cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity

The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age;
* provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* be in good general health as determined by the Investigator/designee; and
* have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.

Exclusion Criteria:

* allergy to rosin or to pine nuts;
* self-reported pregnancy or nursing;
* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
* active treatment for periodontitis;
* fixed facial orthodontic appliances;
* any diseases or conditions that might interfere with the safe completion of the study; or
* an inability to undergo any study procedures.
Taping Versus Conventional Physiotherapy in Knee Osteoarthritis

The purpose of this study is to determine the effects of kinesio taping versus conventional physiotherapy in women with knee osteoarthritis.

* This study will be a Randomized control trial. The calculated sample size for this study was 68 (34 in each group). To compensate the expected dropouts the sample size was increased by 15 %. Hence the final sample size will be 80 (40 in each group).
* The participants of this study will be female patients having Grade.2 knee osteoarthritis aged in between 50 to 60 years having BODY MASS INDEX (BMI) range 25-29.9(Overweight), who are being referred to Dow Ojha Physiotherapy OUT PATIENT DEPARTMENT. The subjects will be divided into 2 equal groups through Randomization Technique (Coin toss).
* Intervention group will receive regular physiotherapy exercises with Kinesio tape application, Whereas Control group will be given the same exercises without Kinesio taping.
* First assessment will be done at the baseline and second(final) will be conducted at the end of 3rd week (after 9 sessions).
* Data will be analyzed through SPSS (Statistical Package for the Social Sciences) Version-26. For mean comparison of dependent variables among Experimental and Control group Repeated Measure two-way Analysis of covariance will be performed. P-value less than 0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with knee Osteoarthritis who are being referred to Physiotherapy OPD of Dow University Ojha Campus.
* Having grade-2 Osteoarthritis (mild).)
* Aged between 50 to 60 years.
* BMI (25-29.9) -Category Overweight .
* In case of bilateral knee pain, the most painful side will be identified for intervention to see the outcome.

Exclusion Criteria:

* Total knee replacement done or any other knee surgeries.
* Rheumatoid arthritis.
* Intra articular injections received within a month.
* Knee OA -grade1(doubtful), grade3 (moderate)and grade 4 (severe).
* Altered skin sensation around the knee area.
* Having known sensitivity to tape materials.
* Underlying skin disorders.
* Recent knee trauma or fracture.
German Colon Capsule Registry

Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This is to investigate safety, quality assurance and quality control of colon capsule endoscopy.

Colon capsule endoscopy (CCE, Pill Cam Colon 2, (Given Imaging Ltd, Yoqneam, Israel and Given Imaging EMEA, Hamburg, Germany) provides direct visualization of the colon mucosa, enabling the investigator to diagnose colonic disease. CCE is a complementary means to flexible ileo-colonoscopy andt safety, quality assurance and quality control of CCE is not well understood. There are about 15 000 investigations performed worldwide until now, but systematic data on performance in a community based setting are lacking.

This study aims to investigate safety, quality assurance and quality control of colon capsule endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Indication for colon capsule endoscopy
* Age of 18 years or older
* Consent of the patient

Exclusion Criteria:

* Intestinal obstruction
* Dyphagia
* Pregnancy
OPTImal Management of Antithrombotic Agents: OPTIMA-5

This is a prospective, randomized, open-label clinical trial which will enroll 80 acute coronary syndrome (ACS) patients after Percutaneous Transluminal Coronary Intervention (PCI) in China. Patients on maintenance dosing (MD) of aspirin (100 mg/d) and ticagrelor (90 mg twice daily) will be divided into two groups switching from ongoing ticagrelor to clopidogrel 600 mg loading dose (LD)/ 75 mg MD according to their bleeding risk. Then each group will randomly switch at different times(24 hours/ 12 hours after the last MD of ticagrelor). Pharmacodynamic assessments are performed at baseline, and at 4h, 8h, 24h, 48h, 72h hours with platelet aggregation rate by Light Transmittance Aggregometry method (LTA). All patients are followed-up for 30 days.

The primary endpoint of the study was platelet inhibition measured by Light Transmittance Aggregometry method(LTA). Secondary clinical endpoints included a 30-day major adverse cardiovascular endpoint (MACE) defined as a composite of cardiovascular death, recurrent myocardial infarction, target vessel revascularisation or stroke and individual components of the MACE. Safety endpoints of 30-day TIMI major and minor bleed were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years.
* ACS patients.
* Patients who are treated with ticagrelor and do not tolerate it.
* Volunteer to participate and sign informed consent.
* Approved by national regulatory authorities ethics committees.

