cyrilzakka/clinical-trials huggingface dataset:
Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation

The purpose of this study are:

* Assess the impact of an intervention to the adoption of healthy lifestyles among pregnant women at high risk of gestational diabetes mellitus on:

  * weight gain in pregnancy
  * the levels of maternal and fetal adipokines and
  * glycemic control maternal and fetal.
* Determine whether the adoption of healthy lifestyles in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.


Eligibility Criteria:
Inclusion Criteria:

* be aged ≥ 18 years,
* have a pre-pregnancy BMI ≥ 25 kg/m2,
* be at risk of developing a gestational diabetes mellitus (a history of gestational diabetes mellitus or glucose 1 hour post-50g \> 7.1 mmol/L.

Exclusion Criteria:

* Pre-pregnancy diabetes detected in the first trimester (A1c \> 6.5%, fasting glucose \> 7.0 mmol/L, random blood glucose\> 11.1 mmol/L, glucose \> 10.3 mmol/L 1 hour post-50g)
* twin pregnancy
* taking medications that can affect blood sugar or weight,
* practice ≥ 150 minutes of physical activity per week
* against formal-indication for physical activity.
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria

* Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria.
* Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline.
* Evidence of AD pathology.
* Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II).
* Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive).

Exclusion Criteria

* Any evidence of a condition that may affect cognition other than AD.
* Contraindications to PET imaging.
* Inability to tolerate or contraindication to magnetic resonance imaging.
* Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments.
* Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.

Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (\>20%))
* Women of childbearing potential
* Aged \>18 years
* Signed written informed consent form
* Willing to comply to the follow-up schedule

Exclusion Criteria:

* Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
* Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amstel criteria (clue cells detection)
* Current genital malignancies
* Chemotherapy for any reason in last 6 months
* Radiotherapy in the genitourinary system in the last 12 months
* Use of antibiotics for any reason in the last 14 days
* Use of intravaginal devices during the investigation or in the last 14 days
* Pregnancy or currently attempting to conceive
* Lactation
* Use of other treatment for vaginal conditions during the course of the clinical investigation
* Known allergies to ingredients of the product
* Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation
Intravesical Ozone Therapy for Interstitial Cystitis/Bladder Pain Syndrome

This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of intravesical ozone therapy in 60 patients with interstitial cystitis (IC). Participants were assigned to ozone therapy, placebo, or standard care groups for 3 weeks, with follow-up at 6 weeks. The primary outcome was the change in O'Leary-Sant ICSI score. Secondary outcomes included VAS pain score, SF-36 physical health, and urinary frequency.

Patients received either 50 mL ozonated saline (20-40 µg/mL), normal saline (placebo), or continued standard care twice weekly for 3 weeks. Assessments were conducted at baseline, week 3, and week 6. The study aimed to determine if ozone therapy reduces interstitial cystitis symptoms compared to placebo and standard care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Histopathologically or clinically confirmed IC (per AUA guidelines)
* Symptoms for at least 6 months
* Willing to provide informed consent

Exclusion Criteria:

* Active urinary tract infection
* Bladder malignancy
* Pregnancy or breastfeeding
* Known ozone allergy
* Intravesical therapy within 3 months
* G6PD deficiency
Effect of Medical Marijuana on Neurocognition and Escalation of Use

This study will use a randomized controlled design to test whether patients who use medical marijuana, compared to a waitlist control group, experience a change in health outcomes (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use disorders, neurocognitive impairments) or brain-based changes.

This trial is a randomized, longitudinal study of medical marijuana (MM) that will: (1) characterize the impact of MM on indices of addiction, such as CUD, escalation of use, tolerance, and withdrawal among those who stop using, (2) assess, via dosing diaries, the effect of MM use patterns on use of other medications, and perception of underlying disease symptomatology, (3) characterize the impact of MM on neurocognitive performance, including executive function, memory, attention, and decision-making and (4) examine evidence for impact of MM on brain structure and function. This study will enroll 200 adults with no prior history of CUD or heavy marijuana use, who express interest in using MM to treat pain, insomnia, anxiety, and/or depression. Participants will be randomly assigned to either an active MM arm (n = 100), or to a waitlist control arm (WLC) (n = 100). Participants will be assessed at baseline, regularly for 3 months, and at a 6-month and 12-month follow-up for MM use behaviors, development of CUD, perception of disease symptomatology, and neurocognitive performance. Urine collected at each visit will be assessed with quantitative assays. MRI scans will be collected to longitudinally investigate possible brain changes associated with MM use.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18-65 years, inclusive;
2. Competent and willing to provide written informed consent;
3. Desire to use medical marijuana for self-reported pain, sleep, or affective (mood and/or anxiety including PTSD) symptoms.
4. Not in possession of a medical marijuana card, but expressing intent to get one.
5. Able to communicate in English language.

