cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Parenting Programs on Child Development and Maternal Well-being in Rural Uganda

The purpose of the current study involves the development, implementation and evaluation of a parenting program to target maternal well-being and child health, growth and development in Lira, Uganda. The current study aims to address maternal care within a parenting program as well as parenting practices emphasizing nutrition, hygiene, and psychosocial stimulation through peer-support, practice and problem-solving. Outcomes include child health, growth and development, maternal mental health, mother-child interactions, and maternal-spousal relations.

We hypothesize that:

1. Children of parents who attend the parenting program will have better health, height and cognitive/language development at post-test, than children whose parents did not have the opportunity to attend parenting sessions.
2. Parents who attend the parenting program will have more knowledge about child development and provide more home stimulation, dietary diversity and preventive health practices than parents who do not have the opportunity to attend parenting sessions.
3. Mothers who attend the parenting program will have improved well-being compared to mothers who do not have the opportunity to attend parenting sessions.


Eligibility Criteria:
Inclusion Criteria:

* mothers of children ages 12-24 months

Exclusion Criteria:

* disabled children
Effect of Apical Negative Pressure Irrigation System at Cleaning Lateral Canals and Reduction of Periapical Lesions After Endodontic Therapy

The aim of the present study is to assess with PA x-rays and CBCT scans the volumetric changes in periapical radiolucencies in endodontically treated teeth 1 year after endodontic treatment and evaluate how well the lateral canals are filled after irrigation with the new generation of negative irrigation pressure unit with and without the ultrasonic irrigation.

This is a single center, prospective clinical study conducted in patients who present for routine endodontic therapy. The study has been reviewed and approved by the Institutional Review Board (Ethics Committee) Aspire IRB located at Santee, CA. The clinical investigator will treat patients who present with radiographic evidence of periapical pathology and will randomize the subjects to either negative pressure irrigation system treatment (EndoVac Pure) with ultrasonic irrigation or negative pressure irrigation system treatment (Endovac Pure) without ultrasonic irrigation. All other aspects of the treatment (access, instrumentation and obturation will be according to clinicians conventional clinical judgment. Subjects will have a pre-treatment PA x-ray and CBCT scan before treatment, a PA x-ray at six months and a CBCT scan at one year post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Aged at least 18 years.
* Understands and is willing, able and likely to comply with all study procedures and restrictions.
* Good general and mental health in the opinion of the investigator or medically qualified designee;
* No clinically significant and relevant abnormalities of medical history or oral examination;
* Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
* Single or multi rooted-canal teeth diagnosed with pulp necrosis and symptomatic/ asymptomatic apical periodontitis as tested with routine diagnostics.
* Radiographic evidence of periapical lesion.

Exclusion Criteria:

* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
* Women who are breast-feeding.
* Pre-existing oral irritations. b) Recent (within 30 days) gingival/oral surgery. c) Any clinically significant or relevant oral abnormality.
* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
* Any subject requiring re-treatment.
Is an Online-tool Capable of Improving Patients' Outcomes After Surgery?

Recovery after the surgery depends on psychological factors such as preoperative information, expectations, and surgery-associated anxiety. Prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes. However, the content of these interventions needs further examination. This study aims to examine if the developed preoperative intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome and postoperative recovery. Therefore an online-tool has been developed. Using an online-approach makes it possible to reach many patients taking as little time and cost as possible.

Patients who undergo surgery in the next two weeks and want to participate in the study will be asked for the planned surgical procedure. There will be a filter (stratum) for surgery. Patients with the same kind of surgery are randomized into two groups (Control vs. intervention group) after they've filled some questionnaires at the baseline assessment. Following this, the intervention group will participate in the psychological online intervention (around 30 minutes). The intervention will focus on the treatment outcome expectations and personal control expectations to increase patients' positive expectations. The control group will receive no psychological intervention. Both groups will fill out questionnaires again in the evening, two days before the surgery, around one week after the surgery, and three months after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* In-patient operation under general anesthetic
* Age 18 or above
* Fluency in German
* Informed consent

Exclusion Criteria:

* Participation in other research programs: in agreement with Coordinating Investigator patient can participate substudies, if this do not interfere with the main study
* Emergency surgery
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC

The primary purpose of this study is to:

1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially diverse HIV+ population (males and females) who are three-class (nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and protease inhibitor (PI)) experienced with documented resistance to more than one PI.
2. Determine pharmacokinetic data in this racially and gender diverse population.
3. Determine the potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.


