cyrilzakka/clinical-trials huggingface dataset:
Predictors and Outcomes of Kangaroo Mother Care: A Quasi-Experimental Study in Pakistan

This quasi-experimental study evaluated the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on the growth, developmental milestones, breastfeeding, vaccination, and mortality of low birth weight infants in Services Hospital Lahore, Pakistan. A total of 400 infants were enrolled and followed for one year.

This quasi-experimental study was conducted in the Obstetrics and Gynecology Department of Services Institute of Medical Sciences (SIMS), Lahore, Pakistan, to compare the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on low birth weight infants. A total of 400 infants (200 in each group) born between January 2020 and December 2022 were included in the study, with participants selected based on specific inclusion criteria and informed consent obtained. KMC involved continuous skin-to-skin contact between mother and infant during the hospital stay and continued at home for at least 8 hours daily. The follow-up schedule included appointments at six weeks after birth, monthly visits until six months of age, and quarterly visits until the infants reached one year of age. During these visits, the study collected data on infant growth, developmental milestones, breastfeeding practices, and vaccination status. The study was ethically approved by the research ethics committee, and data collection was conducted during scheduled follow-up visits to the outpatient department.

Eligibility Criteria:
Inclusion Criteria:

* women who were able to follow the program instructions,
* permanent residents of Lahore and its periphery and willing to be part of program for the one-year time period,
* live newborn babies delivered either vaginally or through caesarean section with birth weight of 1.5 to 2 kg,
* gestational age between 28 to 36 weeks.

Exclusion Criteria:

* an infant or mother diagnosed with a life-threatening ailment, major disease, or major malformations,
* early-detected major conditions arising from perinatal problems, such as severe hypoxic-ischemic encephalopathy, pulmonary hypertension,
* incidence of severe infection measured as nosocomial infections requiring systemic antibiotics or infections, severe respiratory distress, and hypothermia episodes (temperature less than 35C).
Feasibility Study of CBCT for IGRT in Cancer Patients

Cone beam computed tomography (CBCT) is an imaging technology that is incorporated into many modern radiation therapy systems. The quality of conventional CBCT is good enough to align patients for their daily radiation therapy but CBCT images have poor contrast and are susceptible to imaging artefacts that limit their usability for other tasks in the radiation therapy workflow.

Varian Medical Systems, the sponsor of this study, has developed new CBCT imaging technology called HyperSight that so far has demonstrated increased image quality compared with conventional CBCT images. This new HyperSight CBCT imager has previously been built into Varian Halcyon and Ethos treatment machines, where the imager is enclosed in a ring that rotates around the patient. Now, HyperSight has been built into a Varian treatment machine, called TrueBeam, where the imager is mounted on a C-shaped arm that rotates around you to acquire an image.

This study is being done to evaluate the image quality of HyperSight CBCT compared to conventional CBCT images, and to determine whether HyperSight CBCT can improve the process of delivering radiation treatments.

The goal of this study is to collect images from this new HyperSight-TrueBeam CBCT imager from a variety of patients and locations in the body. The images will be analyzed to determine whether their quality is high enough to use for tasks other than positioning patients for treatment. For example, the study will determine whether the HyperSight images could be used to calculate a radiation plan.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age ≥ 18
2. Patient is receiving radiation therapy for head and neck, thorax, liver, breast, genitourinary, or gastrointestinal malignancies
3. A CBCT acquisition for localization is standard of care for the radiation therapy treatment plan being delivered

Exclusion Criteria:

1. Patient has ECOG Performance Status ≥3.
2. Patient is wheelchair bound.
3. Patient has a life expectancy \<3 months.
4. Patient is unwilling or unable to provide informed consent to participate in the study.
5. Patient is pregnant or has plans for pregnancy during the period of treatment.
6. Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response"). This includes prisoners.
Bupivacaine Supplementation For Postoperative Pain Control In Surgical Removal Of Mandibular Third Molars

Control of postoperative pain is a foremost goal in achieving a satisfactory postoperative recovery. Surgical removal of lower third molars is accompanied by postoperative pain that is at its peak in the first 12 hours. Our study evaluates if the use of 2% lidocaine hydrochloride for the surgical removal of lower third molars with a postoperative 0.5% bupivacaine supplementation would result in lesser postoperative pain and a decrease in ingestion of oral analgesics to control the pain when compared to a placebo.

