cyrilzakka/clinical-trials huggingface dataset:
Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization (IVFAct)

The most successful treatment for infertility is in vitro fertilization (IVF), but less than 10% of infertile couples undergo IVF because of the high cost and relatively low success rate. Many patients have tried complementary and alternative medical treatments as an adjuvant therapy to improve their IVF success. Acupuncture given 2-4 times around the day of embryo transfer has not been shown to improve the IVF live birth rate. Chinese Herbal Medicine (CHM) may improve the IVF pregnancy rates, but the evidence so far is inconclusive because of high risks of bias in these studies.

The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.

The objective of this multi-centre double blind randomized trial is to evaluate the efficacy of acupuncture with or without CHM on the live birth of IVF. The randomization process will be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in 1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM. Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF during ovarian stimulation, and before and after the embryo transfer. They will also take CHM or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of gestation if pregnant.

Eligibility Criteria:
Inclusion Criteria:

1. Women ≥20 to ≤40 years of age
2. Indications for IVF
3. Duration of infertility \>1 year
4. Undergoing IVF with an intention of fresh ET on day 3 or 5.

Exclusion Criteria:

1. Women with an intention to replace frozen embryos only.
2. Preimplantation genetic testing
3. History of recurrent miscarriages defined as having three consecutive miscarriages.
4. Having acupuncture or CHM for infertility within 3 months prior the IVF
5. Women with abnormal liver or renal function tests
Effects of Osteopathic Treatment on Pulmonary Function After Coronary Artery Bypass Graft Surgery

The purpose of this study is to determine the short and long term effects of osteopathic treatment on pulmonary function, pain and quality of life in patients after coronary artery bypass graft (CABG) surgery. The study is a randomized controlled trial.

Coronary artery bypass graft (CABG) surgery is performed worldwide. Several studies have found that there is a decrease in pulmonary function, loss of thoracic mobility and a high prevalence of chronic poststernotomy pain (CPSP) after CABG. So far there is no effective treatment for these conditions. The OstinCare study aims to investigate whether osteopathic treatment has an added value in the treatment of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Planned Coronary Artery Bypass Graft (CABG) surgery at the Jessa Hospital Hasselt
* Planned Endoscopic Atraumatic Coronary Artery Bypass (endo ACAB) surgery at the Jessa Hospital
* Planned Minimal Invasive Aortic Valve Replacement (mini AVR) surgery at the Jessa Hospital

Exclusion Criteria:

* Thoracic surgery in the past
* Redo CABG
* Complications after CABG, requiring long-term (more than 6 days) admission to intensive care
* Pathologies of the lungs
* Pathologies of the heart, other than the coronary artery disease
* Surgery in the sub diaphragmatic region: epigastric region, left and right hypochondriac region.
Ankle Spine Syndrome "RAFFET Syndrome II

A case series aimed to describe a new clinical condition for the first time in the medical literature called Ankle Spine Syndrome or "RAFFET Syndrome II". This syndrome was reported in 6 patients (2 males and 4 females) out of 1000 patients with a history of chronic ankle injuries affecting their calf muscles' strength throughout the last 3 years. The patients suffered from unresolved CLBP with radiculopathy contralateral to their calf muscle atrophy (i.e., an ipsilateral calf muscle weakness induces contralateral lumbar radiculopathy) that did not respond to physical therapy or any medication for long.

There is a large body of research performed to investigate the etiology of contralateral radiculopathy. However, limited information exists to determine its incidence, underlying pathomechanics, and strategies for management. Therefore, this case series aimed to describe a new clinical condition for the first time in the medical literature called Ankle Spine Syndrome or "RAFFET Syndrome II". This syndrome was reported in 6 patients (2 males and 4 females) out of 1000 patients with a history of chronic ankle injuries affecting their calf muscles' strength throughout the last 3 years. The patients suffered from unresolved CLBP with radiculopathy contralateral to their calf muscle atrophy (i.e., an ipsilateral calf muscle weakness induces contralateral lumbar radiculopathy) that did not respond to physical therapy or any medication for long. Open and closed chain strengthening exercises for the calf muscle were performed. The strengthening exercises include; double leg calf raise (i.e., straight and bent knees), single leg calf raise (i.e., straight and bent knee), seated calf raise, and wall sit calf raise. The patients' long-term back pain and function resolved greatly. By including lumbar stabilization exercises, core training, and myofascial release therapy, the symptoms resolved completely. Furthermore, with a follow-up after 6 months of a tailored home exercise program, the clinical outcome measures still resolved completely.

