cyrilzakka/clinical-trials huggingface dataset:
Comparison of Gait Characteristics in Individuals With Above and Below Knee Limb Loss

Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals will be participants of the study. Participants with lower limb loss will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed.

Twelve individuals with above knee limb loss, 12 individuals with below knee limb loss,15 healthy individuals who were referred to receive amputee rehabilitation at Hacettepe University, Faculty of Health Sciences, department of Physiotherapy and Rehabilitation, Prosthetics and Biomechanics unit, and healthy individuals will be the subjects of this study.

Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass will be recorded. Gait parameters (step length, variation of step length, time on each foot, ambulation index, gait speed) will evaluate with Gait Trainer Biodex 2, at participant's preferred speed. To eliminate the learning effect, participants practiced at treadmill to determine appropriate gait speed. Once participants implied the preferred speed, they asked to walk at their self selected speed for 6 minutes. Data was recorded between the 4nd and 6th minutes at walk.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with unilateral above knee lower limb loss and below knee limb loss
* Age between 20-55 years
* Using conventional type socket design Dynamic foot using

Exclusion Criteria:

* Have passive joint limitation at extremities
* Surgery at last 1 year
* Systemic problems such as neurological disorders, rheumatoid disorders
* Another orthopedic anomalies
Effects of Plant Extracts on Semen Quality

this is a prospective randomized placebo-controlled double-blinded trial investigating the effect of plant extracts from Alpinia galanga and Punica granatum on human semen quality. The investigators hypothesize that these plant extracts will improve semen quality.


Eligibility Criteria:
Inclusion Criteria:

* Reduced semen quality

Exclusion Criteria:

* Total count of motile sperm less than 1 million sperm/ejaculate or more than 200 million sperm/ejaculate
Biofeedback vs Laryngeal Control Therapy in Management of Paradoxical Vocal Fold Motion

Paradoxical Vocal Fold Motion (PVFM) is a condition where vocal cords adduct (move toward another) instead of abduct (move away from one another) during inspiration, thus causing shortness of breath. The goal of this pilot randomized controlled trial is to compare the efficacy of biofeedback as compared to laryngeal control therapy (LCT) in the treatment of PVFM. Participants will take surveys about their symptoms and their expectations of treatment prior to initiating treatment and after completion of their assigned treatment. Researchers will compare the biofeedback group to the LCT group to see if participants have differences in changes of their symptoms.

Paradoxical vocal fold motion (PVFM) is characterized by episodic shortness of breath that can range in severity and acuity. Symptoms may greatly impact daily life. Some patients experience severe respiratory distress, which can lead to emergency department visits and occasionally intubation. The standard treatment is typically behavioral therapy performed by speech and language pathologists. However, new evidence suggests that video biofeedback may be an effective alternative treatment. Video biofeedback allows patients to directly visualize their breathing while performing specific breathing exercises. This is a desirable treatment because it can be performed at the time of diagnosis and requires minimal additional time or resources. The investigators' goal is to conduct a pilot randomized controlled trial (RCT) to compare the relative effectiveness of video biofeedback and behavioral therapy in the treatment of PVFM. The primary endpoint will be the change in Dyspnea Index score before treatment and one month after treatment. Patients will complete surveys to collate data about patient expectations of behavioral therapy, their reasons for pursuing additional treatment if applicable, and the perceived benefits of the specific intervention. The investigators hypothesize that no clinically meaningful difference will be detected between behavioral therapy and video biofeedback for the treatment of PVFM. This pilot RCT will provide critical data for designing a fully powered trial comparing these two interventions, and will advance the investigators' goal of providing clinicians with important evidence for guiding treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 or older
* Referral to the Washington University School of Medicine Voice and Airway Center for concerns for PVFM
* Pre-treatment Dyspnea Index score of 11 or higher (representing the threshold for having an abnormal score)
* Answer yes to the following questions: "Do you sometimes have difficulty breathing?" and "When you have difficulty breathing, is it worse when inhaling (breathing in)?"

Exclusion Criteria:

* Inability to speak or understand English
* Previous treatment of PVFM
* History of laryngeal surgery
* Evidence of alternative laryngeal pathology (e.g. subglottic stenosis, benign or malignant obstructive mass) on flexible laryngoscopy as performed as part of routine clinical care
Intraoperative Measuring of Small Bowel Length Compared to Measuring by Magnetic Resonance Imaging (MRI) in Morbid Obese Patients

An important step during a gastric bypass operation for the treatment of morbid obesity is the measuring of the small bowel length. At several reoperations we found a length increase of the lowest part of the small intestine of up to 80% compared to the measured length at the initial operation. On the one hand, this reflects a normal technical error of small bowel measuring due to the variable state of contraction of the bowel, but on the other hand, it could also be due to a compensatory increase in intestinal length after the operation. New protocols allow measuring of the small bowel length by MRI. Comparing the preoperative and later on several postoperative measurements by MRI with the initial intraoperative length measuring should allow to validate the new MRI protocol and in the same time quantify the eventual small bowel length increase. We plan to include 20 patients in this study.

