cyrilzakka/clinical-trials huggingface dataset:
Effects of Scar Mobilization Versus Myofascial Cupping Technique on Cesarean Scar

Study focuses on comparing the effects of manual scar mobilization and myofascial cupping techniques on the outcomes of pain, physical characteristics, and appearance of cesarean scars. The study aims to contribute valuable insights into tailored interventions for improving cesarean scars. The randomized clinical trial will involve 52 participants, primigravida women aged 20 to 40 with completely healed but painful cesarean scars. Excluding those with previous scar therapy or infectious scars, the participants will be divided into two groups, with Group A receiving manual scar mobilization therapy and Group B receiving myofascial cupping therapy, both administered twice a week for four weeks. Pain assessment will be conducted using a numeric pain rating scale (NPRS), while physical characteristics and appearance will be evaluated using the Manchester Scar Scale for cesarean scars (MSS). The data collected will be analyzed using SPSS version 29.

A cesarean is a surgical procedure used to deliver a baby through an incision in the mother's abdomen and uterus. Manual scar mobilization and myofascial cupping techniques are some of the beneficial techniques to treat the scar. The research aims to understand the comparative effects of both techniques to know the potential benefits of these techniques on the outcome of pain, physical characteristics, and appearance of the cesarean scar. This study contributes valuable insights into comparing tailored interventions for improving the cesarean scar. This will be a randomized clinical trial conducted on 52 participants. Data will be collected from KulsoomShoukat Medical Complex, Faisalabad by using a non-probability convenience sampling technique. Primigravida women aged from 20 to 40 who have 6 months post cesarean completely healed but painful scars and who haven't undergone any scar therapy before will be included in the study. On the contrary, participants with any previous scar therapy or having infectious scars will be excluded from the study. A sample of 48 will be divided into 2 groups through random allocation. Group A will undergo manual scar mobilization therapy for 15 minutes on a cesarean scar twice a week. Group B will receive myofascial cupping therapy for 15 minutes twice a week. Treatment in both groups will be given for 4 weeks and pain will be assessed before 4 weeks and then after 4 weeks by a numeric pain rating scale (NPRS). Physical characteristics and appearance will be assessed by the Manchester Scar Scale for cesarean scar (MSS) in both groups pre and post-intervention. Data will be analyzed using SPSS version 29.

Eligibility Criteria:
Inclusion Criteria:

* Women with Pfannenstiel Cesarean section scar
* Primigravida
* Women who didn't undergo any scar therapy
* The age of the scar should be under 6 months
* Women with a completely healed scar
* Women with painful scar

Exclusion Criteria:

* Diabetic women
* Skin irritation or infection at the scar site
* Women with Diastasis Recti Abdominis
* Obese women (BMI\<35%)
* Women with Hysterectomy
Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1 or Type2 Diabetes

Assess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week) administration to Type 1 and Type 2 diabetes patients (non-smokers)

Pfizer announced in October 2007 that it would stop marketing CP-464,005. At that time recruitment for study, A2171105 was placed on hold. Nektar, the company from which Pfizer licensed CP-464,005, announced on April 9, 2008 that it had stopped its search for a new marketing partner. As a result, study A2171105 was terminated on April 10, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with Type 1 or Type 2 diabetes for at least 1 year, based on the diagnostic criteria for diabetes.

Exclusion Criteria:

* Patients who have smoked during the 6 months prior to screening (smoking shall be prohibited during the term of this study, as well)
* Patients exhibiting pulmonary function test (spirometry) abnormalities (FVC or FEV1 \< 70% of predicted) ) at Week -4.
Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study

This study was designed to investigate the effect of Gum Arabic (GA) on cancer patients to prevent chemotherapy-induced oral mucositis. Cancer patients who will receive chemotherapy were divided into two groups; study "Gum Arabic" group (which received GA with chemotherapy) and control group (chemotherapy alone); and the participants were recruited to reach 190 patients in the study group and 184 patients in control group. This clinical trial was conducted in outpatient chemotherapy sections at Radiation and Isotopes Center of Khartoum. This study was designed to test the theory that say the chemotherapy-induced oral mucositis will significantly decrease after ingestion 30 grams as daily dose of Gum Arabic in a form of solution for six weeks during therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients whom well diagnosed with cancer in any stage were eligible for enrolment if chemotherapy is part of their treatment plan.

