cyrilzakka/clinical-trials huggingface dataset:
Comparison of Low-Level Laser Therapy and Transcutaneous Electrical Nerve Stimulation for Myofascial Pain in Temporomandibular Disorders

Myofascial pain is the most common form of temporomandibular disorder (TMD) encountered in maxillofacial practice. Treatment options range from conservative management to open surgical procedures, with physical therapies identified as the safest and most effective. Among these, transcutaneous electrical nerve stimulation (TENS) is a widely used technique, while low-level laser therapy (LLLT) is a recent therapeutic advancement. This study is designed to compare the efficacy of these two therapies, aiming to identify the more effective option.

A randomized clinical trial will be conducted at the Oral and Maxillofacial Surgery department, Punjab Dental Hospital, Lahore. Sample size of 40 patients will be selected through convenience sampling and divided into two equal groups, based on computergenerated random numbers. A written consent will be obtained from all the participants. Group A will receive LLLT, while Group B will receive TENS. The primary variables like pain score and mouth opening will be recorded preoperatively and during followup sessions. The proforma used for data collection will be designed, tailored to the needs of this study based on standard Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Both groups will receive their assigned therapies on alternate days for three weeks, with evaluations at 1st, 3rd, and 4th weeks post-treatment. All collected data will be entered into SPSS version 25 for statistical analysis. Independent sample t-test will be used to compare the mean pain score and mouth opening between the two groups. Repeated measures ANOVA will be applied to compare the primary variables in both groups on all follow-ups. P-value ≤0.05 will be considered as significant.

This study aims to offer tailored insights and practical recommendations, potentially improving patient care by providing safer and non-invasive alternatives to more invasive procedures thus enhancing overall treatment strategies. It is assumed that expected results shall be in favor of the LLLT group. Possible limitations may include failure of patients to come for multiple sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed cases of myofascial pain in TMD patients, which fall under diagnostic criteria (DC/TMD).
2. Myofascial pain that persists for more than 3 months.
3. Involvement of trigger points in the masseter and temporalis muscles.
4. Impaired or limited mouth opening (less than 35mm).

Exclusion Criteria:

1. Congenital abnormality or neoplastic condition around TMJ.
2. Recent history of trauma affecting head and neck region.
3. Patients with known dermatological disorders (eczema, psoriasis).
4. Patients with pacemakers and cardiovascular diseases.
5. Epileptic patients.
6. Patients allergic to adhesive tapes or electrodes of TENS
Dose Finding Study of HP802-247 in Venous Leg Ulcers

This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.


Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
* Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.

Exclusion Criteria:

* Women who are pregnant or lactating
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* A target ulcer of non-venous etiologies.
* Refusal of or inability to tolerate compression therapy.
* Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.
* Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.
Recommendations for a Radiotherapy Comfort Intervention Package Radiotherapy

A consensus study using nominal group technique is planned to develop recommendations for a comfort intervention package for radiotherapy with patients and therapeutic radiographers. This includes completed work from a systematic literature review (Prospero 59688) of comfort interventions applicable to radiotherapy and qualitative interviews (NCT03984435) with patients and therapeutic radiographers exploring comfort management in radiotherapy.

Study Design

The aim of this study is to develop a radiotherapy comfort intervention package with patients and therapeutic radiographers.

The objectives are to:

Objective 1 - Identify and prioritise intervention components for inclusion in recommendations for a radiotherapy comfort intervention package.

Objective 2 - Determine the feasibility of delivering the component of the radiotherapy comfort intervention package.

Modified nominal group technique (NGT) will employed to develop recommendations for a comfort intervention package in radiotherapy in a consensus study with patients and therapeutic radiographers. This study follows earlier phases of the COMFORT study which included a systematic literature review of comfort interventions applicable to radiotherapy and qualitative interviews exploring comfort management in radiotherapy.

Study Participants

Patients

The inclusion criteria are: 1) diagnosed with a malignancy; 2) aged over 18 years owing to different treatment options for children and young adults; 3) recently referred for radiotherapy, currently receiving treatment or had had radiotherapy within the previous 3 months; 4) treatment delivery time exceeding 10 minutes (the time the patient is immobilised on the radiotherapy couch).

Therapeutic radiographers

The inclusion criteria are: 1) practicing radiographers; 2) administering radiotherapy with treatment delivery times exceeding 10 minutes per radiotherapy treatment session (the time the patient is immobilised on the radiotherapy couch).

The consensus study will be conducted by video conference.

Planned Size of Sample (if applicable)

6-12 participants (4-9 Patients and 2-3 Therapeutic radiographers)

Follow up duration (if applicable)

Follow up is not planned.

Planned Study Period

6 months

Research Question/Aim(s)

The aim of this study is to develop recommendations for a radiotherapy comfort intervention with patients and therapeutic radiographers.

