. Patients with diabetes, pregnancy, immunosuppression and cardiovascular disease,
3. Absence of a coronal restoration
4. Presence of pain on palpation and percussion, mobility.
Short-time Intervention in Post-Covid Syndrome Syndrome (SIPCOV): A Pragmatic Randomised Controlled Trial

The present study is a 2-arm pragmatic randomised controlled trial (RCT) in which 310 patients who suffer from post-Covid syndrome are randomised to either a short-time outpatient-based rehabilitation program (the intervention) or care as usual in a 1:1 ratio. Assessments will take place immediately before randomisation (T0), after intervention or care as usual (T1), and 6 months after T1 (T2). Patients will be recruited from General Practitioners (GP's) as well as social media and self-referral to the involved institutions.


Eligibility Criteria:
Inclusion Criteria:

* Fulfils pragmatic diagnostic criteria of idiopathic post-Covid syndrome: a) Confirmed acute Covid-19 by a positive PCR for SARS-CoV-2; b) Persistent symptoms at least 3 months following acute Covid-19 without symptom-free interval; c) Functional disability to an extent that interrupts all or a majority of normal activities (such as work/school attendance, physical exercise, social activities, etc.)
* Lives in one of the following Norwegian counties: Oslo, Viken, Innlandet, Vestfold og Telemark, Agder
* Informed consent to participation

Exclusion criteria

* Other chronic illnesses or demanding life situations that might explain persistent symptoms and disability
* Sustained organ damage (lung, heart, brain) following acute, serious Covid-19
* Bedridden
* Insufficient command of Norwegian language
Laser Hemorrhoidoplasty Versus Open Surgical Hemorrhoidectomy in Second and Third Degree Piles

The study aims to compare the pain , duration of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

Hemorrhoidal disease is ranked first among diseases of the rectum and large intestine, and the estimated worldwide prevalence ranges from 2.9% to 27.9%, of which more than 4% are symptomatic .

Age distribution demonstrates a Gaussian distribution with a peak incidence between 45 and 65 years with subsequent decline after 65 years .Men are more frequently affected than women .

The anorectal vascular cushions along with the internal anal sphincter are essential in the maintenance of continence by providing soft tissue support and keeping the anal canal closed tightly. Hemorrhoids are considered to be due to the downward displacement of suspensory (Treitz) muscle .

There are many treatments of hemorrhoids varying from medications and band ligation to stapled hemorrhoidopexy, laser photocoagulation, sclerotherapy, Doppler-guided artery ligation, and finally surgery .

The indications for the surgical treatment include the presence of a significant external component, hypertrophied papillae, associated fissure, extensive thrombosis or recurrence of symptoms after repeated RBL. The technique employed may be open (Milligan-Morgan) or closed (Ferguson) .

Post hemorrhoidectomy pain is the commonest problem associated with the surgical techniques. The other early complications are urinary retention (20.1%), bleeding (secondary or reactionary) (2.4%-6%) and subcutaneous abscess (0.5%). The long-term complications include anal fissure (1% -2.6%), anal stenosis (1%), incontinence (0.4%), fistula (0.5%) and recurrence of hemorrhoids .

The study aims to compare the pain , duration time of intervention and long term outcomes of laser hemorrhoidoplasty versus open surgical hemorrhoidectomy

Eligibility Criteria:
Inclusion Criteria:

* II-III hemorrhoidal disease
* failure of conservative treatment

Exclusion Criteria:

* grade IV
* acutely thrombosed haemorrhoids
* patients affected by IBD involving rectum or anus
* patients previously surgically treated for hemorrhoidal disease and the inability to complete study protocol
The Effects of Dietary Intake of Cod Residual Material Meal on Lipid Regulation, Glucose Regulation and Body Composition in Physically Active Adults

A high intake of fish is associated with positive health effects, including prevention and treatment of chronic non-communicable diseases, such as cardiovascular diseases (CVDs) and type 2 diabetes. These health effects have traditionally been attributed to the omega-3 fatty acids in fatty fish, but recent studies have suggested that also fish proteins may improve biomarkers of metabolic disease. Intake of cod fillet have previously shown beneficial effects on blood lipids, glucose regulation and body composition in adults with overweight or obesity. Health effect of cod residual material from fillet production (i.e., head, backbone, skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish species have shown promising effects on glucose regulation in rats. The main aim of the current study is to investigate the effects of cod residual meal on serum lipids and glucose regulation in healthy, physically active adults.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 18.5 kg/m2
* Fasting blood glucose ≤7 mmol/L
* Physically active
* Percent body fat, 5-25 % for men and 12-35 % for women

Exclusion Criteria:

* Allergies towards fish, milk, egg, gluten
* Tobacco use \> 10 cigarettes (or snus) per day
* Diseases affecting the heart, intestinal function, kidney function or insulin secretion
* Medications targeting cholesterol -or glucose metabolism, hypertension
* Use of dietary supplements
* Pregnancy or lactation
Peri-implant Papillary Height Comparison in Microsurgically and Macrosurgically Placed Dental Implants

This study compares the peri-implant soft tissue and crestal bone loss around single implants when placed macrosurgically and microsurgically.

Black triangles in dentition especially in the anterior teeth would pose an esthetic concern. Interdental papilla height is crucial for eliminating this black triangle.