Exclusion Criteria: Patients were excluded if

* they had received recent previous chemotherapy or radiotherapy,
* they had oral mucositis or periodontitis,
* there is evidence of any systemic diseases.
Product Performance of a Daily Disposable Contact Lens

The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch \& Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be females of Chinese descent and of legal age and no older than 38. OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent.
* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.

Exclusion Criteria:

* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Subjects who have any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or are using any ocular medication.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea.
* Subjects who are aphakic or amblyopic.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who currently wear monovision, multifocal, or toric contact lenses.
Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions in Healthy Adult Male Subjects

The treatment of allergic contact dermatitis (ACD) can be unsatisfactory, and that other skin diseases such as atopic dermatitis have an increased likelihood of ACD, improved systemic treatments are needed.

This research study explores the effectiveness of Baricitinib in treating Delayed-Type Hypersensitivity (allergic) versus Irritant Skin reactions. Subjects for this study need to be healthy males between the ages of 18 and 40. This study will evaluate this by injecting antigens as well as applying them on top of the skin to the forearm then measure the effects of Baricitinib by skin and blood testing.


Eligibility Criteria:
Inclusion Criteria:

* Males 18-40 years of age at the time of signing the informed consent document
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
* Able to adhere to the study visit schedule and other protocol requirements
* Must be in good health as judged by the Investigator, based on medical history and physical examination, and no laboratory abnormalities

Exclusion Criteria:

* Any known severe allergies to yeast products
* Currently active skin diseases such as psoriasis, atopic dermatitis, allergic contact dermatitis or irritant contact dermatitis
* Inability to understand informed consent
* Any medical condition that the investigator feels would interfere with study
* Any abnormalities on physical exam or screening laboratory studies (to progress to Part II)
* Agree to discontinue use of prohibited medications at least 4 weeks prior to screening:

topical corticosteroids, oral or injectable systemic steroids, systemic immunomodulators (cyclosporine, methotrexate, etc.), oral or topical antihistamines

* Positive reaction to tuberculin test (PPD) or negative control
* Negative reaction to initial skin testing for Candida, Trichophyton, or Sodium Laurel Sulfate
Effect of Saliva Substitutes on Dental Hard Tissues in Situ

Symptomatic hyposalivation is associated not only with Sjögren's syndrome or salivary gland hypofunction in elderly patients, but also with medications containing antimuscarinic drugs, chemo radiotherapy for head and neck carcinomas, and psychiatric disorders (Atkinson \& Ava, 1994, Kielbassa et al., 2006).

Human saliva possesses important physiological functions in protecting and moistening the oral hard and soft tissues (Piotrowski et al., 1992, ). Consequently, decreasing salivation causes oral dysfunction and promotes severe oral side effects (reduced antibacterial function, lack of remineralisation, reduced buffer capacity) (Tschoppe et al., 2010a). These have been identified as being responsible for the rapid destruction of the dentition (Willich et al., 1988). Saliva substitutes are frequently applied for relieving the symptoms in patients suffering from hyposalivation (Hahnel et al., 2009, Nieuw Amerongen \& Veerman, 2003, Vissink et al., 2004). Besides the moistening and lubrication of the oral mucosa, these products should also protect dental hard tissues. However, in vitro studies revealed that some marketed products have only a neutral or even a demineralising potential on enamel as well as on dentin (Kielbassa et al., 2001, Meyer-Lueckel et al., 2002, Smith et al., 2001, Tschoppe et al., 2009). Inorganic ions such as calcium, phosphates, and fluorides have been added to saliva substitutes in order to enhance their remineralising property or minimize their demineralising potential (Tschoppe et al., 2009). Furthermore, as most patients suffering from hyposalivation are elderly people, recessions and subsequently exposed dentin surfaces are very common. Since dentin is not as acid resistant as enamel, an earlier and more severe demineralisation can be expected (Saunders \& Meyerowitz, 2005).