Eligibility Criteria:
Inclusion Criteria:

* Clinical presentation of lumbar radicular pain (i.e., contralateral radiculopathy) was sharp, distinctive, shooting, or lancinating. It felt like a narrow band of pain (i.e., not more than 5-8 cm wide) throughout the length of the lower limb. It was experienced superficially and deeply.

They had back pain intensity scores that ranged from 8 to 10 indicating a severe degree of pain during dynamic activity while almost all patients scored zero while resting Our patients with this syndrome had functional disability scores that ranged from 10 to 22 indicating mild and moderate degrees of disability.

had a history of physical therapy visits for back pain and sciatica at many specialized centers

Exclusion Criteria:

* pain score less than 8 functional disability scores less than 10 red flags as tumor or osteoprosis or bone infection previous back surgery
Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox

Researchers want to find out if urine heavy metal levels are changed in persons who use Mineralox Basic C™ (Mineralox). Mineralox is a zeolite (clinoptilolite) in combination with Vitamin C. Zeolites are natural supplements (nutraceuticals) that work at the cellular level to remove heavy metals and toxins that are accumulated in every day life safely from the body through the urine. The study doctor will give Mineralox to 20 people in this study to see if it helps with the heavy metal removal from the body.


Eligibility Criteria:
Inclusion Criteria:

1. Females and Males age 18-75 without significant health problems as determined by the Principal Investigator.
2. Nonsmoker
3. Ability to understand informed consent

Exclusion Criteria:

1. Pregnancy
2. Any serious or unstable disease within 6 months; seizure risk; diabetes mellitus requiring insulin or oral hypoglycemic medication; diagnosis of eating disorder, use of MAOI in the prior 14 days; hepatic or renal impairment; clinically significant cardiovascular disease within 6 months; uncontrolled hypertension; severe chronic obstructive pulmonary disease; baseline systolic blood pressure higher than150mm Hg or diastolic blood pressure higher than 95 mm Hg; history of cancer (except treated basal cell or squamous cell carcinoma of the skin); history of clinically significant allergic reactions or laboratory abnormalities,and patients taking AREDS Eye Vitamins.
3. Major depressive disorder within the past year requiring treatment; history of panic disorder, psychosis, bipolar disorder, or eating disorder
4. Intention to donate blood or blood products during treatment phase of the study;
5. Alcohol or drug abuse/dependency within the past year
6. Use of tobacco products other than cigarettes or use of marijuana
7. Body mass index (calculated as weight in kilograms divided by the square height in meters) less than 15 or greater than 38 or weight less than 45.5 kg
8. NRT, antidepressants, antipsychotics, mood stabilizers/anticonvulsants, naltrexone, steroids or insulin.
Plasma P-tau2017 and Quantitative Amyloid PET Imaging

The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels.

The overall goal of this protocol is to compare amyloid burden assessed by amyloid PET to plasma P-tau217 levels. Other relevant AD-related investigational biomarkers may also be assessed in the provided samples. Apolipoprotein E (ApoE) genetic status will be evaluated with a serum sample.

Eligibility Criteria:
Inclusion Criteria (for all participants):

* Signed and dated written informed consent obtained from the subject.
* Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, one of which is a barrier method for male participants for the study duration.
* Male participants must not donate sperm for the study duration.
* Willing and able to cooperate with study procedures.
* Males and females.
* Participants aged ≥ 70, inclusive, at the time of Screening.
* Judged to be cognitively normal by an Investigator based on clinical judgment.

Exclusion Criteria (for all participants):

* Subject has received an investigational drug or device within 30 days of enrollment, unless in the opinion of the Investigator such medication or device will not impair subject safety or scientific integrity of the data.
* Contraindication to amyloid PET imaging or blood sampling.
* Have ever received an experimental or approved medication targeting amyloid or tau.
* Prior participation in other research protocols or clinical care in the last year that would result in radiation exposure exceeding the acceptable annual limit established by the U.S. Federal Guidelines (effective dose of 50 mSv, including the procedures in this clinical protocol).
* Pregnancy, lactating or breastfeeding.
* Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease that in the Investigator's judgment may interfere with the objectives of the study.
* Unsuitable veins for venipuncture.
Critically Ill Patients With COVID-19 in Hong Kong: a Multicentre Observational Cohort Study

The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China 1. It has manifest into a global health crisis with escalating confirmed cases and spread across 15 countries. Whilst it is currently an epidemic in China, The World Health Organization (WHO) Global Level risk assessment is set at high 2.

