cyrilzakka/clinical-trials huggingface dataset:
Ghana MHL Project, Tamale

This study is designed to test a nutrition education program that focuses on local foods in northern Ghana. The goal is to help pregnant women eat a wider variety of foods, increase their intake of protein, energy, and iron-rich foods, and support healthy weight gain during pregnancy. We want to understand how this program impacts mothers' knowledge about nutrition and health, and how it affects the health of their babies. The program was created with input from pregnant women and health professionals in the community.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous pregnant (first-time) mothers (BMI\<20kg/m2) between the ages of 18 and 40 attending antenatal sessions and in their second trimester, gestational ages (GA) of 16 weeks to 20 weeks, who are not carrying multiple fetuses

Exclusion Criteria:

* Women with pregnancies greater than 20 weeks gestation, to ensure adequate exposure to the intervention; mothers presenting with significant morbidity or who are admitted due to complications and mothers who cannot confirm an address or contact information and do not plan to deliver at a health facility as well as those who indicate that they would not deliver in the study region (those who will be out of town at time of delivery).
Imaging of Trabeculectomy Blebs Using the Spectral Domain Optical Coherence Tomography

The aim of this study is imaging of trabeculectomy blebs regarding structure and function with the spectral domain optical coherence tomography.

After a trabeculectomy with mitomycin C 0,02% for 3 minutes, the blebs are controlled by a glaucoma specialist on day 1, week 1,2,3,4, month 3 and 6 after surgery. The glaucoma specialist will evaluate the bleb appearance according to a standardized protocol. At the same time points the bleb will be imaged with the spectral domain optical coherence tomography, to monitor bleb changes objectively. The investigators hope to see signs of bleb incapsulation and scarring earlier and then treat the patient accordingly.

Eligibility Criteria:
Inclusion Criteria:

glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure, informed consent

Exclusion Criteria:

patient without glaucoma, under 18 years of age, not willing to take part in the study
Exploring the Relationship Between ICOPE Framework and Frailty Among Community-dwelling Elderly Individuals

This study aims to (1) compare the assessment outcome of the ICOPE-I and ICOPE-S, and (2) investigate the correlation between both versions of the ICOPE step 1 screening tools and frailty in Taiwan.

The prevalence of frailty among the elderly increases annually as the population ages. The World Health Organization (WHO) has introduced the Integrated Care for Older People (ICOPE) framework, which aims to support healthy aging by evaluating the intrinsic capacity (IC) of the elderly in six different areas. In Taiwan, two versions of the ICOPE step 1 screening tools are available: an interview-based version (ICOPE-I) and a self-administered version (ICOPE-S) based on the WHO's model. There are two main models for frailty status assessments: Dr. Fried's phenotype of frailty and Dr. Rockwood's accumulation of deficit models. A comparative study is necessary to assess the consistency of both versions of ICOPE in Taiwan and their associations with frailty.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 65 years old
* Community-dwelling elderly
* Walking independently (with/without assistive devices)

Exclusion Criteria:

* Participants with a MoCA score \< 26
* Being unable to give informed consent (e.g., aphasia, deafness, and blindness)
* Being unable to finish all the physical and screening assessment assessments
Modified Shell Technique Versus Onlay Bone Graft in Anterior Maxilla

Amount of bone volume and (width and height):

Will be measured using linear measurements from CBCT after 6 month from implant insertion.

Will be measured using Histometric analysis of bone area percent sampling from recipient site after 6 months.

Augmentation of insufficient bone volume can be brought about by different methods, including, particulate and block grafting materials, Guided Bone Regeneration with or without growth and differentiation factors, ridge splitting, expansion and distraction osteogenesis, either alone or in combination. These techniques may be used for horizontal/vertical ridge augmentation

Autograft is considered as the Gold Standard for bone transplantation and various studies have shown efficacy for it. It is osteogenic, osteoconductive and osteoinductive. Autografts can be derived from extra oral source (iliac crest, ribs) or intraoral source (chin, ramus). They can be used in block or particulate form. Corticocancellous block grafts are preferred because of enhanced revascularization of the cancellous portion, and mechanical support and rigidity of the cortical portion, which ensures optimal ridge augmentation.