Background:

An important step during a gastric bypass operation for the treatment of morbid obesity is the measuring of the small bowel length in order to define the lengths of the alimentary, biliopancreatic and common channel. The measuring itself is technically simple but has always an error due to the variable state of contraction of the small bowel. In distal gastric bypass a common channel length of 100 to 150 cm is chosen which induces an iatrogenic short bowel syndrome. At several reoperations we found a length increase of the common channel of up to 80% compared to the measured length at the initial operation. Former studies seem to indicate that an adaptation of small bowel length may occur in animals with short bowel syndrome or after intestinal bypass surgery. Longterm results of gastric bypass surgery often show weight regain after 3 to 5 years which could be due to the afore mentioned compensatory mechanism.

Newer MRI protocols allow for non-invasive measurement of the small bowel length. Comparing the preoperative and later on several postoperative measurements by MRI with the initial intraoperative length measuring should allow to validate the new MRI protocol and in the same time quantify the eventual small bowel length increase.

Objective:

In-vivo verification of small bowel length measurements made by MRI, quantification of a possible increase of the common channel length in the long run after distal gastric bypass.

Methods:

The preoperative small bowel length measurement by MRI is compared to the length measured intraoperatively. MRIs before discharge postoperatively as well as after 6 and 12 months are used to detect an eventual increase of the common channel length.

Eligibility Criteria:
Inclusion Criteria:

* morbid obese patient
* scheduled for distal gastric bypass
* informed consent for operation and study obtained

Exclusion Criteria:

* history of former small bowel resection
* weight \> 150 kg
* history of claustrophobia
* general contraindications for MRI (pacer, joint prosthesis, ear implant, etc.)
Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).


Eligibility Criteria:
Inclusion Criteria:

* Adults \>=18 to \<=55 years of age
* Confirmed diagnosis of T1DM, diagnosed prior to age 40 years, and for at least 6 months prior to Screening
* Willing to refrain from using carbohydrate counting to adjust insulin during the study
* Willing and able to wear and operate a continuous glucose monitor
* Willing and able to self-assess blood glucose
* Willing and able to provide written informed consent.

Exclusion Criteria:

* History of type 2 diabetes mellitus or diabetes resulting from acromegaly, Cushing's disease, chronic pancreatitis, or pancreatectomy
* Two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to Screening
* Use of premixed insulin
* History of diabetic ketoacidosis within 1 year of screening
* Presence of active hepatic disease or clinically significant abnormal liver function tests
* History of chronic pancreatitis
* Participants with a history of heart attack, severe/unstable angina, or coronary revascularization procedure
* History of clinically significant cardiac arrhythmias within 1 year prior to screening
* Participants with congestive heart failure
* Participants with uncontrolled Stage III hypertension
* History of human immunodeficiency virus (HIV) or hepatitis C
* History of illicit drug or alcohol abuse within 12 months prior to Screening
* Use of any investigational agent or device within 30 days prior to Screening or any therapeutic protein or antibody within 90 days prior to Screening
* Use of medication or herbal supplements taken for weight loss within 2 weeks of screening
* Chronic use of any antidiabetic therapy other than insulin within 2 months prior to Screening
* Use of systemic or inhaled corticosteroids within 2 weeks prior to Screening
* Participants who underwent major surgery within 6 months prior to Screening
* Inability or difficulty swallowing whole tablets or capsules
* Women who were pregnant or breastfeeding.
Comparison of Different Methods for the Analysis of Gut Microbiome Composition

The human gastrointestinal tract shelters a complex and dynamic population of microorganisms, the gut microbiota, which plays an important role in immune and metabolic homeostasis. In recent years several major diseases were linked with alterations in the gut microbiome composition.

There are known factors which can influence gut microbiata composition. For example diet is known to play a fundamental role in determining the composition of the intestinal microbiota over time. However, there are very few studies evaluating how collection and DNA isolation methods affect microbiome composition.