The study intends to enroll 100 patients \[ASA 1\] with bilateral symmetrical impacted mandibular third molars requiring surgical removal under local anesthesia. 2% Lidocaine hydrochloride with epinephrine bitartrate 1: 80000 in 3ml quantity will be utilized to achieve local anesthesia at the surgical site on both quadrants. Additional supplementation postoperative at the surgical site will be provided with either 1.5 ml of 0.5% bupivacaine with 1:80000 epinephrine solution or saline based on a split mouth randomized study design using a color and number coded envelop. All procedures will be performed by a single surgeon using a similar technique, under identical conditions at one month apart intervals. Pain scores will be assessed by the patient based on a 10cm Visual Analog Scale at intervals of 2, 4, 6, 12, 24, 36, 48, 72, 96 and 120 hours. The duration of soft tissue anesthesia postoperatively will be recorded by the patient. The number of analgesics ingested over 120 hours will be recorded by the patient. Results will be evaluated statistically by the Wilcoxon test and two tailed test to determine the ratio. Statistical significance will be considered at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* healthy ASA \[American Society of Anaesthesiologists\] class 1 patients with mandibular bilateral, symmetrical, impacted third molars indicated for extraction.

Exclusion Criteria:

* unilateral impacted and bilateral asymmetrical impacted molars;
* those who misused alcohol, had chronic pain,
* those who took narcotic drugs, beta-blockers, or any analgesic drug within 24 hours before the operation
* those with known hypersensitivity to amide types of local anesthetics.
Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients

The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and quantitative analysis of bone neoformation.

The reconstruction of the craniofacial skeleton in development between 2 and 10 years old, remains a major challenge for reconstructive plastic surgery. Local autogenous bone is practically unavailable, the distant bone graft has significant morbidity and use of alloplastic materials is incompatible with the growing facial skeleton. With the advent of bioengineered tissue, however, osteogenesis induced by the use of mesenchymal stem cells associated with biomaterials has become a potential solution to the shortage bone-related morbidity and donor bone in the region in pediatric patients.

The association of mesenchymal stem cells to biomaterials has provided new bone formation and a significant reduction of morbidity, for rehabilitation of the alveolar bone in patients with cleft lip palate.

To perform the rehabilitation of alveolar bone cleft, other donor regions of bone (iliac crest, ribs, skull) suffer morbidity for obtaining bone to be used in alveolar bone grafting. In order to eliminate the morbidity at the bone donor region for these patients and reduce costs of patient permanence in the operating room the aim of this study is to perform the bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and quantitative analysis of bone neoformation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unilateral cleft lip and palate ;
* Patient who has performed the treatment to align the dental arches in the ambulatory of odontology at Hospital Municipal Infantil Menino Jesus;
* Patient that have Goslow index 1, 2 or 3;
* Patiente which have 2/3 of the root of the canine tooth (cleft region) formed.

Exclusion Criteria:

* Prior alveolar surgery;
* Canine teeth erupted before the bone graft;
* Presence of co-morbidities;
* Incomplete documentation;
* Patients who have not done all the multidisciplinary treatment at Hospital Municipal Infantil Menino Jesus.
A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis (AD)

This is a A multicenter, open label, phase II clinical study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics(PD), and preliminary efficacy of AK120 in adolescents with moderate-to-severe atopic dermatitis

This is a A multicenter, open label, phase II clinical study aimed to evaluate the safety, PK, PD, and preliminary efficacy of AK120 in adolescents with moderate-to-severe AD. The entire study include screening period(week -4 to week 0), treatment and follow-up period(16 weeks). The duration of the study is about 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥12 \<18 years old.
* Weight≥30kg at baseline.
* AD diagnosed at least half a year before screening.
* Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.

Exclusion Criteria:

* Acute onset of AD in 4 weeks prior to enrollment.
* Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
* Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
* Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
* Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer).
* Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Study of Risk Factors for the Occurrence and Severity of Exertional Heatstroke in the Military Environment

Although the circumstances of onset and management of exertional heatstroke have been identified for several years, its pathophysiology remains imperfectly understood. Exertional heatstroke is the result of both extrinsic (i.e. environmental) and intrinsic (i.e. individual) contributing factors.

