cyrilzakka/clinical-trials huggingface dataset:
Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)

The purpose of this study is to evaluate the safety and feasibility of laparoscopy-assisted total gastrectomy for early upper gastric cancer compared with open total gastrectomy. This study will performed via prospective, multicenter design.

Gastric cancer remains one of the most common neoplasms in Asia and some western countries, although the incidence is decreasing worldwide. Recently,as the rate of detection of early gastric cancer has increased and surgical techniques have been developed, laparoscopic procedures have been introduced and tried for the treatment of early-stage gastric cancer.

Already the prospective, randomized trials for safety and oncologic outcomes of laparoscopy-assisted distal gastrectomy for gastric cancer had been tried, but the large-scaled, prospective study for laparoscopy-assisted total gastrectomy (LATG) is seldom.

One reason for the low popularity is that LATG requires the dissection of lymph nodes at the splenic hilum or along the short gastric arteries and the other reason is that the reconstruction after total gastrectomy is also more complicated. The third reason is that the chance for total gastrectomy is less frequent than distal gastrectomy because of the low incidence of upper gastric cancer.

This KLASS-03 trial is a prospective, multicenter trial for LATG for early upper gastric cancer. The primary purpose of this study is to evaluate the incidence of postoperative morbidity and mortality and the second purpose is to evaluate the surgical outcomes after several methods of reconstruction in laparoscopic total gastrectomy and the postoperative course of LATG patients.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy
* range of age ; over 20 years to under 80 years
* preoperative stage : cT1N0M0, cT1N1M0, cT2N0M0 (7th UICC)
* The patient who is needed the total gastrectomy because the upper margin of cancer is located between upper 1cm and lower 5cm to esophagogastric junction
* the gastric cancer which is not included the indication of the endoscopic mucosal dissection
* ECOG (Eastern Cooperative Oncology Group) performance status; 0 and 1
* ASA (American Society of Anesthesiology) score ; 1, 2, 3
* Written informed consent

Exclusion Criteria:

* The patient who shows distant metastasis under preoperative examination
* The patient with medical history for upper abdominal surgery with open method in the past
* The patient with medical history for distal gastrectomy due to benign or malignant gastric disease in the past(remnant stomach cancer)
* The patient with double cancer synchronous or metachronous within 5 years
* Enlarged lymph nodes of the splenic hilum in the preoperative evaluation
* The patient who has been enrolled other clinical study within 6 months
* Vulnerable patients who lacks mental capacity and are pregnant or planning a pregnancy
Prediction of Uterine Atony After Vaginal Delivery by Elastography

Prospective study evaluating the feasibility of shear-wave elastography of the uterus during the third stage of labour and following placental delivery. The investigators hypothesize that the stiffness of the myometrium can be measured by using shear-wave technology. This study involves 30 patients with a healthy pregnancy and spontaneous vaginal delivery. One co-investigator will carry out measurements at the uterine fundus, at three different time points: after fetal delivery, after placental delivery and 30 minutes after placental delivery.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* cephalic presentation
* maternal age \> 18 years old
* nulliparous
* healthy uncomplicated pregnancy
* gestational age between 37-42 weeks of gestation
* spontaneous labour and delivery
* uncomplicated progression of labour (cervical dilatation at \>1 cm/h)
* administration of less than 3 units of oxytocin during the second stage of labour
* patient having read, accepted and signed the consent form

Exclusion Criteria:

* antepartum hemorrhage in the present pregnancy
* protracted second stage of labour (more than two hours from full dilatation to delivery)
* more than 30 minutes of active pushing
* BMI \> 35 kg/m2
* distance from skin to uterus \> 8 cm
* age \> 35 years old
* instrumental deliveries
* bleeding disorders
* polyhydramnios
* diabetes
* pre-eclampsia
* high blood pressure
* use of anticoagulant medications
* clinical chorioamnionitis
* placental abnormality (low-lying or abruption)
* fetal macrosomia
* uterine fibroids
* uterine anomalies
* previous uterine scar
* multiple pregnancy
* placental retention
* inability to follow procedures or insufficient knowledge of project language
* inability to give consent
* refusal to participate
Quorn in Community Health Experiment

In overweight individuals (BMI \> 27.5 kg/m2), does daily consumption of mycoprotein containing Quorn Food products lower blood cholesterol compared with daily meat/fish consumption?