An observational clinical study with 28 healthy subjects is planned to assess how different commercially available stool sampling kits and fecal DNA extraction kits influence the apparent composition of the gut microbiome. Participants will be instructed to collect stool samples at two time points separated by one week using six different methods (naïve and Zymo DNA/RNA Shield kit on dry ice as well as OMNIgene GUT, RNALater, 95% EtOH, Zymo DNA/RNA Shield at room temperature). DNA extraction from all samples will be performed using QIAamp Power Fecal (Qiagen, N. V) and ZymoBIOMICS (Zymo Research, CA.).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-60
* Body mass index (BMI) 18,5- 29,9 kg/m2
* Willingness to participate in the study examination and fecal sample collection process

Exclusion Criteria:

* Subjects currently on medication (with the exception of contraceptives)
* Subjects with acute or chronic disease
* Pregnant or lactating women
* Subjects with a history of drug or alcohol abuse
* Subjects on a vegan diet
* Subjects who are legal incapacitated or their circumstances do not enable the patient to fully understand the nature, significance and scope of this study.
A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)

Part 1 is an open-label randomized study of volixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability of two doses of volixibat. Part 2 is a double-blind, placebo controlled, study designed to evaluate the safety and efficacy of a selected volixibat dose.


Eligibility Criteria:
Inclusion Criteria:

1. Female aged ≥18 and ≤45 years with a viable pregnancy.
2. Provide signed informed consent as described in the protocol and willing to comply with all study visits and requirements.
3. Diagnosis of ICP.
4. (Part 2 only) Qualified level of pruritus associated with ICP, during screening.

Exclusion Criteria:

1. At the time of either the screening or baseline visit, decision has already been made to deliver within the next 7 days, for any indication.
2. Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG or BPP) at or within 7 days before the baseline visit.
3. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.
4. Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.
Clopidogrel/Aspirin Interaction Study

This study will explore the effect of different doses of aspirin on the effects of double-dose or standard dose clopidogrel.

Study Hypothesis: Patients receiving double-dose compared with standard-dose clopidogrel will have increased blood concentrations of the active metabolite of clopidogrel and greater inhibition of ADP-induced platelet aggregation when also treated with acetylsalicylic acid (ASA) 325 mg/d as compared to ASA 81 mg/d.

Eligibility Criteria:
Inclusion Criteria:

* \> 1 month post myocardial infarction (MI), unstable angina or stent patients with stable condition
* Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
* Written informed consent

Exclusion Criteria:

* Age \< 18 years old
* Liver disease with transaminases and/or bilirubin \> 1.5x upper limits of normal (ULN) (within 3 months of randomization)
* Renal impairment with creatinine clearance \< 30 ml/min (within 3 months of randomization)
* Platelet count \< 100x109/L and/or Hb\< 100g/L (within 3 months of randomization)
* Use of oral anticoagulants or nonsteroidal antiinflammatory drug (NSAID) within the last 10 days or planned use during the study
* Use of antiplatelet agent other than aspirin and clopidogrel within the last 10 days
* High risk of bleeding (e.g. recent gastrointestinal bleeding, bleeding diathesis)
* Uncontrolled hypertension (\> 180/110mmHg)
* Current smoker with ≥ 5 cigarettes/day
* Previously entered in this study or just finished other study within 2 weeks before recruitment
* Medical, geographic, or social factors making study participation impractical, or inability to provide written informed consent
Set Volume of Optimal Resistance Exercise to Generate Hypotension

This study evaluates the volume of optimal resistance exercise to generate postexercise hypotension after performing a single exercise in hypertensive elderly subjects. 20 subjects will perform 1 control session and 3 resistance training sessions with different volume: 3, 6 and 9 sets


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive subjects treated with antihypertensive medication
* Controlled blood pressure
* Age between 55 and 70 years old
* Sedentary (less than 150 minutes per week of moderate physical activity and/or 75 minutes per week of vigorous physical activity)
* Non-smokers
* Non-alcoholics
* Informed consent

Exclusion Criteria:

* Any kidney, lung, neurological or psychiatric disease
* Unable to perform exercises
* Participation in other physical activity programs during the study or in the previous 3 months
Acetylamantadine Excretion by Cancer Patients

Several factors discourage the implementation of cancer screening to the population in general, which would result in earlier diagnosis and an expected improved survival. Concurrent in vivo and in vitro research has shown that drug acetylation activity is increased in cancer. Amantadine may be of value in detecting the presence of cancer. Accordingly, this study will examine how Amantadine is eliminated by the body in cancer patients. This is an important step in validating a cancer detection method that can be implemented economically for screening of large numbers of people.

