cyrilzakka/clinical-trials huggingface dataset:
Chemical Debridement and Leg Ulcers

A pilot study to investigate the relative effectiveness and safety of chemical wound debridement and curettage in the treatment of venous and mixed aetiology leg ulcers.

A pilot study to investigate the relative effectiveness and safety of chemical wound debridement versus the curettage wound debridement in the treatment of venous and mixed aetiology leg ulcers in the United Kingdom

Eligibility Criteria:
Inclusion Criteria:

* Participants with a venous leg ulcer or mixed aetiology ulcer.
* Duration of wound ≥ 6 weeks ≤ 5 years
* Wound is ≥ 5 cm2 ≤ 200cm2
* Presence of at least 25% visible slough within the wound bed
* The Participant must be able to understand the study and provide written informed consent
* No clinical signs of infection

Exclusion Criteria:

* Known hypersensitivity or contraindications to any of the wound treatments, dressings or compression bandaging to be used in the trial
* Current local or systemic antibiotics in the week prior to inclusion
* Clinically infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema
* Prolonged treatment with immunosuppressive agents or high dose corticosteroids
* Participants who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
* Participants who have participated in a clinical trial on wound healing within the past month
* Participants with a known history of non- adherence with medical treatment
Mifepristone and Two Doses of Misoprostol for Abortion at 11&12 Weeks

This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Seeking medical abortion services at one of the enrolling clinics
* Have an intrauterine pregnancy 71-77 days of gestation or 78-84 days
* Meet standard eligibility criteria for medical abortion
* Be able to return to clinic for in-person follow up
* Speak/read/write English or Spanish
* Have access to a mobile phone with texting capability
* Be in general good health
* Be willing and able to sign consent forms
* Agree to comply with the study procedures and follow up.

Exclusion Criteria:

* Not eligible to consent on their own to being in a study (Age criteria may vary by site according to state law.)
* With known allergies or other contraindications to mifepristone or misoprostol
* Desiring to start depot medroxyprogesterone acetate (DMPA) as contraception method immediately because of potential interaction with mifepristone. Those who wish to wait until abortion completion to start DMPA will be eligible for enrollment.
Evaluating Ability of HT-6184 to Reduce Inflammation and Pain After Third Molar Extraction

The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal.

The main question it aims to answer are:

* Does HT-6184 decrease inflammation in patients after third molar removal?
* Does HT-6184 decrease pain in patients after third molar removal?

Participants will be asked to do the following during the clinical trial:

* Take a single oral dose of HT-6184 or placebo
* Allow a oral surgeon remove their third molar teeth
* Blood draws on 5 occurrences
* Rate their pain intensity
* Attend two follow-up appointments on day 1 and day 2 after third molar removal
* Participate in one follow-up phone call 5-7 days after third molar removal


Eligibility Criteria:
Inclusion Criteria:

* The candidate is 18 years of age or older, capable of understanding and providing written informed consent to participate and willing to comply with study procedures including providing a blood sample to be saved for potential pharmacokinetic and/or genetic analysis.
* The candidate, for any reason, requires surgical extraction of two or more third molars of which at least one is partially or fully impacted in mandibular bone.
* The candidate is postmenopausal, surgically sterile or agrees to use an effective and medically acceptable method of contraception for 1 week after his or her last dose of study drug.
* If female with child-bearing potential, the candidate must have a negative pregnancy test at screening and pre-surgery on the day of surgery.

Exclusion Criteria:

* The candidate typically or on average consumes more than one alcoholic beverage per day.
* The candidate is pregnant or nursing.
* The candidate has received an investigational drug or used an experimental medical device within 30 days prior to screening.
* The candidate has donated 1 or more pints of blood within 8 weeks prior to screening.
* The candidate has any hypersensitivity to components of the HT-6184/placebo formulations or the protocol-specified analgesic rescue medication, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs).
* The candidate has any contraindication to oral surgery or any serious or major medical problems that, in the investigator's opinion, may compromise the safety or the candidate or interfere with the interpretation of study results
* The candidate has taken acetaminophen, NSAIDs (including aspirin) or other medications for pain within 72 hours of the surgical procedure.
* The candidate has any abnormal laboratory value or physical finding that, in the opinion of the investigator, may compromise the individual's safety, interfere with interpretation of the study results, or be indicative of an underlying disease state.
Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 52 weeks by subjects with atopic dermatitis (eczema).