Exclusion Criteria:

1. Current daily marijuana use (prior to enrollment)
2. Current substance use disorders (e.g. cocaine, opiate, stimulant). Light to moderate alcohol use is permitted (defined as 16 or less on the AUDIT), and nicotine dependence is permitted because of the high co-use of nicotine and marijuana. Participants cannot meet current SCID criteria for a use disorder on any illicit substance other than nicotine.
3. Pregnant (verified by a urine test).
4. In the opinion of the investigator, not able to safely participate in this study because of any medical or psychological issues (e.g. psychosis) that might compromise their safety.
Financial Incentives to Increase Pediatric HIV Testing

The purpose of this study is to determine whether giving small financial incentives will motivate parents to test their children for HIV.

The study will be a randomized controlled trial (RCT) with 5 arms with equal allocation to each arm: no incentive, or one of 4 different levels of financial incentive. We will randomize 800 parents with children of unknown status at HIV treatment clinics in Western Kenya.

Eligibility Criteria:
Inclusion Criteria:

* Parent/caregiver receiving HIV care
* Parent/caregiver has one or more children \<13 years old
* Child is HIV exposed (parent/caregiver report or clinic confirmation)
* Caregiver reports child's HIV status is unknown

Exclusion Criteria:

* None

  * The investigators reserve the right to exclude any potential enrollee who is deemed to be at high personal risk, or whose children are at high personal risk, of interpersonal violence, by study participation .
Study to Asses Efficacy of Intralymphatic Immunotherapy

The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm.

The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).

The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary.

The patients will be divided into three groups using allocation:

1 group with 6 injections of allergen

1 group with 3 injections of allergen and 3 injections of placebo

1 group with 6 injections of placebo. The trial will be double blinded.


Eligibility Criteria:
Inclusion Criteria:

* grass pollen allergy through at least 2 seasons
* positive skin prick test
* positive Specific IgE of at least 2. (CAP)
* Signed informed consent
* for females a negative pregnancy test.

Exclusion Criteria:

* out of age limits
* rhinoconjunctivitis all year round.
* uncontrolled seasonal asthma
* patients treated with steroids continuously or beta-blockers.
* pregnancy and breastfeeding
* HIV, Hepatitis B+c, and other immunological diseases.
* psychiatric disease
* treatment with SCIT or SLIT within the last 5 years
* participation in other clinical trials within the last 3 months.
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis

The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.

Eligibility Criteria:
Inclusion Criteria:

1. Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
2. Subject completes the informed consent process
3. Subject agrees to take study medication when scheduled
4. Subject complies with all clinical trial instructions. Commits to all follow-up visits

Exclusion Criteria:

1. had any other sexually transmitted disease or gynaecological abnormality requiring treatment
2. had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
3. were pregnant
4. had used antifungal medication in the week before entry
5. were expected to menstruate within seven days of the start of treatment
6. infected more than one candida species
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study

The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.

Single Arm, multi-center, device registry study capturing de-identified data on a minimum of 100 subjects with peripheral artery disease (PAD) and/or dysfunctional native or synthetic arteriovenous dialysis fistulae. The study will capture acute angiographic data.

Eligibility Criteria:
* Subject requires angioplasty
* Subject has a lesion in the iliac, femoral, iliofemoral, popliteal artery, or obstructive lesion of native or synthetic arteriovenous dialysis fistulae as per the product indications for use
18F-AV-1451 PET Imaging in TBI

This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.


Eligibility Criteria:
TBI Subjects

Inclusion Criteria:

TBI Subjects

* Subjects that have consented and are currently enrolled in either Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury Protocol Number: CNS: 10-N-N122, or Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI): Protocol Number: 11-N-0084
* History of having sustained a TBI \< 6 weeks prior to enrollment
* Can tolerate PET and MRI scan procedures

Control Subjects

* MMSE ≥ 28
* No significant history of cognitive impairment
* No prior history of TBI
* Can tolerate PET and MRI scan procedures

Exclusion Criteria:

* Have behavior dysfunction that is likely to interfere with imaging
* Are claustrophobic or otherwise unable to tolerate the imaging procedure
* Have current clinically significant cardiovascular disease, or clinically significant abnormalities on screening ECG
* A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
* Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the 18F-AV-1451 imaging session
* Have current alcohol dependence or alcohol dependence within the past 1 year
* Are currently participating in another interventional clinical trial
* Have evidence of a penetrating brain injury
* Have participated in contact sports in college or after high school age
Periodontal Treatment and Psychology

There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.

Background: Depression is a multi-factorial disease characterized by a variety of symptoms. Psychiatric disorders seem to be more prone to periodontitis compared to patients without psychiatric disorders. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal disease can also be an effect on depression. The aim of this randomized controlled clinical study is to determine the effect of non-surgical mechanical periodontal treatment on psychological state.