Sequencing showed that 2019-nCov is similar to bat severe acute syndrome (SARS)-related coronaviruses found in Chinese horseshoe bats 3. This is compatible with the initial epidemiological link with a local wet market which sells bats. Furthermore, data sharing and sequencing data has facilitated development of accurate diagnostic tests.

In contrast, our current understanding of the epidemiological and clinical features of 2019-nCov is limited. In a case series of 41 hospitalized patients with confirmed infection, at least 30% of these patients required critical care admission. These patients developed severe respiratory failure and 10% required mechanical ventilation and 5% needed extracorporeal membrane oxygenation support. More worryingly 2019-nCov infection was associated with 15% mortality. Although these figures are likely overestimates due to unreported mild cases, there is currently no effective treatment. The optimal supportive care for patients with severe 2019-nCov infection is a research priority.

The spread of the 2019-nCov epidemic to Hong Kong has started. Patients have been admitted to the Intensive Care Unit for multiorgan dysfunction. Currently there are no published data focused specifically on critically ill patients with nCov infection. The purpose of this case series is to describe the characteristics, organ dysfunction and support and 2 week outcomes of critically ill patients with nCov infection.

Eligibility Criteria:
Inclusion Criteria:

* admission to ICU
* adult (≥18 years old)
* confirmed case of 2019-nCov infection by 2019-nCov RNA by reverse transcription polymerase chain reaction , isolation in cell culture of 2019-nCov from a clinical specimen or serum antibody to 2019-nCov

Exclusion Criteria:

- none
The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol

This study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion.

38 patients with traumatic brain injuries requiring mechanical ventilation and sedation were randomly allocated to two groups (melatonin group)19 patients and (control group)19 patients. In both groups a bolus of propofol 1mglkg was given by titration till the patient reached a sedation level value of (60-70) on the bispectral index (BIS), Then propofol infusion started at a rate of 1mglkglhr as a maintenance and rate adjusted according to our targeted sedation level, melatonin 10 mg tablet was crushed and mixed with 20 ml of water and administrated through a nasogastric tube followed by another 20 ml to flush out the residue for (melatonin group). While (control Group) received a placebo tablets by the same wayBIS value and propofol infusion rate was recorded over 12 hours.

Eligibility Criteria:
Inclusion Criteria:

* Age group from 18 to 65
* Both sexes
* Patients on a mechanical ventilation and need sedation
* Patients who are vitally stable

Exclusion Criteria:

* Gastro intestinal tract impractabililty
* Pregnant female
* Vitally unstable patients who cannot tolerate propofol infusion
Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650

The purpose of this study is to determine the safety and tolerability of AV650 in healthy subjects given single and multi-doses under fasted and fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* Body mass index between 18.5 and 29.9 kg/m2 or body mass index greater than 29.9 kg/m2 with good to excellent body fat percentage

Exclusion Criteria:

* Known hypersensitivity to lidocaine or non-steroidal anti-inflammatory agents (NSAIDS)
* History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric disease
* History of HIV or Hepatitis B
* History of symptomatic hypotension
* History of mental illness, drug addiction, drug abuse or alcoholism
* History of cancer
* History of inflammatory arthritis (rheumatoid, lupus, psoriatic arthritis)
* Current use of immunosuppressive therapy (systemic steroids, cyclosporine) or use of nasal or topical steroids
* History of gastric or duodenal ulcer disease
* History of severe physical injury, direct impact trauma or neurological trauma within 6 months of Study Day 1
* Female subjects who are pregnant or nursing
* Have donated blood within 90 days of Study Day -1
* Have received an investigational drug within 90 days of Screening
* Require regular use of antihistamines, H2 blockers (such as cimetidine, ranitidine), TCAs or SSRIs or who have taken these medications witin 14 days of Study Day 1
Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).

cPTFEi s a mesh-like product designed to reduce associated post surgical complications.