Fouad Khoury presented a three-dimensional (3D) reconstruction technique for atrophic ridges and complicated vertical bone defects using mandibular bone block graft "the Gold standard". There are several possibilities for augmentation of bone volume depending on situation, indication and adequate diagnosis; the treatment options can be extended from minimally invasive procedures with locally harvested bone grafts in local anesthesia, to very sophisticated grafting techniques for 3D bone reconstruction with extra oral harvested bone grafts. Khoury reported that his ascending ramus grafts is almost 5 times more than chin grafts

Eligibility Criteria:
Inclusion Criteria:

* patients with atrophic anterior maxilla
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement
* Both sexes.

Exclusion Criteria:

* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.


Eligibility Criteria:
Inclusion Criteria:

* Documented/confirmed first/second refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
* No more than 2 prior induction regimens (excluding prior HSCT) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione)
* Eastern Cooperative Oncology Group performance status of 0 to 2
* Adequate hepatic and renal function
* White blood cell (WBC) count at randomization less than or equal to (\</=) 50000 cells per cubic millimeter (/mm\^3)

Exclusion Criteria:

* First relapsed participants aged less than (\<) 60 years with first CR duration greater than (\>) 1 year
* Participants with prior documented antecedent hematological disorder (AHD)
* AML secondary to any prior chemotherapy unrelated to leukemia
* Participants who are either refractory to or relapsed within 90 days of receiving a regimen containing a cumulative dose of greater than or equal to (\>/=) 18 g/m\^2 of cytarabine
* Participants who have received allogeneic HSCT within 90 days prior to randomization
* Participants who have received immunosuppressive therapy for graft versus host disease or for engraftment syndrome after autologous stem cell transplantation within 2 weeks prior to randomization
* Prior treatment with an Murine Double Minute 2 (MDM2) antagonist
* Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 30 days from first receipt of study drug
* Participants with a history of other malignancy within 5 years prior to screening except for malignancy that has been in remission without treatment for at least 2 years prior to randomization
* Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Participants with extramedullary AML with no evidence of systemic involvement
* Pregnant or breastfeeding participants
Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.

OBJECTIVES:

Primary

* To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic therapy when administered continuously or in fractionated doses in patients with premalignant or early stage head and neck lesions.

Secondary

* To assess the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of photodynamic therapy. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
* Arm II: Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.

After completion of study therapy, patients are followed up at 1 month, every 3 months for 2 years, and then annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of 1 of the following within the past 3 months:

  * Erythroplakia with dysplasia
  * Severe dysplasia
  * Carcinoma in situ of the head and neck for which standard therapy is not indicated, according to any of the following:

    * Medical condition that precludes surgery
    * Lesions that cannot be completely resected based on size or location
    * Significant functional morbidity would be anticipated with further surgery
    * Refused standard therapy after the treatment has been discussed and offered
* No invasive squamous cell carcinoma of the head and neck

PATIENT CHARACTERISTICS:

* ECOG performance status of 0-2
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 2 times upper limit of normal (ULN)
* AST or ALT ≤ 2 times ULN
* Alkaline phosphatase ≤ 2 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chronic liver disease or cirrhosis of the liver
* No porphyria or hypersensitivity to porphyrins
* No significant cardiovascular history that, in the opinion of a cardiologist, would deem the patient at risk for hypotension that may occur with oral administration of aminolevulinic acid (Levulan®)
* No prior adverse reaction to ondansetron or lorazepam

PRIOR CONCURRENT THERAPY:

* Not specified
Cohort Study Comparing Short Daily Hemodialysis (HD) With Conventional HD

This study is examining the effects of short daily hemodialysis on platelet function, fluid volume control, arterial stiffness and patient quality of life, as compared to conventional hemodialysis.