Exclusion Criteria:

* Patients who are contraindicated, intolerant or resistant to clopidogrel.
* History of hematological disease or bleeding tendency; platelet count \< 100 × 10\^9 cells/L, or \> 600 × 10\^9 cells/L, hemoglobin \< 100 g/L.
* Abnormal liver or kidney function (ALT \> 3 ULN; estimated CrCl \< 30 ml/min calculated by Cockcroft-Gault equation); diagnosed severe pulmonary disease.
* Patients in need of drugs which affect the efficacy of clopidogrel such as miconazole, ketoconazole, andfluconazole.
* Malignancies or other comorbid conditions with life expectancy less than 1 year.
* Pregnant or lactating woman.
A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France

This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation,please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Participants with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease
* Decision to treat with adjuvant nivolumab therapy has already been taken
* Participants who provide oral informed consent to participate in the study

Exclusion Criteria:

* Any participant with a current diagnosis of persisting advanced melanoma
* Participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
* Any participants currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for OS/RFS can be enrolled. In case of a blinded study, the treatment arm needs to be known).
* Pregnant women
* Person under guardianship

Other protocol defined inclusion/exclusion criteria apply
A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a symptom of overactive bladder for more than 6 months.
* Patients who meet the following condition during the 3-day bladder diary period.

  * the mean number of micturitions per 24 hours is ≥8 times
  * the mean number of urgency episodes per 24 hours is ≥1 time

Exclusion Criteria:

* Patients who are diagnosed as stress urinary incontinence are predominant.
* Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.
Oxidative Stress Links Aging, Activity, and Mobility Limitation

The purpose of this study is to understand why and how oxidative stress negatively impacts mobility in the elderly, and to determine whether antioxidant supplements can increase vascular health and mobility.

With the premise that U.S. Veteran demographics reveal an aging population with significant mobility limitation and oxidative stress is tightly linked to both of these characteristics, a series of skeletal muscle/vascular studies are proposed. Specifically, in a series of recent studies the investigators' group has documented positive vascular consequences of antioxidant supplementation during exercise in older subjects that negatively impacted young people. Further provocative findings revealed that following exercise training the older subjects were now also negatively impacted by the antioxidant supplementation. These findings have implications for the understanding of the complex balance between the positive effects of exercise-based rehabilitation, exercise induced oxidative stress, aging, frailty, and subsequent mobility limitation. Therefore four specific aims are proposed that will answer the questions of where (I) oxidative stress is most prevalent in the elderly, why (II) oxidative stress occurs in the elderly, what (III) are the acute consequences of oxidative stress in the elderly, and finally how (IV) can exercise-induced oxidative stress as the result of exercise training in elderly be appropriately managed with exogenous antioxidant therapy to promote compliance and the positive outcome of increased mobility.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged either between 18 - 30 years (young group) and \>70 years (old group)
* Free of overt disease. Subjects will be non-obese (BMI \< 30) and have plasma glucose concentrations \< 7.0 mmol/L under fasting conditions and \< 11.1 mmol/L at 120 minutes of an oral glucose tolerance test (OGTT)
* Subjects will be sedentary, defined here as no regular physical activity for at least the prior 2 years
* Candidates must have no orthopedic limitations that would prohibit them from performing cycle or knee-extensor exercise
* All women will be postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years, and in women without a uterus, follicle stimulating hormone (FSH) \> 40 IU/L

Exclusion Criteria:

* Candidates demonstrating dyslipidemia based on the National Cholesterol Education Program Guidelines of plasma total cholesterol \> 240 mg/dl with LDL-cholesterol \> 160 mg/dl will be excluded from participation
* Candidates who smoke or are taking medications (blood pressure medications, statins, antioxidants etc.) that could influence the results of the study will not be eligible
* In terms of diet, subjects will be asked to maintain a dietary record for one week prior to the pre-screening and if this reveals a diet that differs substantially from the "typical" average diet in both the young and old, the subject will not be eligible
* Women currently taking hormone replacement therapy (HRT) in the preceding year will be excluded from the proposed studies
ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.

This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic Colorectal Cancer Patients with ALK mutation.


Eligibility Criteria:
Inclusion Criteria:

Patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; Patients with ALK mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;

Exclusion Criteria:

Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.
Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention

The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring:

1. changes in brachial artery flow-mediated dilatation (FMD) and
2. changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized, double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to the alternate treatment arm after a six-week washout period.

HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Member of the Michigan Lupus Cohort
* Meet the American College of Rheumatology (ACR) criteria for SLE
* Premenopausal

Exclusion Criteria:

* Smoker
* Diabetic
* Prednisone dose \> 10 mg
A Study of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.

Evaluate the safety and tolerability of ZG19018 in Patients with KRAS G12C mutant advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who fully understood this trial and voluntarily signed the informed consent form;
* Men or women ≥ 18 years old;
* ECOG Performance Status (PS) 0 or 1;
* Life expectancy \> 3 months.

Exclusion Criteria:

* Received any treatment with inhibitors against KRAS G12C mutation at any time, e.g., AMG 510, MRTX 849, etc.;
* Patients requiring medications that can potentially prolong QTc interval;
* Other conditions that the investigator considers to be unsuitable for participation in this study.
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2

The aim of the present split-mouth study was to investigate the effect of Hyaluronic Acid (HA) in improving the post-extraction tooth socket healing in subjects with diabetes mellitus type 2.

The null hypothesis was that HA can significantly improve the post extractive healing of diabetic patients compared with no treatment.

