cyrilzakka/clinical-trials huggingface dataset:
Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT

This study aims to identify the relationship between genital C. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital C. trachomatis in pregnant women can reduce adverse pregnancy outcomes.

Approximately 200 pregnant women from Nanhai Hospital of Southern Medical University in Guangzhou, China will be enrolled and randomized to the intervention or control group.

Women recruited for the study will be randomized to the intervention or control groups. Women in the intervention group will be tested in real time for C. trachomatis and Neisseria gonorrhoeae. Patients who test positive for either infection will be linked to physicians at the Center for treatment. For the control group, women will be tested immediately after childbirth or in the event of an adverse pregnancy outcome. In the event of a positive test result, a confirmation test will be run and if positive, the patient will be referred for treatment. The endpoint of the study is defined as either the occurrence of an adverse pregnancy outcome or delivery of a newborn.

Qualitative in-depth interviews will also be conducted with 20 of the women to explore their opinions, attitudes and feedback on the study process. University of North Carolina at Chapel Hill (UNC) investigators will work with the Nanhai Hospital of Southern Medical University and staff at Dermatology Hospital of Southern Medical University to oversee the study.

Eligibility Criteria:
Inclusion Criteria:

1. pregnant women on their first visit to the hospital (regardless of gestational age);
2. aged 18 or above;
3. agree to participate and sign an informed consent.

Exclusion Criteria:

1. systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit;
2. comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension);
3. diagnosed adverse pregnancy outcomes at recruitment (e.g., stillbirth); Women with a previous history of CT or NG and women with a prior adverse outcome will not be excluded. Instead, the investigators will conduct sub-analysis and check whether the intervention has different effects on different groups of pregnant women.
Moses vs. Thulium Laser Study

The incidence of urinary tract stone disease is increasing. According to the National Health and Nutrition Examination Survey, as of 2012, 10.6% of men and 7.1% of women in the United States are affected by renal stone disease. This has led to an increased demand on Urologists for efficient and safe surgical treatment of stone disease. Over the past two decades, ureteroscopy with laser lithotripsy has become the treatment of choice for most ureteral and renal stones globally. The holmium laser is considered the gold standard for laser lithotripsy. Holmium laser lithotripsy with Moses and the thulium laser are new technologies meant to improve the efficiency of laser lithotripsy. Both are FDA approved treatment modalities for stone disease. Two in vitro studies have compared Moses versus thulium and shown that thulium has higher ablative volumes then the holmium laser with Moses, but no clinical trials have compared the two treatment modalities.

In this study, investigators are going to conduct a prospective, randomized clinical trial to determine whether there is a difference in procedural time, intraoperative parameters or stone free rate between the Holmium laser with Moses and the thulium laser. This is significant as this may lead to shorter overall operative times, which may result in decreased operative costs and complications.


Eligibility Criteria:
Inclusion Criteria:

* Participants with renal or ureteral urinary stones who require endoscopic treatment in the outpatient operating room
* Participant's stone size in a single renal unit of 3-10 mm and 11-20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT. Participants with multiple stones will be included as long as their largest stone size falls within the above parameters.

Exclusion Criteria:

* Participants under 18 years of age and over 89 years old.
* Pregnant participants
* Participants with transplant kidneys
* Participants with irreversible coagulopathy
* Participants with known ureteral stricture disease
* Participants who do not have a pre-operative CT.
* Non-English speaking, vulnerable participants such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.
Cardiac Coherence Combined With Personal Physical Activity in Patients With Cancer

APACCHE (Adapted Physical Activity and Cardiac Coherence in HEmatologic patients) study investigates effects of heart rate variability biofeedback training, combined with classical adapted physical activity, on health-related quality of life in patients previously treated for hematologic malignancies. It is a prospective, randomized clinical trial from University Hospital of Reunion Island. The main objective is evaluated with QLQ-C30 survey score differences.

Hematologic malignancies are aggressive cancers with significant long-term effects on physical and psychological health, due to the disease itself or aggressive treatments. Physical activity, with specific treatments, improves physical and psychological health in solid tumors patients. However, in hematologic malignancies, there is unsatisfactory quality of evidence that physical activity alone improves the various dimensions of quality of life.

