cyrilzakka/clinical-trials huggingface dataset:
Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream

The purpose of this study is to determine the safety potential of Helioblock® SX Cream as a sunscreen product in long term intermittent use conditions among pediatric subjects.. Each subject will be enrolled to participate for six months. The test product should be applied every day that outdoor activities are planned, prior to any significant sun exposure during out-door activities (such as the beach, outdoor sport activities), or whenever the subject needs to be protected against sunburn or other damage due to the sun. A minimum of 14 days test product use and sun exposure is required.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of any race or skin type, 6 months to 12 years of age inclusive, willing to use the test product intermittently for six months during outside activities

Exclusion Criteria:

* Subjects with known sensitivities to any of the study ingredients or subjects with a condition or in a situation, which in the Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or interfere with the subject's participation in the study.
* Subjects who are pregnant or lactating
Spinal Manipulation for Treatment of Chronic Headaches

This study will determine the effectiveness of spinal manipulation in reducing pain in people with chronic headaches accompanied by neck pain. This study will also determine the number of spinal manipulation treatments necessary for optimal pain relief.

Spinal manipulation is the signature therapy of chiropractic care involving manual adjustment of joints in the neck and back. Data indicate that spinal manipulation is an effective treatment for back pain and chronic headaches, particularly cervicogenic headaches, which are caused by problems in the cervical spine. However, studies that have determined the optimal frequency and duration of spinal manipulation treatment are limited. This study will determine the feasibility of conducting a large spinal manipulation clinical trial. This study will also determine the effectiveness of spinal manipulation in treating cervicogenic headaches and neck pain and the optimal number of treatments necessary to sustain spinal manipulation benefits.

Participants will be randomly assigned to receive weekly sessions of either spinal manipulation or light massage treatments for 8 to 16 weeks. Self-report scales will be used to assess participants' headache frequency, pain, satisfaction with treatment, and overall physical and mental health. Assessments will occur at study entry, at the end of each week, and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* History of cervicogenic headaches

Exclusion Criteria:

* Contraindications to spinal manipulation or massage
* Use of chiropractic or therapeutic massage care prior to study entry
* Use of any prophylactic prescription medication
* Involved in any type of lawsuit prior to study entry
* Headaches with several different causes
Community-based Intergenerational Oral Health Study

The purpose of this study is to determine whether giving brief motivational interviewing counseling during the prenatal and/or postnatal period(s) will increase utilization of preventive dental care and improve the oral health of rural, low-income pregnant and postpartum women and their children, and to increase the number of home oral health practices taken by these women to prevent caries in their young children.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant (week 26 or earlier)
* At least 15 years of age
* Medicaid eligible
* Speaks English
* Willing and able to comply with study instructions
* Mother AND child available for length of the study (\~ 24 months)

Exclusion Criteria:

-
Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy

The trial is to test the resolution of pain, swelling and other signs of periapical infection and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as root canal irrigant in Pulpectomy treatment for children.

To compare the effectiveness of neem leaf extract with that of Chlorhexidine gluconate when used as an intracanal irrigant in primary molar teeth indicated for pulpectomy treatment.

P: children with primary necrotic molars indicated for pulpectomy I: Neem leaf extract (alcoholic solution). C: 2% chlorhexidine gluconate. O: Pain and swelling resolution. T:Over 12 months. S: Randomised controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient and parent cooperation.

  * Absence of any systemic disease that would contraindicate pulp therapy.
  * Non vital molar teeth presenting with an acute or chronic periapical infection as a result of pulp necrosis ( Periapical abscess ,a sinus tract formation as a sequelae )
  * Making sure the patient is not taking an antibiotic and has not taken it for the past 2 weeks.
  * Absence of physiologic or pathologic root resorption that contraindicate pulp therapy.
  * Restorable teeth
  * Molars with at least two thirds of root remaining.

Exclusion Criteria:

* Children with any condition that contraindicates pulp therapy will be excluded (rheumatic fever, infective endocarditis , leukemia , corticosteroid therapy and immunosuppressed children).
Integration of Intraoperative Neuromonitoring Into Decompression Surgery

To describe a novel technique by integrating the intraoperative neurophysiological monitoring (IONM) into laparoscopy to protect pelvic nerves by continuously monitoring when they are at risk during surgery.

