cyrilzakka/clinical-trials huggingface dataset:
Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study

The objective of this study is to find out what the pharmacodynamic (PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are:

* Are differences related to the pathophysiological factors involved in nocturia?
* Are there age/gender/size differences?
* Can the investigators identify patients who are likely to develop hyponatraemia?
* Can the investigators individualize treatment and reduce risk for hyponatraemia?

The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.

There are two groups of patients:

Group A:

Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1).

Group B:

This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.

The study starts when the patients takes his first prescribed Minirin Melt tablet:

* On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days.
* On day 3 the patient has to give a urine sample.
* Patients have to fill out a frequency/volume chart during the first 14 days.
* On day 30, a 3rd blood sample will be taken


Eligibility Criteria:
Inclusion Criteria:

* written informed consent prior to the performance of any study-related activity
* patients, men and women, 18 years and older, with an average of ≥ 2 nocturnal voids per night
* evidence for nocturnal polyuria (nocturnal urine volume \>33% of total volume over 24h), determined on frequency/volume chart
* Diuresis \<2.5L

Exclusion Criteria:

* hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances
* pregnancy
* genitourinary tract pathology (infection, tumor,...)
* urolithiasis
* suspicion or evidence of cardiac failure
* moderate to severe renal insufficiency (creatinin clearance \< 60 ml/min)
* psychogenic or habitual polydipsia
* hyponatraemia or predisposition for hyponatraemia
* diabetes insipidus
* syndrome of inadequate ADH production
* suspicion or evidence of liver failure
Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.

Through the MALDI-TOF MS platform, explore the proteomics and peptidomics differences of fasting serum/plasma and urine between non pregnant people with normal glucose tolerance test and prediabetes /diabetes patients, pregnant people with normal glucose tolerance test and pregnant diabetes patients respectively; To explore the role of its proteomics and peptidomics differences in the diagnosis of prediabetes and diabetes, and to establish a new method of differential diagnosis by using the omics data and key characteristic peaks to find potential new diagnostic markers.

Prediabetes is a stage of abnormal glucose metabolism between normal blood glucose level and diabetes, which is a "gray zone" between normal and abnormal, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both. It is a very important high-risk group of diabetes. Diabetes is a group of metabolic diseases characterized by hyperglycemia caused by a variety of causes. Gestational diabetes mellitus refers to varying degrees of abnormal glucose metabolism that occur during pregnancy. This project aims to detect differential feature peaks through MALDI-TOF MS technology between non pregnant people with normal glucose tolerance test and prediabetes/diabetes patients, pregnant people with normal glucose tolerance test and pregnant diabetes patients respectively and to establish a clinical predictive diagnostic model based on differences, and to evaluate the model.

Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria for cases:

   Non pregnant people: the remaining fasting serum/plasma and urine samples of prediabetes/diabetes patients (prediabetes: IFG: FPG 6.1-6.9mmol/L, Blood glucose 2h after meal\<7.8mmol/L（WHO）; IGT: FPG\<7.0mmol/L, Blood glucose 2h after meal 7.8-11.1mmol/L（WHO）; diabetes: Typical symptoms of diabetes, FPG \>= 7.0mmol/L or 75g OGTT 2h blood glucose \>= 11.1mmol/L).

   Pregnant people: the remaining fasting serum/plasma and urine samples of gestational diabetes patients (75g OGTT test FPG \>= 5.1mmol/L or 1h blood glucose \>= 10.0mmol/L or 2h blood glucose \>= 8.5mmol/L（IADPSG; ADA)).
2. Inclusion criteria of the controls were as follows:

Non pregnant people: the remaining fasting serum/plasma and urine samples of normal population for glucose tolerance test (FPG 3.9-6.1mmol/L,75g OGTT test 1h blood glucose 6.7-11.1mmol/L,75g OGTT test 2h blood glucose 3.6-7.8mmol/L).

Pregnant people: the remaining fasting serum/plasma and urine samples of people who do not meet the diagnostic criteria for gestational diabetes (3.9\<=75g OGTT test FPG\<5.1mmol/L,6.7 \<= 1h blood glucose\<10.0mmol/L,3.6\<=2h blood glucose\<8.5mmol/L).

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Exclusion Criteria:

Common exclusion criteria for cases and control were as follows: The sample volume of serum/plasma/urine is less than 300ul; Improper storage of samples or repeated freezing and thawing; The serum /plasma has obvious hemolysis, lipemia or jaundice.