This is an open-label study in which ARQ-151 cream is applied once daily x 52 weeks to subjects with atopic dermatitis (eczema).

Eligibility Criteria:
Inclusion Criteria:

1. For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws.
2. Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)
3. Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study.
4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
5. Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

1. Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.
2. Subjects that use any Excluded Medications and Treatments.
3. Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
4. Subjects with known genetic dermatological conditions that overlap with AD.
5. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
6. Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
7. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151 cream) living in the same house.
Laparoscopic Surgery for T4 Tumor of the Colon Cancer

The purpose of this study is to compare the short- and long-term survival of laparoscopic surgery and conventional open surgery for T4 colon cancer.

The investigators previous study indicated that laparoscopic surgery is feasible in T4 colon cancers with comparable clinical and oncologic outcomes. Laparoscopy can be considered as an alternative approach for T4 colon cancers with the advantage of faster recovery. However, the clinical value of laparoscopic surgery for T4 colon cancer was only validated in some retrospective study and some prospective study in single institute with small sample of patients. The aim of the present study is to compare the short-and long-term survival outcomes of laparoscopic surgery and conventional open surgery for T4 colon cancer as well as the mortality and the morbidity.

The number of patients needed to get a 80% power is 1960. The average number of patients/surgical center is approximately 200 in each of 10 surgical centers.

The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

Systematically analyze and compare the disease free survival rate, the mortality, the morbidity, and the proportion of completion of laparoscopic surgery of the two surgical strategies (laparoscopy VS conventional open surgery).

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Histologically confirmed diagnosis of colon carcinoma
* CT or MRI verified as T4 colon cancer without involvement of other organs
* Without multiple lesion other than carcinoma in situ
* Tumor size \< 8 cm
* No bowel obstruction
* Sufficient organ function
* No history of gastrointestinal surgery
* 18 years of age or older
* Performance Status (ECOG) 0, 1 or 2 and life expectancy \> 12 weeks
* Operable patients

Exclusion Criteria:

* Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
* Unstable or uncompensated respiratory or cardiac disease
* Serious active infections
* Hypersensitivity to capecitabine/fluorouracil or oxaliplatin
* Stomatitis, ulceration in the mouth or gastrointestinal tract
* Severe diarrhea
* Peripheral sensory neuropathy with functional impairment
Adaptation and Evaluation of Bright Horizons

This study will test if a program called 'Bright Horizons' is effective at reducing binge substance use among adolescents.

Bright Horizons is a culturally adapted intervention developed and tested through a partnership between The White Mountain Apache Tribe and Johns Hopkins University. Bright Horizons is a brief intervention that teaches emotion regulation, coping skills, and problem solving. The intervention also uses goal setting to reduce alcohol and other substance use and to connect to individuals with treatment.

The goal of this study is to understand how Bright Horizons impacts adolescents who have a recent binge substance use event. Participants will receive a lesson on binge substance use and answer questions at three different time points: when participants enroll in the study; 4 weeks later; and 4 weeks after that visit. Evaluation questions will ask about participants' substance use, family and peer relationships, and other emotions and behaviors.

Control participants will receive the Bright Horizons intervention after enrollment of all intervention participants is complete.