Eligibility Criteria:
Inclusion Criteria:

Patients and therapeutic radiographers who previously participated in COMFORT study interviews

Exclusion Criteria:

Patients and therapeutic radiographers who did not participate in COMFORT study interviews
A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages

To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.


Eligibility Criteria:
Participants must meet all of the inclusion criteria to participate in this study:

Inclusion Criteria

1. Ability and willingness to give written informed consent and comply with follow-up requirements
2. PAD with Rutherford Class 2-5
3. Stenotic lesion(s) in the peripheral vasculature
4. Subject is a candidate for atherectomy for infrainguinal peripheral artery disease

Angiographic Inclusion Criteria

1. Target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by Investigator)
2. Target vessel ≤ 3.0 mm in diameter
3. Target Lesion ≤ 25cm in length
4. The lesion to be treated is not severely calcified
5. Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access
6. No use of another atherectomy device in the same procedure
7. Treatment site is not located in a graft
8. Treatment site is not in, or distal to, a previously placed stent
9. No flow limiting dissection proximal, distal, or in the target lesion (prior to the use of the investigational device)

Participants meeting any of the exclusion criteria at the time of enrollment (index procedure/ intervention) will be excluded from study participation:

Exclusion Criteria

1. Age below 22 years
2. Pregnant, breastfeeding, planning to become pregnant. If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately.
3. Myocardial infarction (MI) ≤ 60 days prior to procedure
4. Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure
5. Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure
6. Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast
7. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated
8. Life expectancy ≤ 12 months
9. Patient is participating in another investigational drug or device study
Health and Environmental Effects of Boiler Management Systems in Social Housing

The purpose of this study is to evaluate the impact of a passive safety measure, namely a reduction in centrally controlled hot tap water temperatures in social housing using a boiler management system, as an effective public health intervention.

The annual hospital admission rate in England for burns and scalds is 31 children per 100,000 population. While reducing the temperature in domestic hot water tanks is a recommended injury prevention strategy, the UK has been slow to adopt such 'passive' safety measures. However, Camden Council employs a Boiler Management System (BMS) in boiler houses to centrally set the hot water temperature for parts of its social housing stock, providing the opportunity to evaluate various impacts of a 'passive' safety measure, including quantifying the effects of the BMS on average hot water temperatures at delivery, annual energy costs, and annual greenhouse gas emissions; modelling the reduction in scald injuries; identifying the cost-effectiveness of the system as a public health intervention; as well as describing experiences/ perceptions of risk of scalding and identifying health and social benefits of the BMS. Boiler houses with BMS will be randomised to remain at their constant set temperature or to BMS reduced temperature and sterilisation programme. A process evaluation will also be undertaken to assess the acceptability of water temperatures to tenants.

Eligibility Criteria:
Inclusion Criteria:

* Individuals living in social housing in the London Borough of Camden where the Boiler Management system has been installed.

Exclusion Criteria:

* Aged under 18 years
Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions

To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers


Eligibility Criteria:
Inclusion Criteria:

* 18≤ age ≤ 45, male or female;
* Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m\^2 (inclusive);
* Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
* The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.

Exclusion Criteria:

* Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
* Participants with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator;
* Participants with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history);
* With positive alcohol breath test;
* Volunteers may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.
The Effect of Probiotics on Symptoms of Infantile Colic

The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.

Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.

The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female.
2. Age ≤ 8 weeks old.
3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behaviour for 3 or more hours per day, during 3 or more days in 7 days.
4. Exclusively breastfeeding and planning to breastfeed for duration of study.
5. With a written informed consent signed by the father, mother, or legal guardian, and with expressed or implied consent of the other parent.
6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and telephone calls.

Exclusion Criteria:

1. Birthweight \< 2500 g.
2. Gestational age \< 37 weeks.
3. Apgar score at 5 minutes \< 7.
4. Partially or fully formula fed infants, with the exception of the first 4 days after birth.
5. Stunted growth/weight loss (\< 100 g/week from birth to last reported).
6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases or gastrointestinal malformations.
7. Fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
8. Genetic diseases and chromosomal abnormalities.
9. Metabolic diseases or pancreatic insufficiency.
10. Immunodeficiency.
11. Neurological diseases.
12. Suspected or confirmed food allergies and intolerances.
13. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening.
14. Use of anti-colic medication at any time from birth to the moment of screening.
15. Use of probiotic supplements by the mother between the birth of their infant and the moment of screening.
16. Currently enrolled in another clinical study or having participated in another clinical trial from birth to the moment of screening.
A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue

Investigation of a tear-based, lab-developed biological test for breast cancer, as a supplemental tool to current screening recommendations for women with dense breast tissue will explore if a tear-based biological test can be used as a support tool in the breast cancer screening protocol for women with dense breast tissue. The test was designed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.