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* BMI \>27.5 kg/m2
* Non allergic to penicillin/mycoprotein
* Moderate levels of physical activity or below (self-identified; NDNS servey)
* Omnivores
* Not currently using cholesterol lowering medication

Exclusion Criteria:

* \<18 or \>70 years old
* BMI \<27.5 kg/m2
* Allergies to penicillin/mycoprotein
* Heavy exercisers (self idenfiied)
* Vegetarian/vegans
* Currently using cholesterol lowering medication
Safety and Effectiveness of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease

This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

1. 25 to 79 years old.
2. Provide voluntary written informed consent to participate.
3. Smoking history of at least 10 pack years (1 pack of cigarettes per day for 10 years).
4. Diagnosis of chronic obstructive pulmonary disease.
5. Become short of breath with physical activity.
6. Elevated systolic pulmonary artery pressures.
7. Not pregnant, nursing, or planning a pregnancy.

Exclusion Criteria:

1. Left ventricular ejection fraction \<30%.
2. Heart attack or stroke within the last 6 months.
3. History of lung resection surgery.
4. Use of supplemental oxygen \>20 hours/day.
5. Blood donation or significant blood loss within the last 56 days.
6. Plasma donation within the last 14 days.
7. Use of any drugs for another research study within the last 30 days.
8. Use of vasodilators, long acting nitrates, prostacyclin analogs, endothelin antagonists, or phosphodiesterase inhibitor drugs within the last 14 days.
9. Positive blood screen Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody.
10. Major surgery within the last 28 days.
11. Any other medical condition that may jeopardize the safety of the subject, the validity of the study results, or interfere with the completion of the study according to the protocol.
A Trial of Wellbutrin for Crohn's Disease

The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical remission in Crohn's disease.

Wellbutrin (bupropion) is approved for use as an antidepressant. There have been some cases in which people on Wellbutrin had significant improvement clinically in their Crohn's disease. In this trial, the hypothesis that Wellbutrin can induce clinical remission in Crohn's disease will be tested. The investigators will also be looking to see if Wellbutrin can lower levels of the inflammatory cytokine tumor necrosis factor-alpha (TNF).

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe Crohn's disease with 220 \< CDAI \< 400.
* All patients in the study must have not had any anti-TNF antibodies for at least eight weeks.

Exclusion Criteria:

* Patients will be excluded from the study if they have fulminant Crohn's disease requiring parenteral steroid treatment, hospitalization, or need of surgery imminently.
* Patients with serious infections in the preceding three months, opportunistic infections within one month, or current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological, or cerebral disease will be excluded.
* Patients will also be excluded from the study if they have a history of a seizure, epilepsy, presumed current central nervous system tumor, have or have had anorexia nervosa or bulimia, are currently taking or have taken in the last four weeks any drug in the monoamine oxidase inhibitor class, or are allergic to Wellbutrin.
* Patients with active major depression or suicidal ideation will be excluded, as will patients with a score of 19 or higher on the Beck depression inventory.
* Patients will be excluded if they are currently or have taken a medicine in the selective serotonin reuptake class, mirtazapine, venlafaxine, a tricyclic antidepressant, a mood stabilizing, or antipsychotic medication in the previous two weeks.
* Patients will be excluded if they are currently abusing alcohol or have alcohol dependence.
* Patients will be excluded from the study if their baseline liver function tests are greater than twice the upper limit of normal, or if a clinical investigator believes that their baseline chemistry, liver function tests or complete blood count contraindicates entry into the study.
* Pregnant or lactating females are excluded.
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

The purpose of this study is partly to continue the good experience the investigators have with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding a biological antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral oncogene homolog (KRAS).

Cholangiocarcinoma is a relatively rare disease. In Denmark approximately 150 patients are diagnosed each year. A small part of the patients can be offered surgery, but the operation will rarely be radical, and most patients with cholangiocarcinoma are therefore candidates for chemotherapy.

In Denmark the combination therapy of Gemcitabine, Oxaliplatin and Capecitabine has been used in recent years. Based on experience with gastrointestinal tumors, however, there seems to be an effect of new biological substances, including EGFR antibodies. There are casuistic reports on the specific effect of a monoclonal antibody against EGFR in cholangiocarcinoma.

The effect of EGF is mediated through an intracellular pathway involving the KRAS protein. It has been shown that a mutation of KRAS causes the EGF system to be constantly activated. Effect in patients with a KRAS mutation is therefore not to be expected. Approximately 50% of the patients present this mutation.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma arisen from gallbladder, extra or intrahepatic bile ducts or malignant cells consistent with the above and concomitant radiologic findings consistent with cholangiocarcinoma.
* Curative treatment presently discounted (surgery, stereotactic radiotherapy, etc.)
* KRAS analyzed and found wild-type (wt) or mutated
* PS 0-2
* Evaluable disease according to RECIST criteria, i.e., the disease does not need to be measurable
* Haematology:

  * ANC ≥ 1.5 x 10\^9/l
  * Thrombocytes ≥ 100x10\^9/l
* Biochemistry:

  * Bilirubinaemia ≤ 3 x upper normal value
  * ALAT ≤ 5 x upper normal value
* Creatinin ≤ upper normal value. If raised creatinin, the measured or calculated GFR must be at least 50% of the lower normal value.
* Fertile women must present a negative pregnancy test and use birth control during and 3 months after treatment. The following methods are considered safe birth control: Birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid)
* Oral and written informed consent

Exclusion Criteria:

* Chemotherapy within 4 weeks
* Radiotherapy within 4 weeks
* Immunotherapy within 4 weeks
* Other concomitant experimental treatment
* Known neuropathy ≥ grade 2
* Serious congruous medical disease
* Other previous malignant disease within 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri
* Previous serious and unexpected reactions to fluoropyrimidine treatment
* Hypersensitivity to one or more of the active substances, auxiliary substances or fluoruracil
* Patients with interstitial pneumonitis or pulmonary fibrosis
ACCESS (Access for Cancer Caregivers for Education and Support for Shared Decision Making)

The project will test the effect of educating and supporting family caregivers of hospice cancer patients on their active participation in shared decision making in the plan of care for their patients.

This intervention will target education and emotional support to family caregivers of hospice cancer patients for a shared decision making process in the hospice care plan meetings The intervention ACCESS will consist of three components:

1: a Facebook group to provide the education and support; 2. web conferencing for family members into the hospice interdisciplinary care plan meeting 3, a structured shared decision making process to guide the team discussion.

Participants (family caregivers) will be randomly assigned to one of three groups, usual care, Facebook only, and Access.

The specific aims are to:

1. Evaluate the effect of access on family caregiver anxiety, pain knowledge and patient pain.
2. Evaluate the effect of Facebook groups as educational emotional support for family caregivers
3. Assess staff and family caregiver satisfaction with the shared decision making process.

Eligibility Criteria:
Inclusion Criteria:

* Is caregiving for a patient enrolled in the participating hospice
* Over 18 years of age
* Is caregiving for a patient with a diagnosis of cancer
* Willing to have a Facebook account and post at least 1x per week if in intervention group

Exclusion Criteria:

* No one under the age of 18
* Is caregiving for a patient enrolled in hospice agencies other than those participating in the study
* Unwilling to participate in social media
* Is caregiving for a patient with a diagnosis other than cancer
* Is caregiving for a patient with a life expectancy of less than 2 weeks
Efficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment

The laser areas treated with biocellulose sheet from coconut juice containing anti-hyperpigmentation agent ("biocellulose mask", "Farhorm®") heal faster than vaseline ointment which is a standard treatment.

Volar surface at upper arm (2X2 cm) on both sides were treated with semi ablative, 1,550 nm Erbium: glass fractional laser. Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent ("biocellulose mask","Farhorm®")was applied for 20 min on one side and the other side was treated with vaseline ointment. The redness, skin hydration and skin pigmentation were evaluated at that area before laser, immediately after laser and after applying the treatment. These parameters were compared between treatment (area treated with Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent, "biocellulose mask", "Farhorm®") and control (vaseline ointment).

Eligibility Criteria:
Inclusion Criteria:

* Age 20-50 years old
* No skin problem such as inflammation, fresh wounds
* Not receive laser treatment during last 3 months
* No history of smoking or alcohol drinking
* No allergy to licorice extract, Vit C, Vit E, arbutin or stearyl glycyrrhetinate
* Willing to participate in this study and can comply with study protocol

Exclusion Criteria:

* Has history of hyperallergic reaction
* Has wound(s) on face during last 4 weeks
* Has history of eczema, psoriasis during last 6 months
* Has laser treatment during last month
* Use steroid, antibiotic, anti-inflammatory drugs or antihistamine during 3 days before recruiting
* Had major surgery during last 12 months
* Has history of cancer during last 12 months
* Pregnant or lactation
Defecation Postures for Functional Consumption

Whether functional consumption is influenced by defecation postures is unclear. The investigators investigated effects of defecation postures on functional consumption.

Constipation is a chronic problem in many patients all over the world. In some groups of patients such as the elderly, constipation is a significant health care problem. A prospective study was performed at 3 hospitals in China. The included patients were functional consumption patients with defecation sitting on a standard-sized toilet. Patients received standard functional consumption treatment according to the guideline and were randomly assigned to groups that using a squatting pan or a standard-sized toilet.

Eligibility Criteria:
Inclusion Criteria:

* Subject has functional constipation
* Subject does not receive other treatments

Exclusion Criteria:

* History of heart cerebrovascular disease
* History of other types of constipation
* Pregnant, trying to become pregnant or breast feeding
* Age\< 18-year and \>70-year
Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants

Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual nutrients as compared to breast-milk in term Chinese infants.