Eligibility Criteria:
Inclusion Criteria:

* Aged 12-17
* Confirmed binge alcohol use event reported to the surveillance system within 90 days
* Self identify as Native American
* Reside on or near the Fort Apache Indian Reservation
* Have parental or legal guardian consent/provide youth assent

Exclusion Criteria:

* Unstable and severe medical, psychiatric or drug use problems that necessitates inpatient treatment
* Acute suicidal or homicidal ideation requiring immediate intervention
* Recent and severe stressful life events such as physical or sexual abuse, or violent crime victimization that requires specific and high intensity interventions or out of home placement
* Doesn't speak English
* Severally visually impaired
Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery

Vasoplegic syndrome is a common complication after cardiac surgery. Low dose vasopressin can up-regulate blood pressure and improve clinical outcomes compared with norepinephrine (mainly acute kidney injury Anesthesiology 2017; 126:85-93). Pituitrin is used as a substitute for vasopressin in our center, which contains both vasopressin and oxytocin. Oxytocin may alleviate inflammatory process-associated kidney injury (Peptides 2006;27:2249-57). Therefore, the investigators hypothesize Pituitrin may be preferable to norepinephrine in the renal protection of patients with vasoplegic syndrome after cardiac surgery. Moreover, the serum levels of vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone will be measured.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as vasoplegic syndrome(defined as mean arterial pressure less than 65 mmHg resistant to fluid challenge and cardiac index greater than 2.2 L/min · m2) within 24 hours after cardiac surgery.

Exclusion Criteria:

1. Age \< 18 and \> 75 years.
2. Received renal replacement therapy before cardiac surgery.
3. Diagnosed as endocrine disease before cardiac surgery.
4. Diagnosed as sever peripheral vascular disease before cardiac surgery.
5. Extracorporeal membrane oxygenation support before admission.
6. To receive heart transplantation.
7. Infection on admission.
8. Pregnant or maternal patients.
9. Refusal of consent
Predicting Normal vs. Carrier Status in Euploid Embryos of Translocation Carriers

The purpose of this study is to assess the accuracy of predicting the normal or carrier status of human embryos resulting from in vitro-fertilization (IVF) from patients carrying a balanced translocation.

This study aims to evaluate the validity of using informative SNPs to distinguish balanced from normal embryos. This will involve acquiring material from families to set phase for informative SNPs, evaluation of existing and new embryo SNP array data, and follow up analysis of children born after applying the procedure.

Eligibility Criteria:
Inclusion Criteria:

* patients with balanced translocations who have undergone IVF

Exclusion Criteria:

* those who do not wish to know their child(s) karyotype
A Portion-controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.

A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial

1. ACTOS plus a standard diet
2. ACTOS plus a portion-controlled diet
3. Metformin plus a standard diet. The end-point of the trial is the change in body fat content from baseline to the end of the trial

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 35 to 75 who have type 2 diabetes mellitus

Exclusion Criteria:

* Individuals with co-existing other diseases
China Nutrition Fundamental Data 2022

Malnutrition caused by reduced food intake or assimilation and varying degrees of acute or chronic inflammation is a serious and underappreciated risk factor for adverse clinical outcomes. Despite the substantial health and economic burden, malnutrition remains to affect a considerable proportion of hospitalized patients worldwide. Nationally representative studies from the USA, Australia, and European countries have reported prevalence figures in the range of 8.9% to 80.4%. However, national data in some resource-poor countries, such as China, the largest developing country in the world, are scarce.

During 2020 to 2022, the investigators conducted the China Nutrition Fundamental Data 2020 (CNFD 2020). This project provides a reference for nutritional risk assessment, malnutrition diagnosis, and treatment criteria for hospitalized patients in China. This project also provides data to promote the construction of clinical nutrition departments and improve the nutritional status of hospitalized patients. Thus, the investigators plan to conduct the China Nutrition Fundamental Data 2022 in a large, nationally representative sample of Chinese adult inpatients to 1) To further explore the relationship between nutrition and health; 2) To further understand the capacity of nutrition services in Chinese medical institutions.

