cyrilzakka/clinical-trials huggingface dataset:
Customized Titanium Membrane for Growing Jaw Bone Horizontally

A single center, randomized, controlled, parallel-arm study is planned to investigate clinical outcomes of horizontal ridge augmentation with simultaneous single implant placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the inclusion criteria will be enrolled. They will be randomly placed into one of two treatment groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a control. The decision of which material to use will be made after an implant is placed. Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after which the implants will be surgically uncovered and restored. Outcome analyses will be performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from the implant surgery. Clinical and radiographic parameters will be compared between the two experimental groups. The primary outcome is linear increase of horizontal ridge width from direct measurements.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age \>18
* Overall good, stable health
* A single missing mandibular 1st molar for at least 3 months

Exclusion Criteria:

* Any medical conditions that may contradict implant and bone surgery or influence the outcome (detailed criteria in case report form)
* Pregnancy or lactating mothers
* Current heavy smokers (\>10 cigarettes/day) or previous heavy smokers who have quit less than one year
* Unstable or unsuitable oral conditions for implant and bone surgery (detailed criteria in case report form)
Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation

The purpose of this study is to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population

Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Liver transplantation is the most effective treatment for HCC and is in high demand in China. However, recurrence of HCC among liver transplantation recipients is still a great challenge and threat to the survival of recipients. So it is of great significance to establish a non-invasive way to filter high liver transplantation recipient population before transplantation. Based on large scales of pre-treatment MR images, the investigator's study aims to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population. This study will contribute to the precise selection of HCC-related liver transplantation recipients.

Eligibility Criteria:
Inclusion Criteria:

* All patients had postoperative pathological diagnosis of HCC
* All patients had underwent contrast-enhanced MRI scan within 2 weeks before liver transplantation

Exclusion Criteria:

* patients whose pathological diagnosis is not HCC
* patients whose CT images were affected by strong imaging artifacts, i.e. artifacts obscuring more than 10% of whole volume of interest
* patients whose clinical data or CT images were missing
Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease

The objective of this study is to assess the effect of alkali administration on bicarbonate and potassium levels in patients with Sickle Cell Disease (SCD) and depressed serum bicarbonate levels. The study is a prospective non-blinded evaluation of tolerability and efficacy of alkali repletion with 4 weeks of observation and two sequential 4 week courses of escalating oral sodium bicarbonate treatment.

Primary Objective:

To assess the effect of alkali administration on bicarbonate and potassium levels in patients with SCD and depressed serum bicarbonate levels.

Secondary Objectives:

To assess the effect of alkali administration on improvement in hemolysis and on sequelae of impaired kidney function, ie, LDH, Hgb, reticulocyte count, red cell half-life, and muscle strength, Vitamin D levels, and markers of bone turnover, respectively.

To assess the influence of alkali administrations on markers of kidney tubule inflammation.

To evaluate intraparenchymal iron in patients with SCD and renal dysfunction. Safety and adverse events of alkali patients with sickle cell disease will be monitored. This research will supplement current knowledge about management of the clinically important subset of people with SCD who have renal insufficiency and acid-base perturbation.

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease patients with HbSS
* eGFR \<90 ml/min/1.73m2 (determined by abbreviated 4 variable modification MDRD equation) and/or measured urinary albumin to creatinine ratio \>30mg/g.
* Age ≥18 years

Exclusion Criteria:

* Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)
* Bicarbonate level \>25 mEq/L
* Decompensated heart failure
* Uncontrolled systolic blood pressure \>140 mm/Hg (the cutoff for systolic hypertension in SCD is lower than in non-SCD)
* Moderate-to-severe lower extremity edema
* Projected progression to ESRD within 6 months
* Kidney transplantation
* Treatment with immunosuppressives within the last 3 months
* Vasoocclusive (VOC) within 1 week of study entry
* Active (open) leg ulcer
* Change in hydroxyurea dose within the last 3 months, unless a self-limited interruption of a stable dose
* Blood transfusion within 8 weeks, unless on chronic transfusions
* Pregnancy
* Inability to give informed consent
Communication Model to Self-Care - Regardless of Health Literacy

Healthcare systems all over the world are developing in a way that compels patients to become more active in the management of their own health and disease - a development that changes the role of modern patients and the skills needed to navigate the healthcare system. Demographic changes resulting in more elderly people have led to increases in the burden of chronic diseases and put pressure on increasingly scarce healthcare resources. One strategy for overcoming this burden is to reduce the utilization of healthcare resources in the secondary sector by reducing the length of stay and placing more health care services in the primary sector, thus allowing more rehabilitation actions, where the goal is to have patients take control of their own life situation and health.