36 patients with diabetes mellitus type 2 requiring bilateral extraction of the homologous, not included, teeth were enrolled. After the extractions carried out in the same appointment, following the split-mouth design of the study, one site was randomly assigned to the test (T) group, while the other one was assigned to the control group (C).

T group included: Post-operative application of Hyaluronic acid gels 3 times per day

C group included: no treatment.

Patients were then followed after 3, 7,14 and 21 days and the healing of each socket was evaluated and compared between the 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old
* diabetic type 2 patients with glycaemia levels under control but with a positive history for diabetes complications (e.g., nephropathy, neuropathy, retinopathy, cardiopathy, peripheral vascular disease)
* agreement to be enrolled in the study
* availability to come at the control visit

Exclusion Criteria:

* presence of platelet dysfunction
* presence of thrombocytopenia
* corticosteroid treatment
* smokers
* refusal to participate in the study
* assumption of drugs possibly interacting with the wound healing
* extractions requiring the elevation of a flap
The Effect of Turkish Music on Pain and Anxiety During Childbirth

Nurses and midwives stand at the forefront during childbirth; their expertise in using natural pain relief techniques not only lessens the sensation of labor pain but also helps in calming the nerves of expectant mothers. These techniques are not only safe and easy to use but also kind on the pocket and devoid of any adverse effects. Such methods can make childbirth experiences as positive and comfortable as possible. Research has delved deeper into how music shaped by cultural tastes can significantly affect individuals, leading to a closer examination of how Turkish tunes influence discomfort and nervousness during labor. The goal of this research was to explore how Turkish melodies impact pain and anxiety feelings among women going through childbirth for the first time.


Eligibility Criteria:
Inclusion Criteria:

* primigravida women with term pregnancies (38-40 weeks) in the early active phase of labor
* cervical dilatation between 4 and 6 cm

Exclusion Criteria:

* Women who used narcotic analgesics or sedatives during labor
* listened to music during childbirth
* underwent induction
* delivered via cesarean section
Absorb GT1 Japan PMS

The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.


Eligibility Criteria:
Inclusion Criteria:

* General Percutaneous coronary intervention (PCI) population.

Exclusion Criteria:

* No specific exclusion criteria.
Autonomic Dysreflexia in Spinal Cord Injury

Autonomic dysreflexia in high spinal cord-injured can be initiated by a full bladder or bowel, or when trying to empty either. This randomised study aims at evaluating whether irrigation procedure or digital stimulation or evacuation of the rectum is less provocative of autonomic dysreflexia. Participants have their bowels emptied on different days, in the morning fasting. Bladder filling with sterile saline water is evaluated on a third day as a control.


Eligibility Criteria:
Inclusion Criteria:

1. People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia.
2. At least one year post injury.
3. 18 years or older.
4. Informed consent.

Exclusion Criteria:

1. Usage of prophylactic anti-autonomic dysreflexia medication.
2. Pregnant or breastfeeding.
3. People who is not able to follow the sudy protocol.
4. No former major surgery in the abdomen or pelvic region.
5. No former radiotherapy in the pelvic region.
Restoring Empowerment and Choosing Hope (REACH)

The goals of REACH are to help adults develop the skills they need to develop healthy relationship and marriage skills, improve ability to parent and co-parent effectively, identify and enhance skills and abilities required to gain or retain economic self-sufficiency, and foster family stability and increase successful marriage rates. Data from the tri-county region comprised of Sarasota, Manatee, and Charlotte counties demonstrates the presence of a number of risk factors affecting family stability, including high rates of single-parent households, births to unwed mothers, and high median rent costs compared to poverty rates and income. By providing families with relationship enhancement, parenting, and economic self-sufficiency services, this should help to optimize each family member's quality of life and improve child well-being.

REACH will serve a minimum of 337 individual adults during each full year of the five-year grant term in Sarasota, Manatee, and Charlotte counties on the Gulf Coast of Florida. REACH will target individual participants and, in cases where both members of a couple are interested in participating, will deliver services to each partner individually. The primary target population for REACH is low-income, at-risk individuals.

Coupled with its successful history of providing healthy marriage programming, JFCS is well-positioned to help families in crisis become more stable and self-sufficient. Understanding the inextricable link between financial security and family stability, REACH is targeting and reaching the most vulnerable individuals based solely on economic risk factors. REACH will incorporate a comprehensive employment program combining both job and career advancement. This will help families in crisis reach improved financial stability, which will in turn improve the ability of individual participants to be better parents and better partners, furthering the goal of promoting healthy marriages and reducing local divorce rates.

Eligibility Criteria:
Inclusion Criteria:

* adults age 18 or older
* interested in education about strengthening their current marriage or committed relationship
* reside in Sarasota, Manatee, and Charlotte counties on the Gulf Coast of Florida

Exclusion Criteria:

* under age 18
* do not reside in Sarasota, Manatee, and Charlotte counties
HD21 for Advanced Stages

Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective).

If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven classical Hodgkin lymphoma
* First diagnosis, no previous treatment, 18 to 60 years of age
* Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV

Exclusion Criteria:

* Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
* Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
* Prior chemotherapy or radiotherapy