Therefore, the current in situ study was performed to assess the effects of a demineralising and a remineralising saliva substitutes on the mineralisation of dental hard tissues. It was hypothesized that storage in Glandosane(cell pharm, Hannover, Germany) would not result in pronounced mineral loss of dentin specimens, and that storage in Saliva natura would not result in enhanced remineralisation when combined with a remineralising artificial saliva (Saliva natura supersaturated with respect to relevant calcium phosphates; medac, Hamburg, Germany) (H0). These null hypotheses were tested against the alternative hypothesis of a difference.

see application for the German Federal Institute for Drugs and Medical Devices at Eudra-CT

Eligibility Criteria:
Inclusion Criteria:

* stimulated salivary flow rate \< 0.5 ml/min
* partial denture upper or lower jaw
* radiationtherapy in the head and neck area
* patient age above 18 years
* Signed informed consent (AMG §40 (1) 3b)

Exclusion Criteria:

* stimulated salivary flow rate \> 0.5 ml/min
* missing partial denture upper or lower jaw
* missing Radiationtherapy in the head and neck area
* paraben allergy
* not signed informed consent (AMG §40 (1) 3b)
Comparison of Two Hysteroscopy Approaches

This randomized clinical trial compares two methods of diagnostic hysteroscopy: vaginoscopic hysteroscopy vs. traditional method. Pain intensity was estimated using a visual analogue scale (VAS), and patient satisfaction was evaluated. These endpoints were compared by treatment assignment. Vaginoscopic hysteroscopy was associated with significantly lower VAS scores, indicating reduced experience of pain in this treatment group; however, this was not associated with improved patient satisfaction.

OBJECTIVE: To compare the vaginoscopic approach of diagnostic hysteroscopy without anesthesia with the traditional diagnostic hysteroscopy after intracervical injection of Mepivacaine Hydrochloride 3%.

METHODS: A total of 130 women undergoing diagnostic hysteroscopy were included in the study and were randomized, using a computer-generated randomization list, into two groups with a ratio of 2:1. Eighty three women underwent vaginoscopy without speculum, tenaculum or anesthesia. Forty seven women received intracervical anesthesia with 10 ml of 3% mepivacaine hydrochloride solution injected at two sites (3:00 and 9:00 positions) and underwent traditional hysteroscopy using a speculum and tenaculum. Hysteroscopy was performed using a rigid 3.7 mm hysteroscope in a medium of 0.9% saline, and the image was transmitted to a screen visible to the patient. A Visual Scale Analogue (VAS) consisting of a 10 cm line was used to assess the intensity of pain experienced during and after the procedure. Overall patient satisfaction was assessed during, immediately after, 15 minutes later, and three days post hysteroscopy.

RESULTS: The mean pain score was significantly lower in the vaginoscopy group (3.8±2.7 vs 5.34±3.23, p=0.01). Patient satisfaction rate was similar in both groups.

CONCLUSION: Patients reported significantly less pain with the vaginoscopic approach to diagnostic hysteroscopy even without anesthesia compared to patients undergoing the traditional procedure with anesthesia. This new approach should therefore be considered as a replacement for the traditional hysteroscopic technique.

Eligibility Criteria:
Inclusion Criteria:adult female, referred for outpatient diagnostic hysteroscopy, subscriber to Maccabe health maintenance organization -

Exclusion Criteria:heavy vaginal bleeding; severe cervical stenosis; patients refusing the examination on an outpatient basis.

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PH-797804 LPS Study in Healthy Volunteers

The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in the sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female (WONCBP), non atopic volunteers aged 18-50 years
* Able to produce sputum

Exclusion Criteria:

* Current Smokers
* Abnormal liver function test
* Respiratory Tract Infection within 4 weeks
An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates

This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects. Pharmacokinetics of the probe substrate drugs will be measured prior to and following administration of multiple doses of BCX7353.

This is a single centre, single sequence, open-label, study to evaluate the effect of BCX7353 on hepatic and intestinal cytochrome P450 (CYP) 3A4 (midazolam IV and PO, respectively), CYP2C9 (tolbutamide), CYP2C19 (omeprazole) and CYP2D6 (dextromethorphan) enzyme activity using probe substrate drugs in healthy subjects. Pharmacokinetics of the probe substrate drugs will be measured prior to and following administration of multiple doses of BCX7353.

Twenty healthy male and female subjects are planned for dosing.

Each subject will receive the following treatments:

Day 1: 1 mg midazolam will be administered as an IV bolus simultaneously to administration of 500 mg tolbutamide, 40 mg omeprazole, and 30 mg dextromethorphan orally.