Recent studies on heart-brain connections suggest that a high level of coherence in the heart rate variability may induce psychophysiological positive effects. Cardiac coherence is reached when the heart rhythm pattern becomes sine-wave-like at a frequency around 0.1 Hz. This status can be increased by the mean of deep and slow breathing control and/or positive emotions. By using a heart rate variability biofeedback training, previous studies have shown effects on physiological variables such as reduction of blood pressure or increase of vagal heart rate control, and also on psychological variables such as reduction of stress, anxiety, and depression.

The APACCHE protocol investigate if cardiac coherence biofeedback training, associated with an adapted physical activity program, can improve health related quality of life in adult hematologic patients.

70 patients are randomly assigned to receive either ten sessions of cardiac coherence biofeedback (CC-BF) and the adapted physical activity program (APA) or just APA. Both interventions are conducted simultaneously over 12 weeks, with 10 sessions of CC-BF (45mn) weekly and 24 sessions of APA (1h30) bi-weekly.

Data are collected at enrollment(T1), at 6 weeks (T2), at intervention ending at 12 weeks (T3) and after a 24 weeks follow-up (T4).

Eligibility Criteria:
Inclusion Criteria:

* All patients, previously treated and in remission for an Hematologic malignancy, in whom APA is indicated.
* Adult patients aged 18-65 yo
* Followed at South University Hospital of La Réunion Island
* Previously treated for Hematologic Malignancy, and in Remission (complete or partial)
* 6 months or less since last treatment
* Hemoglobin steady ≥ 90g/L
* In whom APA is prescribed
* Ability to give oral informed consent
* French understanding

Exclusion Criteria:

* With contraindication for APA
* Under anti-arhythmic or beta-blocker drugs
* Cardiac insufficiency (Left ventriculi Ejection Fraction less than 40%)
* Participation in another trial
Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy

18F-Fluoro-deoxy-glucose (18F-FDG) positron emission tomography (PET) has a high sensitivity for temporal lobe epilepsy (TLE), the most common form of focal epilepsy, with a detection range of 86-90% . Therefore, 18F-FDG PET is a useful tool to identify the epileptogenic zone (ETZ) in the inter-ictal phase of drug-resistant temporal epilepsy during pre-surgical evaluation . Based on stereotactic electroencephalography (SEEG) findings, a correspondence between electrical data and metabolic changes on PET was found at the group level by identifying four different patterns of TLE . As expected, hypometabolism was not limited to the EZ defined by SEEG, but underlay broader epileptic networks . Because of the different electroclinical presentations of TLE, 18F-FDG PET appears to be a very useful tool in these temporal epilepsies. Indeed, it has been recently demonstrated that a gradient of PET hypometabolism from the uninvolved area to the spreading area, then to the epileptogenic area and to the lesion area is observed with consequently a good performance of 18F-FDG PET in defining the EZ .

Therefore, it is interesting to study PET metabolism as a network and not as a combination of regional metabolic measures in epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with drug-resistant temporal epilepsy with an accurate diagnosis on SEEG
* Patients with epilepsy who have had a PET/CT scan with 18F-FDG as part of a pre-operative assessment
* Person having received complete information on the organization of the research and not having objected to the use of these data;
* Patients affiliated to a social security system

Exclusion Criteria:

* Person who has not received full information on the organization of the research and who has opposed the use of this data
* A person of full age who is the subject of a legal protection measure (guardianship, curatorship, safeguard of justice).
* A person of full age who is unable to give consent and who is not subject to a legal protection measure
A Randomized Clinical Trial for Depressed Mothers at Primary Care Level

A randomized clinical trial was carried out at primary care level in Santiago, Chile to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health.

Hypothesis: pharmacological intervention for depression controlled by phone from a central level will be more effective than usual care in depressed mothers.

Aim:to compare a pharmacological intervention for depressed mothers controlled by phone from a central level (TM) and the usual treatment (TH) and its impact on children's mental health.