Participants：189 healthy termed-infants with ages of 5-14 days at the enrollment.

Study Design: A multiple-center, quasi-randomized,open labeled, controlled trial. Random allocation between the two infant formula.

Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) JINLINGGUAN Formula Group：fed with JINLINGGUAN infant formula (PRO-KIDO™ I-PROTECH®, Phase I); (3) TOFER Formula Group: feeding TOFER infant formula (TOFER®, Phase I). Random allocation performed between the two formula groups.

Intervention Duration: 12 weeks.

Visits: 1 week(baseline), 7 and 13 weeks of age

Outcome measures: (1) General information, general health and wellbeing, regular body check;(2) Anthropometric parameters: body length, body weight, and head circumferences; (3) Stool characteristics (color , volume, stool consistency, and frequency;(4)Behavior and habits; (5) Gut microbiota; (6) Residual nutrients in feces (nitrogen,total fat, fatty acids, minerals); (7) adverse events and concomitant medications; (8) compliance. Slopes of changes from baseline to 6 and 12 weeks post intervention in anthropometric parameters, stool characteristic index, fecal residual nutrients, pattern score of gut microbiota, behavior and habit index were be calculated.


Eligibility Criteria:
Inclusion Criteria:

* The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants)
* Term infant of Chinese origin born at 37-42 gestation weeks
* Birth weight: 2500-4000g
* The infant is apparently healthy at birth and entry to study
* Apgar after 5 minutes \>7
* age at the enrollment: 5-14 days

Exclusion Criteria:

* Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
* The infant suffers from a major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth
* The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth (not including photo treatment for infantile hepatitis)
* The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism
Study of the Soliton Rapid Acoustic Pulse (RAP) Device for the Treatment of Cellulite

To evaluate the safety, and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the temporary improvement in the appearance of cellulite.

Multi-site clinical study to evaluate the safety, efficacy and tolerability of Soliton's Rapid Acoustic Pulse (RAP) device fo the temporary improvement in the appearance of cellulite.

Eligibility Criteria:
Inclusion Criteria:

* Female ages 18-50 years
* Seeking treatment of cellulite in the thigh and/or buttock areas
* Area of severe cellulite on the thigh and/or buttock with an average simplified Cellulite Severity Scale at Baseline ≥ 4.0 (Table 2)
* Having at least one dimple, or ridge-depression, in the treatment area, with a depth of approximately 5 mm or greater.
* Stable weight nominally +/- 5% for at least the past 6 months.
* Body Mass Index (B.M.I.) is ≤ 30
* Participant will not have had invasive or energy based cellulite treatments (liposuction, subcision, RF, laser, ESWT, etc.) for the prior 12 months.
* Participant will not have used topical based cellulite treatments for prior 6 months and will not use during the trial.
* Will not undergo any other cellulite treatments for a period of 12 months following RAP treatment.
* Participant is willing to participate in study and adhere to follow-up schedule
* Participant is able to read and comprehend English
* Participant has completed the Informed Consent Form

Exclusion Criteria:

* Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
* Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
* Participant is pregnant or planning to become pregnant during the duration of the study.
* Has atrophic scars, or has a history of atrophic scars or keloids.
* Tattoo or former tattoo at or near treatment area.
* Metal or plastic implants in the area of the treatment (vascular stent, or implants in the hips, knees, etc.).
* Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
* Medical disorder that would hinder the wound healing or immune response (no blood disorder, inflammatory disease, etc.).
* History of coagulopathy(ies) and/or on anticoagulant medication.
* Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
* Current smoker.
* Any surgical procedure in the prior 3 months, or planned during the duration of the study.
Observational Study of Effectiveness and Safety of Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Residual Invasive Disease Following Neoadjuvant Chemotherapy and Anti-HER2 Target Therapy

This is an observational, multi-centre study analysing data from patients treated with T-DM1 within the compassionate use program AL41711. During the compassionate use program AL41711, subjects received T-DM1 treatment for a total of 14 cycles or less, in case of disease recurrence or unmanageable toxicity. After the completion of the treatment, and 90 days of wash-out period, they can be enrolled in the study. After the signature of the Informed Consent Form, all their data reported in the medical charts up to then (as detailed in section 12 of the protocol) will be extracted retrospectively and inserted in the study database. From the end of the washout period following the last treatment with T-DM1, each subject will enter in an observation phase for a maximum of 3 years, or until death whichever happens first. This phase will be prospective after the signature of the Informed Consent Form.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Patients who have received T-DM1 treatment within the compassionate use program AL41711 and have completed the entire treatment for at least 90 days or have interrupted it prematurely, due to disease recurrence or unmanageable toxicity, for at least 90 days, corresponding to the wash out period;

Exclusion Criteria:

* NA