Extrinsic factors are well known (high ambient temperature and hygrometry, poorly "breathable" clothing, intense and prolonged physical effort) but some of them may be observed in milder conditions. In the French Armed Forces, 25% of the exertional heatstrokes that have been reported between 2005 and 2011 occurred below 17°C.

Intrinsic factors, on the other hand, are numerous and less consensual, partly because of the imperfect knowledge of exertional heatstroke physiopathology. Potential factors include a thermoregulatory defect (inability to maintain a temperature plateau during an effort) and several genetic mutations may also contribute to explain a propensity to present an exertional heatstroke. While exertional heatstroke is clearly not a monogenic pathology, the association of several polymorphisms could contribute to this vulnerability. Among the genes that have been explored, mutations in ryanodine receptor type 1 (RyR 1), calsequestrin-1 or angiotensin-1 converting enzyme (ACE) appear to be potential candidates. However, it is very likely that other polymorphisms may be involved, such as: genes involved in sports performance and exercise rhabdomyolysis, in the inflammatory cascade, permeability of the digestive epithelial barrier, adenosine receptors and susceptibility to anxiety.

Finally, motivation is a mixed factor often claimed to be involved in exertional heatstroke but has never been quantified and needs to be objectified.

To date, none of these hypotheses has been clearly assessed by comparing patients who experienced exertional heatstroke to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Active military
* Between 18 and 45 years old
* Ability to the walk/run test

Exclusion Criteria:

* Ongoing drug treatment (for the control group only),
* BMI greater than or equal to 30,
* Contraindication to the ingestion of a core temperature capsule
IUD Self-Removal: Evaluating an Online Guide for Self-removal in Clinical and Non-clinical Settings

Investigators previously developed a guide to help people with IUD self-removal. In this randomized study, the goal is to see if this guide makes it easier for IUD-users to remove their own IUDs.

The main question the study aims to answer is:

-Does use of the previously developed IUD self-removal guide increase rates of self removal?

Participants will:

* Complete a pre-study survey
* Be randomized to self-removal with use of the guide or no additional resource
* Self-select participation at home or in clinic
* Attempt IUD self-removal either at home or in clinic
* Complete a post-study survey.

Investigators will compare rates of successful self-removal between those randomized to the guide to those randomized to no additional resource to see if increases success.


Eligibility Criteria:
Inclusion Criteria:

* Ages 14 and older
* IUD in place and desiring removal
* Interest in attempting self-removal
* English speaking
* Working cell-phone with camera.

Exclusion Criteria:

* Not meeting above inclusion criteria, no other specific exclusion criteria
TACE Combined With Penpulimab and Anlotinib for Advanced HCC

The purpose of this multicenter, dual-cohort, prospective real-world study is to explore the efficacy and safety of penpulimab and anlotinib combined with or without TACE, as well as the optimum interval of the combination of penpulimab and anlotinib with TACE in advanced HCC patients.

The efficacy and safety of transarterial chemoembolization (TACE) combined with penpulimab and anlotinib in the treatment of advanced hepatocellular carcinoma (HCC) remain unknown. This is a multicenter, dual-cohort, prospective real-world study with patients receiving normal clinical care. Patients in cohort I will receive TACE combined with penpulimab and anlotinib (TACE-A-A Cohort), and patients in cohort II will just receive penpulimab and anlotinib (A-A Cohort). The primary endpoints of this study are the efficacy of penpulimab and anlotinib combined with or without TACE in advanced HCC patients. While the secondary endpoints include the safety of penpulimab and anlotinib combined with or without TACE, as well as the optimum interval of the combination of penpulimab and anlotinib with TACE in advanced HCC patients. The results will provide further evidence for the clinical practice and the design of future trials.

Eligibility Criteria:
Inclusion criteria:

* Pathologically or clinically diagnosed HCC patients;
* Age of 18-80;
* Barcelona Clinic Liver Cancer (BCLC) stage C (ie, China Liver Cancer Staging (CNLC) stage III);
* with expect survival ≥ 3 months;
* with obtained informed consent;
* will receive penpulimab and anlotinib combined with or without TACE.

