cyrilzakka/clinical-trials huggingface dataset:
Effect of Hyaluronic Acid and Single Dose Corticosteroid Injection to Improve Wound Healing in Controlled Diabetic Patients Post Tooth Extraction.

The goal of this clinical trial is to learn if hyaluronic acid and corticosteroid improves wound healing in diabetic patients after oral extraction.

After sample size estimation via Open Epi of 128, randomized clinical trial was performed on the patients from Oral and Maxillofacial Surgery Department in Madinah Teaching Hospital, Faisalabad. Patients were divided into three groups. Group 1 was subjected as control group, Group 2 was treated post extraction with 0.2 % Hyaluronic acid (Gengigel Gingival Gel 20ml, Ricerfarma, Milan, Italy) and Group 3 was treated with single dose Hy-Cortisone Injection 250 mg (Generic name: Hydrocortisone Sodium Succinate, Cirin Pharmaceuticals Pakistan) intramuscularly after extraction. Wound healing was assessed through Landry Healing Index. One-way ANOVA test was applied for comparative analysis and Post Hoc Tuckey's test was applied for pairwise comparisons between the groups

Eligibility Criteria:
Inclusion Criteria:

* • Controlled diabetic patients who had random blood glucose levels of 80 to 130 mg/dl, according to World Health Organization.

  * Age was defined from 25-55, irrespective of the gender.
  * Tooth extractions in maxilla or mandible without the presence of an acute infection or compromised periodontal state.

Exclusion Criteria:

* • Patients who declined to participate.

  * Patients below the age of 25 and above the age of 55.
  * Patients with uncontrolled diabetes mellitus (blood sugar levels high than the defined range)
  * Patients with history of adverse effects to local anesthetics or who are currently taking corticosteroids.
  * Patients with unmaintained oral hygiene and smoking habits.
  * Confirmation of any chronic illness, including those with hypertension or cardiac disorders.
  * Patients who have undergone any recent major surgical procedure.
Estrogen and Gender Biased Autoimmunity

This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.

This is a 3-year study. The total number of subjects enrolled will depend on the results obtained. The subjects will be at least 18 years of age and pre-menopausal. Exclusion to include pregnant women, and all subjects are told not to get pregnant while on study. Also, they cannot take hormones by mouth or patch while on study. The study can include healthy subjects as well. Blood will be drawn (120 ml) four times a year, randomly.

Eligibility Criteria:
Inclusion Criteria:

* female subjects with Lupus, and female subjects without Lupus. age at least 18, not pregnant and not planning to get pregnant.

Exclusion Criteria:

* Pregnant or planning to get pregnant. On hormone replacement, or birth control of any kind.
Prevalence of Postpartum Family Planning and Its Association With Spousal Joint Decision-Making in Family Planning

This community-based cross-sectional study investigates the prevalence of postpartum family planning (PPFP) uptake and its association with joint spousal family planning decision-making among married women in rural Sindh, Pakistan. The study, conducted in Thatta District with a population of approximately 0.98 million people, addresses sociodemographic challenges including high fertility rates, maternal and newborn mortality, and low contemporary contraception use. Targeting married women aged 18-49 who gave birth within the past year, the research utilizes data from the Global Network's Maternal and Newborn Health Registry. Data collection involves a pretested questionnaire administered by trained female data collectors. Statistical analysis includes descriptive statistics and logistic regression using STATA 17. The study aims to fill knowledge gaps regarding factors influencing PPFP uptake, particularly the role of joint decision-making in family planning. Findings could inform targeted interventions to enhance maternal and child health, contribute to existing knowledge, and guide policymakers and healthcare providers in addressing the unmet need for family planning in rural Pakistan.


Eligibility Criteria:
Inclusion Criteria:

* Women who are married and gave birth a year ago
* Living within the Maternal Neonatal Health Registry catchment area for at least one year.
* Women who will give their consent.

Exclusion Criteria:

* Pregnant women.
* Women who are critically ill and who face significant cognitive barriers that hinder their understanding and participation in the study.
Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise

The propose of this study is to evaluate the feasibility and the clinical efficiency of feedback-controlled robotics-assisted treadmill exercise (RATE) technology for cardiovascular rehabilitation early after stroke. The investigators hypothesize that feedback-controlled RATE might be suitable and effective to improve cardiovascular fitness and functional carryover in non-ambulatory individuals with sub-acute stroke.