32 participants, 16 in two groups were assigned randomly. Microsurgical approach using microsurgical instruments and magnifying loupes were used for one group participants and similar procedure without magnifying loupes and microsurgical instruments was done in the other group.

comparsion of the microsurgical outcome is done by measuring peri implant papilla gain and radiographic crestal bone loss will be done between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients desiring implant placement for replacement of missing tooth and willing to participate in the study

  * Non smokers
  * Patients who do not report any relevant medically comprimising conditions or had not received any radiation therapy in head and neck region for cancer therapy.
  * Subjects with satisfactory residual ridges who demonstrated adequate bucco-lingual and mesio-distal space for implant placement, that facilitates primary stability.
  * Patients who demonstrate Plaque Index \<10% and good compliance.
  * Full mouth bleeding scores ≤25% before the implant placement.
  * Sites with sufficient band of keratinised mucosa.

Exclusion Criteria:

* • Pregnant and lactating females

  * Patients on anticancer therapy and immunosuppressant drugs.
  * Implants to be placed in sites with previous periodontal disease
  * Bleeding disorder or on anticoagulant therapy
  * Systemic diseases that would negatively influence wound healing
Rehabilitation for Arm Coordination and Hand Movement in Systemic Sclerosis

The purpose of this study is to test two rehabilitation programs to improve arm function for patients with scleroderma. This is a Phase 2 randomized controlled trial in which participants will be assessed at baseline, 8 weeks, and 18 weeks. Participants will be randomized into an intensive intervention (8 individual sessions of occupational therapy plus a home exercise app) versus a home app treatment alone. The results of this study will be used to design a large multi-site trial in which optimized rehabilitation strategies can be used to help patients improve their arm function.

The specific aims of this study are to:

1. Determine the short and longer-term effects of an intensive (8-week in-person occupational therapy treatment with prescribed home exercises) on improving arm function versus home exercise alone.

   This study's hypothesis is that immediately following treatment at 8 weeks and at 18 weeks, participants randomized to the in-person occupational therapy will have significant improvements in the QuickDASH disability measure, PROMIS physical function measure, and total active hand function compared to the home exercise alone.
2. Determine how adherence to home exercise in both groups influences treatment effects.

This study's hypothesis is that adherence will independently predict improvement in outcomes at 8 and 18 weeks regardless of treatment group assignment and that higher adherence to the home exercise program will result in greater and more long-lasting improvements.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of systemic sclerosis including:

  * Diffuse cutaneous subset
  * Disease duration \< 5 years from 1st non Raynaud phenomenon sign or symptom
* Have a contracture of the hand and other joint in at least one arm, such as wrist, elbow, or shoulder, with the ability to demonstrate active range of motion in that arm
* Willing to travel to participate in therapy and outcome assessments.
* Have an Android, iPhone, iPad or computer tablet to load the home exercise App.
* English speaking

Exclusion Criteria:

* issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to use home exercise app, etc.)
Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars

Recently, few studies have attempted to test the regenerative effects of human insulin application by microneedling on atrophic scars versus other topical preparations. However, the scars were limited etiologically to acne scars. In addition, a lack of inclusion of a control group instead of comparing topical preparations with insulin was also a limitation to these studies. A control group consisting of microneedling alone would have served as a better comparison in order to determine whether the effects of microneedling are augmented by topical protein-rich preparations.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 12 to 60 years
2. Atrophic scars (traumatic or surgical)
3. Completely healed scars

Exclusion Criteria:

1. Patients with a tendency or history of hypertrophic or keloidal scars
2. Patients who received treatment for their scar in the past 3 months
3. Diabetic patients or those with a history of Dysglycemia
4. Pregnant, or lactating females
5. Patients with active infection at the site of scar
6. Patients currently receiving isotretinoin treatment or in the past month
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III, Cross-over)

The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo. An additional baseline-controlled open-label arm will be included to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with JEB and to RDEB subjects \< 1 year.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects with a diagnosis of RDEB or JEB confirmed by genetic testing or by a skin biopsy with immunofluorescence mapping (IFM);
2. Subject is eligible to participate in this clinical trial based on general health condition;
3. Subject with a target wound meeting the following criteria: 5-50 cm2, ≥ 21 days and \< 9 months, no signs of acute infection;
4. Patient/legal representative understands the nature of the procedure and provide written informed consent/assent prior to any clinical trial procedure;
5. Women of childbearing potential must have a negative urine pregnancy test at Visit 1. Women of childbearing potential, male participants, and their partner must be willing to use highly effective contraceptive methods during the course of the entire clinical trial.

Exclusion Criteria:

1. Any current tumor diseases, including squamous cell carcinoma and basal cell carcinoma;
2. Any known allergies to components of the IP or premedication;
3. Patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol;
4. Pregnant or lactating women;
5. Current or previous (within 30 days of screening) treatment with another IP, or participation and/or under follow-up in another interventional clinical trial;
6. Previous participation in this clinical trial (except for screening failures);
7. Clinically significant or unstable concurrent disease or other clinical contraindications like an uncontrolled or poorly controlled mental health condition of the subject and/or his/her legal representative that could impact on patient's safety or interfere with study compliance such as inability to attend scheduled study visits; Confidential
8. Employees of the sponsor, or employees or relatives of the investigator.