This means that community nurses are compelled to strengthen citizens' ability to manage their own disease and everyday life. A focus on health literacy and its significance for everyday life with chronic disease can increase the probability of citizens' acquiring the instructions and guidance given by community nurses, and thus strengthen the ability for self-care and self-rehabilitation. In line with this, a systematic interactive communication model has been developed to help strengthen self-care for citizens with chronic diseases. For more information, see the description of the intervention above.

The study is targeted citizens, who receive community nursing. A possible benefit of participating is an improvement of quality of life in everyday life for citizens receiving community nursing. No risks related to participation in the study.

The study is run from four community nursing districts in Aalborg Municipality. The development of the intervention was initiated in september 2019, and the study is expected finalised in july 2022.

This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Age \> 18
* Fixed residence in Aalborg Municipality
* Receives home healthcare services for a period of more than three months
* Ability to speak, read and write Danish

Exclusion Criteria:

* Diagnosed with a severe psychiatric disease
* Diagnosed with dementia or other severe cognitive impairments
* Terminal
* Unable to understand and speak Danish
* Pregnancy
* Participation in other studies that could effect the primary outcome of this study
Correlation of PET-CT Studies With Serum Protein Analysis

To correlate serum proteomics patterns with PET/CT findings to improve cancer diagnosis, staging, prognosis, and therapy monitoring.


Eligibility Criteria:
Inclusion Criteria:1. Patients must have a PET/CT study performed at the time of blood collection.

2. Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them. Exclusion Criteria:1. Patients who are not eligible for a PET/CT study.
Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women

Aim of this study is to demonstrate the bioequivalence of single subcutaneous doses of XM17 and Gonal-f® in a confirmatory design. Furthermore, safety and tolerability will be assessed in human healthy female subjects. Only female subjects will be included in the study to reach the objectives of the study.


Eligibility Criteria:
Inclusion Criteria:

* Having signed written informed consent
* Healthy female subjects of any racial origin
* 18-39 years at the time of screening
* Body mass index (BMI) between 18-29 kg/m2 and a body weight of ≥ 50 kg
* Use of oral contraceptives for contraceptive purposes only and not for regularization of menstrual cycle, for at least 3 months
* Normal uterus and two functioning ovaries
* Agrees to use an adequate method of contraception during the study
* Non-smoking or moderate smokers of \< 10 cigarettes a day

Exclusion Criteria:

* Pregnancy
* Polycystic ovary syndrome, impaired ovarian function, severe endometriosis class III or IV, submucosal myoma uteri
* History of endocrine abnormalities with treatment within the last six months.
* Contraindications for the use of gonadotropins and goserelin
* Breast-feeding or being within a period of 2 months after delivery or abortion.
* Use of an injectable hormonal contraceptive within a period of 6 months prior to screening
* Treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ
Gastrectomy Outcomes in Elderly Patients

In this study, the investigators aimed to identify independent prognostic factors for early postoperative complications and survival in elderly patients (aged ≥65 years) with gastric cancer.

Gastric cancer is the 5th most common type of cancer diagnosed worldwide and ranks 3rd in cancer-related deaths. Along with surgical resection, perioperative chemotherapy or chemoradiotherapy are the main treatment method. Various complications can be seen in the postoperative period, mainly pulmonary complications (13%), cardiac complications (6%), intra-abdominal abscesses (4%), and anastomotic leaks (3%). Approximately 5% of the patients die because of postoperative complications. It is known that low body mass index as a patient-specific factor is associated with postoperative complications and poor prognosis.

The incidence of gastric cancer remains relatively high and, with increasing life expectancy, the incidence of gastric cancer in elderly patients is increasing. Characteristics of elderly patients, such as reduced physiological function, poor nutritional status, and surgical trauma from radical gastrectomy, seem to result in higher postoperative morbidity, a longer length of hospital stays, increased healthcare costs, and higher postoperative mortality. Elderly patients may have a worse prognosis compared to younger patients, primarily because of the increased risk of postoperative complications. Perioperative nutritional support and preoperative rehabilitation are beneficial for elderly patients with gastric cancer and may reduce surgical complications and mortality. Although some studies in the literature state that radical surgery can be performed for those aged 80 and over, some studies have argued that complications increase in elderly patients and that surgery should be limited.