We integrated intraoperative neuromonitoring system into laparoscopic lumbosacral plexus nerve decompression surgery and simultaneusly recorded nerve roots from lumbar 5 to sacral 4 during the operation. Diseases that cause pelvic nerve compression such as abnormal vascular conflict, aberrant priformis muscle, and endometriosis have settled in hard-to-reach deep areas of the pelvis. Sacral and sciatic nerves might be damaged when performing decompression surgery in these deep pelvic areas. We described a novel technique by integrating the intraoperative neurophysiological monitoring (IONM) into laparoscopy to protect pelvic nerves by continuously monitoring when they are at risk during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptoms of chronic pelvic pain , dyspareunia, dysmenorrhea and severe, burning sharp pain on the lower extremity dermatomes, which had been present for at least one year were included.

Exclusion Criteria:

* Patients who underwent laparoscopic decompression surgery but did not give informed consent were not included in the study.
Internet Walking Program and Pedometer in Chronic Obstructive Pulmonary Disease

Higher levels of physical activity are associated with better functional status, fewer hospital admissions, and lower mortality. The investigators studied the feasibility and safety of a novel program that combines a pedometer with a website to increase walking. This is a pilot study.


Eligibility Criteria:
Inclusion Criteria:

* COPD
* able to ambulate
* internet access

Exclusion Criteria:

* current pulmonary rehab
Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis

Mesenchymal stem cells (MSC) are stromal cells that have the ability to self-renew and also exhibit multilineage differentiation. MSCs can be isolated from a variety of tissues, such as umbilical cord, bone marrow, and adipose tissue. The multipotent properties of MSCs make them a promising option for the treatment of osteoarthritis (OA).

Bone marrow mesenchymal stem cells (BM-MSC) and adipose derived mesenchymal stem cells (AD-MSC) have been used separately to treat OA. The aim of the present study will be to compare in a randomized non blind controlled clinical trial 3 types of intra-articular injections containing MSC populations obtained from two clinically relevant sources: BM-MSC, AD-MSC and a combination of both BM-MSC and AD-MSC.

The aim of the present study will be to compare 3 types of intra-articular injections of MSC populations obtained from two clinically relevant sources: injections containing BM-MSC or AD-MSC or a combination of both BM-MSC,and AD-MSC in a randomized non blind clinical trial.

To assess the efficacy and safety of 3 kind of MSC injections in relation to pain, function and quality of life in patients with knee OA.

A total of 54 patients with the diagnosis of knee OA grade II and III will be recruited to receive a single intra-articular injection of MSC: Group 1 (n 18 patients) will receive BM-MSC, Group 3 (n 18 patients) will receive AD-MSC. Group 3 (18 patients) will receive a combination of BM-MSC and AD-MSC.

A randomized non blind clinical trial with active control. For this purpose, the random number generator is 54, found on the RANDOM.ORG ® website (available at https://www.random.org/integers/)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 70 years, with grade II and III knee OA, according to the Ahlbäck classification will be included.
* Minimal VAS pain score of 4.
* Chronic knee pain of mechanical origin.
* All patients who sign a specially prepared informed consent for this clinical trial.

Exclusion Criteria:

* Varus or valgus knee mal alignment superior to 10°.
* OA grade IV according Ahlbäck classification.
* Bone marrow cancer like lymphoma.
* Severe anemia.
* Active infections.
* Pregnant patients.
* Inmune diseases such as Rheumatoid arthritis, gout or pseudogout arthritis, psoriasis.
* Bone diseases such as Kahler and Paget.
* Corticoesteroid and hyaluronic injections within the last 3 months.
* Knee surgery in the last 6 months.
A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

This study will assess the safety of RAD001 when given together with cetuximab and irinotecan


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years old and ≤ 65 years old.
* Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor.
* Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevacizumab or XELOX (capecitabine and oxaliplatin) plus bevacizumab.
* Patients with at least one measurable lesion by RECIST as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI) or physical examination.
* Patients with a WHO performance status of 0 or 1.

Exclusion criteria:

* Patients with Gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
* Patients who are homozygous for the UGT1A1\*28 allele as determined by sequencing.
* Patients who have received previous irinotecan-based therapy.
* Prior treatment with an mTOR inhibitor.