Exclusion criteria:

* Contraindications of penpulimab and anlotinib;
* Child-Pugh C;
* Key information (such as imaging, liver function, Eastern Cooperative Oncology Group(ECOG) score, etc.) missing.
Effectiveness and Safety Study of Overnight Intensive Patch in Scars

To investigate the effectiveness of an Overnight Intensive Patch (OIP) on improvement of post dermatological surgery scars and its safety over 12 to 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subject has two or more newly formed post dermatological surgery scars of 1-10 (inclusive) cm each, with comparable length, located on a comparable skin area (upon the discretion of the investigator, considering e.g. the skin thickness or body tension). Scars located at the upper back of the body will not be investigated due to a higher risk of wound dehiscence.
* The dermatological surgery takes place within the last 3 weeks prior to baseline visit and the baseline visit is on the day of post-surgery control with optional suture removal, the wound must be closed by then.

Exclusion Criteria:

* Subject with known history of keloids or hypertrophic scars.
* Subject with derma resurfacing procedures or non-invasive skin-tightening procedures including medium/ deep chemical peeling, dermabrasion treatments or laser therapy in the skin area intended to be treated for less than 8 weeks prior to screening/ baseline visit.
* Subject with any planned topical application containing active ingredients (e.g. self-tanning agents, however, hydration lotion is allowed provided the scars are left free) in the skin area intended to be treated.
* Subject anticipated spending excessive time in the sun (e.g. outdoor workers) or in the sun tanning bed during the investigation.
* Subject with any infection or wound in the area intended to be treated.
* Subject with known hypersensitivity to any ingredient of OIP (e.g. acrylic adhesive, extractum cepae or allantoin).
* Subject who is taking, or anticipated to take during the investigation, systemic corticosteroids or topical corticosteroids applied on the investigation skin area.
* Subject with eczema requiring treatment in the skin area intended to be treated.
* Subject with any ongoing severe or uncontrolled systemic disease (cardiac, respiratory, hepatic, renal or gastrointestinal), malignant tumor (except for basalioma), or known HIV infection.
Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease

Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.

Consecutive patients with- and low risk endometrial cancer will be approached for eligibility for inclusion in a study evaluating the detection rates of pelvic metastatic disease by detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy.

A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant treatment.

The detection rate will be evaluated from a non-inferiority perspective against the expected rate of nodal metastases based on detailed final histological data.

Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel nodes), time for the intervention, and an objective evaluation of lymphatic complications (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Women of age 18 years and older at the time of informed consent.
* Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery
* A uterine size allowing minimally invasive surgery
* Women must be able to understand and sign an informed consent in Swedish language.
* Absence of any exclusion criteria

Exclusion Criteria:

* Non consenting patients
* Ongoing pregnancy
* Inability to understand written and/or oral study information
* WHO performance status or conditions contraindicating adjuvant oncological treatment (WHO III or more)
* Previous lower limb lymphedema ( only for the lymphedema part of study)
* Evidence of locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography.
* Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
* Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
* Allergy to Iodine
* Patients with a known liver disease
* Patients with a bleeding disorder or mandatory antithrombotic treatment.
Adhesion of Connective Tissue Around Laser-treated Abutments for Dental Implants - Clinical Trial in Humans

This study aims to demonstrate the histological differences in the connective tissue surrounding laser-treated abutments and untreated abutments in humans.

Working hypothesis: There are differences in the adhesion of collagen fibres around implant abutments with laser-produced microgrooves and standard abutments.

All patients will receive both abutment systems. The assignment of the abutments to each of the implants will be made randomly using SPSS 15.0 (SPSS Inc., Chicago, Il, United States) software.

Eligibility Criteria:
Inclusion Criteria:

* patient must have partial edentulism of at least 2 teeth
* patients that have scheduled treatment for the placement of at least 2 implants
* patients with favourable attached gingiva
* patients without systemic diseases that would prevent the emplacement of implants
* patient must accept participation in the study by signing an informed consent form

Exclusion Criteria:

* smokers of 1 or more cigarettes per day
* patients who suffer from any known condition that could be an absolute or relative contraindication to dental implant placement
* patients requiring any additional surgical technique for bone or gum graft in order to insert the dental implant
* patients who refuse to be included in the study or do not sign the informed consent form