Material and methods: A RCT wasw carried out at primary care clinics in Santiago.Sample:three hundred and forty five depressed women . One children of each mother was randomly selected. Women are randomly assigned to receive the usual therapy or a pharmacological intervention with periodical telephone contacts with medical collaboration personnel, to reinforce compliance with treatment and educate about the disease, for 6 months. Women were blindly evaluated at 3, 6 and 12 months with the Hamilton depression rating score (HDRS) and the SF-36 to assess depressive symptoms and quality of life, respectively; the Dyadic Adjustment Scale to assess marital adjustment.

Child psychopathology was assessed with the Child Behavior Checklist (CBCL), the Brief Psychiatric Rating Scale for Children (BPRS-C), Screen for Child Anxiety Related Emotional Disorders(SCARED)and the Children's Depression Inventory.

Eligibility Criteria:
Inclusion Criteria:

* depressed mothers with al least one child aged 6-16

Exclusion Criteria:

* currently treatment for depression,psychosis,bipolar depression,alcohol or drug abuse, gravidity.
Community-based HEARTS Intervention (Pilot)

The goal of this pilot study is to assess the feasibility of health system change intervention with a focus on recruitment of patients with hypertension, initiation of antihypertensive medication, and retention of patients in care at the Community Clinics (CC) with a goal of finalizing the key features of a team- and community-based intervention in rural Bangladesh.

Patients with uncomplicated hypertension will be enrolled, their medical treatment will be provided from CC by a Community Health Care Provider (CHCP) according to the telemedicine-based instruction of Medical Officer from Upazila Health Complex (UHC) with provision of referral to UHC for an in-person evaluation. Participants will be followed up periodically and their medicine will be refilled accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Patients residing in the catchment area of the selected 4 Community Clinics under selected 2 Upazila Health Complexes (UHCs)
* Aged 18 years and older
* Raised BP during screening \[Systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg (based on an average of minimum two measurements)\]
* Not currently taking antihypertensive medications
* Eligible for the HEARTS technical package, defined as not being treated for an acute illness or medical emergency and not having a terminal illness

Exclusion Criteria:

* Patients with cardiovascular diseases, chronic kidney diseases (as evident by previous laboratory report of serum creatinine or urinary protein more than ++ on dipstick test prior to the enrollment), diabetes, or BP \>180/110 mmHg (based on the mean of last two BP measurements) at screening or after 14 days of recommended lifestyle modification will be excluded and referred directly to UHC for further management
* Pregnancy or intent to become pregnant
* Patients who otherwise meet inclusion criteria but decline to participate in the hypertension program evaluation or do not provide written informed consent
Effect of Sleep Hygiene and Sleep Extension on Performance in Soccer Players

Sleep is essential for recovery and performance in athletes, yet they often struggle with inadequate sleep duration and quality. Theoretically, strategies such as sleep extension and sleep hygiene could improve sleep and subsequent recovery in athletes, but their effectiveness remains largely unstudied in the literature. This study aimed to analyze the effects of sleep extension and sleep hygiene on physical and cognitive performance in soccer players.

Twenty soccer players will be randomized (1:1 ratio) into intervention and control groups. The study will last 4 weeks, divided into two periods: baseline (2 weeks) and intervention (2 weeks). In the baseline period, the players will maintain their normal routine and their sleep habits will be monitored by actigraphy and sleep diaries. The players physical performance will be assessed by the 30-15 intermittent fitness test, countermovement jump, isometric mid-thigh pull and 30-meter sprint, while the cognitive performance will be assessed with the 3-minute psychomotor vigilance test. During the intervention period, the intervention group will extend their usual time in bed by 25% than their baseline period, and adopt sleep hygiene behaviors, while the control group will maintain their usual sleep routine. The physical performance of the players of both groups will be assessed with the same physical tests of the baseline period at the end of week 1 and week 2.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 years old
* Sex: Male
* Football players competed in an official competition, organized by the Portuguese Football - Federation (FPF) or regional football associations

Exclusion Criteria:

* Players who take sleep medication
* Injured players
* Players with clinical sleep problems
Maintenance Infusion of Oxytocin Following Elective Cesarean Deliveries

This study is designed to determine the minimal effective oxytocin maintenance dose required during cesarean delivery to achieve the best effect. Oxytocin is a drug which is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta. The aim of oxytocin is to reduce the amount of blood that might be lost. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. If the uterus contracts well, this is considered satisfactory and the next patient will receive the same dose. If the uterus does not contract well, this is considered unsatisfactory and the next patient will receive a higher dose. The dose for the next patient will be determined based on the results of the uterine contraction of the previous patient.