Eligibility Criteria:
Inclusion Criteria:

Main inclusion criteria for the study are:

1. HIV-1 infected adults, men and women at least 18 years of age.
2. 3-class (nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and protease inhibitor (PI)) treatment-experienced (min of 3-months duration for each class) with resistance to more than one PI (on screening resistance testing). NNRTI-naïve patients who have genotypically documented NNRTI-resistance mutations on past or screening resistance testing would be eligible.
3. CD4+ T lymphocyte count \>=50 cells/mm3.
4. HIV-1 viral load \>=1,000 copies/mL at screening.
5. The antiretroviral (ARV) study treatment regimen must consist of TPV/r in combo with an optimized background regimen (OBR) of 2-4 agents: N(t)RTIs (NRTI or NtRTI), enfuvirtide (ENF), and/or, where available, a trial approved expanded access program (EAP) investigational agent.
6. Acceptable screening laboratory values that indicate adequate baseline organ function.
7. Acceptable medical history with a chest X-ray without evidence of active disease and an electrocardiogram (ECG) without clinically important abnormalities within one year of the study.
8. A reliable method of barrier contraception will be used by all female patients who are of childbearing potential.

Exclusion Criteria:

Main exclusion criteria for the study are:

1. Known hypersensitivity to the tipranavir (TPV) or ritonavir (RTV).
2. ARV medication naïve.
3. Genotypic resistance to TPV (defined as a TPV mutation score \>7).
4. Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the month prior to screening.
5. Prior tipranavir use.
6. Inability to adhere to the requirements of the protocol.
7. Patients with prior history of hemorrhagic stroke or intracranial aneurysm.
8. Patients with a history of ischemic stroke, neurosurgery or skull trauma within 4 weeks prior to screening.
9. History of Progressive Multifocal Leukoencephalopathy, Visceral Kaposi's Sarcoma, and/or any malignancy.
10. Any acquired immunodeficiency syndrome (AIDS) defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
Acceptability Assessment of an "Organization of Care Integrating Artificial Intelligence and a Solution of Telemedicine" on Care of the Nursing Home Residents Located in a Medical Desert: Pilot Study INTEL@MED-POC

While depend elderly people needs are important in Nursing Home, the medical resources are weak from both inside and outside residences located in a medical desert. The goal of this project is to measure the acceptability of Artificial Intelligence and Telemedicine in Nursing Home located in medical desert for patients, nurses, and medical doctor

The ageing of the population comes along with the problematic of chronic pathologies and dependence, with sometimes serious consequences resulting in an admission in Nursing Home. While the low require a medical doctor in each Nursing Home, one third of the Nursing Home does not have. Some Nursing Homes can be in a tricky situation with no medical doctor coordinator and the difficulty of access to a medical doctor who covered a wide territory. In this context, the emergence of Artificial Intelligence coupled with Telemedicine is a new opportunity to find solution in healthcare organization and to develop advanced geriatric medical practice in medical desert territory. The goal of this study is to quantify and characterize the acceptability of Artificial Intelligence and Telemedicine in Nursing Home located in medical desert for patients, nurses, and medical doctor.

All the patients were examined by a nurse. The symptoms filled by the nurse in the Artificial Intelligence/Telemedicine device are sent and then analyzed by a distant medical doctor to purpose a care. The nurse also solicited the attending medical doctor as usual care.

The recommendations of the both medical doctors could be (i) Vital emergency, (ii) non-vital emergency necessitate medication or hospitalization, and (iii) non-emergency with medical appointment.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 65 years old.
* Patient living in Nursing Home located in medical desert.
* Patient presenting symptoms involved medical doctor call.
* Patient or legal representative having signed consent form
* Patient covered by social security

Exclusion Criteria:

* End of life patient.
* Chronic aphasic patient.
Dermacyd Breeze (Lactic Acid) Pocket BR - Compatibility

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Breeze (Lactic Acid) Pocket BR.