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SedestActiv Project: Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients

Primary care centres are a key setting to treat people with overweight and moderate obesity. There is growing evidence that sitting for a long time is negatively associated with people's health. Interventions with the aim of reducing daily time of sedentary activities can be an effective strategy to increase daily energy expenditure. To improve the effectiveness of programmes promoting physical activity in primary care we need some clear action protocols that can be easily integrated in the daily routines of primary care professionals.

Objective. The objective of the study is to evaluate the effectiveness of a six-moth primary care intervention to reduce diary hours of sitting time in overweight and obese sedentary patients, as well as to increase their weekly caloric spend.

Methods. The design of the study is a simple randomized controlled trial. Ten primary care centers will be invited to participate and will be randomized into control (CG) and intervention group (IG). Each professional will randomly invite to participate voluntarily moderate obese or overweight patients (BMI: 25-34,9 kg/m2) of both sexes, aged between 25 and 65 years old, who are 6 or more than 6 hours daily sitting. A total of 400 subjects (200 individuals in each group) are needed. In addition, 50 subjects with fibromyalgia will be included in the study to know the feasibility of the intervention among them.

The main dependent variable (sitting times) will be measured with an ActivPAL during first and last intervention week. There will be a follow up after 3, 6 and 12 months of the end of the intervention. Other variables included in the study: number of steps walked, subjective level of physical activity, weight, height, BMI, skinfolds, waist circumference, triglycerides, total cholesterol, (LDL and HDL), glucose, sociodemographic variables, blood pressure and quality of life related to health. A descriptive analysis of all variables and a multivariate analysis to assess differences among intervention and control group will be undertaken. Multivariate analysis will be carried out to assess time changes of dependent variables. All the analysis will be done under the intention to treat principle.

The intervention will be based on a recommendation to find alternatives to progressively substitute Sitting time by doing the regular activities standing or walking. Control group will receive minimum advice.

Eligibility Criteria:
Inclusion Criteria:

* Overweight and moderate obese patients (BMI: 25-34,9 kg/m2).
* Be 6 or more than 6 hours daily sitting.
* Able to walk and stand up from a chair unaided.
* Subjects who can guarantee a year continuity in the study.

Exclusion Criteria:

* Recommended contradictions to advising physical activity to overweight and obese people.
* Have an obesity surgical operation.
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)

This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number of subjects. UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel disorders (BD). It electrically stimulates the dorsal genital nerve (DGN) through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient.

The study is conducted at multiple hospitals in Denmark (Aarhus University Hospital, Odense University Hospital and Herlev Hospital). It is estimated that 20 subjects with OAB and 20 subjects with BD will need to be enrolled at the investigational sites to account for screening attrition and dropouts. Screening and baseline measurements includes a 7-days bladder diary (OAB) / 14-days bowel diary (BD) and quality-of-life measures. Following the screening and baseline measurements, the subjects will be introduced and trained on how to set up and use UCon. For 1 month the subjects will use UCon at home and complete a daily bladder/bowel diary and a stimulation diary. After completion of the interventional period, subjects will fill out the quality-of-life measures once again.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years of age.
2. Subject is diagnosed with OAB or BD.
3. Subject is able to communicate, provide feedback, understand and follow instructions during the course of the study.
4. Subject has signed an informed consent.

Exclusion Criteria:

1. Subject is medically unstable.
2. Subject has an active infection in the genital area.
3. Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function).
4. Subject is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test within 14 days prior to enrolment). Women of childbearing potential must maintain effective contraception\* during the study period judged by the investigator.
5. Subject is enrolled or planning to enrol in another investigational study or was enrolled in an investigational drug or medical device trial within four weeks to enrolment.
6. Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
7. Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.
8. Subject has addictive behaviour defined as abuse of cannabis, opioids, or other intoxicating drugs.
9. Subject does not speak and understand Danish.
Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery

The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery.

The secondary objective is to evaluate the safety of extended AVE5026 administration.

The total duration of observation per participant is 56-63 days from surgery broken down as follows:

* 7 to 10-day initial treatment period with open-label Semuloparin sodium;
* Randomization;
* 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo;
* 30-day follow-up period.

Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.