Aim of the study is to identify prognostic factors for postoperative outcomes in elderly patients who underwent surgery for gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 and older
* Operable patients with histologically confirmed gastric cancer
* Complete follow-up information

Exclusion Criteria:

* Patients under 65 years of age
* Gastric resection for non-neoplastic diseases
* Missing follow-up information
Investigation of Quality of Life in Adolescent Idiopathic Scoliosis

the aim of our study is to identify independent predictors of quality of life in AIS.

Adolescent idiopathic scoliosis (AIS) is the lateral and horizontal deformity of the columna vertebralis which occurs idiopathically in adolescence ages. The aim of this study is to identify independent predictors of quality of life in AIS

Eligibility Criteria:
Inclusion Criteria:

* volunteered for the study participants were diagnosed with adolescent idiopathic scoliosis,
* between ages 10-18
* Cobb angle between 10-30 degrees
* Lenke curve type 1

Exclusion Criteria:

* non-idiopathic scoliosis,
* who had exercise contraindications
* who had previous spinal surgery
* who had orthotic treatment for scoliosis before
* who had exercise contraindications
* who had another neuromuscular
* who had cardiopulmonary and rheumateulogical problem
Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response

Background: The immunologic response to stress is regulated by the cytokines. Anti-Tumor Necrosis Factor-α agents are antibodies directed against a key cytokine in the process angiogenesis and collagen synthesis. It is not known whether they intervene with surgical stress response increasing the rate of postoperative complications.

Method: Un-blinded prospective, non-interventional cohort single centre study including all the patients with Crohn's disease and Ulcerative Colitis undergoing abdominal surgery. Immunological and endocrinological parameters will measured in blood samples taken from these patients before and after surgery. Power calculations showed that 17 patients in each arm are needed.

The baseline patient characteristics will be evaluated based on pilot tested data extraction sheets. The assessment will include demographics, clinical data as well as laboratory work up. The Charlson morbidity index, will be used to assess co-morbidity, the Nutritional risk score (NRS) to assess nutrition status and the Harvey-Bradshaw index (HBI) to evaluate the activity of Crohn's disease. The duration of surgical procedure, along with the amount of blood transfused, will be recorded in all patients.

Laboratory variables

The following variables will be assessed based on previous evidence about their role in surgical stress response:

1. Immunological parameters: Tumor necrosis factor-alpha, interleukin-1, interleukin-6, interleukin-10, C reactive protein, and white blood cell counts.
2. Endocrinological parameters: plasma cortisol, growth hormone , adrenocorticotropic hormone, epinephrin and norepinephrine

Eligibility Criteria:
Inclusion Criteria:

Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)

Exclusion Criteria:

No patients will be excluded
Study of a Single Dose of Danicopan in Healthy Participants

This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams \[mg\], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
* Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.

Exclusion Criteria:

* History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Any condition possibly affecting drug absorption (for example, gastrectomy), cholecystectomy to be considered acceptable.
* Body temperature ≥ 38°Celcius on Day -1 or Day 1 Hour 0; history of febrile illness or other evidence of infection within 14 days prior to study drug administration.
* Current tobacco/nicotine users; consumption of any alcohol within 72 hours before study drug administration or a history of regular alcohol consumption exceeding 21 drinks/week within 6 months of Screening; positive urine drug screen at Screening or Day -1.
* Clinically significant laboratory abnormalities at either Screening or Day -1.
Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)

The objective of this study is to identify a safe dose of MK-2248 in participants with Hepatitis C Virus (HCV) that mediates at least a 3 log10 reduction in viral load (VL) from baseline. It is anticipated that once-daily administration of a safe and well tolerated dose of MK-2248 will reduce VL by at least 3 log10 IU/mL.

In this Phase 1b study, the pharmacokinetic (PK), pharmacodynamic (PD), and safety profile of MK-2248 in HCV-infected participants will be evaluated as follows: Part I will assess sequentially ascending MK-2248 doses from 200 mg to ≤800 mg over 4 panels (A, B, C, and D). Part II will assess sequentially ascending MK-2248 doses from 200 mg to ≤800 mg over 4 panels (E, F, G, and H). Part III will assess sequentially ascending MK-2248 doses ranging up to ≤800 mg in 2 panels (I and J). The potential relationship between plasma MK-2248 levels and VL reduction will be determined.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of chronic HCV defined by positive serology for HCV or positive HCV RNA for at least 6 months and detectable HCV RNA in peripheral blood ≥10\^5 IU/mL at screening
* Body Mass Index (BMI) ≥18 to \<37 kg/m\^2
* in good health other than HCV infection with normal laboratory values