Eligibility Criteria:
Inclusion criteria:

* Age between 18 and 60 years old;
* Phototype Skin I,II, III e IV
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs one month before the study;
* Personal history of atopy;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.


Eligibility Criteria:
Inclusion Criteria:

* children 0-6 years of age.
* clinical diagnosis of blepharoconjunctivitis
* Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
* Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

* Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
* Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
* Subjects who are monocular.
* Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
* Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.
Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)

Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing impairment. Although the use of a robotic assistant provides technical assistance to the surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due to inter-individual variability of preoperative audiometric thresholds and the various possible intrascalar positions of the electrode array. WThe investigators aim to compare the hearing results of patients who underwent bilateral cochlear implantation, one side was performed with manual insertion and the other side with robot-assisted insertion. The electrode array intrascalar positioning and the surgery duration were also studied.

This retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation. The unique composition of this cohort enabled the investigators to utilize each patient as their own control.

Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing impairment. Although the use of a robotic assistant provides technical assistance to the surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due to inter-individual variability of preoperative audiometric thresholds and the various possible intrascalar positions of the electrode array. The investigators aim to compare the hearing results of patients who underwent bilateral cochlear implantation, one side was performed with manual insertion and the other side with robot-assisted insertion. The electrode array intrascalar positioning and the surgery duration were also studied.

This retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation. The unique composition of this cohort enabled the investigators to utilize each patient as their own control.

Eligibility Criteria:
Inclusion Criteria:

* bilateral cochlear implantation at a tertiary referral center
* one side manual
* one side robot-assisted

Exclusion Criteria:

* opposition
* under curatorship
Comparison of Modified-Otago and Tai Chi Exercises in Patients With Stroke

The study aims to determine the comparative effects of Modified-Otago and Tai Chi Exercises on Balance and Motor Function in Patients with Stroke.

This randomized clinical trial will be conducted at the Physiotherapy and Chiropractor Centre, Lahore. Data will be collected within seven months after the approval of synopsis. A total of 64 patients will be recruited through convenience sampling technique after inclusion and exclusion criteria. After the baseline assessment, randomizations will be performed through the lottery method. Group A will receive Modified Otago exercises for 60 minutes, 3 times per week for 12 weeks, and Group B will receive Tai Chi Qigong exercises for 60 minutes, 3 times per week for 12 weeks. To assess the balance and motor function, the Berg Balance Scale (BBS) and Motor Assessment Scale will be used, respectively. The data will be analyzed by using the SPSS (Statistical Package for Social Sciences) 23 version.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosed stroke patients with ischemic type.
2. Post-stroke ≥ 3 months.
3. Survivors of both hemorrhagic and ischemic stroke.
4. Subjects should have stable conditions after the stroke incidence.
5. Community-dwelling survivors of stroke who were aged ≥40 years.
6. Both genders can participate in the study.
7. Mini-Mental State Exam score equal to or greater than 24.
8. Modified Rankin Scale score of three or less.
9. Berg Balance Scale score is between 41 and 52.
10. Muscle strength grade should be of grade 4 and above.

Exclusion Criteria:

1. Subjects with diagnosed peripheral neuropathy.
2. The subject is unable to perform Tai Chi exercises.
3. No history of other neurological and musculoskeletal conditions.
4. Subjects with diagnosed vestibular disease.
5. Subjects have cardiac abnormalities.
6. Contracture, fracture, or pain in the musculoskeletal system.
7. Subjects who have undergone strength and balance training in the past 3 months.
8. Subject taking medications that increase the incidence of falls.
9. Subjects have been diagnosed with malignancy of any type.
Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension

The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also contain a comparison of the bioavailability of the suspension given with food and on an empty stomach.

This is an open, randomized 3-way crossover study in 12 healthy volunteers. Subjects will receive single oral 30-mg doses of nitisinone as a suspension (fasting and with food) and as hard gelatin capsules (fasting only). There will be a 2-week washout period between the doses.