Eligibility Criteria:
Inclusion Criteria:

Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired

Exclusion Criteria:

Non-pregnant, breast feeding or plans to become pregnant during the study; Using adequate birth control methods and agrees to continue using those methods for the duration of the study

Confirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction

Acceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dL (0.15 g/L), serum albumin ≥ 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study.

For subjects with Diabetes Mellitus, HbA1C \<12%

BMI ≤ 40 kg/m²
Effect of CP-778,875 on HDL-C in Subjects With Abnormal Lipid Levels and Type 2 Diabetes.

To assess the effect of CP-778,875 on HDL-C cholesterol in adult subjects with dyslipidemia and type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* HDL-C \< or = 45 mg/dL for men and \< or = 55 mg/dL for women
* Triglycerides between 150-500 mg/dL
* Fasting Plasma Glucose 140-240 mg/dL

Exclusion Criteria:

* Known cardiovascular, carotid, or peripheral vascular disease
A Study of MT-4561 in Patients With Various Advanced Solid Tumors

This is a First In Human (FIH), multicenter, open-label, Phase I/II study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors. This study will be conducted in 3 parts.

Part 1 is aimed at evaluating safety, tolerability, PK and pharmacodynamics of MT-4561 and determining the Maximum Tolerated Dose (MTD) using the Bayesian Optimal Interval (BOIN) design.

The study details and doses of Part 2 (dose-optimization) and Part 3 (Drug-Drug Interaction) will be available after review of applicable Part 1 results.


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female patient aged 18 years or older at the time of signing the informed consent form
* ≥ 1 measurable lesion by the RECIST v1.1 and ≥ 1 disease site for tumor biopsy
* Eastern Cooperative Oncology Group performance status: 0 to 1
* Life expectancy of at least 3 months
* Adequate bone marrow function
* Adequate hepatic function
* Adequate renal function estimated creatinine clearance ≥ 60 mL/min calculated using the Cockcroft and Gault equation or by institutional method
* Part 1: Patients must have a confirmed histologic or cytologic diagnosis of one of the following solid tumors for participation in the study: head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), esophageal cancer, gastric cancer, biliary tract cancer, pancreatic ductal adenocarcinoma (PDAC), breast cancer, ovarian cancer, cervical cancer, endometrial cancer, prostate cancer, urothelial carcinoma, neuroendocrine tumor (NET) or neuroendocrine carcinoma (NEC), soft tissue sarcoma, and NUT carcinoma.

Main Exclusion Criteria:

* Patients with active brain or leptomeningeal metastases
* Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for alopecia
* Prior systemic anticancer therapy within 4 weeks before first dose of investigational medicinal product (IMP) or 5 half-lives, whichever is shorter, and prior radiotherapy within 2 weeks before first dose of IMP
* History of congenital long QT syndrome or clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation or Torsades de pointes)
* Patients who received drugs with a known risk of QT interval prolongation or Torsades de pointes within 14 days or 5 half-lives, whichever is longer, before the start of IMP administration
* QT interval corrected for heart rate using Fridericia's correction (QTcF) \> 470 msec at screening
Urokinase Therapy in Patients With Diabetic Foot Syndrome

The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.

Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation, especially if limbs can not be revascularized. Urokinase is effective in critical limb ischemia by lowering fibrinogen and might improve outcomes. The effect and safety of urokinase treatment was investigated in a phase II clinical trial. Based on the results this trial was planned to investigate the effect and safety of an additional therapy with urokinase versus a single conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with angiopathic or angioneuropathic diabetic foot syndrome and criticial limb ischemia
* No surgical or interventional treatment option
* No healing tendency of ulcerations despite of antibiosis and wound debridement after two-week treatment
* Fibrinogen \> 4.0 g/l
* No previous major amputation

Exclusion Criteria:

* Prior treatment of the current ulceration with urokinase
* Need for dialysis and/or creatinine-clearance \< 20ml/min
* INR \> 1,5 at screening
* Any kind of cerebral event within 3 months prior inclusion
* Proliferative retinopathy
* Uncontrolled hypertension
* Hemorraghic diathesis
* Gastrointestinal bleeding
* Pregnancy
* No compliance and/or participation in another trial