Other protocol-defined inclusion/exclusion criteria may apply
Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer

The purpose of this study is to evaluate the safety and clinical activity of tadalafil, pembrolizumab, ipilimumab, and CRS-207 in subjects with metastatic pancreatic adenocarcinoma who have progressed after at least 1 prior chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Have histologically or cytologically proven adenocarcinoma of the pancreas.
* Have previously treated metastatic disease.
* Have radiographic disease progression.
* Patients with the presence of at least one measurable tumor lesion.
* Patient's acceptance to have a tumor biopsy at baseline and on
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
* For both Women and Men, must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Known history or evidence of brain metastases.
* Had chemotherapy, radiation, or biological cancer therapy within the last 14 days.
* Have received an investigational agent or device within the last 28 days.
* Had surgery within the last 28 days.
* Expected to require any other form of systemic or localized cancer therapy while on study.
* Have received a vaccine within the last 14 days (7 days for the COVID vaccine) or received a live vaccine within the last 30 days.
* Have received steroids within the last 14 days.
* Use more than 4 g/day of acetaminophen.
* Use of organic nitrates.
* Use of guanylate cyclase (GC) stimulators such as riociguat.
* Consumption of substantial amounts of alcohol (≥5 units/day)
* Use of strong or moderate cytochrome P450 3A4 (CYP3A4) inhibitor or inducer.
* Patients on immunosuppressive agents within the last 7 days
* Known allergy to both penicillin and sulfa.
* Severe hypersensitivity reaction to any monoclonal antibody.
* History of severe hypersensitivity to tadalafil.
* Have implant(s) or device(s) that has not and cannot be easily removed.
* Have artificial joints or implanted medical devices that cannot be easily removed.
* Have any evidence of clinical or radiographic ascites.
* Have significant and/or malignant pleural effusion
* Uncontrolled intercurrent illness.
* Subjects with active, known or suspected autoimmune disease.
* Have a tissue or organ allograft, including corneal allograft.
* Have been diagnosed HIV, Hepatitis B or C positive.
* Is on supplemental home oxygen.
* Has an unhealed surgical wound or ulcer, or a bone fracture considered non-healing.
* Has clinically significant heart disease
* Prior history of non-arterial ischemic optic retinopathy.
* History of significant hypotensive episode requiring hospitalization within 6 months.
* Has insufficient peripheral vein access.
* Is unwilling or unable to follow the study schedule for any reason.
* Is pregnant or breastfeeding.
Bioavailability of BIBR 1048 MS With and Without Pantoprazole Under Influence of Food in Healthy Subjects

To assess the extent of absorption of 150 mg of BIBR 1048 administered as capsule formulation with and without coadministration of 40 mg Pantoprazole and to assess the effect of food on rate and extent of absorption.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP and local legislation
* Age ≥ 18 and ≤ 55 years
* BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of relevant orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of:

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after a car accident)
  * commotio cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl
The Efficacy of Probe-based Confocal Laser Endomicroscopy in Staging OLGIM

Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40 years or older with Helicobacter pylori infection;
* Histologically verified GIM, atrophic gastritis or dysplasia.

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;
* Pregnancy or breastfeeding;
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Effect Of PRF Versus Xenograft In Closed Sinus Lift.

Indirect sinus lift with used PRF as a graft material versus xenograft

Crestal incision and reflect the tissue until exposure of the bone, then use drilling to make osteotomy. Then use sutable osteotomes to elevate the sinus floor, then pack of Prf or bone graft in the osteotomy and implant placement . Then closed the flap and suturing.

Eligibility Criteria:
Inclusion Criteria:

* Edentulous area and bone high at least 5-6 mm below the maxillary sinus at maxillary premolar.
* Good oral hygiene.

Exclusion Criteria:

* bad oral hygiene.
* patient with systemic disease that may affect normal healing
* pregnant patients.
* patients with bone diseases and presence of periapical pathology affecting the neighboring teeth.
* Heavy smoker more than 20 cigarettes per day
Intestinal Microbiota and Colorectal Cancer in Inflammatory Bowel Disease

Build a collection of fecal microbiota in order to determine the characteristics of gut microbiota associated with colorectal cancer in Inflammatory bowel disease (IBD).