This project will adopt a multistage, stratified, cluster-sampling procedure based on administrative divisions in China. For each participant, a structured interview will be done by trained nutritionists or clinicians. The following data will be acquired: weight change within and beyond six months, food intake change within two weeks, nutrition therapy during this hospitalization, Karnofsky score, clinical outcome, total hospitalization costs, and laboratory tests. The investigators will also collect information on participants' sociodemographic characteristics and medical history. The investigators will take physical measurements, including height, weight, waist circumference, hip circumference, mid-arm circumference, calf circumference, handgrip strength, and blood pressure following standard protocols. Body composition will be measured using bioimpedance analysis (BIA).

In addition, the investigators plan to collect information on the number of beds, the nutrition support team, the nutrition treatment plan and the construction of a full-time nutrition physician or nutrition nurse, the routine monitoring methods, interventions, and distribution of brochures for patients with malnutrition or nutritional risk in each project hospital.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Admitted to hospital within 24-48 hours (not emergency) due to tumor or digestive system, respiratory system, cardiovascular system, endocrine system, nervous system, and urinary system disease.

Exclusion Criteria:

* With mental illness or memory disorder who were unable to answer questions correctly
* Critically ill patients
* Lack behavioral ability
The Protective Effect of Friendship on Peer Rejection in Overweight and Normal Weight Youth

This study examines youth's motivation for food or social rewards after a brief episode of simulated ostracism. The investigators hypothesize that youth who think about a friend after being ostracized will mediate their decision to resort to food, which is typically evidenced in socially isolated overweight youth.


Eligibility Criteria:
Inclusion Criteria:

* General liking for all study foods

Exclusion Criteria:

* Food allergies
* Medical or Psychological disorders
Effects of Physical Exercise on Postmenopausal Risk Factors in Women With Osteopenia

Menopause usually have a serious impact on a woman's life, associated with negative consequences for health and quality of life. Early preventive assessments are very difficult to implement due to the complex hormone-deficiency-induced effects on a large variety of organs and systems with estrogen receptors. In fact, only a few types of interventions have the potential to comprehensively improve the various risk factors and complaints of the menopausal transition. In detail, however, not every form of exercise training or every training protocol is effective for exerting positive effects on selected risk factors. In particular, the training concept for addressing musculoskeletal or cardio-metabolic risk factors differ fundamentally.

In several studies, we confirmed the effect of different complex training programs on risk factors of different postmenopausal female cohorts with special consideration of osteoporotic aspects. The training programs applied in this context were characterized by the consistent implementation of recognized training principles and an in general exercise intensity-oriented approach. Recent studies confirmed the effectiveness of this proceeding for women with relevant postmenopausal risk factors including low bone strength. However, the crucial issue of the most effective, feasible and easily customizable training protocol for addressing postmenopausal risk factors remains to be answered, taking into account that the majority of exercise programs were realized in an ambulatory group setting.

The aim of the study will be to evaluate the effects of an optimized physical training on risk factors and complaints of (early) postmenopausal women with special consideration of the osseous fracture risk.

Note (05.06.2020): Of importance, the intervention has to be cancelled due to COVID-19 lockdown in March 2020 after 13 months of intervention.


Eligibility Criteria:
Inclusion Criteria:

* (early)postmenopausal women, ( normal menopause, 1-5 years post)
* Osteopenia and osteoporosis at the lumbar spine or femoral neck Bone Mineral Density (BMD) \<-1.0 standard deviation (SD) T-Score, WHO)

Exclusion Criteria:

* BMD \<-4.0 SD T-Score (BMD threshold for pharmaceutical therapy according to Dachverband Osteologie (DVO) guideline (mandatory for Germany, Austria, Suisse) for woman 50-60 years).
* Prevalent clinical, low-trauma fractures
* Diseases and drugs with relevant effects on bone and muscle metabolism (e.g. glucocorticoids \>7.5 mg/d or bisphosphonate therapy); individual case assessment
* Diseases and drugs with relevant effects on cardiometabolic risk factors (e.g. severe hypertension with corresponding medical therapy); individual case assessment
* Severe cardiovascular events (e.g. stroke, coronary infarction) in the past.
* Other conditions, diseases that exclude exercise training in a group (≤10 persons).