Eligibility Criteria:
Inclusion Criteria:

Categorized as having heterogeneously dense or extremely dense tissue 18 years of age or older Able to understand the informed consent process Willing to comply with all study procedures

Exclusion Criteria:

Have an active eye infection Categorized as having fibro glandular densities or fatty breast tissue Currently diagnosed or are receiving treatment for breast cancer Under 18 years of age
Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar

Evaluation of cesarean scar using saline-infused sonography in women with history of cesarean scar pregnancy.

Over the past few decades, cesarean delivery rates worldwide have risen considerably. The surgery may lead to deficient uterine scar healing, thinning of the myometrium and formation of cesarean scar defects or uterine scar niche. The prevalence of clinically relevant cesarean scar defects is unclear and has been reported between 20-88%, it is identified by using transvaginal ultrasound or saline-infused sonography in non-pregnant patients. Women may be asymptomatic or present a wide gynecologic sequela including cesarean scar pregnancy, abnormal uterine bleeding, dysmenorrhea, chronic pelvic pain, infertility, and increased risk of complications during gynecologic procedures such as uterine evacuation and insertion of intrauterine device.

Cesarean scar pregnancy (CSP) is defined as an early pregnancy implantation in the scar from a prior cesarean delivery. This pregnancy is implanted in a fibrous scar tissue and may lead to substantial risk for severe maternal morbidity such as adherent placenta, second or third trimester uterine dehiscence or rupture, severe maternal bleeding, and adherence to adjacent tissues. The prevalence of scar pregnancy is reported to be between 1:1800-2500 pregnancies, with increasing diagnosis in the last decade due to increasing use of transvaginal ultrasound early in pregnancy and possible increased physician awareness of this condition.

The ultrasound criteria for CSP have been redefined recently, and now propose transvaginal ultrasound as the imaging technique of choice at this early stage. In 2022, the Niche Task-force convened a Delphi consensus to develop a standardized sonographic evaluation and reporting system for a CSP in the first trimester. According to this consensus, CSPs were classified into three subgroups, Subgroup A in which the largest part of the gestational sac protruded towards the uterine cavity, subgroup B in which the largest part of the gestational sac was embedded in the myometrium, and subgroup C in which the gestational was partially located outside the outer contour of the cervix or uterus. This sonographic classification has yet to be validated clinically.

In the present report the investigators aim to evaluate the uterine cavity and potential cesarean scar defects or niche in women with history of CSP using saline infused sonography. In the second stage of the research, we will classify the past cesarean pregnancies according to the new Delphi criteria and examine correlation between the different CSP subgroups and presence of cesarean scar defects.

Eligibility Criteria:
Inclusion Criteria:

* women with history of cesarean scar pregnancy

Exclusion Criteria:

* ongoing pregnancy
* vaginal bleeding
* active or suspected inflammation of genital tract including pelvic inflammatory disease
* women engaged in unprotected intercourse
* presence of intra-uterine device contraception
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fed Condition

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 × 75 mg of Bristol-Myers Squibb/Sanofi Pharmaceuticals, USA. Dosing periods were separated by a washout period of 7 days.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P. Respiratory rate less than 12/minute or more than 20/minute History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse Positive breath alcohol test Recent history of kidney or liver dysfunction. History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc. History of heart failure. HIV, HCV, HBsAg positive volunteers. Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder. Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Knowledge of Living Will in Patients With Rheumatic Diseases

The living will is a legal document derived from a communication and deliberation process, medical ethical aspect, currently regulated in Mexico by the General Health Law and the Health Law of Mexico City.

Knowledge of living will in the population with chronic diseases, including rheumatic diseases, has been little addressed. Most patients do not know what the living will document is, so they do not carry it out and others, despite knowing it, have a passive attitude toward doing it.

A study will be carried out on patients with rheumatic diseases and healthy family controls. Patients will be selected from those attending the Department of Immunology and Rheumatology in Mexico City outpatient department, including consecutive cases.

The patients will be assessed for their quality of life and disability. Patients and controls will be evaluated on the knowledge of living will, their perceptions about specific health outcomes, sociodemographic characteristics, comorbidities, and psychiatric pathology.

Eligibility Criteria:
Inclusion Criteria:

Cases

* Patients with a rheumatic disease diagnostic by a rheumatologist
* Patients with rheumatic diseases attending the Department of Immunology and Rheumatology in Mexico City outpatient department
* Patients who agree to participate in the study, who complete and sign the informed consent Controls
* Relative of a patient with rheumatic diseases of the same sex and age ± 5 years, without known rheumatic and/or chronic disease and without the use of pharmacological treatment for more than 7 days during the month before study entry.

Exclusion Criteria:

Cases

* Patients with severe diseases or in palliative care by a rheumatologist

Controls

- Withdrawal of the study