Eligibility Criteria:
Inclusion Criteria:

* In the run-in phase:

  * Standard surgery for fracture of the upper third of the femur, including femoral head and neck
* In the double-blind phase following the run-in phase:

  * Completion of the run-in phase without permanent treatment discontinuation

Exclusion Criteria:

* Any major orthopedic surgery within 3 months prior to enrolment;
* Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
* High risk of bleeding;
* Known hypersensitivity to heparins;
* Any contraindication to the performance of venography;
* End stage renal disease or patient on dialysis

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effects of High-intensity Noninvasive Positive Pressure Ventilation in AECOPD

This study aims to investigate the effects of high-intensity noninvasive positive pressure ventilation (NPPV), as compared with low-intensity NPPV, on hypercapnia, consciousness, inspiratory muscle effort, dyspnea, NPPV tolerance, inflammatory response, adverse events and other outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of COPD according to the criteria of the Global Initiative for Chronic Obstructive Lung Disease in 2019
2. Presence of acute exacerbation
3. Arterial pH \<7.35 with arterial carbon dioxide tension (PaCO2) \>45 mmHg on room air or supplemental oxygen
4. PaCO2 \>45 mmHg following low-intensity NPPV of ≥6 hours

Exclusion Criteria:

1. Age \<18 years
2. Excessive amount of respiratory secretions or weak cough
3. Upper airway obstruction
4. Recent oral, facial, or cranial trauma or surgery; recent gastric or esophageal surgery
5. Potential risk factors for restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, and severe abdominal distention)
6. Active upper gastrointestinal bleeding
7. Cardiac or respiratory arrest
8. Arterial oxygen tension/fraction of inspired oxygen \<100 mmHg
9. Pneumothorax
10. Severe ventricular arrhythmia or myocardial ischemia
11. Severe hemodynamic instability despite fluid repletion and use of vasoactive agents
12. Severe metabolic acidosis
13. Refusal to receive NPPV
14. Endotracheal intubation already performed before ICU admission
Symptom Management, Education and Telephone Follow-up, Quality of Life,

This study was planned as an experimental design study with pretest-posttest control group in order to determine the effects of education and telephone follow-up given to patients receiving androgen deprivation therapy (ADT) for prostate cancer on quality of life and symptom management.The main question\[s\] it aims to answer are:

* Is the quality of life higher in patients receiving androgen deprivation therapy who are trained and followed up over the phone compared to patients who are only given an education booklet?
* Is symptom management higher in patients receiving androgen deprivation therapy who received training and followed-up over the phone compared to patients who were only given an education booklet?

The number of samples to be taken in each group was determined as 24 (total 48) with the help of the G-power (version 3.1) package program. Considering the possible losses in the research and in order to increase the power of the study, it was planned to carry out the research with a total of 60 people, 30 people in the experimental and control groups.

While evaluating the findings obtained in the study, SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA) program will be used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the research,
* Literate and open to communication,
* Knowing the diagnosis,
* Those aged 45 and over,
* Receiving short-term or long-term ADT treatment,
* The patient or his/her relatives have telephone access,

Exclusion Criteria:

* Having a mental or psychiatric illness that prevents communication,
* Those with vision-hearing problems
Early Goal Directed Therapy in Cardiac Surgery

Early goal directed therapy (EGDT) based on information from arterial waveform derived cardiac output (APCO) FloTrac/EV1000 system has been proved to improve postoperative outcomes in patients undergoing major surgery. This system, however, has the limitation to be applied in open-chest surgery, especially cardiac surgery. The efficiency of FloTrac/EV1000 system to improve postoperative outcomes in cardiac surgery is still inconclusive.

Hypothesis: Intraoperative management in patients undergoing cardiac surgery guided by FloTrac/EV1000 system, compared with conventional protocol, results in better clinical outcomes.

Primary outcomes: Immediate postoperative inotropic/vasoactive drugs requirement.

Methods: Adult patients undergoing cardiac surgery will be randomized into 2 groups: EGDT group managed by FloTrac/EV1000 system and Control group managed by conventional protocol.

Outcome analyses: Compare the number of inotropic/vasoactive drugs requirement at the end of surgery, as well as intensive care unit (ICU) stay between both groups.

Objective: To compare postoperative clinical outcome in adult patients undergoing cardiac surgery.

Primary outcome: Postoperative inotropic/vasoactive drugs reqirement.

Secondary outcome: ICU stay.

Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid and inotropic/vasoactive drugs management protocol. EGDT group will be managed according to information derived from FloTrac/EV1000 system, i.e., control stroke volume variation (SVV) 10-13% and give fluid when SVV \> 13%, give inotropic to maintain cardiac index (CI) 2.5-4 L/min/m2, and give vasoactive drugs to maintain systemic vascular resistance index (SVRI) of 1,900-2,400 dynes-sec/cm-5/m2 . Control group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP \< 8 mmHg, give inotropic/vasoactive drugs according to blood pressure and heart rate as well as clinical signs at the discretion of attending anesthesiologists.

Outcome analyses: Postoperative number of inotropic/vasoactive drugs requirement as well as ICU stay of both groups will be compared using unpaired Student-t test or Mann-Whitney U test.

Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old
2. Patient has ischemic or valvular heart disease
3. Scheduled for elective cardiac surgery
4. New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III
5. Body mass index (BMI) 18-24 kg/m2
6. Provided informed consent before surgery

Exclusion Criteria:

1. Scheduled for emergency or redo surgery
2. Difficulty (or contraindication to) placing a central venous catheter
3. Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation)
4. Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency
Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses

The intermediate coronary stenoses defined by a degree of stenosis from 40 to 70 % are frequent. The Flow Fraction Reserve (FFR), realized during coronarography, is an hemodynamic evaluation by the functional impact measuring the loss of load in upstream / approval of the stenosis inthe basal state and in situation of hyperemia led by adenosine. Further to the study FAME, the threshold of definition of the significant character of one Stenosis was fixed for a value of FFR = 0,80. However, the impact forecasts intermediate values badly known rest.

We hypothetized that coronary stenosis associated with borderline values of FFR 0.81-0.85 were associated with a higher rate of clinical events than those with a FFR \>0.85


Eligibility Criteria:
Inclusion Criteria:

* patient with FFR\> 0,80 between september 2012 till december 2016

Exclusion Criteria:

* refusal of participation
Clinical Efficacy of Darqeen Capsule for the Management of Hypothyroidism Associated with Female Reproductive Hormonal Imbalance

STUDY OBJECTIVES

1. To assess the safety of Darqeen capsule for the management of Hypothyroidism
2. Evaluate the efficacy of Darqeen capsule for the management of Hypothyroidism
3. To provide an alternative cost-effective treatment for the management of females suffering from hypothyroidism.

NULL HYPOTHESIS (HO) The Unani Medicine Darqeen capsule is not effective for the management of Hypothyroidism.

ALTERNATE HYPOTHESIS (H1) Unani medicine Darqeen capsule is effective for the management of Hypothyroidism.

Hypothyroidism is a common endocrine disorder characterized by deficiency in the thyroid hormones, thyroxine (T4) and triiodothyronine (T3) which are crucial for regulating metabolism and maintaining overall bodily functions. There are several etiologies and manifestations of hypothyroidism. The most common clinical signs are weight gain, hair loss, sensitivity to cold, tiredness, constipation, dry skin, and voice changes.

The prevalence in Pakistan has been a growing concern, necessitating extensive research to address the underlying causes, risk factors, and optimal management strategies. It is estimated that hypothyroidism impacts approximately 5% of the population and 15% in females, with up to 5% possibly having undiagnosed thyroid failure. In Pakistan, the prevalence of hypothyroidism is reported to be 4.1%.

The description of Qillat-e-Ifraz-e-Darqiyya (hypothyroidism) in Unani system of medicine resembles the clinical manifestation associated with Su-e-Mizaj Barid Maddi (derangement in cold temperament).

The management of hypothyroidism involves thyroid hormone replacement therapy with levothyroxine, regular monitoring of hormone levels, and lifestyle modifications like a balanced diet, exercise, and stress management. Iodine supplementation is recommended in iodine-deficient regions, while underlying causes and pregnancy considerations should be managed. Educating patients about their condition and treatment plan is essential for active involvement in their health management.

Darqeen capsule is an Unani polyherbal formulation that primarily consists of natural ingredients, it is time tested pharmacopoeia formulation that is further modified by Hamdard Research Center. It is being used clinically for more than two years at Hamdard Matabs all around Pakistan and found effective for managing hypothyroidism and its associated symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with hypothyroidism
* Having raised TSH
* T3 \& T4 hormones level below normal limits
* Females between the age group of 15-45 years

Exclusion Criteria:

* Subjects below the age group of 15 and above 45
* Suffering from chronic liver diseases and kidney failure, cancer or any other comorbid condition
* Currently taking any medication for Hypothyroidism or having history of adverse drug reaction
* Pregnant and lactating mothers.