There will be a screening visit within 3 weeks prior to the first dose. During each treatment period, subjects will be admitted to the clinic from the afternoon on the day before drug administration (i.e., on Day -1) and remain at the clinic until the 48-hour post-dose blood sample has been collected in the morning of Day 3. They will then return for ambulatory visit in the morning of Day 4 (72-hour sample). A follow-up visit will take place 7-14 days after the last dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Age: 18-55 years, inclusive
* BMI: 18,5-30,0 kg/m2, inclusive

Exclusion Criteria:

* heavy smokers
* Consumption of more than 4 cups of coffee per day.
* History of drug and/or alcohol abuse.
* Positive drug screen or alcohol breath test.
* Positive screens for hepatitis B surface antigen, hepatitis C antibodies and human immunodeficiency virus (HIV) 1-2 antibodies.
* Enrollment in another concurrent clinical study
* Intake of an investigational medicinal product within three months prior to inclusion in this study.
* Donation of more than 50 mL of blood within 60 days prior to drug administration
* Donation of more than 1,5 liters of blood in the 10 months prior to first drug administration.
Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire

The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life.

The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to evaluate disease activity. It has the advantage of being inexpensive, easy to use in large cohorts and has been used in several studies. It has never been validated in French. The Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is specific to systemic lupus erythematous; it was developed from interviews with patients.

This tool, validated in a British population, has never been validated in French.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous.
* Patients able to understand written and spoken French.
* Patients who have been informed about the research

Exclusion Criteria:

* Severe mental retardation.
* Any impairment of ability to understand making self-evaluation impossible.
* Age \< 18 years.
* Age \> 75 years.
The Research of French PaRole OncO : A Peer Supported Program for Cancer Patients

Peer support is a valuable mode of accompaniment between individuals who are facing or have faced similar challenging life experiences. In this context, a patient advisor (PA) shares their experiential knowledge, derived from living with a disease, to offer emotional, experiential, and informational support to other patients. This PA intervention represents an innovative form of support for oncology patients, potentially addressing their needs more comprehensively throughout the care pathway by integrating psychosocial dimensions into the support approach.

The present pilot study aims to investigate the implementation and effectiveness of the peer-to-peer support program "PaRole OncO France" in the oncology setting. The study will focus on:

1. Evaluating clinical and psychosocial parameters
2. Utilizing an in-depth multiple case study approach This research seeks to provide insights into how peer support can enhance the overall care experience for oncology patients, potentially leading to improved patient outcomes and a more holistic approach to cancer care.

Peer support is a valuable mode of accompaniment between individuals who are facing or have faced similar challenging life experiences. In this context, a patient advisor (PA) shares their experiential knowledge, derived from living with a disease, to offer emotional, experiential, and informational support to other patients. This PA intervention represents an innovative form of support for oncology patients, potentially addressing their needs more comprehensively throughout the care pathway by integrating psychosocial dimensions into the support approach.

The present pilot study aims to investigate the implementation and effectiveness of the peer-to-peer support program "PaRole OncO France" in the oncology setting. The study will focus on:

1. Evaluating clinical and psychosocial parameters
2. Utilizing an in-depth multiple case study approach This research seeks to provide insights into how peer support can enhance the overall care experience for oncology patients, potentially leading to improved patient outcomes and a more holistic approach to cancer care.

Eligibility Criteria:
Inclusion Criteria:

* Patient participants :

  * Patients with newly diagnosed or recurrent cancer (urological, digestive, mammary, pulmonary, ORL, peritoneal carcinosis, melanoma, oncohaematology)
  * French-speaking patients
* Patients adivsors :

  * Patient advisors will be past cancer patients not currently undergoing treatment for their cancer, and considered without evidence of disease
  * French-speaking patients

Exclusion Criteria:

* Patients participants :

  * Not followed in one of the participating units
  * Persons deprived of their liberty by judicial or administrative decision
  * Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
* Patient advisors :

  * Recurrence of the disease
  * Currently undergoing treatment for active cancer