The study will involve the screening of volunteer patients with various types of cancer to provide a first indication of which types of cancer and at what stage of tumor burden acetylamantadine will be found in patients' plasma, saliva and urine samples. Volunteers will provide complete first morning urine collection prior to amantadine ingestion. The volunteers will then ingest a therapeutic dose of amantadine (200 mg: 2x100mg capsules), at least 2 hours before breakfast (nothing to eat or drink except water after midnight before the scheduled appointment), and their complete urine will be collected at 2 and 4 hours (plus or minus 1 hour) after amantadine ingestion. In addition, blood samples will be taken by venipuncture before and at 2 and 4 hours after drug ingestion. The patients will be asked to provide a saliva sample at the same time as the urine samples are taken after drug ingestion.

Eligibility Criteria:
Inclusion Criteria: newly diagnosed or untreated cancer (GI, lung, prostate and breast cancer)

-

Exclusion Criteria: Any previous adverse reaction to Amantadine

* currently pregnant or lactating
Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography and Correlation to Imaging Data in Young Athletes

This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on smartphones or tablets, to record eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in young athletes. This study also aims to correlate these measurements with volumetric data from cerebral imaging (if MRI done in routine care at the same period, more or less 1 month).

e-VOG Young athletes is a collaborative study between the Memory Center of the Rainier III Center (Princess Grace Hospital, Monaco), the Neurology Department of Nice University Hospital (France), and the AS Monaco Football Academy medical team.

Memory Center of the Rainier III Center is expert in eye-tracking and is equipped with a standard video-oculography device (Eye-Tracker®T2), which records eye movements at a high frequency and measures saccades parameters (latency, speed, amplitudes etc...).

e-VOG is a mobile application, home-developed by the Neurology Department team of Nice University Hospital, to measure eye movements.

In the continuity of the e-VOG(YA) study (NCT05211752), we set-up study named e-VOG-Young Athletes-Extension. This study will increase the number of assessments carried out (standard video-oculography assessment versus e-VOG digital assessment) in a population of athletes without major health problems, and who have not presented concussion, in order to meet more powerfully the main objective of the e-VOG(YA) study. It will also make it possible to observe whether there is a correlation between disturbed oculomotor movements, oculomotor anomalies and volumetric data measured by cerebral MRI (obtained using automatic segmentation software on cerebral regions specifically involved in the eye movement control).

Eligibility Criteria:
Inclusion Criteria:

* Young Athletes from AS Monaco Academy
* referred by AS Monaco Medical Team to perform a video-oculography (Eye-Tracking) examination as part of routine care.
* covered by a health insurance system
* volunteer, able to give free, informed and written consent.

Exclusion Criteria:

* General anaesthesia within 3 months.
* Head trauma within 3 months
* Neurological, ophthalmological or general pathology preventing the realization of a video-oculography examination.
* Oculomotor abnormality detectable on clinical examination by the neurologist prescribing the standard video-oculography examination.
Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Only subjects previously participating in two specific studies are eligible to enroll into this study. Enrollment is not open to subjects if not previously enrolled in studies B1871006 or B1871008.

Exclusion Criteria:

* All subjects are excluded unless previously participating in studies B1871006 or B1871008.
Patellar Tendon Regeneration With Platelet-rich Plasma

The central third of the patellar tendon is used as a donor site for anterior cruciate ligament (ACL) reconstruction. After months or years the harvest site partially regenerates. The regeneration process is accomplished by biological mechanisms,including cells and proteins known as growth factors. The platelets are natural reservoirs of growth factors, and a platelet concentrate known as Platelet-Rich Plasma (PRP) has a three to five fold increase in growth factors. The hypothesis of the study is that the PRP can improve the regeneration of the patellar tendon.

The platelets are obtained from the patient's blood through a filtration system called apheresis, with the use of 250 milliliters of blood, with a sterile system. All the others components of blood (red cells, plasma, white cells) returns to the patient. The PRP is then applied in the harvest site on the patellar tendon, at the end of ACL reconstruction.

The patients are randomized in two groups, one with the use of PRP and the other group without PRP. This information for the patients will be granted just at the end of the research. After the surgery the rehabilitation protocol is the same for both groups. An isokinetic testing is done before the surgery and after six months. Questionnaires about the knee function are asked before the surgery and after six months. A magnetic resonance imaging is performed after six months to evaluate the tendon regeneration.


Eligibility Criteria:
Inclusion Criteria:

* indication of anterior cruciate ligament surgery with patellar ligament
* skeletal maturity

Exclusion Criteria:

* other knee ligament injuries
* severe chondral lesions
* osteoarthritis
* non-compliance to the rehabilitation
* previous surgery in the affected knee
* reoperation during the time of the study for an unrelated condition
* infection