Bleeding is a common cause of morbidity and mortality in patients with end stage renal disease. A major cause of uremic bleeding is due to platelet dysfunction. It has been theorized that in renal failure, toxins accumulate, some of which inhibit primary hemostasis. All aspects of normal platelet function are affected. Platelet function has previously been difficult to quantify but recently a novel test, the platelet function analyzer (PFA-100) has been determined to be both sensitive and specific in assessing platelet function. Conventional hemodialysis (CHD) has been shown to partially correct thrombocytopathy. Enhanced uremic clearance can now be attained through the use of short daily hemodialysis (SDHD). Cardiovascular disease is the most common cause of mortality in dialysis patients, accounting for 40% of deaths. Volume overload is associated with high blood pressure, left ventricular hypertrophy and elevated markers of inflammation and these factors have been associated with increased cardiovascular mortality. SDHD has been shown to control blood pressure and limit volume expansion. Pulse wave velocity (PWV) has been used to assess arterial compliance and reduction of arterial elasticity of large and small arteries which have been associated with cardiovascular outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patient is enrolled in short daily hemodialysis program
* Patient is minimum of 18 years old

Exclusion Criteria:

* Patient is unable to consent due to language barrier
* Patient is unable to consent due to cognitive difficulties
* Patient refuses consent
Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma

The main objective is to describe the evolution of patients treated for a primary malignant hepatobiliary tumor (hepatocellular carcinoma or cholangiocarcinoma) over the long course.

The collection of data from patients with CHC and cholangiocarcinomas who are cancers with poor prognosis is a major challenge to improve patients'care (diagnosis, prognosis); facilitate the search for new therapeutic targets and the follow-up of clinical studies; and develop personalized treatments.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria :

* Age ≥ 18 years olds
* Medical care in Nephrology department since 2015

Cholangiocarcinoma:

- Histologically and cytologically documented cholangiocarcinoma, regardless of the stage of the disease

Hepatocellular carcinoma:

* Hepatocellular carcinoma at any stage of the disease, presenting the diagnostic criteria according to the diagnostic criteria of Barcelona : Tumor of more than 1 cm, developed on cirrhosis liver with arterial phase hyperenhancement and washout in the portal venous or delayed phases on CT and MRI
* Hepatocellular histologically documented

Exclusion Criteria:

- Lack of patient non-opposition
Ripple Mapping for Epicardial Mapping of Brugada Syndrome

Whether a mapping algorithm "Ripple-mapping" is able to rapidly identify the areas of long-duration multicomponent electrograms which constitute the targets for ablation for an automated strategy remains to be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Brugada syndrome patients requiring ablation

Exclusion Criteria:

* Patients not able to consent
Synthetic Human Secretin in Children With Autism

The purpose of the study is to determine whether multiple doses of secretin are safe and effective in the treatment of children with autism.


Eligibility Criteria:
Autism
Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.


Eligibility Criteria:
Summary of Inclusion Criteria:

* Able to voluntarily provide written informed consent to participate in the study.
* User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.
* For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 - 45.

Summary of Exclusion Criteria:

* Female subjects who are pregnant or lactating.
* Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
* User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.
A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU

The purpose of this small pilot study is to refine a combined intervention of IV amino acids and cycle ergometry in critically ill patients, and to gather preliminary data, before proceeding with a larger multi-center RCT. A total of 10 patients will receive the combined intervention.


Eligibility Criteria:
Inclusion Criteria:

1. \>=18 years old
2. Requiring mechanical ventilation or high flow nasal cannula (HFNC) with actual or expected total duration of mechanical ventilation or HFNC \>48 hours
3. Expected ICU stay \>4 days after enrollment (to permit adequate exposure to the proposed intervention)

Exclusion Criteria:

1. \>120 continuous hours of mechanical ventilation or HFNC before enrollment
2. Expected death or withdrawal of life-sustaining treatments within 7 days from enrollment
3. No expectation for any nutritional intake within the subsequent 72 hours
4. Severe chronic liver disease (MELD score \>20) or acute fulminant hepatitis.
5. Documented allergy to the amino acid intervention
6. Not ambulating independently prior to ICU admission (use of gait aid permitted)
7. Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre)
8. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
9. Pre-existing intracranial or spinal process affecting motor function
10. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
11. Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury)
12. Weight \>150kg
13. Pregnant
14. Incarcerated
Study of Innate Host Immune Response to C. Glabrata Clinical Isolates Resistant to Echinocandins: Impact on the Management of Candidemia in High-risk Patients