Day 2: a single oral dose of 2 mg midazolam. Days 3 to 9: 350 mg BCX7353 once a day. Day 10: 1 mg midazolam will be administered as an IV bolus simultaneously to administration of 500 mg tolbutamide, 40 mg omeprazole, 30 mg dextromethorphan and 350 mg BCX7353, orally.

Day 11: a single oral dose of 2 mg of midazolam along with 350 mg BCX7353.

Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent
* Body mass index 18 to 32 kg/m2
* Abides by study restrictions
* Attends all study visits and agrees to remain in study center for the confinement period
* Acceptable birth control measures for male subjects and women of childbearing potential

Key Exclusion Criteria:

* Clinically significant medical history, current medical or psychiatric condition. This includes a history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, or cardiac disease
* Clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline
* Poor or ultra- metabolizers of CYP2C19 or CYP2D6 Use of over the counter or prescription medication within 14 days of dosing and anticipated use through the follow-up visit
* Use of medication or consumption of any substance that is known to inhibit or induce metabolic enzymes or transporters within 30 days of dosing
* Participation in any other investigational drug study within 90 days of screening
* Recent or current history of alcohol or drug abuse
* Regular recent use of tobacco or nicotine products
* Positive serology for HBV, HCV, or HIV
* Pregnant or nursing
* Donation or loss of greater than 400 mL of blood within 3 months
* Serious adverse reaction or serious hypersensitivity to any drug
Methotrexate Adherence in Rheumatoid Arthritis Patients

This study was conducted for assessment of adherence of Rheumatoid Arthritis patients to Methotrexate as a gold standard drug for treatment of R.A. Moreover, evaluating the effect of drug adherence to patient quality of life.

Rheumatoid arthritis one of most common autoimmune diseases. characterized by numerous complications which may affect patient quality of life. Hence, this review aim to search the relation between patient"s drug adherence and clinical health outcome. our review utilizing survey as a tool to collect needed data from rheumatoid patients. survey consisted of number of questions , participants were required to answer these questions. participation to this questionnaire was optional.

Eligibility Criteria:
Inclusion Criteria:

1. The study was carried out among all RA patients (adults patients ≥ 18 years).
2. Patients not suffering from severe mental disorders.
3. Patients with a disease duration from (1-5) years.
4. Patients on MTX treatment from (1-5) years.
5. Patients taking MTX alone or in combination with other DMARDs.

Exclusion Criteria:

1. Patient who on MTX for more than 5 years
2. Patient who have complications like:-

   * History of liver or kidney disease
   * Diabetic patients
   * Hypertensive patients
   * Bone marrow hypoplasia
   * Leukopenia or significant anemia
   * Peptic ulcer or any GIT problems
   * Hereditary alopecia.
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU

The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.

It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 18 years old
* Patients with a diabetic foot ulcer as defined by Wagner grade 1 - 2
* ABPI of ≥0.6 to ensure ischemia will not impact healing
* No restriction on wound size or wound location
* Duration of ulcer ≥ 6 weeks ≤ 2 years
* The patient must be able to understand the trial and provide written informed consent
* No local or systemic signs of infection, with normal CRP and leukocyte levels below 10 000
* Wound has not been treated with PROMOGRAN® in 4 weeks prior to inclusion

Exclusion Criteria:

* Wound duration of less than 6 weeks or longer than 2 years
* Known hypersensitivity to any of the wound dressing used in the trial
* Current local or systemic antibiotics in the week prior to inclusion
* Patients with significant ischemia as defined by ABPI of ≤0.6
* Clinical infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema.
* Progressive neoplastic lesion treated by radiotherapy or chemotherapy
* Prolonged treatment with immunosuppressive agents or high dose corticosteroids
* Patients who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
* Patients with renal insufficiency (with eGFR values \<30 or on RRT) Life expectancy of \<6 months
* Patients with uncontrolled diabetes as determined by Hb-A1c ≥ 12% ( = Hb-1CIFCC ≥ 107.65 mmol/mol)
* Patients who have participated in a clinical trial on wound healing within the past month
* Patients who are unable to understand the aims and objectives of the trial
* Patients with a known history of non adherence with medical treatment
* Females who are pregnant
* Subject has Acquired Immunodeficiency Syndrome (AIDS) or is known to be infected with Human Immunodeficiency Virus (HIV)
* Subject has viral hepatitis