Inflammatory bowel disease (IBD) are chronic and relapsing disabling disease. Crohn's disease (CD) and Ulcerative colitis (UC) are the two main types of IBD.

Patients with IBD are at greater risk of intestinal infection including viral infections (including cytomegalovirus) and bacterial (especially Clostridium difficile). In the long term, patients with colonic involvement are at an increased risk of colorectal cancer (CRC). Moreover, it has been reported in several cohort studies that patients with primary sclerosing cholangitis (PSC) associated with IBD (PSC-IBD), have an even increased risk of CRC (about 10 to 20% at 10 years). Other studies also suggest that the microbiota has an impact on liver diseases. Conversely, cholestatic liver diseases (such as PSC) can influence the microbiota, notably through modification of the production of bile acids. Finally, the role of the gut microbiota in the development of the CRC in IBD has been well established in animal models. The pathophysiological mechanisms are not well understood but may involve an alteration of the balance between protective bacteria against harmful microbiota.

This study aims to investigate the link between gut microbiota, intestinal inflammation, colorectal cancer, bile acid and liver diseases and this, through the creation of a biological collection of fecal microbiota from fecal samples from 8 groups of subjects: (i) IBD without CCR (ii) IBD with CCR, (iii) IBD with dysplasia, (iv) non IBD without CCR, (v) non IBD with CCR, (vi) IBD-CSP without CCR, (vii ) IBD-CSP with CCR, (viii) IBD-CSP with dysplasia. In these patients, microbiota composition will be assessed by sequencing technology.

Eligibility Criteria:
Inclusion Criteria:

* Patient with the capacity to give informed consent.
* Age ≥ 18 years.
* A patient with IBD (Crohn's disease or ulcerative colitis) or healthy subject having a screening colonoscopy scheduled.
* Diagnosis of pathologies in question established or confirmed in any of the services involved in the study and according to international diagnostic criteria (Consensus ECCO).
* Patient follow-up in one of the services involved in the study

Exclusion Criteria:

* trusteeship, guardianship or safeguard justice.
* Subject does not speak French.
* Subject unable to answer questions or to speak.
* Previous history of colonic resection
* Taking antibiotics within 8 weeks preceding the stool sample Temporary exclusion criterium)
* Taking a bowel preparation for colonoscopy within 6 weeks before the stool sample (temporary exclusion criterium). Sampling is possible before bowel preparation or on the first stool after starting the bowel preparation.
* Ostomy at the time of sampling
* Current treatment by radiotherapy, chemotherapy
The Importance of Including Reproductive Life Plan Counseling During Contraceptive Counseling

The reproductive life plan is a protocol intended to promote preconception planning, improve reproductive health and increase health knowledge. The aim of the study is to evaluate the importance of including the reproductive life plan counseling during contraceptive counseling.

The aim of the study is to evaluate the outcomes of the reproductive life plan counseling on knowledge about fertility and awareness of preconception health.

2 groups of women visiting a primary health care center for contraceptive counseling are formed: a control group that will receive the standard care (standard family planning counseling) and the intervention group that will receive the standard family planning counseling in addition to the reproductive life plan counseling.

The included women are aged between 20 and 40 years. They are informed about the study when they call the center to make their appointment. When they attend the center, they receive a written and oral information and they are also informed that participation is voluntary and that they can interrupt their participation at any time without explanation. The women who agree to participate will sign an informed consent.

The midwives will be trained to reproductive life plan counseling before the commencement of the study. They have access to a template with discussion points to choose from, depending on the woman's answer to the first question (Do you want children/more children in the future?). If the answer is "no" the counseling will focus on contraceptive methods and sexual health (avoiding sexually transmitted diseases). If the answer is "yes" the discussion will focus on preconception and reproductive health (avoiding alcohol and tobacco, taking folic acid at least one month before conception, avoiding under and overweight,...).

Randomization: sealed envelopes are prepared with notes for CG (control group) or IG (intervention group). Before starting the counseling, the midwife opens the envelope containing instructions for either CG or IG.

A questionnaire is filled by the women before starting the counseling session and another one 2 months after the intervention. The questionnaire contains questions about demographics, knowledge about fertility, preconception health and the use of contraceptives.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 20 and 40 years old visiting the health center

Exclusion Criteria:

* Women that refuse to participate in the study