In the context of Candida yeast infections, a large number of studies have been published over the past two decades specifying the molecular mechanisms of antifungal resistance in different Candida species. However, few of these studies have explored how these mechanisms influence host immune response to this opportunistic pathogen. Recent advances in understanding how the host's immune system responds to Candida have initiated the emergence of a new research theme aimed at better understanding Candida's intrinsic and adaptive resistance mechanisms to antifungals can modulate "escape to" or "recognition by" the host's immune system. This knowledge could lead to (i) a better understanding of the predominance of certain Candida species with antifungal resistance in certain patient populations, (ii) a better understanding of why high levels of in vitro resistance are not necessarily correlated with in vivo therapeutic failure, and (iii) effective immunotherapeutic strategies to control Candida resistance to antifungals.

It is therefore crucial to investigate the impact of Candida's resistance to antifungals on the host's innate immune response. Indeed, most antifungal resistance mechanisms have a direct or indirect structural modification of the fungal wall. However, it is the composition of this wall that is involved in the recognition of Candida by the host cell via the pattern recognition receptors (PRRs). We therefore put forward the very probable hypothesis that changes in the fungal wall, induced by the appearance of resistance, could alter the recognition of Candida by PRRs and thus trigger a different immune response, either qualitatively (type of cytokines secreted) or quantitatively (amplitude and duration of the immune response). However, even if initial experimental data support the hypothesis of a possible link between resistance and a modulation of the innate immune response in digestive mucosa (the most frequent starting point for disseminated candidiasis), many questions remain regarding (i) the proteins and mechanisms of the modulated immune cascade, (ii) the modification of the immune response according to the Candida species in question and (iii) the modification of the immune response according to the resistance phenotype in question.


Eligibility Criteria:
Inclusion Criteria:

* 10 clinical isolates sensitive to all antifungal agents
* 10 echinocandin-resistant clinical isolates (Eucast, caspofungin \> 8µg/ml)

Clinical strains of C. glabrata susceptible or resistant to echinocandins will be selected on selected criteria:

* patient's immune status
* therapeutic management
* clinical developments

Exclusion Criteria:

* Not applicable
Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting

Gastric emptying is delayed after cardiac surgery, but the efficacy of the nasogastric (NG) tube in preventing distension and reducing vomiting is unclear. Nasogastric (NG) tubes are routinely used in patients undergoing surgery. They are presumed to reduce postoperative nausea and vomiting (PONV) and to lessen the risk of aspiration by reducing residual gastric volumes; however, their insertion and use is not however without potentially serious complications. Existing literature does not address their efficacy in reducing PONV after cardiac surgery. However, current evidence suggests that up to 50% of patients in this group suffer significant nausea and vomiting. The objective of this study is to determine whether NG tubes should continue to be inserted routinely during cardiac surgery to reduce PONV.


Eligibility Criteria:
Inclusion Criteria:

* undergoing coronary artery bypass graft and/or valvular surgery,
* age 18-80 year olds
* signed informed consent
* elective or urgent surgery

Exclusion Criteria:

* past history of oesophageal surgery, oesophageal varices or stricture,
* patients who have received antiemetic medication in the 24 hours before surgery
* emergency surgery
* patients that require re-sternotomy, or are not extubated 24 hours after admission to the intensive care unit, will be excluded from the study.
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products

This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.

The Prolapse Registry was an observational study of patients who were implanted with AMS devices for the surgical repair of female pelvic prolapse. The registry followed patients post-operatively for up to 2 years and collected demographic, clinical, surgical, safety, and patient outcomes data.

The registry was a web-based system in which surgeons entered patient information with regard to their prolapse surgery. All information entered was de-identified (no names, no date of birth, no date of surgery, etc).

Eligibility Criteria:
Inclusion Criteria:

* Female at least 21 years old
* Has pelvic organ prolapse requiring surgical repair
* Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse

Exclusion Criteria:

* Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.