For detailed info: Stoller O, de Bruin ED, Schuster-Amft C, Schindelholz M, de Bie RA, Hunt KJ. Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomized controlled pilot trial. Trials. 2013 Sep 22;14(1):304.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of an initial supratentorial stroke
* ≤20 weeks post stroke at intervention onset
* Age ≥18 years
* Functional Ambulation Category (FAC) ≤3
* Ability to understand the procedures and provide informed consent

Exclusion Criteria:

* Contraindications for exercise testing outlined by American College of Sports Medicine (ACSM)
* Contraindications for RATE according to the manufacturer
* Concurrent neurological disease
* Concurrent pulmonary disease
* History of dementia
MONOCENTRIC PERSPECTIVE STUDY: USE OF LIQUID BIOPSY WITH DIAGNOSTIC IMAGING

Evaluation of the diagnostic accuracy of Mammography in the morpho-structural analysis of mammographic images in breast cancer-diagnosed patients or patients in follow-up for breast cancer by extracting a number of features describing the texture and morphology of the lesions reported in the form of a structured report explicitly developed for the study. Correlation of the data obtained from evaluating the primary endpoint with the genetic/molecular analysis on liquid biopsy.


Eligibility Criteria:
Inclusion Criteria:

* full information on the study and signature of the informed consent
* biopsy-proven breast cancer or previous surgery for breast cancer
* willingness of the patient to undergo liquid biopsy

Exclusion Criteria:

* state of pregnancy or breastfeeding
* patients operated on for benign or inflammatory diseases
Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug
* Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug

Exclusion Criteria:

* Is pregnant or breastfeeding
* Has another clinically significant medical conditions or laboratory abnormality(s)
6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients with metastatic kidney cancer.

OBJECTIVES: I. Evaluate the efficacy of 6-hydroxymethylacylfulvene (HMAF) in patients with metastatic renal cell carcinoma. II. Investigate the safety of HMAF given to this patient population.

OUTLINE: Patients receive 6-hydroxymethylacylfulvene intravenously for 5 minutes every day for 5 consecutive days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed after every 2 treatment courses.

PROJECTED ACCRUAL: Approximately 12-37 patients will be accrued for this study within 6-19 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma and evidence of metastatic disease Bidimensionally measurable disease No active brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within normal range ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine within 1.5 times ULN AND Creatinine clearance at least 50 mL/min Other: Not pregnant or lactating Fertile patients must use effective contraception No prior malignancy within 5 years and at low risk for recurrence Must have undergone potentially curative therapy for prior malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since biological therapy and recovered Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since hormone therapy and recovered Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 4 weeks since major surgery
Study to Assess PXL770 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD)

A randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL770 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN).

A randomized open-label Phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of PXL770 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (AMN).

There are 3 study periods.

* Screening Visit: within a maximum of 4 weeks prior to the open-label Treatment Period
* Open-label Treatment Period: 12 weeks
* Follow-up Period: 2 weeks after the last intake of the treatment

During the treatment period, VLCFA will be assessed every 4 weeks, to evaluate the kinetics of the effect. NfL will be assessed after 8 and 12 weeks of treatment, and other exploratory biomarkers after 12 weeks of treatment. A follow up period will allow monitoring the subjects' safety as well as the duration of the effect on the 2 main biomarkers (VLCFA and NfL) at 2 and 4 weeks after the drug withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects with either a confirmed diagnosis of AMN by genetic testing (mutation in the ATP binding cassette subfamily D (ABCD1 gene)) or a family history of X-linked adrenoleukodystrophy (ALD) together with an elevation in VLCFA obtained from overnight fasting plasma sample at Screening Visit (V1).
* Age: ≥ 18 to ≤ 65 years at informed consent signature.
* Normal brain magnetic resonance imaging (MRI) or brain MRI showing non-specific abnormalities that can be observed in AMN subjects without signs of cerebral form of ALD (C-ALD). MRI must be performed within 6 months prior to V2. If there is no available brain MRI within this period, a brain MRI must be performed before V2.