Material and methods: The study population consisted of 184 depressed patients with non-treated periodontal diseases. Two randomized group is formed from these patients. Immediately periodontal treatment (test group, n = 92) and delayed periodontal treatment (control group, n = 92). Clinical periodontal and psychological measures were performed at baseline and 6th weeks on control and test group.

Eligibility Criteria:
Inclusion Criteria:

* the presence of periodontal diseases,
* the presence of diagnosed minor depression
* being under maintenance therapy regarding the depression

Exclusion Criteria:

* any hormonal condition such as pregnancy or lactation
* received any periodontal treatment within six months
HDL Dysfunction During the Acute Stage of Stroke

The study investigates the effect of plasma myeloperoxidase (MPO) concentrations on HDL dysfunction during the acute stage of ischemic and haemorrhagic strokes.

MRI or CT scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke.

Plasma anf HDL-MPO concentrations, as well as potent HDL dysfunction, are compared in the 3 cases.

The investigators hypothesis is that MPO concentrations and subsequent HDL dysfunction could be higher in ischemic strokes than in haemorrhagic ones. MPO could be a examined as a potent marker of early stage of ischemic stroke.

Plasma MPO levels could also be discriminant regarding the mimick strokes in patient exhibiting stroke clinical picture.

Eligibility Criteria:
Inclusion Criteria:

Patients with less than 12 hours stroke clinical signs:

* hemiparesis or hemiplegia
* unilateral sensitivity disorder
* language impairment
* balance disorder
* dizziness, bilateral or monocular vision totally or partially lost

Exclusion Criteria:

* Pregnancy
* head trauma since the last 3 months
* stroke since the last 3 months
* myocardial infarction since the last 3 months
* patient disagrees to be enrolled in the study
Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer

The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer

Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted total gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic assisted total gastrectomy in the treatment of clinical Stage I gastric adenocarcinoma （cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0））.

Eligibility Criteria:
Inclusion Criteria:

* Age from over 18 to under 75 years
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
* The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall results.
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) class I to III
* Written informed consent

Exclusion Criteria:

* cStage IIA or more advaned at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* Multiple primary cancer
* History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
* Gastric multiple primary carcinoma
* Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
* History of other malignant disease within the past 5 years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within the past 6 months
* History of cerebrovascular accident within the past 6 months
* History of continuous systematic administration of corticosteroids within 1 month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of the predicted values
Validation of the German Version of the Injustice Experience Questionnaire

Purpose of the study is the validation of the German version of the Injustice Experience Questionnaire.

Pretest: Participants were informed about the aims of the study and fill in a consent form. They filled in a paper version of the German translation of the Injustice Experience Questionnaire. In a structured interview patients were asked if there were any items difficult to understand, unacceptable or offending them. Subsequently they had to answer questions about the content and meaning of the IEQ-items.

Validation Study: Participants were informed about the aims of the study and filled in a consent form. By e-mail they received an access link to the online survey. The questionnaires of the survey could be filled in at home. The survey could be interrupted and terminated later. About 20 minutes were needed to answer the 80 questions of the survey. All data was saved anonymously during the survey.

Pretest: Participants were informed about the aims of the study and filled in a consent form. A paper version of the German translation of the Injustice Experience Questionnaire was completed in presence of the interviewer. The structure of the standardized interview followed the recommendations for pretesting transcultural translations of questionnaires. Patients were asked if there were any items difficult to understand, unacceptable or offending them. Subsequently they had to answer questions about the content and meaning of the IEQ-items. The interviewer asked all questions and entered the responses. All data were directly stored in a MySQL database at a Swiss commercial web-server (www.scientific-affairs.ch).

Validation Study: Participants are informed about the aims of the study and fill in a consent sheet. By e-mail they receive an access link to the online survey which can be completed at home. The survey includes the following questionnaires: Injustice Experience Questionnaire (IEQ), Depression subscale of the Depression, Anxiety and Stress Scale (DASS), Tampa Scale for Kinesiophobia (TSK), McGill Pain Questionnaire (MPQ), Pain Catastrophizing Scale (PCS), Pain Disability Index (PDI) and part concerning causes of pain of the German Pain Questionnaire (DSF). About 20 minutes is needed to answer the 80 questions of the survey. After completing the survey participant can choose if they would like to be informed about the results of the filled in questionnaires. All data is saved anonymously during the survey and stored in a MySQL database at a Swiss commercial web-server (www.scientific-affairs.ch).

Eligibility Criteria:
Inclusion Criteria:

* pain (face, head or rest of the body)
* good competence of German language
* internet access
* being able to fill in a web-based survey
* adults

Exclusion Criteria:

* disuse / dependency on medication / drugs