Exclusion Criteria:

* history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary, or major neurological abnormalities or disease
* history of cancer other than adequately treated non-melanomatous skin carcinoma, malignancies which have been successfully treated ≥10 years prior with no recurrence, or cancer that is unlikely to sustain a recurrence for the duration of the trial
* history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* positive for hepatitis B surface antigen or human immunodeficiency virus
* had major surgery or lost 1 unit of blood within 4 weeks prior to screening
* QTc interval ≥470 msec (males) or ≥480 msec (females)
* received prior treatment with other HCV inhibitors
* clinical or laboratory evidence of decompensated liver disease
The Effect of the Modified Perineal Protection Device During Delivery

The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.

RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length.

Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery at term (week 36 - 41)

Exclusion Criteria:

* Age below 18
* Breech delivery
* Not understanding written and oral information
Lipid Metabolism in Obese Subjects Undergoing Bariatric Surgery

The aim of the study is to evaluate modifications in the metabolism of polyunsaturated fatty acids (PUFA) and biosynthesis of the lipid mediators N-acylethanolamines (NAE), both known to induce and be induced by the nuclear peroxisome proliferator-activated receptor (PPAR)-α, which may also explain the well-established improved lipid and energy metabolism after bariatric surgery. The study is focused on understanding the weight loss mechanisms in order to develop targeted dietary protocols.

The study involves a careful preliminary medical history of the patients, with physical examination, anthropometric parameters measurements and blood sampling for blood chemistry routine and evaluation of any adverse events to assess suitability for the study. The evening before bariatric surgery, one month and six months after bariatric surgery anthropometric parameters measurements, blood sampling for blood chemistry routine, inflammatory and lipid-metabolomic profile, and evaluation of any adverse events are performed. For the study samples are stored identified by a code to be analyzed anonymously. Study interruption criteria are: development of allergic reactions, ketonemia\> 1.5 mmol/L, acute gout

Eligibility Criteria:
Inclusion Criteria:

* subjects with pathological obesity suitable for bariatric surgery
* Body Mass Index (BMI) range 35-59

Exclusion Criteria:

* established diagnoses of a major disease (e.g., diabetes or kidney disease)
* pregnancy or breastfeeding,
* food allergies,
* use of drugs that could affect lipid metabolism
Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery

The purpose of this study is to compare to the patients undergoing nonintubated general anesthesia with laryngeal mask and undergoing intubated general anesthesia with double-lumen endotracheal intubation in Video-assisted thoracic surgery (VATS).

Although general anesthesia with double-lumen intubation is generally mandatory for Video-assisted thoracic surgery procedures intubation with double lumen tube is related to several risks. Nonintubated general anesthesia with laryngeal mask in patients with spontaneous breathing may be an alternative choice for minor VATS procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective minor VATS procedures will be enrolled the study

Exclusion Criteria:

* patients \<18 years old,
* body mass index (BMI)\>30 kg/m2,
* American Society Association (ASA) Class\>3,
* heart failure (New York Heart Association class \> II),
* a history of arrhythmia or treatment with antiarrhythmic drugs,
* bradycardia (heart rate (HR) \<45 beats min1)
* atrioventricular block,
* hepatic or renal dysfunction,
* coagulopathy,
* asthma
* sleep apnea syndrome
Low-back Pain During Pregnancy and Its Psycho-social Implications

Pregnancy-related pelvic girdle pain (PPP) and pregnancy-related lumbar pain (PLBP) are two distinct symptoms, which can occur together as lumbar-pelvic pain.The primary objective is to measure the impact of osteopathic manipulative treatment on pregnancy-related lumbar and pelvic pain. The secondary objective is to study the interaction between pain and psycho-social factors during the gestational period.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-44
* Primiparae
* Single pregnancy
* Spontaneous pregnancy - fisiological pregnancy
* pregnancy \>= 12 weeks
* low-back pain (between the 12th rib and the lumbo-pelvic region) and/or pelvic (in the pubic region and/or in one or both of the sacro-iliac joint and/or of the gluteal region) non specific
* consent to treatment
* absence of linguistic barriers

Exclusion Criteria:

* Women aged \<18 o \>44
* Pathological pregnancy, twins
* Metabolic pathologies
* Obstetrician's emergencies
* Pre-term birth
* Specific lumbar and/or pelvic pain - Genetics disorders
* Major congenital anomalies
* Absence of consent to treatment
* Presence of linguistic barriers