Exclusion Criteria:

* Any progressive neurological disease other than AMN.
* Arrested or progressing C-ALD as defined by cerebral lesions (except for non-specific abnormalities that can be observed in AMN subjects).
* Prior receipt of an allogeneic hematopoietic stem cell transplant or gene therapy.
Patient Registry of Intrathecal Pain Management in Europe for Prialt (Ziconotide Intrathecal Infusion) and Alternative Drugs for the Management of Severe, Chronic Pain.

This is an open-label, long-term, multi-center multi-national post-marketing observational registry. The objective of this study is to monitor the long-term efficacy, safety, tolerability and quality of life outcomes associated with ziconotide (Prialt) and other analgesics utilized in the intrathecal (IT) management of severe chronic pain.

This is an observational non-interventional registry. All patients will sign and date an Informed Consent Form (ICF) before enrollment (Baseline Visit). Normal clinical practice will be followed. Patients will continue to follow their usual schedule of clinic visits as determined by their physician, during which information and patient-completed questionnaires will be collected (at scheduled intervals timed to coincide with pump refill).

Eligibility Criteria:
Inclusion Criteria

Patients will be eligible to enroll onto the registry if they have given informed consent and meet the following criteria:

* Patient's physician has deemed that the initiation/switch of intrathecal analgesia appropriate, or patient is presently utilizing ziconotide (Prialt)
* Patient has a diagnosis of severe, chronic pain for which intrathecal infusion is indicated
* Patient is at least 18 years of age at time of study entry

All patients starting ziconotide (Prialt) should comply with the indications and warnings in the current approved version of the Summary of Product Characteristics (SmPC).

Exclusion Criteria

Patients who meet any of the following criteria will not be eligible to enroll in the registry:

* Patient is a pregnant or lactating female
* Patient is receiving intrathecal chemotherapy
Modified FOLFIRINOX for Gemcitabine Refractory Pancreatic Cancer: A Phase II Multicenter Trial

Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for advanced pancreatic patients, no drug or combination of drugs has significantly improved the prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies, modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved safety profile in digestive malignancies. The purpose of this phase II multicenter study was to investigate the efficacy and safety in patients with pancreatic cancer who progressed in gemcitabine-based first line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)
* Refractory or progress to Gemcitabine based 1st line chemotherapy
* Older than 19 years old and younger than 75 years old
* Life expectancy\> 3 months
* ECOG Performance status ≤2
* Only patients with measurable lesions in imaging study
* Adequete BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
* Adequete liver function (total bilirubin \< 1.5 X the upper limits of normal (ULN), AST and ALT \<3 X UNL, and alkaline phosphatases \< 3 X ULN or \< 5 x ULN in case of liver involvement)
* Adequete renal function (serum creatinine \< 1.5 mg/dl)
* Adequete cardiopulmonary function

Exclusion Criteria:

* Pathologically confirmed another type of pancreatic cancer (except ductal adenocarcinoma)
* Metastatic adenocarcinoma of originating at other organs
* Evidence with CNS metastasis
* Active infection
* Uncontrolled serious medical or psychiatric illness which can induce toxicity ro complication of treatment, such as inability to swallow, lacking physical integrity of the gastrointestinal tract, malabsorption syndrome, or active ulceration at upper gastrointestinal tract.
* Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin
* Participation in any other investigational drug study within 1 month
* No signed informed consent
Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults

This is a multicenter, parallel groups, partially randomized, open-label, blank-controlled adaptive platform study to evaluate the effectiveness of a second COVID-19 vaccine booster in Chinese adults who are charactered as the majority of whom with hybrid immunity of COVID-19 vaccination and COVID-19 breakthrough infection. Individuals aged 18 years and over, include the elderly over 60 years old or those with underlying diseases (history of underlying medical conditions diagnosed by a clinician, including hypertension, diabetes, heart disease, etc). The eligible participants with an interval ≥ 4 months after previous SARS-CoV-2 infection (or had never been infected) and ≥ 6 months from the first COVID-19 vaccine booster will be recruited. Participants who are not willing to receive the second booster but are consent to participate the surveillance for COVID-19, will be included as a blank control. Informed consent will be acquired from eligible participants. Other participants who are willing to receive the second booster and participate the surveillance for COVID-19, will be randomly allocated in a ratio of 1: k (k is the number of vaccine types) to the different investigational vaccines, stratified according to age and history of COVID-19 infection. The symptomatic COVID-19 cases will be reported and documented in both the investigational and control groups. The occurrence of serious adverse events within 6 months after vaccination will be observed. Moreover, blood and nasal mucosa samples will be collected on the day 0 before and day 14, month 3 and 6 after the booster vaccination in a subgroup for humoral, cellular and mucosal immunogenicity analysis. Moreover, oral specimens will be collected once for all participants on the day of enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years and over, including the elderly over 60 years and those with underlying diseases.
2. Volunteers are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
3. ≥ 4 months from the last SARS-CoV-2 infection (or never been infected), and 6 months or more from the first booster immunization of the COVID-19 vaccine.

Exclusion Criteria:

1. Volunteers have suspected symptoms of COVID-19 when enrolled, such as dry throat, sore throat, cough, etc.
2. The COVID-19 Antigen Quick Test Kit is positive when volunteers are enrolled.
3. Fever, temperature \> 37.0°C.
4. Have received a second COVID-19 vaccine booster immunization.
5. Have a history of serious adverse reactions related to the vaccine and/or have a history of severe allergic reactions to any component of the investigational vaccine (only applicable to the vaccine groups).
6. Pregnant or lactating women.
7. HIV infection, tuberculosis, low immunity caused by disease or long-term medication.
8. Acute disease or acute onset of chronic disease.
9. Epilepsy and other progressive neurological disorders.
10. Other situations that are not suitable for participating in this research, according to the judgment of the researcher.
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use

KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients.

The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries.

The aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.

As this study is observational in nature, subject follow-up was not specified by the protocol but was left to the judgment of each physician within the 18 months period, which defines the survey for each participant. For indicative purposes, follow-up of each participant should enable approximately 7 visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following inclusion (usually at the end of the first treatment month) and apart from visits required because of intercurrent events. Participant visits were assigned as follows: Baseline/Day 0 (start of lopinavir/ritonavir treatment), Month 1 (day 1 to day 45), Month 3 (day 46 to day 136), Month 6 (day 137 to day 228), Month 9 (day 229 to day 319), Month 12 (day 320 to day 410), Month 15 (day 411 to day 501), Month 18 (day 502 to day 593). Each participant is planned to be observed during his/her lopinavir/ritonavir capsule containing treatment regimen for a maximum period of 18 months, and each participant is planned to be observed during his/her lopinavir/ritonavir tablet containing treatment regimen for a maximum period of 9 months.

Eligibility Criteria:
Inclusion Criteria:

Patients infected by HIV-1 infection who are either:

* Antiretroviral treatment (ART) naive or
* Had failed or had been intolerant to one previous combined antiretroviral treatment (cART), not including a Protease inhibitor (PI) (first-line pretreated without a Protease inhibitor) or
* Had failed or had been intolerant to one previous antiretroviral treatment ART, including one Protease inhibitor (first-line pretreated with a Protease Inhibitor).

A ritonavir-boosted Protease inhibitor PI is considered as treatment with one Protease inhibitor PI.

Exclusion Criteria:

* Treatment with drugs at risk for interactions with lopinavir/ritonavir
* Uncontrolled AIDS defining disease
* Two or more previous Protease inhibitors (PIs)
* Participation in another study or clinical trial
The Effect of Orthosis and Exercise in Pes Planus

There is no definite evidence for the conservative treatment of pes planus. We want to verify the combination efficacy of orthosis and toe walking exercise for the treatment of pes planus.

Observation cohort study

We prescribe UCBL orthosis and teach toe walking exercise. And we will check standing foot radiography (AP/Lateral) annually. And we will compare the changes of talometatarsal angle and calcaneal pitch angle.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with pes planus
* Calcaneal pitch angle \< 15 degree

Exclusion Criteria:

* peripheral neuropathy
* infection
* rheumatoid arthritis
* operation history