The investigators hypothesize that the ED90 of an oxytocin infusion rate to maintain a satisfactory uterine tone during a cesarean delivery in non-laboring women, would be lower than that found in previous studies without an initial bolus (less than 16 IU/h).

This study will be conducted as a prospective, double blinded clinical trial (patient, anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential allocation fashion. The objective of the study is to determine the minimum effective dose of oxytocin infusion required to produce appropriate uterine contraction during and after cesarean delivery under neuraxial anesthesia in non-laboring women. For the purpose of this study, the minimum effective dose is defined to be that at which adequate response occurs in 90% of patients, i.e. ED90.

Eligibility Criteria:
Inclusion Criteria:

* Elective uncomplicated cesarean delivery under neuraxial anesthesia
* \>18 year-old with ASA status II or III, with a singleton gestation and a gestational age between 37 to 42 weeks Informed consent to participate in this study

Exclusion Criteria:

* Refusal to give written informed consent
* Allergy or hypersensitivity to oxytocin
* Body mass index ≥ 40 kg/m2on the day of admission
* A history of hypertension and/ or severe cardiac disease(s)
* Contra-indications for neuraxial anesthesia
* Conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, macrosomia (≥ 4 kg), polyhydramnios, uterine fibroids in and near operating field, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
DIABASE; Diabetes Mellitus Registry in Second Care

This study aims to examine real world data from medical devices and clinical outcome from diabetes mellitus patients to gain the necessary insights to be able to improve individual patient care by building a registry.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 or type 2 diabetes
* Patients aged 18 years or older
* Patients visiting the outpatient clinic internal medicine in the ZGT Hospital
* Written informed consent

Exclusion Criteria:

* Severe general diseases or mental disorders making the participation in the study impossible
A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of the effect of GB-102, as measured by time to first rescue treatment across multiple dose levels of GB-102 administered every 6 months as compared to intravitreal (IVT) aflibercept administered every 2 months in subjects with neovascular (wet) age-related macular degeneration who have received prior induction with anti-vascular endothelial growth factor (VEGF)

Extension Study:

To monitor the safety and duration of effect of IVT GB-102 administered every 6 months compared to IVT aflibercept administered every 2 months in subjects in ALTISSIMO (Core Study) who complete all study visits through Month 12 (Day 360) and who do not require/receive rescue treatment at the Month 12 (Day 360) final study visit

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 50 years of age
* Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab).
* Demonstrated response to prior anti-VEGF treatment since diagnosis
* Best-corrected visual acuity (BCVA) of 35 letters or better

Exclusion Criteria:

* History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
* Uncontrolled hypertension, diabetes mellitus or intraocular pressure (IOP)
* Chronic renal disease
* Abnormal liver function
* Women who are pregnant or lactating
Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of clindamycin on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.

Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded.

Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.

Before root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking 600 mg of clindamycin orally) or control group (taking placebo ) 30 minutes before the start of the treatment. Single-visit root canal treatment will be performed.

Each patient will receive a 7-day diary to record postoperative pain and swelling.In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome

Eligibility Criteria:
Inclusion Criteria:

1. Patients with symptomatic apical periodontitis and do not have evidence of spreading infection or systemic involvement.
2. Mandibular posterior teeth.
3. Patients in good health.
4. Patients who can understand pain scales (NRS).
5. Patients able to sign informed consent.

Exclusion Criteria:

1. Patients who have draining sinus tract.
2. Retreatment cases
3. Patients with weeping canals.